Main : General Hepatitis C News/Updates Archives

May 18, 2009

An Overview of the HCV Drug Development Process

Although often dismissed as non-crucial medical jargon, understanding the stages of development provides a more realistic appreciation of potential new Hepatitis C drugs.

by Nicole Cutler, L.Ac.

Keeping current on the potential arrival of new, improved Hepatitis C drugs is a regular research venture for many who are living with the Hepatitis C virus (HCV). Because the current standard of care for HCV works for less than 50 percent of those infected, doctors, scientists and pharmaceutical companies are feverishly searching for a solution that is more effective and has fewer side effects than interferon combination therapy. However, keeping up with the seemingly endless announcements of discoveries and successes demands a layman’s road map for deciphering what it all means.

The testing of new drugs is a long process that typically takes about 12 years from pre-clinical testing, through clinical trials, to U.S. Food and Drug Association (FDA) approval until it can finally reach the general public.

Pre-Clinical
Drug companies continuously analyze thousands of compounds, seeking ones of therapeutic value. During the average six to seven years of pre-clinical testing, the manufacturer completes synthesis and purification of the drug and conducts limited animal testing. Under FDA requirements, a drug company must first submit data showing that their drug is reasonably safe before it can be evaluated by humans in initial, small-scale clinical studies.

Only after proving its safety and efficacy in vitro (in a test tube) or in laboratory animal testing can a drug be administered to humans in clinical trials. During pre-clinical drug development, the following is evaluated:

1. Toxicity
2. Pharmacologic effects
3. Genotoxicity – genotoxic substances cause cancer, through genetic mutation or contribution to tumor development
4. Absorption and metabolism
5. Speed of excretion

If any evidence surfaces that it is unsafe or ineffective, the drug will likely never make it to human testing. Actually, only about 1 in 1,000 investigational compounds survives pre-clinical testing favorably and proceeds to clinical studies. Of those drugs that make it to human testing, approximately 1 in 5 will persevere through the many steps and receive FDA marketing approval. Therefore, a person living with HCV who hopes to find a new medicine may be disappointed if he/she gets too excited about drugs in the pre-clinical testing phase.

When a company is ready to proceed to clinical trials, it files an investigational new drug application with the FDA. Most clinical trials are designated as Phases I, II or III, and sometimes IV based on the type of questions that the study is seeking to answer. Although the phases of human clinical studies are generally conducted sequentially, there are cases when the phases overlap.

Clinical Trial: Phase I
Once granted approval by the FDA as an investigational new drug, testing can begin on humans. Phase I studies are typically conducted in healthy volunteer subjects, with the intent of determining:

· Metabolic and pharmacologic actions
· Side effects with increasing doses
· If possible, early insight into drug effectiveness

Typically considered to be smaller trials, Phase 1 studies generally recruit between 20 to 80 human subjects. Typically the drug remains in Phase I for one to two years.

Clinical Trial: Phase II
Instead of recruiting solely healthy people, Phase II clinical trials begin to evaluate the drug’s effectiveness in the target population. This stage of testing is where the preliminary data on a potential drug’s effectiveness for HCV emerges. Additionally, Phase II helps determine the common short-term side effects and risks associated with the drug. Several hundred people are usually enrolled in a Phase II clinical study. At the end of this round of studies, the manufacturer meets with FDA officials to discuss the development process, continued human testing, any concerns the FDA may have and the protocols for Phase III.

Clinical Trial: Phase III
Usually the most extensive and expensive part of drug development, Phase III studies are intended to evaluate the overall benefit-risk relationship of the drug. By gathering additional information about the drug’s effectiveness, safety, side effects and comparison to commonly used treatments, Phase III studies involve large groups of participants. Usually tested on several thousand people, Phase III studies also provide the basis for extrapolating results for physician labeling should the drug be granted FDA approval.

Once Phase III is complete, the manufacturer may file a new drug application. Review of the new drug application typically lasts one to two years, bringing drug development time after pre-clinical trials to approximately nine years. If the FDA approves the new drug, it may be marketed with FDA regulated labeling. The FDA also gathers safety information as the drug is used and adverse events are reported, and it will occasionally request changes in a labeling or will submit press releases as new contraindications arise. If adverse events appear to be systematic and serious, the FDA may withdraw a product from the market at any time.

Clinical Trial: Phase IV
In Phase IV studies, the drug is already on the market for a particular indication, but is now being tested for a different indication, use or disease.

Fast Track Status
During the phases of investigational drug development, the manufacturer can obtain accelerated development or review of its drug. If granted fast track status by the FDA, the timelines for clinical trials can take some shortcuts. Geared towards facilitating the development and expedition of new drugs that have the potential to address an unmet medical need for serious or life-threatening conditions, many HCV potential drugs are granted fast track status.

Once a drug receives fast track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

Having a general concept of the many steps and length of time involved in the approval of a new medication gives us a greater appreciation of what it takes to develop a drug. Patience is definitely required to see a potential cure come to fruition. While it may be premature to place all of your hope in a compound with promising pre-clinical trial results, go ahead and visualize how a drug emerging positively from Phase III will help you defeat HCV.

References:

http://en.wikipedia.org, Genotoxicity, Wikimedia Foundation, Inc., 2007.

www.fda.gov, Frequently Asked Questions on Drug Development and Investigational New Drug Applications, US Food and Drug Administration, 2007.

www.fdareview.org, The Drug Development and Approval Process, The Independent Institute, 2007.

www.hcvadvocate.org, Hepatitis C Treatments in Current Clinical Development, Alan Franciscus, Hepatitis C Support Project, October 2007.

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May 11, 2009

Scientists Isolate Antibody that Neutralizes Hepatitis C

Although not yet tested in humans, Massachusetts researchers have found an antibody to the Hepatitis C virus that can prevent and help clear Hepatitis C infection.

New Antibody Prevents Infection By Hepatitis C Virus

Wednesday, May 06, 2009

Taking aim at a leading cause of liver failure in the United States, a team of scientists at the Massachusetts Biologic Laboratories (MBL) of the University of Massachusetts Medical School (UMMS) has developed a human monoclonal antibody that neutralizes the Hepatitis C virus (HCV). The new antibody effectively neutralized the virus in culture, and then prevented infection by the virus in a pre-clinical animal model of the disease.

Details of the research were presented April 23 in Copenhagen, Denmark at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL). "We are pleased with the progress of this program," said Donna Ambrosino, MD, executive director of the MBL and a professor of pediatrics at the Medical School. "This antibody shows significant efficacy against the virus."

In the current study, MBL scientists injected transgenic mice (HuMAb Mouse® technology, Medarex, Inc.) with elements of HCV and then painstakingly searched for individual human antibodies produced in the mice that would recognize and bind to the HCV's outer coat, known as the glycoprotein. Once they found human antibodies that looked promising, they evaluated in vitro the ability of those antibodies to neutralize the virus and selected a lead candidate antibody for further characterization. Collaborative work with clinical researchers from the Department of Medicine at the Medical School's Worcester campus demonstrated that this antibody, now known as MBL-HCV1, was able to bind tightly with all genotypes of HCV tested from infected patient samples.

MBL-HCV1 was then tested off-site on three non-human primates. In that study, one animal received no antibody, one a low dose of the new antibody, and one a higher dose. Then all three animals were exposed to HCV. The animals with low or no antibody dosages developed HCV infections, but the animal with the higher dose was protected. Subsequently, researchers gave the high-dose of the antibody to the animal that originally received no antibody, and in that case the HCV was cleared from that animal's system. "These results are encouraging as a possible treatment for HCV infected patients, but more work needs to be done before we know how effective it will be in people," Dr. Ambrosino noted.

HCV attacks the liver and can eventually lead to liver failure. According to the U.S. Centers for Disease Control and Prevention, 3.2 million Americans are chronically infected with HCV and some 10,000 die annually of the disease. Globally, as many as 170 million people are estimated to suffer from HCV infection. For the most serious cases of HCV that do not respond to antiviral drugs, liver transplantation is the only option.

Typically 2,000 to 4,000 liver transplants are done each year in the United States (far less than the number of people on the waiting list for available organs). Transplantation can be a life saving treatment; however, in nearly all cases the patient's new liver is eventually infected by HCV because the virus remains in the patient's bloodstream during surgery. The powerful antiviral drugs now used to attack HCV prior to end-stage liver failure are not routinely used during surgery due to the patients' weakened condition and because of the strong medication used to avoid rejection of the new liver. After re-infection with HCV, nearly 40 percent of patients suffer rapid liver failure.

To close that clinical gap, the new antibody developed at MBL is designed to be a therapy shortly before and after transplant surgery. By giving a patient the new antibody before and during the time when the donor liver is implanted, researchers hope the HCV virus left in the bloodstream will be neutralized and rendered unable to infect the new liver. Then, because monoclonal antibodies are highly specific and typically have little or no side-effects, additional dosages of the new antibody could, theoretically, be given immediately after transplant surgery to continue neutralizing any remaining virus.

It is also possible, researchers theorize, that the antibody could be used in combination with new antiviral drugs for treatment in patients with newly diagnosed HCV infection. Use of the new antibody for both liver transplant patients and in newly diagnosed HCV patients will now be further evaluated. A Phase 1 human clinical trial of MBL-HCV1 in healthy subjects is expected to begin later this year.

Source-Eurekalert
SRM

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URL for Article Source:
http://www.medindia.net/news/New-Antibody-Prevents-Infection-By-Hepatitis-C-Virus-50949-2.htm

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May 07, 2009

Hepatitis C Progress Hampered by Re-Infection and Superinfection

Through documenting Hepatitis C re-infection and superinfection in IV drug users, researchers better understand why a vaccine or cure has been so elusive.

by Nicole Cutler, L.Ac.

Hepatitis C is the most common blood-borne infection in the United States. It is also extremely prominent in intravenous drug users. Even with all of the ongoing research into Hepatitis C prevention and therapy, the current treatment is generally only effective in approximately half of those infected. The scientific community has uncovered a variety of stumbling blocks in their quest to create a Hepatitis C vaccine or a cure. Two of the barriers complicating their search for improved Hepatitis C treatment are that the largest population of people with Hepatitis C, intravenous drug users, is often prone to re-infection or superinfection.

Hepatitis C in Intravenous (IV) Drug Users
Considered to be approximately seven times more infectious than HIV in a single drop of blood, Hepatitis C is extremely likely to be acquired if contaminated needle and syringe sharing is occurring. Investigators know the following:

· Within only six months to a year after beginning intravenous drug use, 50 to 80 percent of IV drug users test positive for the Hepatitis C antibody.

· Intravenous drug users account for about 30 to 40 percent of all identified Hepatitis C cases, and about 50 percent of all new cases.

Representing the largest single risk group for Hepatitis C, many studies have attempted to determine the percentage of IV drug users infected. While trial results vary, they all demonstrate that over half of IV drug users have the virus. And some researchers even claim that nearly 100 percent of those using needles to inject drugs have antibodies to Hepatitis C.

Hepatitis C Is Mysterious
Most experts believe that finding an effective Hepatitis C vaccine or therapy is such a challenge because of the virus’ ability to mutate. The following facts have made this infectious disease harder for scientists to eliminate:

· Hepatitis C is an RNA virus that lacks an efficient proofreading ability as it replicates.

· This inefficient proofreading allows the virus to evolve, creating a collection of quasi-species. There are currently 11 major genotypes, many subtypes and 100 different strains of Hepatitis C.

· Because it constantly mutates, many believe Hepatitis C escapes host immunologic detection and elimination.

Re-Infection
The immune system’s memory is credited for building up resistance to various diseases and is the theoretical basis behind most preventative vaccines. Many infectious diseases teach the immune system how to combat a particular pathogen so that subsequent exposure does not cause re-infection. To aid the investigation into vaccine development, researchers are trying to confirm or deny immune memory with Hepatitis C.

Superinfection
A reasonable path for the highly mutable Hepatitis C virus, superinfection is when a cell previously infected by one virus becomes co-infected with a different strain of the virus. Unfortunately, viral superinfections are common causes of treatment resistance – where a previously effective therapy loses its efficacy. In addition, superinfections have been known to reduce the overall effectiveness of the immune response.

Study
As described in an oral presentation at the 13th International Symposium on Viral Hepatitis and Liver Disease in April of 2009, investigators studied intravenous drug users to assess Hepatitis C re-infection and superinfection. Based on their results, the researchers concluded that Hepatitis C re-infection and superinfection “are common among actively injecting drug users.” They proclaimed further that these findings demonstrate Hepatitis C does not create protective immunity and further complicates the quest for developing a Hepatitis C vaccine.

Because of Hepatitis C’s high transmission rate in those sharing contaminated needles and syringes, studying IV drug users can yield very important information. By recognizing the existence of Hepatitis C re-infection and superinfection and understanding how it impedes vaccine and drug development, researchers are that much closer to unraveling the mystery of Hepatitis C.

References:

http://en.wikipedia.org/wiki/Superinfection, Superinfection, Retrieved April 14, 2009, Wikimedia Foundation, Inc., 2009.

http://www.drugabuse.gov/HepatitisAlert/HepatitisAlert.html, NIDA Community Drug Alert Bulletin – Hepatitis, Alan I. Leshner, PhD, Retrieved April 15, 2009, National Institute on Drug Abuse, 2009.

http://www.epidemic.org/theFacts/theEpidemic/USRiskGroups/, High Risk Groups – United States, Retrieved April 15, 2009, Trustees of Dartmouth College, 2009.

http://www.hivandhepatitis.com/hep_c/news/2009/032409_a.html, HCV Reinfection and Superinfection Are Common among Injection Drug Users, Retrieved April 13, 2009, hivandhepatitis.com, March 2009.

http://www.knowcrystal.org/hiv/crystalhiv_p4.htm, What is Superinfection?, Retrieved April 14, 2009, knowcrystal.org, 2009.

http://www.ncbi.nlm.nih.gov/pubmed/15378431, Frequent hepatitis C virus superinfection in injection drug users, Herring BL, et al, Retrieved April 14, 2009, The Journal of Infectious Diseases, Infectious Diseases Society of America, October 2004.

http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index2.html, The Hepatitis C Virus, Retrieved April 16, 2009, World Health Organization, 2009.

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April 28, 2009

Cleaning Safety for Hepatitis C

Despite the claim that cleanliness is next to godliness, the products you use to keep your home clean may be worsening Hepatitis C. Particularly important for those with chronic liver disease, this informative article describes the most dangerous cleaning products and details how you can make toxin-free cleaning solutions.

by Nicole Cutler, L.Ac.

Without a successful course of treatment, Hepatitis C often causes gradual, progressive liver damage. Thus, anyone living with this virus must take additional steps to protect themselves from toxins capable of causing additional liver injury. Unfortunately, potential liver hazard items can be found in all aspects of modern day life. Inside most people’s homes, cleaning products harbor some of the most hazardous chemicals known. By reducing exposure to these toxins, those with Hepatitis C can protect themselves from unintentionally worsening their liver’s condition.

Because the chemicals in cleaning products are not dispersed as easily indoors as outdoors, concentrations of toxic chemicals are highest indoors. According to a United States Environmental Protection Agency (EPA) report, dangerous compounds in the home may exceed the toxins found outside by up to 100 times or more.

Those with chronic Hepatitis C are more vulnerable to the toxins in cleaning products because:

· Chronic liver disease may have damaged portions of their liver, leaving fewer functioning cells to detoxify poisons.

· Chronic liver disease can cause liver inflammation, which diminishes the liver’s ability to detoxify poisons.

· Scarring from chronic liver disease can interfere with circulation throughout the liver, leaving more toxins in the blood to further damage liver cells.

Dangerous Cleaning Products
While there is a long list of potentially hazardous ingredients in cleaning products, the following appear to be some of the worst offenders:

1. Air Fresheners and Deodorizers – These products can contain hormone-disrupting phthalates, cancer-causing chemicals such as formaldehyde and benzene, and other volatile organic compounds (VOCs) such as d-limonene that can irritate your eyes, skin and respiratory system, and cause headaches, nausea and dizziness.

2. Alkyl Phenol Ethoxylates (APEs) – Also known as surfactants, these chemicals are found in laundry detergents, all-purpose cleaners and stain removers. Unfortunate for those with diminished liver function, APEs break down into hormone-disrupting chemicals.

3. Glycol Ethers – Found in glass cleaners, floor cleaners and oven cleaners, glycol ethers can damage the nervous system, kidneys and liver, and be absorbed by the skin from the air.

4. Petroleum Distillates – Typically used as solvents, petroleum distillates are found in metal polishes and adhesive removers. They can cause temporary eye clouding, as well as long-term damage to the nervous system, kidneys and eyes.

5. Phenol and Cresol – Often found in disinfectants, phenol and cresol can cause diarrhea, fainting, dizziness and kidney and liver damage.

6. Toilet Bowl Cleaners – These emit naphthalene fumes, which can cause liver and kidney damage if ingested. Toilet bowl cleaners typically contain aradichlorobenzene, a toxin believed to cause cancer.

7. Citrus – Cleaners containing citrus can claim to be natural, but are often concocted with d’limonene, a chemical more toxic than toluene, which can damage bone marrow, liver and kidneys.

8. Laundry Aids – Fabric softeners and dryer sheets contain chemicals such as chloroform and benzyl acetate that are neurotoxic and carcinogenic. Exposure can be through inhalation or skin contact from dryer exhaust or from treated clothes, sheets and towels.

Toxin-Free Cleaning Solutions
Those who are alerted to the dangers posed by cleaning products often purchase products from their local health food store. Luckily, several environment-friendly companies have identified the negligence of traditional cleaning product manufactures and offer alternatives for those concerned with toxin exposure. However, those on a budget may find the prices of toxin-free cleaning products to be significantly pricier than their traditional counterparts.

Fortunately, making your own supply of cleaners is relatively easy and inexpensive. Below are some recipes that can be confidently and safely used in the home of someone with Hepatitis C:

· All-Purpose Cleaner – To clean many hard surfaces (excluding marble), combine equal parts of white vinegar and water in a spray bottle.

· Scouring Powder – Mix 3 parts baking soda with 1 part borax. Keep handy in a shaker jar and use gloves when using, but keep away from children as it should not be ingested and may cause skin irritation.

· Microwave Cleaner – Put several slices of lemon in 1 microwaveable cup of water. Heat on high for three minutes, then let it sit for three minutes. Open up the microwave and wipe clean; the steam loosens any grime and the lemon kills germs and has a pleasant scent.

· Mold and Mildew Remover – Combine two teaspoons of tea tree oil in two cups of water in a spray bottle. Shake to blend and spray on problem areas. Do not rinse. The smell of tea tree oil is very strong, but will dissipate in a few days.

· Furniture Polish – In a glass jar, mix ½ teaspoon olive or jojoba oil with ¼ cup vinegar or fresh lemon juice. Dab a soft rag into the solution and wipe onto wood surfaces to polish.

· Laundry Detergent – Use 1/3 cup washing soda plus 1 ½ cup natural soap flakes. Add ½ cup Borax for whitening and softening. You can reduce the amount of cleaner needed by magnetizing your water using magnetic laundry disks or balls; these rip apart water molecule bonds to create ‘activated’ or ‘structured’ water and make it easier to remove dirt.

· Dryer Sheets – To eliminate static cling, toss a small wet towel into the dryer a few minutes before the end of the cycle.

· Carpet Cleaner – Sprinkle cornstarch on a dry carpet, leave on for five minutes and then vacuum.

Undoubtedly, there are many toxins in the average person’s arsenal of household cleaners. Since the ingredients in many cleaning products put an additional toxic load on the liver, people with Hepatitis C are advised to use cleaners made with non-toxic ingredients whenever possible. Besides buying products devoid of dangerous chemicals, making several of these simple, homemade remedies can help individuals with Hepatitis C keep within a budget, maintain cleanliness and protect their liver.

References:

http://earth911.com/household/household-cleaners/facts-about-
cleaning-products/, Facts About Cleaning Products, Retrieved April 24, 2009, earth911.com.

http://today.msnbc.msn.com/id/26903507//, The Dirty Truth About Cleaning Products, Retrieved April 24, 2009, Microsoft, October 2008.

http://www.alive.com/1271a4a2.php?subject_bread_cramb=598, So Clean, It’s Sickening, Michael Downey, BSc, Retrieved April 24, 2009, Alive Publishing Group, 2009.

http://www.care2.com/greenliving/make-your-own-non-toxic-cleaning-
kit.html, How to Make a Non-Toxic Cleaning Kit, Annie B. Bond, Retrieved April 24, 2009, Care2.com Inc., 2009.

http://www.healthyhepper.com/liverhazzards.htm, Substances that are Harmful (or potentially harmful) to the Liver, Retrieved April 24, 2009, healthyhepper.com, 2009.

http://www.sierraclubgreenhome.com/uncategorized/green-household-
cleaning/, Green Cleaning Supplies, Retrieved April 24, 2009, Sierra Club Green Home, 2009.

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April 21, 2009

Preventing Bleeding Varices: A Liver Transplant Must

Information about preventing a complication of advanced Hepatitis C infection is now available. Learn why scientists are considering beta blockers to be the best line of defense against bleeding varices, a condition prohibitive of a liver transplant and one that can also be life threatening.

by Nicole Cutler, L.Ac.

In the United States, Hepatitis C is the most prevalent cause of chronic liver disease and the most common reason for a liver transplant. Reserved for those who have run out of options, a liver transplant is the last resort for a person battling the most advanced stages of Hepatitis C infection. For one in need of a liver transplant, many obstacles must be overcome, including preventing bleeding varices.

There are many steps to be taken before a liver transplant can begin. Of the many hurdles leading to this surgery, below are three essential considerations:

1. Risky – A liver transplant is a major operation accompanied by many risks, and is therefore only considered when a person’s liver is no longer capable of sustaining life. Even though it is the most common reason to receive a liver transplant, a majority of Hepatitis C patients experience viral recurrence with their new liver.

2. Donor Matching – Being approved to be a recipient places someone on the donor list, a list that may involve a very long waiting period. Only a select few of those on the list are lucky enough to find an appropriate donor. Even though it is a last resort for those with liver disease, thousands of people are put on a liver donor recipient list every day.

3. Preventing Bleeding Varices – A flare-up of this common advanced liver disease problem will prohibit liver transplant surgery. When waiting for a new liver, one must work with his/her physician to prevent variceal bleeding in order to maintain transplant eligibility.

Bleeding Varices
Varices are dilated blood vessels typically located in the esophagus or stomach. If these vessels rupture and bleed, a dangerous situation is on hand. As a result of fibrosis from advanced liver disease, blood flow is inhibited in the liver. The circulatory inhibition that ensues causes pressure to build up in the vein carrying blood to the liver. Known as portal hypertension, this blood circulation backup causes the vessels to balloon, putting them at risk of rupturing and bleeding. A life-threatening complication of portal hypertension, bleeding from these varices is typically evidenced by blood in the vomit or stool.

Medical Intervention
Because bleeding varices can be a medical emergency, Western medicine relies on a handful of interventions to stop the bleeding. Among those are:

· Banding – By placing small rubber bands directly over the dilated blood vessels, this procedure can stop the bleeding and reduce the vessel’s dilation.

· Sclerotherapy – By injecting the dilated blood vessel with a blood-clotting solution, this method stops dangerous bleeding.

· Stent – By re-routing the blood vessels under pressure, a hollow tube is surgically inserted into the affected vasculature to reduce the high blood pressure.

· Devascularization – This surgical procedure literally removes the bleeding varices. This procedure is done when the other choices are not an option.

Prevention
While stopping the crisis of bleeding varices saves lives, preventing them is just as important. People living with an advanced case of Hepatitis C can benefit from taking prophylactic steps to avoiding a bleeding varices crisis.

According to a study published in the March 2006 edition of the American Journal of Gastroenterology, certain medications offer bleeding varices prevention. The authors concluded that pharmacologic reduction of portal hypertension is associated with a dramatic decrease in the risk of variceal bleeding in cirrhotic patients with esophageal varices.

According to an article published in the September 2007 issue of Liver Transplantation, beta blocker drugs should be the first choice treatment for preventing variceal bleeding in people with cirrhosis and portal hypertension. To compare the safety and efficacy of the two most popular therapies in preventing bleeding varices, banding and the use of beta blockers, Italian researchers conducted a randomized controlled trial among patients awaiting liver transplantation.

The researchers found that, while banding is similarly effective as beta blockers in reducing the incidence of bleeding varices, it can have fatal complications and is more expensive compared with the beta blocker, propranolol. Both propranolol and banding were found to reduce the expected incidence of bleeding by approximately 30 percent after one year. Although some patients in each group experienced adverse events related to their treatment, only banding had a fatal outcome. The authors concluded that although banding should be used when beta blockers are contraindicated, beta blockers should remain the first choice of prophylactic therapy in candidates for liver transplantation.

Even though the complications of portal hypertension must be kept under control to permit a liver transplant, anyone with advanced liver disease should aim for preventing a variceal bleed. Those with Hepatitis C who have advanced to cirrhosis with esophageal or gastric varices must speak with their physician about the best way to prevent a bleeding episode. Although beta blockers may not be the solution for everyone, they can reduce the risk of bleeding varices, a risk most people with liver disease cannot afford to take.

References:

www.clevelandclinic.org, Bleeding Varices, The Cleveland Clinic Department of Patient Education and Health Information, 2007.

www.hivandhepatitis.com, Prevention of Variceal Bleeding in Candidates Awaiting Liver Transplantation, hivandhepatitis.com, September 2007.

www.medscape.com, Long-Term Prophylaxis Can Prevent Variceal Bleeding in Cirrhotic Patients, Reteurs Ltd. 2006.

www.sciencedaily.com, Preventing Variceal Bleeding, John Wiley & Sons, Inc., ScienceDaily LLC, September 2007.

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April 07, 2009

Perspective on the Progression of Hepatitis C

Those with Hepatitis C likely know that their disease can get worse, but may want to know more about the average speed of liver disease progression.

by Nicole Cutler, L.Ac.

Upon receiving a Hepatitis C diagnosis, learning that the virus progressively damages the liver takes center stage. While there is no formula to compute the speed at which Hepatitis C advances in the body, understanding the stages of illness and whether alcohol is consumed can help someone assess where they lie in the scope of their illness.

Accounting for at least 25 percent of all cases of chronic liver disease, chronic Hepatitis C is a progressive condition. Although a significant portion of those infected have no symptoms, normal liver enzymes and normal liver histology, experts believe the virus still progresses – it just does so more slowly than in others. Because of this steady progression, slowing disease progression is a valid goal in chronic Hepatitis C management.

Once a liver is infected with the Hepatitis C virus, it becomes increasingly damaged. A basic progression of liver disease is described below:

· Inflammation – As the liver tries to fight infection, the liver becomes inflamed, tender and enlarged.

· Fibrosis – Known as fibrosis, an inflamed liver will eventually scar. As excess scar tissue grows, it replaces healthy liver tissue, causing a decrease in liver function.

· Cirrhosis – When the liver becomes so scarred that it can no longer heal itself, cirrhosis has occurred.

· Liver Cancer – With a liver struggling to perform its job of processing toxins, the ideal environment for cells to mutate into cancer exists.

· Liver Failure – Once the liver has completely lost its ability to function, the life-threatening condition of liver failure has arrived.

Chronic Hepatitis C progression is typically evaluated in one of three ways:

1. Retrospectively – A retrospective study identifies patients with established infection and correlates their current stage of liver disease to the duration of their infection. A problematic bias of retrospective studies is their inclination to select participants who have sought medical attention due to their symptoms. Because the actual duration of infection in these patients may be underestimated, disease progression approximates may be inaccurate.

2. Prospectively – A prospective study looks at an entire group of people with Hepatitis C from the time they first become infected. These studies typically involve those who received contaminated blood, since their time of viral acquisition can be accurately determined.

3. Retrospectively and Prospectively Combined – Retrospective/prospective studies identify a group of patients who were exposed to Hepatitis C in the past and then follow them prospectively. The advantage of these studies is that there is a head start to the follow-up as compared to a prospective study.

Although the statistics describing Hepatitis C progression are not necessarily straightforward, some generalized assumptions that have resulted from a combination of retrospective, prospective and retrospective/prospective studies include:

· After acquiring the Hepatitis C virus, it takes an average of between 10 to 14 years for biopsy evidence of chronic hepatitis to appear.

· After acquiring the Hepatitis C virus, it takes an average of about 20 years to develop cirrhosis.

· After acquiring the Hepatitis C virus, it takes an average of about 28 years to develop liver cancer.

· About 10 to 25 percent of people with chronic Hepatitis C develop cirrhosis within 10 to 15 years.

· While the overall rate of fibrosis progression in people with Hepatitis C is low, it is increased in those who are older or already have fibrosis as indicated on their index biopsy.

The combined results of dozens of studies confirm that the natural progression of the chronic Hepatitis C virus is slow and, in general, complications develop over decades, not years. Although a timeline for how Hepatitis C evolves covers a wide spectrum, scientists agree on three factors that favor rapid progression of the virus: 1.) alcohol use, 2.) co-infection with another hepatitis virus and 3.) duration of infection. While viral genotypes, co-infection with HIV and gender have been suspected of affecting Hepatitis C progression, these claims lack conclusive evidence.

Understanding how liver disease progresses from inflammation to liver failure confirms the importance of maintaining any healthy liver cells. Thankfully, this progression usually takes many years. If you’ve recently acquired Hepatitis C, this affords plenty of time to protect remaining liver cells. However, if you have been living with Hepatitis C for a long time, the only clear instruction is to completely abstain from alcohol, since it is the only definite route for accelerating Hepatitis C progression.

References:

Ryder, SD, MD, Progression of hepatic fibrosis in patients with hepatitis C: a prospective repeat liver biopsy study, Gut, 2004.

www.brown.edu, Hepatitis C: Epidemiology, Brown University, 2008.

www.medicinenet.com, Hepatitis C, MedicineNet Inc., 2008.

www.medpagetoday.com, Mortality from Hepatitis C-Related Disease at Near-Record High, Michael Smith, MedPage Today LLC, March 2008.

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April 06, 2009

Do Sunlight and Hepatitis C Meds Mix?

Sun exposure has health benefits specific to those with Hepatitis C, yet it may be cautioned for those on combination treatment. Knowing about photosensitivity can help you overcome this Catch-22.

by Nicole Cutler, L.Ac.

As one of the many amazing functions we are capable of, the human body can produce Vitamin D simply from its exposure to the sun’s ultraviolet rays. Since researchers have recognized that most people with chronic liver disease have a Vitamin D deficiency, it seems logical that those with chronic Hepatitis C seek opportunities where they can enjoy the sunshine. However, those undergoing treatment for Hepatitis C are at an increased risk of burning from the sun’s rays. Known as photosensitivity, one of the medications used in Hepatitis C combination therapy has been identified as having the potential to heighten sunburn vulnerability.

The Need for Vitamin D
Presented in October 2008 at the 73rd Annual Scientific Meeting of the American College of Gastroenterology, researchers from the University of Tennessee in Memphis measured the vitamin D levels in people with chronic liver disease. Of those evaluated, 85 percent of the study participants had chronic Hepatitis C, and 92.4 percent of those with chronic liver disease had some degree of vitamin D deficiency.

Since Vitamin D can be made in the body from sunshine, this study provides plenty of incentive for those with Hepatitis C to seek sunny destinations. But just as with anything that is seemingly beneficial, there are limits and safety issues associated with upping Vitamin D via the sun or via supplementation. For more information about Vitamin D, consequences of its deficiency and safe amounts to supplement with, read Caution: Hepatitis C and Vitamin D Deficiency.

Photosensitivity
Dozens of medications, both prescription and over-the-counter, can increase a person’s sensitivity to sunlight. Photosensitivity is a well-known side effect that causes some people to:

· burn more easily
· burn more quickly
· get hives or rashes
· have other skin eruptions

While this list is not exhaustive, some commonly used medications listing photosensitivity as a side effect include:

· Antihistamines
· Non-steroidal anti-inflammatories (NSAIDS)
· Antibiotics including tetracylcines and sulfa drugs
· Antidepressants
· Anti-psychotics
· Cardiovascular drugs
· Cancer chemotherapy drugs
· Oral diabetes medications
· Diuretics
· St. John’s wort (herbal remedy for depression)

Ribavirin
Although it is not categorized as a common medication, the antiviral drug ribavirin may cause or enhance photosensitivity. As an integral part of the prescribed treatment for Hepatitis C, some individuals develop a rash from ribavirin – and this side effect can be exacerbated by exposure to intense sunlight or other UV light, such as tanning beds. In addition, consumers are urged to be aware of the greater potential for a photosensitive reaction when combining ribavirin with one of the above listed drugs known for increasing sensitivity to the sun. For those especially sensitive, a photosensitive reaction may also be triggered by indirect sun exposure, such as light reflected off pavement.

Protect Yourself
Although the skin burns or rashes characteristic of photosensitivity can cause pain, itching and misery, combination therapy for Hepatitis C needn’t keep you confined indoors (unless advised by a physician or pharmacist). For the majority of individuals on photosensitive medications, several extra precautions can help prepare for sun exposure.

The following five tips will help you reap Vitamin D from the sun, even if you are on Hepatitis C medications:

1. Avoid prolonged exposure to sunlight during the high intensity hours between 10 a.m. and 4 p.m.

2. Use a broad-spectrum sunscreen with an SPF of at least 15, preferably 30 – which protects against both UVA and UVB rays. Although most sunburns are caused by UVB rays, some photosensitivity reactions are triggered by UVA rays.

3. Use at least one full ounce of sunscreen 30 minutes prior to sun exposure and reapply after swimming or excessive sweating.

4. Wear protective clothing such as wide-brimmed hats, sunglasses and sun-protective clothing such as tightly-woven, long-sleeved shirts and pants or clothes with a high SPF rating.

5. Women who wear makeup should use makeup containing a sunscreen of SPF 15 or higher.

Since those with chronic Hepatitis C are likely low on Vitamin D and sunshine helps produce it, the arrival of warm, sunny weather is especially embraced. However, those being treated with ribavirin must understand the additional photosensitivity risk of sun worshiping. By being reasonable with your sun exposure levels and properly protecting your skin from radiation, Hepatitis C treatment need not stop you from frolicking in the light.

References:

http://drugs.about.com/b/2008/07/18/sunlight-and-your-medications-may-not
-mix-staying-healthy-at-the-beach.htm, Sunlight and Your Medications May Not Mix: Staying Healthy at the Beach, Michael Bihari, MD, Retrieved April 2, 2009, About.com, July 2008.

http://www.eurekalert.org/pub_releases/2008-10/acog-vdd100308.php, Vitamin D deficiency common in patients with IBD, chronic liver disease, Retrieved April 4, 2009, American College of Gastroenterology, October 6, 2008.

http://www.hivandhepatitis.com/doctor/topics/hcv1.html, Questions from Readers and Answers by Medical Experts on Treatment and Care for Chronic Hepatitis C Virus (HCV) Infection, Mack Mitchell, MD, Retrieved April 2, 2009, hivandhepatitis.com, 2009.

http://www.sciencedaily.com/releases/2000/08/000807070850.htm, Medications May Increase Sensitivity To Sunlight, Retrieved April 2, 2009, ScienceDaily LLC, August 2000.

Palmer, Melissa, MD, Dr. Melissa Palmer’s Guide to Hepatitis and Liver Disease, Avery Publications, Revised Edition 2004; 194-195.

Posted by Editors at 04:24 PM --- Printer-friendly version

April 01, 2009

Smoking with Hepatitis C Raises Liver Cancer Risk

New research demonstrates that a man with Hepatitis C who smokes has a radically greater chance of getting liver cancer than those who steer clear of cigarettes.

by Nicole Cutler, L.Ac.

In order to prevent the worsening of liver disease, those living with chronic Hepatitis C must make the proper lifestyle changes. Since alcoholic drinks are a known liver toxin and have been shown to accelerate liver damage from Hepatitis C, alcohol abstinence is the most obvious change that can positively affect liver health. However, smoking is now believed to be one of the worst things you can do when living with the virus. New research shows that, especially in men, cigarette smoking can dramatically increase the likelihood of Hepatitis C leading to liver cancer.

Liver Disease Progression
Only about half of those infected with the most common type of Hepatitis C in America, genotype 1, can eliminate the virus with the current standard of therapy. Therefore, the remaining half must live with Hepatitis C and hope that the health of their liver does not worsen. Positive lifestyle changes that include alcohol abstinence, quitting smoking, avoiding toxins, eating a healthy diet and regular exercise appear to exert a powerful effect over stopping liver disease from getting worse. When it does advance, liver damage can be progressive and escalates from fibrosis to one of the following final stages of liver disease:

1. Cirrhosis – a worsening of fibrosis, when the liver becomes irreversibly scarred and blood can no longer flow through this organ

2. Liver Cancer – when damage to the liver alters the genes inside the liver’s cells, the cells can become cancerous

Smoking and Liver Disease Progression
Because cigarette smoke contains so many toxins and known carcinogens, its cessation has been advised to people with Hepatitis C for many years. However, proof of liver damage from smoking has been slow to accrue. Nonetheless, several previous studies have examined the relationship between Hepatitis C and cigarette smoking:

· A French study published in the January 2003 edition of Gut found that smoking, independent of alcohol, could aggravate the histological activity of chronic Hepatitis C.

· In the June 2006 issue of Clinical Gastroenterology & Hepatology, California researchers found that smokers with chronic Hepatitis C may be more likely than non-smokers to develop liver fibrosis.

Smoking and Liver Cancer
While there has been evidence pointing to cigarette smoke’s ability to injure the liver, there is now proof that it increases a man with Hepatitis C’s risk for developing liver cancer. Published in the October 2008 edition of the International Journal of Cancer, researchers from Texas investigated smoking and other risky behaviors as risk factors for the most common type of liver cancer, hepatocellular carcinoma (HCC), with men and women who have chronic Hepatitis C. The researchers found the following:

· Differences between men and women were observed in smokers with Hepatitis C who develop HCC.

· Men with Hepatitis C who smoke have a more than 136-fold increased risk of HCC.

· Women with Hepatitis C who consume large amounts of alcohol have a more than 13-fold increased risk of HCC.

The researchers concluded that there appears to be a synergistic link between smoking and Hepatitis C infection in men, leading to a more than 136-fold increased risk of developing HCC. Since increasing the risk of liver cancer by over 100 times is so dramatic, there is no doubt of the evils of cigarettes. So for men with Hepatitis C who have the intent of preventing their liver disease from progressing to cancer, abstaining from smoking cigarettes should lie at the top of their to-do list.

References:

http://www.hcvadvocate.org/news/newsRev/2008/NewsRev-284.html#_
Cigarette_Smoking,_Hepatitis, Cigarette Smoking, Hepatitis C Virus Synergistic in Raising Liver Cancer Risk, Reuters Health, Retrieved November 23, 2008, medscape.com, Hepatitis C Support Project, 2008.

http://www.hivandhepatitis.com/hep_c/news/2006/070706_a.html, Smoking May Worsen Liver Fibrosis in Patients with Hepatitis C, Retrieved November 23, 2008, hivandhepatitis.com, July 2006.

http://www.medicinenet.com/script/main/art.asp?articlekey=18104, Smoking With Liver Disease - A No-No, Jay W. Marks, MD, Retrieved November 23, 2008, MedicineNet Inc., 2008.

http://www.ncbi.nlm.nih.gov/sites/entrez, Effect of different types of smoking and synergism with hepatitis C virus on risk of hepatocellular carcinoma in American men and women: case-control study, Hassan MM, et al, Retrieved November 23, 2008, International Journal of Cancer, October 2008.

http://www.ncbi.nlm.nih.gov/sites/entrez, Impact of smoking on histological liver lesions in chronic hepatitis C, Hezode C, et al, Retrieved November 23, 2008, Gut, January 2003.

Posted by Editors at 04:17 PM --- Printer-friendly version

March 24, 2009

Male Sexual Function During Hepatitis C Treatment

Learn why recent statistics do not tell the entire story about how Hepatitis C treatment affects men’s sexuality.

by Nicole Cutler, L.Ac.

A new study presented at the November 2008 Annual Meeting of the American Association for the Study of Liver Diseases painted a grim picture of the sexual health of men with Hepatitis C who undergo treatment. However, further investigation into the details reveals this trial’s weakness and should put most men at ease.

Although sex usually is a source of great pleasure, it can also be the cause of significant stress. Intertwined with aspects of one’s physical, emotional and spiritual health, an adult’s sexuality is complex. Despite the range of possible causes, a reduction in sexual desire, function or satisfaction can be extremely upsetting. Considering the complex union of neurological, psychological and physiological events that must unite for an optimal sexual experience to occur, it is not surprising when things occasionally are amiss.

The Study
Eight health centers across the U.S.A. collaborated on a study to determine the effect Hepatitis C combination therapy has on men’s sexual health. Self-administered sexual health questionnaires were given to over 400 participants with Hepatitis C genotype 1 receiving a 48-week course of combination therapy. Containing five sexual health questions that assessed sexual desire, function (erection and ejaculation) and satisfaction, the questionnaires were given six times throughout a 72-week period.

At the start of therapy, the following was indicated:

· 37 percent reported an impairment of sexual desire
· 26 percent reported erectile dysfunction
· 21 percent reported ejaculatory problems
· 44 percent reported dissatisfaction with their sex life

Not surprisingly, the respondents reported a worsening in all areas of sexual health during interferon-based therapy:

· 53 percent reported an impairment of sexual desire
· 39 percent reported erectile dysfunction
· 31 percent reported ejaculatory problems
· 54 percent reported dissatisfaction with their sex life

Most areas of sexual health returned to their original levels at the end of the 72-week period. However, those who endured treatment for the full 48 weeks had a slightly higher erectile and ejaculatory dysfunction compared to before treatment began.

Reality
Although the percentages of men in this study with a lower than desired level of sexual function may seem like a lot, these numbers are meaningless without a comparison.

· According to a 1999 survey from the University of Chicago and the Robert Wood Johnson Medical School, approximately 30 percent of men report sexual dysfunction. Although a slightly higher proportion of men with Hepatitis C said they had problems with sexual desire, function or satisfaction, the 1999 research based its findings on the general population.

· According to a Portuguese study published in the June 2008 edition of The Journal of Sexual Medicine, the prevalence of erectile dysfunction is strongly related to age and health status. They concluded that adjusting for age, the total prevalence of erectile dysfunction in men was slightly higher than 48 percent, a statistic that is very close to what was reported by men in the Hepatitis C study.

· According to a publication in the November 2008 edition of the International Journal of Impotence Research, testosterone levels fall as men age. Because testosterone plays a role in general and sexual health in men, it is no surprise that a higher percentage of older men report sexual dissatisfaction as opposed to younger men. Because the Hepatitis C study did not separate results according to age, its statistics are not specific enough to draw any conclusions.

Besides Age
For normal sexual arousal and function to occur, a person must feel good. Feeling well enough for sex involves feeling confident, being free from anxiety, having stamina for mental and physical stimulation, as well as the ability to focus attention on arousing thoughts or behavior. Anything that interferes with these conditions can disrupt a sexual encounter.

The severe side effects that accompany Hepatitis C therapy definitely have the potential to interfere with feeling good. Those affected who discuss their sexual health concerns with their physician have a greater chance of finding solutions. For more information about sexual dysfunction with chronic Hepatitis C, read How Hepatitis C Can Affect a Patient’s Sex Life.

There are many components that must unite for sexual desire, function and satisfaction to work. Thus, isolating antiviral therapy as a predictor of sexual difficulties is unfair. The study disclosed in late 2008 makes it seem like receiving treatment for Hepatitis C spells trouble for a man’s sex life. However, men over 40 years of age who don’t have Hepatitis C and who are not undergoing combination therapy have a similar rate of sexual dysfunction. Therefore, do not dismiss the prospect of combination therapy on the basis of sex alone. Because, chances are, if the treatment works and you eliminate the virus, you will eventually feel good – and feeling good is the strongest predictor of vibrant sexual health.

References:

http://chronicle.uchicago.edu/990218/dysfunction.shtml, Researchers publish new study on sexual dysfunction, William Harms, Retrieved December 4, 2008, The University of Chicago Chronicle, February 1999.

http://www.healthnews.com/family-health/sexual-health/sexual-
dysfunction-affects-almost-half-american-women-2062.html, Sexual Dysfunction Affects Almost Half of American Women, Madeline Ellis, Retrieved December 3, 2008, HealthNews.com, November 2008.

http://www.hivandhepatitis.com/2008icr/aasld/docs/111408_a.html, Sexual Desire, Function, and Satisfaction in Men Undergoing Treatment with Interferon-based Therapy for Chronic Hepatitis C, Liz Highleyman, Retrieved December 2, 2008, hivandhepatitis.com, November 2008.

http://www.mayoclinic.com/health/sexual-health/HQ01363, Sexual health: How to achieve a fulfilling sexual relationship, David Osborne, PhD, Retrieved December 3, 2008, Mayo Foundation for Medical Education and Research, 2008.

http://www.ncbi.nlm.nih.gov/pubmed/18194181?ordinalpos=12&itool=
EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReport
Panel.Pubmed_RVDocSum, Prevalence, severity, and risk factors for erectile dysfunction in a representative sample of 3,548 Portuguese men aged 40 to 69 years attending primary healthcare centers: results of the Portuguese erectile dysfunction study, Teles AG, et al, Retrieved December 3, 2008, The Journal of Sexual Medicine, June 2008.

http://www.ncbi.nlm.nih.gov/pubmed/19037223?ordinalpos=5&itool=
EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReport
Panel.Pubmed_RVDocSum, Are declining testosterone levels a major risk factor for ill-health in aging men?, Yeap BB, Retrieved December 3, 2008, International Journal of Impotence Research, November 2008.

Posted by Editors at 12:03 PM --- Printer-friendly version

March 16, 2009

FDA Expands Use of Schering's Hepatitis C Drugs

While previously only approved for patients who had never taken any Hepatitis C drugs, Pegintron and Rebetol are now approved by the FDA for re-treatment.

Schering say FDA expands hepatitis drug labels

Associated Press, 03.11.09, 04:39 PM EST

The Food and Drug Administration expanded the label for Schering-Plough Corp.'s hepatitis C drugs Pegintron and Rebetol, allowing the company to market the drugs for patients who have not recovered from the disease after previous treatment.

Schering-Plough (nyse: SGP - news - people ) said Wednesday that the FDA approved the drugs for the treatment of chronic hepatitis C in patients with compensated liver disease. They were already approved for use in "treatment-naive" patients, or those who had never taken any drugs for the liver disease.

The drugs are approved for use in patients 3 and older.

The company said more than 100,000 people in the U.S. have received at least one unsuccessful treatment for hepatitis C. Sales of Pegintron totaled $914 million in 2008, and Schering-Plough reported $260 million in Rebetol revenue.

Schering-Plough on Monday accepted a buyout offer from Merck and Co. (nyse: MRK - news - people ) worth $41.1 billion.

Copyright 2009 by Associated Press

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Posted by Editors at 04:09 PM --- Printer-friendly version

March 10, 2009

Stalling Hepatitis C In-Between Health Coverage

Many with Hepatitis C are finding themselves between jobs, and thus without healthcare. Until their health coverage woes turn around, these two simple strategies can help stall Hepatitis C from inflicting liver damage in the interim.

by Nicole Cutler, L.Ac.

Healthcare for chronic Hepatitis C is suffering from our economy’s recent decline. Whether without health insurance or unable to afford co-payments, the expensive care for Hepatitis C can be harder than ever to obtain. However, people can delay further damage from Hepatitis C during a lapse of health coverage. Avoiding alcohol and supplementing with milk thistle helps minimize the damage done by this virus. Until health insurance can be reinstated or supervised medical treatment can be otherwise financed, these two non-pharmaceutical, cost-effective tactics can help the liver defend against Hepatitis C’s constant assault.

Healthcare is one of the top social and economic problems facing Americans today. The majority of Americans (59-61 percent) have health insurance through their employer. Unfortunately, the U.S. Bureau of Labor Statistics reports a growing army of unemployed American adults with the unemployment rate at a 16-year high of 7.2 percent.

An estimated 50 million Americans currently live without health insurance, and of those who are employed and do have health coverage, an estimated 25 million are underinsured. Just as unemployment rates leave more people without affordable health insurance, the financial burden of healthcare for those with coverage is also rising. Many who have health insurance also struggle to pay their healthcare bills. Rising healthcare premiums, deductibles and steep co-payments, as well as limits on coverage for various services, or other limits and excluded services that can increase out-of-pocket expenses, all contribute to this problem. Thus, the inability to finance necessary medical care affects both the uninsured and the underinsured.

Even if a person with Hepatitis C has full health coverage, there are no guarantees. For starters, only about 50 percent of people with Hepatitis C genotype 1 (the most common variety in the U.S.) will successfully eliminate the virus with treatment. In addition, many insurance companies are putting limits on the therapy they will approve based upon the patient’s genotype – not based on the doctor’s recommendations. For more information about this growing trend, read Hepatitis C Genotype Guides Health Plans.

Although the economic crunch exacerbates the high price tag of Hepatitis C treatment, there is tremendous hope for the future. In all stages of development, hundreds of clinical trials are unraveling Hepatitis C’s mysteries, and finding innovative ways to beat this virus without compromising the infected person’s health.

For the underinsured, uninsured or those denied Hepatitis C treatment by a health carrier, there is a way to temporarily maintain the liver’s status quo. Pending therapy being financed or the approval of a more effective Hepatitis C drug cocktail, the liver can be protected by:

1. Avoiding Alcohol – Because alcohol exponentially accelerates the virus’ ability to damage and kill liver cells, abstaining from drinking alcohol is critical for prolonging the health of those with Hepatitis C.

2. Milk Thistle – Although it doesn’t kill the Hepatitis C virus, scientific evidence shows that high quality milk thistle protects the liver by promoting the growth of new liver cells, strengthening liver cell walls to resist damage and inhibiting inflammation.

By keeping your liver as healthy and resilient as possible, the Hepatitis C virus will be thwarted in its attempts at harm. Skipping alcohol and supplementing with milk thistle is not a solution for getting rid of Hepatitis C. However, combining these strategies can help you ride out the economic storm, or wait for the arrival of an improved (and affordable) course of treatment.

References:

http://familydoctor.org/online/famdocen/home/common/infections/
hepatitis/071.html, Hepatitis C, Retrieved January 14, 2009, American Academy of Family Physicians, 2009.

http://nccam.nih.gov/health/hepatitisc/, CAM and Hepatitis C: A Focus on Herbal Supplements, Retrieved January 14, 2009, National Institutes of Health, 2009.

http://news.yahoo.com/s/ap/20090113/ap_on_he_me/meltdown_supplement_sales
;_ylt=AvzLPe41yC5bxKThV0.BvDhZ24cA, With economy sour, consumers sweet on herbal meds, Lindsey Tanner, Retrieved January 14, 2009, The Associated Press, January 2009.

http://www.cpmc.org/learning/documents/hepatitisc-ws.html#How%20Much%20
will%20the%20Treatment%20Cost?, Frequently Asked Questions About Hepatitis C, Retrieved January 14, 2009, California Pacific Medical Center, 2009.

http://www.healthcareproblems.org/health-care-statistics.htm, Health Care Statistics, Retrieved January 15, 2009, HealthCareProblems.org, 2009.

http://www.hepatitis-central.com/mt/archives/2008/12/health_plans_gu.html, Hepatitis C Genotype Guides Health Plans, Angela Mass, Retrieved January 16, 2009, Natural Wellness, December 2008.

http://www.ncsl.org/programs/health/healthmc.htm, Health Insurance and the States, Retrieved January 15, 2009, National Conference of State Legislatures, January 2009.

http://www.nytimes.com/2009/01/10/business/economy/10jobs.html?hp, Jobless Rate Hits 7.2%, a 16-Year High, Louis Uchitelle, Retrieved January 15, 2009, The New York Times, January 9, 2009.

http://www.pbs.org/newshour/indepth_coverage/health/uninsured/how
weareinsured.html, The Uninsured in America, Leah Clapman, Retrieved January 16, 2009, MacNeil/Lehrer Productions, April 2007.

http://www.sciencedaily.com/releases/2008/02/080201155652.htm, Alternative Medicine Use For Hepatitis C: Silymarin (Milk Thistle) Does Not Affect Virus Activity Or ALT Levels, Survey Suggests, Retrieved January 14, 2009, ScienceDaily LLC, February 2008.

Posted by Editors at 04:25 PM --- Printer-friendly version

March 05, 2009

AcroMetrix Makes Progress in HCV Lab Diagnostics

AcroMetrix announces proprietary technology for laboratories to improve cost, consistency and accuracy in determining Hepatitis C virus test results.

AcroMetrix Announces the Release of OptiQuant-S Hepatitis C Virus (HCV) Panel

BENICIA, Calif., March 3 /PRNewswire/ -- AcroMetrix, a leading manufacturer of molecular quality control standards and controls for clinical diagnostic and blood testing laboratories, announced today the release of the OptiQuant-S HCV RNA Quantification Panel. This new panel utilizes AcroMetrix's proprietary SynTura(TM) Technology and provides laboratories with a critical component to fully optimize the Hepatitis C molecular assays available in today's market.

Viral Hepatitis B and C now account for greater than 75% of all cases of liver disease around the world(1). HCV patients are routinely monitored for changes in the amount of virus (i.e. viral load) present in the patient when undergoing therapy for the disease. Physicians rely on the accuracy of the viral load test result provided by the laboratory to adjust and manage the drug regiment for the patient.

"OptiQuant-S HCV represents our continued commitment to Hepatitis C diagnostic testing," says Michael J. Eck, President and CEO. "Medical laboratories utilizing the new OptiQuant-S HCV Panel will experience the benefits of a standardized product that offers consistent results with an enhanced dynamic range; and as a result reducing patient re-testing requirements and increasing savings in both labor and reagent costs."

SynTura(TM) Technology involves a second generation viral RNA material which behaves very similar to enveloped mammalian RNA viruses like HCV or HIV. This new technology allows insertion of synthetic sequences into a mammalian RNA virus which were shown to be stable in replication and capable of forming infectious RNase resistant virus particles. This new proprietary system can be used for designing defined RNA positive controls, quantification standards, internal controls, and calibrators. This product is for Research Use Only and is not for use in diagnostic procedures.

Reference:

(1) http://www.epidemic.org/theFacts/theEpidemic/worldPrevalence/

About AcroMetrix

AcroMetrix, with facilities in Benicia, California and Alkmaar, the Netherlands, provides a comprehensive line of molecular diagnostic quality control products that assist laboratories in meeting current government regulations regarding quality. AcroMetrix maintains this leadership role by consistently developing innovative standards, external run controls, and validation kits for molecular and serological testing in blood screening and clinical diagnostic laboratories. For more information on AcroMetrix and related products, please visit the company web site at http://www.acrometrix.com.

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Posted by Editors at 12:32 PM --- Printer-friendly version

February 23, 2009

Medical Device May Lower Hepatitis C Viral Load

Aethlon's Hemopurifier® completed a 30-day study on a Hepatitis C patient with end-stage-renal disease. While Aethlon hopes this blood-filtering medical device helps millions reduce Hepatitis C viral load, officials are still waiting for laboratory confirmation.

Aethlon Medical Announces Completion of 30-Day Hepatitis-C Treatment Study

Posted : Wed, 18 Feb 2009
Author : Aethlon Medical, Inc.

SAN DIEGO - (Business Wire) Aethlon Medical, Inc. (OTCBB:AEMD) announced today that it has completed a 30-day treatment case study to further evaluate the safety and efficacy of the Aethlon Hemopurifier® as a candidate treatment for Hepatitis-C Virus (HCV) infection. The Hemopurifier® is a first-in-class medical device that assists the immune response in combating infectious disease through real-time therapeutic filtration of infectious viruses and immunosuppressive proteins. As in previous studies, which demonstrated robust viral load reductions resulting from three Hemopurifier® treatments administered in a one-week trial, the study enrolled an HCV patient suffering from end-stage renal disease (ESRD) requiring regular kidney dialysis treatment. The study goal was to further demonstrate the Aethlon Hemopurifier® inhibits the progression of HCV in infected ESRD patients. The study protocol provided for 12 Hemopurifier(R) treatments to be administered during the patient’s normally scheduled dialysis treatment. As a result, a 4-hour Hemopurifier® treatment was administered thrice weekly over a period of 30 days. There were no observed adverse events were reported in any of the treatments. The study was conducted at the Fortis Hospital in Delhi, India. Aethlon will disclose viral load and associated data upon receipt from testing laboratories. The insight obtained from the study will help define future clinical protocols and early commercialization strategies. The study data may also be utilized to expand the scope of an IDE submission to the FDA to include the potential use of the Hemopurifier® in the United States as a device designed for the single-use removal of HCV from blood. At present, the focus of Aethlon’s IDE submission has been directed towards high risk bioterror and emerging pandemic threats.

It is estimated that up to 20% of the 1.6 million global ESRD population is infected with HCV. Beyond the treatment of infected ESRD patients, the overall opportunity for the Hemopurifier® is HCV care is significant, as approximately 180 million people worldwide (3% of the world's population) are HCV infected. According to the World Health Organization (WHO), only 30-50% of infected patients will beneficially respond to the 48-week pegylated interferon-ribavirin treatment standard.

“While we still have much work ahead, I am proud that our research and clinical programs allow us the opportunity to expand the therapeutic filtration industry beyond kidney dialysis and into the much larger infectious disease and cancer markets,” stated Aethlon Chairman and CEO, Jim Joyce. “The continued demonstration of Hemopurifier® safety and effectiveness increases the likelihood that our technology will be available to extend and improve the lives of those suffering from these horrific conditions,” concluded Joyce.

In a previous studies conducted the Fortis Hospital, six ESRD patients received a series of three, 4-hour Hemopurifier® treatments every other day during the course of one week. The treatment regimen also mirrored the patient's normal kidney dialysis schedule, allowing for the inclusion of the Hemopurifier® without disrupting dialysis treatment. Robust viral load reductions were observed in three HCV patients who completed the three-treatment protocol. Patient #1 had a 95% reduction three days post treatment and 89% reduction seven days post treatment. Patient #2 had a 85% reduction three days post treatment and 50% reduction seven days post treatment, and patient #3 had a 60% reduction three days post treatment and 83% reduction seven days post treatment.

Aethlon additionally disclosed that it soon expects the receipt of viral load and blood chemistry data resulting from a recently completed 30-day HIV treatment case study. The Hemopurifier® is the first medical device to target the treatment of both HIV and HCV, as well as a broad-spectrum of other infectious viral pathogens.

About Aethlon Medical

Aethlon Medical creates diagnostic and therapeutic filtration devices to improve the health of individuals afflicted with infectious disease and cancer. The Company’s lead product, the Aethlon Hemopurifier®, is a first-in-class artificial adjunct to the immune system proven to capture infectious viruses and immunosuppressive particles from circulation. The device targets to inhibit disease progression of Hepatitis-C Virus (HCV) and Human Immunodeficiency Virus (HIV), and serves as a broad-spectrum treatment countermeasure against bioterror and emerging pandemic threats. The Hemopurifier® also holds promise in cancer care, as research studies verify the Hemopurifier® effectively captures immunosuppressive exosomes that are secreted by tumors to kill-off immune cells. At present, over sixty-five (65) Hemopurifier® treatments (representing approximately 260 hours of treatment time) have been conducted in multi-site studies at the Apollo Hospital, Fortis Hospital, and Sigma New-Life Hospital in India. The studies enrolled end-stage renal disease (ESRD) patients infected with either HCV or HIV. In addition to establishing treatment safety, robust viral load reductions have been reported in HCV-infected patients who completed a three-treatment protocol during the course of one week.

Research studies have also demonstrated the Hemopurifier® is effective in capturing a broad-spectrum of viruses untreatable with drug therapy, including several of world’s deadliest bioterror and pandemic threats. These include: Dengue hemorrhagic fever (DHF), Ebola hemorrhagic fever (EHF), Lassa hemorrhagic fever (LHF), H5N1 avian influenza (Bird Flu), the reconstructed 1918 influenza virus (r1918), West Nile virus (WNV), and Vaccinia and Monkeypox (MPV), which both serve as models for human smallpox infection. The studies were conducted with the assistance of researchers representing: The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID); The Centers for Disease Control and Prevention (CDC); The National Institute of Virology (NIV); The Battelle Biomedical Research Center (BBRC); and The Southwest Foundation for Biomedical Research (SFBR).

In additional to therapeutic market opportunities, Aethlon is leveraging principles underlying the Hemopurifier® technology platform to establish a pipeline of clinical and research diagnostic products and services. Additional information regarding Aethlon Medical can be accessed online at www.aethlonmedical.com.

Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the Company’s ability to raise capital when needed, the Company’s ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company’s ability to manufacture its products and provide its services, the impact of government regulations, patent protection on the Company’s proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company’s Securities and Exchange Commission filings.

Aethlon Medical, Inc.
Prashant Mehta, Ph.D.
Director of Business Development
858.459.7800 x303
pmehta@aethlonmedical.com

or

Jim Frakes
Senior VP Finance
858.459.7800 x300
jfrakes@aethlonmedical.com

or

Jim Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com

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URL for Article Source:
http://www.earthtimes.org/articles/show/aethlon-medical-announces-
completion-of-30-day-hepatitis-c-treatment-study,720986.shtml

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February 20, 2009

A Cheaper Way to Detect Hepatitis C

Enabling poorer countries to screen their blood banks for the virus, researchers have developed a blood test for Hepatitis C that is high in specificity and low in cost.

Novel Economical Blood Test For Hepatitis C

ScienceDaily (Feb. 19, 2009) — A novel blood test could bring a breakthrough in the battle against the dangerous hepatitis-C virus. This procedure offers a considerably cheaper alternative to the normal commercial tests, whilst maintaining equal sensitivity. So now, for the first time, poorer countries will also have the opportunity to monitor their entire blood banks for the hepatitis C virus using optimum methods.

This procedure has been developed by researchers at Bonn University and the Bernhard-Nocht Institute for Tropical Medicine in Hamburg. Scientists from Brazil, Singapore, South Africa and England were also engaged in this research.

170 million people worldwide have already become infected with the hepatitis C virus. The early stages of the disease often go unnoticed. However, later symptoms include liver cancer and mortally dangerous liver cirrhosis. One of the chief sources of infection lies in contaminated blood banks, which is why all the bloodbanks in Europe or the USA are routinely tested for the hepatitis C virus. However, the poorer countries cannot afford this, or they have to rely on out-dated tests of inadequate sensitivity. The new procedure could change all this. “In Brazil, a standard hepatitis C test costs over 100 dollars a sample – for us, in contrast, the cost lies at just under 19 dollars”, declares Dr. Jan Felix Drexler. 10 dollars of this are licence fees – several major pharmaceutical companies hold patents for the genome of the hepatitis C virus.

Dr. Drexler, who has been engaged in the development of this new test procedure, has just removed from the Bernhard-Nocht Institute in Hamburg to Bonn University. The procedure functions, in principle, in exactly the same way as most of the commercial tests hitherto available on the market: all these procedures recognise genotype sequences in the blood, which originate from the hepatitis C virus. However, the problem is that various types of pathogen exist, whose genotypes are sometimes very different. A good blood test ought to raise the alarm equally well for each of these types. “In Asia, for example, we often find different hepatitis C viruses from ours”, says Dr. Drexler. “But when a tourist becomes infected in Thailand and subsequently donates blood in Germany, we must be able to diagnose these blood samples without fail, too”.

600 Blood Samples examined

At many points, however, the genotypes of diverse pathogens are to a great extent identical. Genetisists speak here of conserved regions, and all commercial tests have been “specialised” with respect to one of these points. The new procedure, in contrast, reacts when it detects sequences from a different conserved region which has not so far been used for HCV diagnosis. Working on the basis of just under 600 blood samples from five different countries, researchers were able to demonstrate just how well this functions. “We are, at least, just as sensitive as the two best standard procedures”, emphasises Professor Dr. Christian Drosten, a virologist from Bonn University. “This is true for all types of virus”.

Passes Practical Test in Brazil

So now, for the first time, poorer countries also have the chance to test their blood banks, and at comparatively small cost. “This would be a significant breakthrough for containing the disease”, Dr. Drexler stresses. “After all, transfusions are a major source of propagation“. In one Brazilian laboratory the new blood test has already been given trials on 127 patients – with outstanding success. In this latest publication, the researchers reveal every detail of their methods. “For anyone wishing to use this test we can also supply the control reagents”, Dr. Drexler declares. Commercial suppliers, in contrast, maintain the strictest secrecy regarding the precise data of their tests.

But this procedure will not only detect the presence of an infection with hepatitis C viruses. Doctors can also determine the total concentration of the viruses in the blood. Hence this blood test can also be used, for example, for monitoring therapeutic success. According to Dr. Drexler, “In this way we could spare many patients months of expensive treatment, and the unpleasant side-effects, too”.

Journal reference:

1. Drexler et al. A Novel Diagnostic Target in the Hepatitis C Virus Genome. PLoS Medicine, 2009; 6 (2): e31 DOI: 10.1371/journal.pmed.1000031

Adapted from materials provided by University of Bonn, via AlphaGalileo.

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URL for Article Source:
http://www.sciencedaily.com/releases/2009/02/090210134744.htm

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February 19, 2009

Inflammation Predicts Complications of Cirrhosis

Upon studying inflammatory markers in those with cirrhosis, researchers found that the degree of systemic inflammation is directly related to the common cirrhosis complications of diminished mental and cardiac function.

Inflammation May Be Common Thread Behind Nervous And Heart Rhythm Problems In Cirrhosis

ScienceDaily (Feb. 17, 2009) — Liver cirrhosis is the seventh leading cause of death in the United States, taking 25,000 lives per year. It is often the result of alcohol over-consumption or exposure to hepatitis C, either of which can damage the liver and prevent it from filtering toxins. These toxins then accumulate in the blood stream and eventually reach the brain where they disrupt neurological and mental performance, a condition known as hepatic encephalopathy.

Individuals with cirrhosis are also susceptible to a change in heart rhythm (decreased heart rate variability). Since cirrhosis, hepatic encephalopathy and heart rate variability are known to be associated with inflammation, researchers have examined what role cytokines (inflammatory molecules) play.

A new study from The American Physiological Society suggests that these cytokines can lead to both the neurological and cognitive abnormalities and changes in heart rhythm in patients with cirrhosis. The results of the study may also apply to other conditions where heart rate variability is also decreased, such as bipolar disorder and post-menopausal depression.

The study, “Decreased heart rate variability in patients with cirrhosis relates to the presence and severity of hepatic encephalopathy,” was carried out by Ali R. Mani, Sara Montagnese, Clive D. Jackson, Christopher W. Jenkins, Ian M. Head, Robert C. Stephens, Kevin P. Moore and Dr. Morgan. All are affiliated with the University College London Medical School, with the exception of Mr. Jackson, who is with the Royal Free Hospital, London. The study appears in The American Journal of Physiology-Gastrointestinal and Liver Physiology.

Three measurements

The study involved 80 patients suffering cirrhosis of the liver. Sixty-five (81%) of the patients had cirrhosis because of chronic alcohol abuse, although none had abused alcohol within three months of the study. Of the remaining 15 participants, seven had developed cirrhosis from chronic hepatitis while the remaining eight had developed the disease in various other ways. The participants were compared to a control group of 11 healthy people.

First, the researchers tested for the presence of hepatic encephalopathy by examining the patient’s mental state. They conducted various cognitive tests and obtained an electroencephalogram (EEG). After examination, the study participants were classified as having either overt hepatic encephalopathy, minimal hepatic encephalopathy or no encephalopathy.

Second, they measured heart rate variability using an electrocardiogram. A healthy heart varies the rate at which it beats depending upon a variety of factors. For example, the heartbeat accelerates when inhaling and decelerates when exhaling. Reduced heart rate variability -- that is, a more regular heartbeat -- has been associated with systemic inflammation and with various neuropsychiatric conditions, such as bipolar disorder.

Third, in a subgroup of 18 patients, the researchers also measured for cytokines, which circulate in the blood as part of the inflammation. Among these cytokines was interleukin-6, a substance that plays a role in cell signaling as part of the body’s response to inflammation.

Connected to inflammation

When the researchers began the study, they knew that cirrhosis of the liver leads to hepatic encephalopathy, systemic inflammation and reduced heart rate variability. It was not known whether and how they were related.

Their first major finding was that reduced heart rate variability and the presence of hepatic encephalopathy were very strongly connected. The second major finding was that blood levels of the inflammatory cytokines (including interleukin-6 levels) closely paralleled both the degree of neuropsychiatric impairment and reduced heart rate variability. This suggests that inflammatory response plays a role in these impairments.

Additional Findings

The researchers also found that:

* In patients with cirrhosis, there were significant concentrations of cytokines. By contrast, concentrations were below the level of detection among healthy volunteers.
* There was no significant differences in heart rate variability between patients with alcohol-related cirrhosis and patients with cirrhosis due to other reasons, such as chronic viral hepatitis.
* The risk of death increased as heart rate variability decreased.

The authors concluded that inflammation plays a role in both the reduction in heart rate variability and the development of hepatic encephalopathy in patients with cirrhosis. In subsequent, yet unpublished research, they have found that treatment for hepatic encephalopathy not only improves mental function but also improves heart rate variability. This treatment also reduces blood levels of cytokines providing further evidence of a link between systemic inflammation, mental and cardiac function in this patient group.

Adapted from materials provided by American Physiological Society.

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URL for Article Source:
http://www.sciencedaily.com/releases/2009/02/090210092728.htm

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February 11, 2009

Son’s Kidney May Save Natalie Cole

Hepatitis C survivor Natalie Cole may receive a much needed kidney transplant from her son.

Natalie Cole's Son to Donate Kidney to Mom

BY: Actress Archives | Thursday, February 5, 2009

Proving that he's a son that really knows how to step up to the plate for his mom, it's been reported that Natalie Cole's son may give her one of his kidneys. Cole was diagnosed with Hepatitis C about a year ago and now it seems she might need a kidney transplant, which would finally put an end to the dialysis treatments she goes through three times a week.

Speaking to Entertainment Tonight at the Grammy Salute to Jazz on Tuesday (Cole is nominated for three Grammys for her 2008 album "Still Unforgettable") she said, "My son [Robert,] may be a possible match. It's very sweet and kind of strange to have people offer something like that." Cole explained that while does not look forward to the recuperation time she'll need to take after the surgery, "in the end it'll be worth it." Her son Robert is 31 years old.

In September of last year, Natalie Cole spoke openly about her struggle with Hepatitis C, which doctors told her she contracted from sharing needles in the eighties when she was a heroin addict. Shedding light on her new health routine, Cole said, "I give myself a weekly injection of chemotherapy in my thigh. When I started in May, I thought I was dying. I couldn't get out of bed for three weeks - literally. I was nauseous every day. I lost 15 pounds from not eating."

Upon learning about the illness, which remained dormant in her body for twenty-five years, Cole says, "My life crumbled before my eyes." She added, "I've learned a lot of lessons. Yes, I could have handled some things better. But they've also made me who I am today."

Cole's illness didn't stop her from touring the world last year. Said Cole, "I've never been through anything like this. I love what I do so much. I just keep going. Nothing can bring me down."

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URL for Article Source:
http://www.actressarchives.com/news.php?id=14562

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Expert Food Tips for Chronic Hepatitis C – Part 2

Whether undergoing treatment or just managing Hepatitis C, hunger and digestive problems can interfere with good eating habits. Compiled from experts in liver disease, Hepatitis C and nutrition, discover 17 tips that can help improve a person’s ability to fulfill their nutritional needs despite having Hepatitis C.

by Nicole Cutler, L.Ac.

Experiencing the symptoms of liver disease and enduring antiviral treatment can present many eating challenges to those with Hepatitis C. Eliminating morsels that are harmful to the liver and choosing foods that are beneficial to hepatic health are crucial to a successful Hepatitis C eating plan. However, the reality of living with chronic liver disease can easily throw additional food concerns into the mix.

Whether a consequence of liver disease or accompanying medications, those with Hepatitis C face several potential barriers to eating well. At the center of the body’s detoxification responsibilities, the liver purifies unwanted substances from the blood. Chronic liver disease puts a strain on this toxin elimination system. Thus, those with chronic Hepatitis C who have sustained liver damage are likely to have excessive toxicity in their bloodstream. When waste is not effectively removed from a person’s body, their hunger and reaction to food are often altered. In addition, fighting chronic Hepatitis C infection leaves many too exhausted to prepare healthful meals.

As the current standard of treatment for Hepatitis C, antiviral therapy has a wide range of severe side affects. Aside from zapping people of their energy, the antiviral drugs frequently interfere with a person’s desire for food, ability to keep food down and they can distort taste and smell.

Because eating healthy food is the most revered way to fuel the body in its quest for wellness, the following tips can help those with Hepatitis C overcome their food obstacles:

When you have no desire to eat:

1. Consume small portions

2. Do some mild exercise to stimulate the appetite

3. Use liquid nutrition supplements if needed

4. Take advantage of when you are hungry

5. Make the most of each mouthful (choose nutritionally dense foods)

If foods you once enjoyed don’t taste or smell appealing:

6. Since red meat can taste bitter when on antiviral drugs, choose other sources of protein like chicken, fish, beans, cheese, yogurt and eggs

7. Since heat can intensify flavors, opt for foods cold or at room temperature

8. Turn on a fan or open the windows while cooking and eating

9. Cook outside or in the microwave

If fatigue is overwhelming:

10. Ask friends and family members to help prepare meals

11. Have liquid nutrition supplements or prepared snacks ready

12. When you have enough energy to cook, prepare extra food and freeze it

When nausea or vomiting interferes with eating:

13. Stay hydrated by sucking on ice chips or taking small sips of non-citrus, clear fluids

14. Choose bland foods because they are easier to digest and keep down

15. Eat small bits every few hours to prevent an empty stomach

16. Avoid foods that trigger your nausea (spicy, greasy and fatty foods are common triggers)

17. Try ginger ale, ginger tea or other products containing ginger to settle your stomach

Eating nutritious food is crucial to living a long life, especially with chronic liver disease. Unfortunately, the obstacles associated with food present an additional daily challenge to managing Hepatitis C. However, this challenge can be overcome by experimenting with the suggestions listed above. By minimizing the difficulties related to food preparation, hunger and digestion, these tips will help those with Hepatitis C get closer to their health and nutrition goals.

References:

http://books.google.com/books?id=Pf5j8RgzkRMC&pg=PA386&lpg=PA386&dq
=eating+tips+with+liver+disease&source=web&ots=Jscacb6ry5&sig=
-FakX8uqvgDI3JHCA-quiCtgOJU&hl=en&sa=X&oi=book_result&resnum=9&ct=
result#PPA407,M1, Dr. Melissa Palmer’s Guide to Hepatitis & Liver Disease, Melissa Palmer, MD, Avery, 2004; 407.

http://www.allabouthepatitisc.com/readytolearn/living/slowing/eating_healthy.jsp, Eating Healthy, Schering Corporation, 2009.

http://www.dietitians.ca/resources/HepC_Guidelines_enC.pdf, Hepatitis C Nutrition Care, Retrieved January 22, 2009, Dieticians of Canada, 2009.

http://www.hepatitisc.org.au/resources/documents/Food03.pdf, Hepatitis C and Food, Retrieved January 21, 2009, Hepatitis C Council of NSW, November 2003.

http://www.mayoclinic.com/health/nausea/DG00019, Nausea and Vomiting, January 21, 2009, Mayo Foundation for Medical Education and Research, 2009.

Posted by Editors at 02:44 PM --- Printer-friendly version

February 02, 2009

Acetaminophen & Caffeine: Bad Combo for Your Liver

Most people with liver disease are aware of being careful when considering taking acetaminophen for pain and fever relief. However, because new evidence now points to a higher risk of liver toxicity when mixing acetaminophen with caffeine, even further caution is warranted.

by Nicole Cutler, L.Ac.

Just when those with chronic hepatitis thought they had a handle on what to eat and what to avoid, new research has emerged complicating their previously memorized liver health consumption list. Keeping up with science’s discoveries has never been more important, as researchers demonstrate that pairing two common items can have devastating consequences to someone with an already compromised liver. Even though most people with chronic hepatitis know that too much acetaminophen can cause liver failure, few are aware that even small amounts can be dangerous when paired with a habitual cup of coffee.

The Warning
As published in an October 2007 issue of Chemical Research in Toxicology, University of Washington researchers reported that those who consume caffeine with acetaminophen could be at a higher risk of liver damage. Acetaminophen often has caffeine added because it enhances the effects of the painkiller. Although previous studies have linked alcohol consumption and acetaminophen use to liver damage, this is the first study to link caffeine to the danger.

The University of Washington team found that caffeine can triple the amount of a toxic byproduct, N-acetyl-p-benzoquinone imine (NAPQI), an enzyme produced while breaking down acetaminophen. This enzyme is also responsible for the liver damage and failure in most toxic alcohol-acetaminophen interactions. Even though the researchers conducted their testing using E. coli bacteria, they confidently conclude that the peril of combining caffeine with acetaminophen also applies to humans.

According to lead researcher Sid Nelson, M.D., “The bottom line is that you don’t have to stop taking acetaminophen or stop taking caffeine products, but you do need to monitor your intake more carefully when taking them together, especially if you drink alcohol.” While this warning appears mild, gambling with these two simultaneously is just too risky for those already living with chronic hepatitis.

Acetaminophen
One of the most popular over-the-counter medications for pain and fever relief is acetaminophen. Although sold over-the-counter, this drug is far from safe for those with liver disease. Capable of causing liver damage or even acute liver failure, acetaminophen poisoning accounts for over 56,000 emergency room visits in the United States each year.

Though most people are only at risk for liver toxicity if they take more than the normal recommended dose, living with chronic hepatitis can render someone more susceptible to acetaminophen toxicity. In fact, a study by the U.S. Food and Drug Administration (FDA) showed that about 20 percent of people with acetaminophen-related liver toxicity had taken less than the recommended daily amount.

Acetaminophen (paracetamol) can be found in the following drugs:

· Tylenol
· Excedrin
· Midol
· NyQuil
· Sudafed
· Vicodin

Acetaminophen with Hepatitis
Despite the plentitude of discomfort it can cause, interferon therapy is the most likely route chosen for those battling chronic hepatitis. Physicians often recommend acetaminophen to relieve the most common side effects of interferon therapy, such as body aches and fever. Even though it can cause liver damage, acetaminophen in restricted dosages and under doctor supervision is often the best choice for pain and fever relief for those with chronic hepatitis. Because the other choices (aspirin and non-steroidal anti-inflammatories) can cause gastrointestinal upset or even stomach bleeding, acetaminophen remains a strong over-the-counter contender.

Caffeine
When it comes to caffeine consumption, the general consensus seems to be opposite that of acetaminophen. A United States population study of nearly 6,000 adults was conducted by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2004. This study divulged a strong association between coffee drinking and a lowered risk of liver injury in those at high risk for liver disease. In this NIDDK report, liver injury was defined as serum alanine aminotransferase (ALT) levels over 43 U/L and the high-risk population was defined as:

· being heavy drinkers of alcohol
· having Hepatitis B or C
· having an iron overload
· being obese
· having impaired glucose metabolism

The researchers concluded that the greater the coffee consumption, the greater the association with liver protection. Upon learning of this coffee advantage, many people with chronic hepatitis heaved a sigh of relief as they continued their relationship with caffeinated beverages.

Bad Combo
Even though you may take doctor-recommended acetaminophen for symptom relief and drink coffee to help protect your liver, those with chronic hepatitis must be careful to separate the two. If caffeine can multiply acetaminophen’s potential toxicity by three, it may not be safe to take Tylenol to relieve those body aches. Until further confirmation arrives on exactly how much you can take of what, at exactly which time intervals, those living with chronic hepatitis are hereby warned to separate their caffeine fix with as much time as possible from a dose of acetaminophen.

References:

www.foxnews.com, Mixing Tylenol with Caffeine May Increase the Risk of Liver Damage, Study Finds, Tina Benitez, Fox News Network, LLC, September 2007.

www.hcvadvocate.org, Acetaminophen and Your Liver, Liz Highleyman, Hepatitis C Support Project, January 2005.

www.medicalnewstoday.com, Combining Acetaminophen with Caffeine Might Cause Liver Damage, Christian Nordqvist, Medical News Today, September 2007.

www.medicinenet.com, Caffeine Plus Acetaminophen Toxic for Some, Steven Reinberg, MedicineNet Inc., September 2007.

www.medscape.com, Coffee, Caffeine Consumption Associated With Reduced Liver Disease, Karla Harby, Medscape, 2007.

www.sciencedaily.com, Acetaminophen, Caffeine Shouldn’t be Mixed, ScienceDaily LLC, September 2007.

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January 19, 2009

Why Depression is Likely With Hepatitis C

Physicians are finding an increasing correlation with HCV infection and clinical depression. Learn about the four possible mechanisms linking depression with Hepatitis C, as well as the role standard combination therapy may play in this relationship.

by Nicole Cutler, L.Ac.

As the most common blood borne viral infection today, the Hepatitis C virus (HCV) is a major cause of chronic liver disease and affects an estimated 180 million people worldwide. For many living with HCV, the standard therapy of peginterferon-alfa and ribavirin is either not an option or it was unsuccessful. Whether an HCV-infected person has not attempted standard therapy or is a non-responder, physicians are finding an increasing correlation with HCV infection and clinical depression. Being aware of depression’s prevalence among this population and its potential mechanisms will encourage both patients and their physicians to take depression seriously.

Defining Depression
According to the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV), major depressive disorder is characterized by a period of depressed mood or anhedonia (inability to experience pleasure from normally pleasurable life events such as eating, exercise, social or sexual interaction) occurring for at least two consecutive weeks. Depressed mood or anhedonia must also be accompanied by at least four of the following:

· Overwhelming sadness or emptiness
· Lack of interest or pleasure in daily activities
· Appetite or weight changes
· Disturbed sleep patterns
· Changes in psychomotor activity
· Fatigue or loss of energy
· Feelings of guilt or worthlessness
· Difficulty focusing, concentrating or making decisions
· Recurrent thoughts of death or suicidal ideation

A result of inconsistent measures of depression, calculating the actual prevalence of depression among patients with chronic HCV infection is challenging. Nevertheless, most researchers and physicians agree that the prevalence of depressive disorders is significantly higher among HCV-infected patients compared with the general population. According to the DSM-IV criteria, reported prevalence rates for major depressive disorder are higher in those with HCV:

· Ranging from 24 to 70 percent with chronic Hepatitis C infection
· Ranging from 6 to 10 percent in the general population

HCV Treatment
Hepatitis C’s current standard of treatment consists of combination therapy with peginterferon-alfa and ribavirin for 24 or 48 weeks depending on viral genotype. Although the treatment response rates are favorable for those able to complete this therapy, many must abandon the treatment protocol due to combination therapy’s severe side effects. Some studies indicate that chemically-induced depression occurs in approximately 20 to 40 percent of treated patients. Administering physicians have observed that depression associated with HCV therapy reduces the likelihood of eliminating the virus with peginterferon-alfa and ribavirin, due to patient non-compliance or even premature discontinuation.

Possible Mechanisms
The various factors contributing to major depressive disorder makes it difficult to establish a causative relationship between HCV infection and depression. The origins of depression with Hepatitis C are most likely a combination of physiological characteristics of the virus, emotional and physical health of the individual, the extent of a person’s social support network, personal beliefs and available treatment options. Following are four potential mechanisms connecting chronic HCV infection and depression:

1. Pre-Existing Condition – This theory suggests that having a psychiatric disorder, such as depression or posttraumatic stress disorder, can lead to high-risk behaviors increasing the probability for HCV infection, such as intravenous drug use or unprotected sexual practices. According to this premise, HCV itself is not the causative agent for depression, but there is a high prevalence of depression in individuals who engage in risky behaviors. Several studies have found higher incidences of drug use and unsafe sexual practices among patients with major depressive disorder or other depressive symptoms.

2. Psychological Impact of HCV – This theory suggests that depression related to HCV infection is due to the psychological burden and distress associated with this chronic disease. Foster and colleagues demonstrated that in a sample of HCV-infected patients without cirrhosis, quality of life scores were reduced, particularly regarding mental health and physical function, when compared with a control group. Many health experts are recognizing that chronic Hepatitis C virus infection alone leads to physical symptoms capable of reducing a person’s quality of life, the springboard for depression.

3. Biological Result of HCV – This theory describes the potential for the Hepatitis C virus to negatively affect the central nervous system bringing about depression. Although not directly proven, this hypothesis is supported by studies demonstrating that HCV directly causes fatigue and other neuro-cognitive symptoms. Adair and colleagues used gene expression analysis to evaluate gene expression in HCV-infected patients and a control group. The researchers found a difference in the expression of 29 genes, including those involved in brain oxidative and energy metabolism. These findings support a biological basis for the link between HCV infection and depression. Additionally, Hepatitis C viral particles noted to cause chemical changes that could initiate depressive symptoms have been found in the central nervous system.

4. Psycho-Spiritual Perception – Best-selling author and motivational speaker, Esther Hicks, describes depression as a location on one extreme edge of an emotional scale. On one end of this scale, good feelings are likened to the perception of freedom; on the other end bad feelings are likened to the perception of bondage. Bondage, otherwise felt as lack of freedom or control, embodies the empty sensation of depression. According to this psycho-spiritual theory, Hepatitis C is often associated with depression, because many affected feel that their ability to recover from this illness is beyond their control. Such feelings of hopelessness in those with Hepatitis C may occur when those affected:

· Are informed their disease is incurable
· Feel doubtful about ridding themselves of Hepatitis C
· Experience severe side effects from standard therapy, causing the perception that their condition is worsening – further confirming a loss of control over their health

By accumulating hopefulness about a Hepatitis C diagnosis, a person will naturally progress on the emotional scale away from fear, and thus away from depression.

Patients and their physicians must be aware of the simultaneous presentation of HCV and depression, the role combination therapy may play in this relationship and the four possible mechanisms linking depression with Hepatitis C. Armed with this knowledge, we can be proactive in addressing major depressive disorder as affiliated with chronic Hepatitis C infection.

References:

http://clinicaloptions.com, Risks and Mechanisms of Depression in HCV, Michael R. Krauss, MD, PhD, Depression Associated With HCV Infection and Its Therapy: Impact on Patient Management, Clinical Care Options, LLC, March 2007.

http://jac.oxfordjournals.org, Interferon-induced depression in chronic hepatitis C, Y. Horsmans, Journal of Antimicrobial Chemotherapy, September 2006.

www.abraham-hicks.com, It’s All About Vibrational Relativity, Abraham-Hicks Publications, 2007.

www.natap.org, Chronic Hepatitis C, Depression and Interferon, Journal of Hepatology, June 2005.

www.psychiatrictimes.com, Depression as Co-Pilot: Clinical Implications of Hepatitis C and Interferon/Ribavirin Treatment, James A. Bourgeois, MD, OD, Lorenzo Rossaro, MD, and Robert D. Canning, PhD, Psychiatric Times, April 2005.

Posted by Editors at 10:59 AM --- Printer-friendly version

Latinos Less Responsive to Hepatitis C Therapy

Once again, ethnicity appears to be a factor in the effectiveness of Hepatitis C treatment. Sponsored by Roche, a recent study shows that Latinos have a lower response rate to standard treatment with peginterferon alfa-2a and ribavirin than non-Latinos.

HCV Therapy Less Effective in Latinos

By Michael Smith, North American Correspondent, MedPage Today

Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.

SAN JUAN, Puerto Rico, Jan. 14 -- Latino whites with chronic hepatitis C virus infection respond poorly to therapy, compared with non-Latino Caucasians, researchers here said.

The finding, from a prospective but non-randomized study, adds ethnicity to the factors that predict outcomes to standard therapy for chronic HCV, according to Maribel Rodriguez-Torres, M.D., of the Fundacion de Investigacion de Diego, and colleagues.

And because the U.S. Latino population is growing, it may also highlight an important public health issue, Dr. Rodriguez-Torres and colleagues said in the Jan. 15 issue of the New England Journal of Medicine.

Previous studies have shown that blacks have a reduced response to standard treatment with peginterferon alfa-2a (Pegasys) and ribavirin (Copegus), the researchers noted, possibly because of a reduced sensitivity to interferon or diminished HCV-specific immunity.

At the same time, more limited data have hinted that a similar effect is present among Latinos, but because Latinos are often under-represented in clinical trials, the findings were not considered conclusive evidence that ethnicity plays a role in response, the researchers said.

To fill the gap, they enrolled 269 Latino and 300 non-Latino whites with chronic HCV genotype 1 infection, who had not previously been treated, for an open-label, non-randomized study.

They were given peginterferon alfa-2a at 180 mcg a week and ribavirin at 1,000 or 1,200 mg daily (depending on body weight) for 48 weeks and followed for another 24 weeks.

The primary endpoint of the study was sustained virologic response -- defined as undetectable HCV RNA level -- less than 28 IU/mL -- 24 weeks after the end of treatment.

The researchers also looked at secondary endpoints such as responses during treatment, rapid responses, and relapses.

Analysis showed:

* Baseline characteristics were similar, although more Latino patients were 40 or younger, had a body mass index of more than 27 or more than 30, and had cirrhosis.
* The rate of sustained virologic response was 49% among non-Latino whites compared with 34% among Latinos, a difference that was significant at P<0.001).
* Non-Latinos were significantly more likely (at P=0.045) to have undetectable HCV RNA in serum at week four and the advantage continued at all subsequent time points (P<0.001 for other comparisons.
* In an analysis adjusted for baseline differences in body mass index, cirrhosis, and other characteristics, non-Latinos were almost seven times more likely to have a sustained virologic response. The odds ratio was 6.93, significant at P<0.001.
* In both groups, a lower baseline HCV RNA level predicted a sustained virologic response.
* Adherence did not differ significantly between the two groups.
* And the number of patients with adverse events and dose modifications was similar, but fewer Latino patients stopped treatment owing to adverse events.

The findings "add to a growing body of evidence of differences in treatment responses among ethnic groups," Dr. Rodriguez-Torres and colleagues concluded.

They added that better treatment strategies are needed to improve the rate of sustained virologic response among Latinos with chronic HCV genotype 1.

They suggested that "Latinos should be considered for clinical trials involving specifically targeted antiviral therapies for hepatitis C to determine whether the addition of investigational agents to standard therapy improves the rate of response in this difficult-to-treat population."

The study was supported by Roche. Dr. Rodriguez-Torres reported financial links with Roche, Abbott Laboratories, Anadys, Pharmasset, Vertex, Glaxo-SmithKline, Bristol-Myers Squibb, Valeant, Novartis, Wyeth, Virochem Pharma, Idera, Intarcia, sanofi-aventis, Human Genome Sciences, Idenix, Pfizer, Gilead, Tibotec, and Merck.

Primary source: New England Journal of Medicine
Source reference:
Rodriguez-Torres M, et al "Peginterferon alfa-2a and ribavirin in Latino and non-Latino whites with hepatitis C" N Engl J Med 2009; 360: 257-67.

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URL for Article Source: http://www.medpagetoday.com/Gastroenterology/Hepatitis/12451

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January 14, 2009

Hepatitis C, Fatigue and Mitochondria

Biologists have known for a long time that the mitochondria in human cells are where energy is made. However, scientists are just now becoming aware of how living with Hepatitis C damages the mitochondria and why this causes fatigue. Fortunately, this understanding offers a unique solution to the exhaustion caused by Hepatitis C.

by Nicole Cutler, L.Ac.

The most commonly encountered symptom in clinical healthcare settings is fatigue, a problem that plagues a majority of people living with chronic disease. While many mechanisms may be responsible for the fatigue characteristic of the Hepatitis C virus (HCV), one burgeoning theory may have a simple remedy. Possibly due to the medications used to treat it or a direct impact from the virus, chronic HCV is believed to damage the cell’s mitochondria.

Remembering back to high school biology, mitochondria are known as the cell’s power centers. Containing hundreds to thousands of mitochondria in each cell, these organelles are responsible for creating adenosine triphosphate (ATP), molecules that release energy. Scientists believe that a breakdown of the mitochondria’s membrane is a significant factor in mitochondrial damage. Occurring with aging and chronic disease, the breakdown of this membrane directly correlates with a decline in energy levels.

Some of the factors capable of causing damage to the mitochondria include:

· Toxic substances
· Oxidative stress from free radicals
· Viruses that attack membranes

When it comes to living with the Hepatitis C virus, two reasons stand out for causing mitochondrial membrane damage and, therefore, fatigue:

1. Drugs used for treatment
2. The Hepatitis C virus itself

Drugs: Mitochondrial Toxicity
When medications cause damage to the mitochondria, it is known as mitochondrial toxicity. Used for standard HCV combination therapy, ribavirin is known to be toxic to mitochondria. Ribavirin is a nucleoside analog drug, a class of medications particularly likely to cause mitochondrial damage.

When viruses replicate, a process that involves building new chains of genetic material, viral enzymes may mistakenly add a nucleoside or nucleotide analog onto the chain instead of a normal nucleotide. This mistake causes the viral replication process to grind to a halt. Nucleoside analog drugs can act similarly, interfering with the production of DNA in mitochondria. Unlike other locations for DNA, mitochondria have no mechanism for detecting and fixing such an error. Although potentially able to stop HCV from replicating, nucleoside analogs can also stop the mitochondria from maintaining its longevity.

While severe mitochondrial toxicity is uncommon among those only taking ribavirin, simultaneously taking two or more drugs that can potentially injure the mitochondria poses a much greater risk. People co-infected with HIV/HCV who take ribavirin in combination with anti-retroviral drugs have exhibited more damage to this valuable cell organelle. Some other drugs in use or in development for Hepatitis C that are also nucleoside analogs include:

· Taribavirin (Viramidine) – this drug is a pro-drug of ribavirin, which is converted to ribavirin.

· Polymerase Inhibitors – while not all polymerase inhibitors are nucleoside analogs, valopicitabine (NM283), R-1626 and MK-0608 are.

Viral Damage
It has been suggested that the actual Hepatitis C virus itself may contribute to mitochondrial dysfunction. In addition to the potential mitochondrial damage from therapeutic drugs, several studies have suggested that the Hepatitis C virus contributes to this organelle’s deterioration:

· According to a study published in the July 2006 edition of Journal of Virology, researchers reported that HCV infection causes cellular DNA damage and mutations. This injury was confirmed to be mediated by nitric oxide (NO), a substance known to damage mitochondria.

· A recent study found an inverse relationship between HCV viral load and the amount of mitochondrial DNA in peripheral blood mononuclear cells. This means that a rise in HCV viral particles in a person’s system corresponds with fewer functional mitochondria.

· According to a study published in the September 2005 Journal of Biological Chemistry, a Hepatitis C viral protein directly affects mitochondria. By looking at the oxidative stress caused by free radicals, researchers concluded that antioxidant therapy may defend against some of HCV’s damage to mitochondria.

Lipid Replacement Therapy
Preventing mitochondrial cell membrane damage and loss of membrane integrity are important for averting the loss of cellular energy. One popular method that has been used to replace damaged components of the mitochondrial membrane is replacement therapy. By replacing the damaged lipids with phospholipids and fatty acids essential to the structure and function of biological membranes, restoration of the mitochondria’s boundaries is possible.

The first outward sign of mitochondrial membrane deterioration is likely to be fatigue. Damage to the mitochondrial membrane results in the following cascade of events:

1. Its phospholipid structure loses fluidity which leads to…
2. An increasingly porous membrane which leads to…
3. A reduction in the membrane’s electrical potential which leads to…
4. A decreased capability of making cellular energy.

Using lipid replacement therapy, the innovation of NT Factor® has been successful in repairing the mitochondrial membrane and restoring people’s energy levels. Shown in clinical studies to increase participant’s energy by up to 40 percent, NT Factor® has helped many people combat the mitochondrial membrane’s decline. With the ability to strengthen this important membrane, the mitochondria become more resilient to nucleoside analogs and virally-induced damage – thus preserving a person’s energy.

Affecting between 65 and 75 percent of people with HCV, profound fatigue is a likely result of a deficiency in the mitochondria. Helping to sustain the fluidity of cell’s mitochondrial membranes has the direct result of maintaining youthful vigor. Whether due to aging, medications or a result of HCV, consider lipid replacement therapy as a means to energize your mitochondria and abandon excessive tiredness.

References:

Agadjanyan, Michael, PhD, Garth L. Nicholson, PhD, et al., Nutritional Supplement (NT Factor™) Restores Mitochondrial Function and Reduces Moderately Severe Fatigue in Aged Subjects, Journal of Chronic Fatigue Syndrome, 2003.

Machida K., et al., Hepatitis C virus triggers mitochondrial permeability transition with production of reactive oxygen species, leading to DNA damage and STAT3 activation, Journal of Virology, July 2006.

Masaaki Korenaga, et al., Hepatitis C virus core protein inhibits mitochondrial electron transport and increases ROS production, Journal of Biological Chemistry, September 2005.

Okuda M., et al., Mitochondrial injury, oxidative stress, and antioxidant gene expression are induced by hepatitis C virus core protein, Gastroenterology, February 2002.

www.hcvadvocate.org, Mitochondrial Toxicity, Liz Highleyman, Hepatitis C Support Project, August 2007.

Posted by Editors at 11:55 AM --- Printer-friendly version

January 06, 2009

Gambling, Alcoholism and Alcoholic Hepatitis

Discover why alcoholic hepatitis, pathological gambling and alcoholism can all benefit from supplementing with a well-known amino acid.

by Nicole Cutler, L.Ac.

Although alcoholism is not a prerequisite to alcoholic hepatitis or pathological gambling, all three of these predicaments are entangled in a web of similarities. Alcoholism is a chronic disease where a person is dependent on alcohol; alcoholic hepatitis is a condition that progressively harms the liver as more alcohol is consumed; and pathological gambling is an inability to stop gambling even when one recognizes that it is causing serious life problems. Each of their respective definitions makes them entities onto themselves. However, one single supplement can help all three of these problems.

Several of the facts supporting their intertwined web are:

· At their core, alcoholism and pathological gambling are both serious addictions.

· Abusing alcohol is the most straightforward path towards developing alcoholic hepatitis.

· As a treatment approach, supplementing with N-Acetyl Cysteine (NAC) has been shown to help alcoholism, alcoholic hepatitis and pathological gambling.

N-Acetyl Cysteine
Glutathione is a powerful antioxidant found within every one of the body’s cells. Known to defend the cell it inhabits against damage, glutathione is often depleted with repeated exposure to toxins, increasing age and chronic disease. Rapidly metabolized to glutathione by the body, NAC is an amino acid supplement. Thus, it is used by many healthcare professionals to protect people’s cells from the universal cause of declining health, cellular damage.

Alcoholism
According to a study published in the Archives of General Psychiatry, approximately thirty percent of U.S. adults have experienced alcohol abuse or alcoholism. Alcohol abuse involves engaging in excessive drinking that causes health or social problems without a full loss of control or dependence on alcohol. Alcoholism, or alcohol dependence, is a disease that includes these four symptoms:

1. Craving alcohol

2. Loss of control – not being able to stop drinking

3. Physical dependence – experiencing withdrawal symptoms such as nausea, sweating, shakiness and anxiety after stopping drinking

4. Tolerance – the need to drink greater amounts of alcohol to get high

With full commitment and support, alcoholism is considered to be treatable. Medications, counseling and self-help groups are among the therapies that can help an alcoholic recover. While taking NAC is not advised as part of this recovery, it can help protect the liver from alcohol’s damage. This is because of the following:

· Responsible for alcohol-induced liver damage, acetaldehyde is a toxic byproduct of alcohol consumption.

· N-Acetyl Cysteine binds to acetaldehyde, thus preventing its damaging effects.

Alcoholic Hepatitis
Inflammation of the liver caused by alcohol consumption, alcoholic hepatitis does not necessarily result from an alcohol addiction. However, alcoholic hepatitis is more likely to develop in heavy drinkers than those who rarely or moderately indulge.

In those unable or unwilling to abstain from drinking alcohol, alcoholic hepatitis can easily progress to cirrhosis and liver failure. Unfortunately, it might be extremely difficult for those with an addiction to alcohol to quit – putting them most in danger of this fate.

Taking a supplement is not a substitute for alcohol abstinence. However, NAC can help the liver of someone with alcoholic hepatitis much in the same way that it may benefit an alcoholic. Because it can replenish depleted glutathione levels, those with all kinds of liver inflammatory diseases could benefit from NAC supplementation.

Pathological Gambling
Although there is no substance that a person swallows, snorts, injects or smokes, pathological gambling is a problematic addiction. Compulsive gambling parallels alcohol and drug addiction in many ways, including losing control over one’s behavior and commonly lying and cheating in order to continue one’s addiction. Problematic gambling is more common among those who abuse or are dependent on alcohol than in those without an alcohol use disorder.

The action that compulsive gamblers crave is an aroused, euphoric state comparable to the high sought by drug users. This aroused state is accompanied by changes in brain chemistry similar to those caused by alcohol or drugs. Those with an addiction typically develop a tolerance to gambling much like alcoholics develop a tolerance to alcohol. In order to create the same amount of excitement, pathological gamblers often increase the size of their bets or the odds against them.

By the time most pathological gamblers seek help, they are in enormous debt and their relationships with friends and family members have been destroyed. Statistics show that about 80 percent of pathological gamblers seriously consider suicide, and 13 to 20 percent actually attempt it or kill themselves.

The gravity of this problem drove researchers at the University of Minnesota to look for unconventional solutions to pathological gambling. They discovered that supplementing with NAC might help curb pathological gamblers’ addiction. Published in the September 2007 edition of Biological Psychiatry, the researchers believe this has to do with NAC’s impact on brain chemistry. Because NAC affects glutamate, a chemical in the brain frequently associated with reward, NAC may help to control various types of addictions – including pathological gambling.

N-Acetyl Cysteine is far from a panacea for addictions or diseases characterized by liver inflammation. However, the more it is studied, the greater range of conditions it proves to aid. By replenishing depleted glutathione levels, protecting liver cells from damaging toxins and affecting the brain to reduce an addict’s need for reward, NAC possesses enormous healing potential. Until this amino acid’s full value is realized, supplementing with N-Acetyl Cysteine could help support those battling alcoholism, alcoholic hepatitis or pathological gambling.

References:

Grant JE, et al, N-acetyl cysteine, a glutamate-modulating agent, in the treatment of pathological gambling: a pilot study, Biological Psychiatry, September 2007.

http://findarticles.com/p/articles/mi_6839/is_2008_Jan/ai_n28493756, N-acetyl cysteine may curb gambling addiction, Life Extension, Dayna Dye, Retrieved December 22, 2008, Life Extension, January 2008, CBS Interactive Inc., 2008.

http://pubs.niaaa.nih.gov/publications/arh26-2/143-150.pdf, Pathological Gambling and Alcohol Use Disorder, Jon E. Grant MD, et al, Retrieved December 22, 2008, Alcohol Research and Health, 2002; 143-50.

http://rf-web.tamu.edu/security/SECGUIDE/Eap/Gamble.htm, Compulsive Gambling, Retrieved December 22, 2008, Texas A&M Research Foundation, 2008.

http://www.lifeextensionvitamins.com/ananwihe.html, Anti-Alcohol Antioxidants with Hepatoprotection, Retrieved December 25, 2008, Life Extension Vitamin Supplies and Life Extension Institute, Inc., 2008.

http://www.mayoclinic.com/health/alcoholism/DS00340, Alcoholism, Retrieved December 25, 2008, Mayo Foundation for Medical Education and Research, 2008.

http://www.medicalnewstoday.com/articles/82240.php, Pathological Gamblers Addiction Targeted By Health Food Supplement, Retrieved December 22, 2008, MediLexicon International Ltd, September 2007.

http://www.webmd.com/mental-health/alcohol-abuse/news/20070702/
alcohol-abuse-alcoholism-common, Alcohol Abuse, Alcoholism Common, Miranda Hitti, Retrieved December 25, 2008, WebMD LLC, 2008.

http://www1.umn.edu/umnnews/Feature_Stories/Curbing_gambling_
addiction_with_food_supplements.html#, Curbing gambling addiction with food supplements, Retrieved December 22, 2008, Regents of the University of Minnesota, September 2007.

Posted by Editors at 11:28 AM --- Printer-friendly version

January 05, 2009

Hepatitis C and Fibromyalgia: The Possible Link

Learn about the potential connection between Hepatitis C and fibromyalgia, and find out why it is possible that Hepatitis C infection may act as a trigger for fibromyalgia syndrome. If you suspect having both conditions, awareness of this link can lead you to seek the expert evaluation and care that may help reduce your symptoms of pain and fatigue.

by Nicole Cutler, L.Ac.

Due to overwhelming empirical evidence, some medical circles believe that the symptoms and presenting patterns shared between Hepatitis C and fibromyalgia are beyond coincidental. While Hepatitis C is known to be transmitted through infected blood, authorities are still debating how fibromyalgia is acquired. Due to similarities in manifestation and physiology, there is a possibility that Hepatitis C infection may be one of fibromyalgia syndrome’s triggers. If you suspect having both conditions, awareness of this link can lead you to seek the specialized evaluation and care that may improve your most frustrating symptoms.

Prevalence
Estimates of disease prevalence in the United States approximate the number of people living with fibromyalgia to be around 6 million people, while the number of people known to be living with Hepatitis C hovers just above 4 million. While accurate statistics of the number of people affected by both diagnoses are not currently available, a surprising number of people dually diagnosed with Hepatitis C and fibromyalgia are emerging. However, one study did find the prevalence of fibromyalgia in people with Hepatitis C (15 to 19 percent) to be much higher than the occurrence of fibromyalgia in the general American population (2 percent).

Fibromyalgia
Fibromyalgia is a syndrome causing widespread muscle pain, extreme fatigue and multiple tender points in specific parts of the body. With pain characterized as aching, burning, stabbing and throbbing, its severity can vary widely. While fibromyalgia is a chronic condition, it is not a progressive disease. However, this condition can greatly reduce the quality of life of those affected.

Experts do not agree on what causes fibromyalgia. When trying to determine the etiology of this complex syndrome, it is challenging to discern between cause and effect. The endless cycle of pain, inactivity, insomnia, fatigue and depression typical of fibromyalgia complicates the isolation needed to trace this syndrome’s origins. Although researchers have identified several possible reasons for fibromyalgia, it remains unclear if they are a cause, or part of the problem. Some of the leading contenders for what triggers fibromyalgia include:

· Hormone Imbalance
· Infectious Disease
· Immune System Malfunction
· Sleep Disorder
· Traumatic Event
· Muscle Abnormality

The Hepatitis C Connection
Although not yet confirmed, many experts believe that Hepatitis C may act as a trigger to the onset of fibromyalgia. The documented links between the two conditions include:

· Symptom Specificity – Fibromyalgia and chronic Hepatitis C infection share many clinical features including musculoskeletal pain and fatigue. While the two conditions do not always accompany each other, some symptoms may be unique when a person has both fibromyalgia and Hepatitis C. One study found that people dually diagnosed with fibromyalgia and Hepatitis C exhibit symptoms such as inflammation around a joint, bursa and/or tendon, and vasculitis (blood or lymph vessel inflammation) that are not seen in Hepatitis C negative people with fibromyalgia.

· Immune Proteins – Cytokines are proteins that regulate immune response. Interleukins are a specific type of cytokine that cause a person to feel pain. Several interleukins have been found to be dramatically elevated in fibromyalgia patients. Harvard researchers found those same interleukins increased in production when exposed to the Hepatitis C virus.

· Hepatitis C and Pain – Many people infected with Hepatitis C virus infection complain of myalgias, arthritis and widespread pain. When compared to other liver diseases, the frequency of musculoskeletal pain clearly favors Hepatitis C. The frequencies of musculoskeletal pain for the following isolated conditions are as follows: Alcoholic liver disease = 48 percent, Hepatitis B = 59 percent and Hepatitis C = 91 percent. As fibromyalgia’s most prominent symptom, it is not surprising that musculoskeletal pain may represent the link to Hepatitis C.

Infectious Cause
Certain infections, notably viruses, often occur in the histories of people with fibromyalgia. As these infectious organisms invade the body, scientists think they may cause damage at a cellular level. While fibromyalgia is considered to be non-contagious, it is possible that it may be a manifestation of a viral disease such as Hepatitis C, which is contagious. While many infectious microorganisms have been tied to fibromyalgia, the link with Hepatitis C is becoming increasingly suspect. At this point, there is sufficient evidence linking infectious diseases and fibromyalgia together, but it is unknown if any of these microorganisms are fibromyalgia’s origin, a simultaneous condition or a result.

Why it Is Important
A high prevalence of fibromyalgia has been found in patients infected with Hepatitis C, especially women. According to Israeli researchers, recognizing fibromyalgia in people with Hepatitis C will prevent misinterpretation of fibromyalgia symptoms as part of the liver disease and enable physicians to correctly focus on alleviating these symptoms.

A doctor well versed in fibromyalgia should be consulted if this syndrome is suspected. Because its diagnosis is not simple and symptoms often overlap with other conditions, a proper evaluation will test for fibromyalgia while ruling out other diseases. Doctors who are familiar with fibromyalgia typically make a diagnosis based on criteria established by the American College of Rheumatology (ACR). Those criteria are:

1. Widespread pain (right and left side body pain, above and below the waist) that lasts for more than 3 months.

2. Eleven or more tender points present at 18 specific sites on the body.

Whenever there is a profound crossover in a disease’s symptoms, we can learn from their parallels. Although many questions shroud the connection between fibromyalgia and Hepatitis C, their relationship exists in many people with either condition. With their comparable symptoms, similar immune biochemistry and irrefutable statistics of simultaneous presentation, exposure to the Hepatitis C virus may be one of fibromyalgia’s triggers.

Understanding this connection may prompt a person with fibromyalgia to get tested for Hepatitis C or it may help a person with Hepatitis C seek evaluation for fibromyalgia. If you think you might be burdened with both conditions, discuss your thoughts with your primary healthcare provider. By taking this proactive stance, you may open yourself up to new ways of reducing Hepatitis C’s challenging symptoms of pain and fatigue.

References:

www.archinte.ama-assn.org, Fibromyalgia in hepatitis C virus infection. Another infectious disease relationship, Buskila D., et al, Archives of Internal Medicine, November 1997.

www.cdc.gov, Viral Hepatitis C Fact Sheet, US Department of Health and Human Services, 2007.

www.hcvadvocate.org, Extrahepatic Manifestations: Hepatitis C and Fibromyalgia, Alan Franciscus, HCV Advocate, July 2006, Hepatitis C Support Project, 2007.

www.ihop-net.org, Fibromyalgia, hepatitis C infection and the Cytokine connection, Thompson ME, Barkhuizen A, Current Pain and Headache Reports, 2003.

www.medscape.com, Fibromyalgia Pain: Do We Know the Source?, Roland Staud, Current Opinion In Rheumatology, April 2004.

www.rheumatology-oxfordjournals.org, Fibromyalgia-associated hepatitis C virus infection, Rivera J, et al., The British Journal of Rheumatology, 1997.

www.vir.sgmjournals.org, Structural proteins of Hepatitis C virus induce interleukin 8 production and apoptosis in human endothelial cells, Anuradha Balasubramanian,, et al., Journal of General Virology, 2005.

Posted by Editors at 04:18 PM --- Printer-friendly version

December 31, 2008

Hepatitis C Genotype Guides Health Plans

Because the suggested treatment length and success rates vary between genotypes, it is typically one of the first distinctions made after a Hepatitis C diagnosis. In order to assure the correct course of therapy is approved, health insurance companies are demanding to know their members' Hepatitis C genotype.

Genotype Testing Is Crucial to Course of Therapy for Hepatitis C Patients

December 30, 2008

Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers manage costs more aggressively and deliver biotechs and injectables more effectively.

By Angela Maas, Managing Editor, (amaas@aispub.com)

With hepatitis C patients, the length of treatment depends upon which of the six hepatitis C genotypes the person has. According to Beckie Fenrick, Pharm.D., director of clinical pharmacy at Blue Cross and Blue Shield of Florida, the treatment regimen for genotypes 2 and 3 is generally 24 weeks, while the regimen for 1, 4, 5 and 6 is 48 weeks. The most common genotypes in the U.S. are 1, 2 and 3.

Many health plans require physicians to provide the organization with the genotype information so they can be sure the patient is receiving the appropriate length of therapy. According to Enoch Strollo, vice president of sales and marketing for BioPlus Specialty Pharmacy, genotype testing costs typically between $450 and $600, and health plans typically cover this expense.

Some plans that spoke to SPN say they require genotype testing either before therapy begins or shortly thereafter.

According to Beverly Franklin-Thompson, Northeast regional pharmacy director for BlueCross BlueShield of Tennessee, BCBST allows patients to immediately begin treatment but then requires the physician to follow up with the patient's genotype. "This minimizes impediments to treatment initiation, allowing a patient to immediately fill the prescriptions for the hepatitis C medications," she says. After a physician notifies BCBST of the patient's genotype, "an approval for a specific duration of treatment is granted," she explains. "A nurse contacts the prescriber to assure that certain tests are being performed and to obtain the results of those tests so that the duration of treatment can be determined and authorization loaded. No prior authorization is required to begin therapy; however, to continue treatment beyond the first few months, clinical parameters such as genotyping must be obtained."

The Florida Blues plan requires physicians to determine patients' genotype so it can make sure patients undergo the appropriate length of therapy. The plan also has practitioners notify it of patients' viral loads at the 12-week mark. If there has been "an appropriate reduction, the approval for additional weeks occurs," Fenrick explains. CIGNA HealthCare also requires a follow-up lab test after the first 12 weeks of therapy, says Todd Cooperman, Pharm.D., director of specialty pharmacy clinical program development.

Mark Leeper, vice president of marketing and clinical program development for PrecisionRx Specialty Solutions, WellPoint, Inc.'s specialty pharmacy, says that when a plan does not require genotype testing, "we do highly encourage it." He explains that "a member's hepatitis C genotype will drive treatment and monitoring. Type 1 genotype is more difficult to treat and requires members to stay on the therapy longer. Also, changes in viral load are influenced by genotype. We conduct baseline information on viral load, and then repeat testing for all genotypes at four, 12 and 24 weeks. For Type 1, we continue testing at 36 weeks and 48 weeks. This schedule is important to allow physicians to adjust dosing to respond to the patient's viral load."

He says if those patients with genotype 1 "don't respond by week 12, they are unlikely to respond, and continuing with therapy is not productive."

Sara Deno, Pharm.D., a manager of clinical services for BioScrip, Inc., who also oversees the adherence and therapy optimization program BioScripCare for hepatitis C, says that plans can structure prior authorizations so that patient response is checked at various intervals.

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http://www.aishealth.com/Bnow/hbd123008.html

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December 30, 2008

Foretelling Hepatitis C Drug Success

By utilizing a mathematical formula on the specific genetics of an individual's Hepatitis C infection, doctors may be able to predict whether or not treatment will be successful.

Study may predict if hepatitis C drugs will work

December 23, 2008

By Julie Steenhuysen

CHICAGO (Reuters) - Doctors hope to be able to better predict which patients will respond to traditional treatment for the hepatitis C virus using a new method for identifying slight variances in the virus' genetic makeup.

U.S. researchers said on Monday that the technique may prove useful for other viruses such as HIV as well. The finding could be used to develop a test that would analyze a patient's specific virus strain before treatment was started.

A team at Saint Louis University in Missouri analyzed genetic patterns of the virus in patients infected with Hepatitis C to see if they could tell why many patients fail to respond to standard treatment with pegylated-interferon and ribavirin.

The year-long therapy activates the body's natural defenses against viruses, but patients often feel as though they have a bad case of influenza. Only about half of the people who suffer through the treatment actually respond.

"This is a very difficult therapy to take. It's really hard on the patient," said John Tavis, a professor of molecular and microbiology at Saint Louis University, whose study appears in the Journal of Clinical Investigation.

"If you can identify those patients who aren't going to respond anyways because they've got a strain that is highly resistant to the drug, then you just don't treat those patients and you save them $20,000 to $30,000 in medical bills just from drugs alone -- not to mention the side effects," Tavis said in a telephone interview.

He and colleagues studied the ribonucleic acid or RNA chains of the hepatitis C virus, looking for patterns that would explain why some people responded to the treatment while others did not.

Using a math formula, they zeroed in on a specific pattern of changes called "covariance networks" that differed depending on whether the drug worked. And these patterns proved to be a strong indicator of whether the virus was especially resistant to therapy.

"What we found will allow a doctor to predict whether or not a medication will work in a patient," Tavis said in a statement.

The finding also may have implications for other types of RNA viruses, such as human immunodeficiency virus or HIV or the influenza virus.

"It's a pretty easy process. The algorithm can be applied fairly quickly," he said. Whether or not it turns up a pattern that will be useful is less clear, he said.

Hepatitis C is a blood-borne liver disease that can lead to chronic liver disease, liver cancer, cirrhosis and death. The virus affects an estimated 3.2 million people in the United States alone and some 170 million worldwide.

Pegylated interferon brands include Roche Holding AG's Pegasys and Schering-Plough Corp's Pegintron.

(Editing by Cynthia Osterman)

© Thomson Reuters 2008 All rights reserved.

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December 15, 2008

Who Is Susceptible to Alcoholic Hepatitis?

The relationship between drinking alcohol and developing alcoholic hepatitis is not necessarily linear. Aside from consuming alcohol, learn which other factors – such as obesity and malnutrition – can play a role in developing this potentially life-threatening liver disease.

by Nicole Cutler, L.Ac.

As the second of the three stages of alcoholic liver disease, alcoholic hepatitis is striking a growing number of people worldwide. With potentially fatal consequences, being able to recognize what predisposes someone to develop this disease may help prompt its early discovery and appropriate action. Since alcohol is the culprit of liver inflammation in alcoholic hepatitis, it may be reversible through abstinence when detected early enough. Unfortunately, when chronic hepatitis is caused by a virus, it is much harder to turn around.

The 3 Stages
There are three primary stages of alcoholic liver disease, although the progression through each stage can vary. Only through a liver biopsy (or comparable method) can the degree of liver damage be evaluated.

· Stage 1 – In the first stage of alcoholic liver disease, the person develops a fatty liver where there is minimal change to liver tissue. While a fatty liver is not linked to deterioration in liver function, abnormalities may be seen in some of the liver function tests. Even though fatty liver is reversible with alcohol abstinence, it is also the first step in progressing toward cirrhosis.

· Stage 2 – As fatty liver worsens, the liver becomes inflamed. Alcoholic hepatitis is the liver inflammation that ensues during the second step in alcoholic liver disease. Alcoholic hepatitis can range from mild to life-threatening, and may be present with or without liver inflammation symptoms. Similar to a fatty liver, abstinence from alcohol can reverse the effects of alcoholic hepatitis, but those who continue to drink heavily have a high risk of developing cirrhosis.

· Stage 3 – The final, irreversible stage of alcoholic liver disease is cirrhosis. Characterized by scarring and nodules on the liver, cirrhosis severely inhibits liver function, reduces life expectancy and increases the likelihood of developing liver cancer or liver failure.

If caught early on, fatty liver or mild alcoholic hepatitis can be mitigated by abstaining from drinking alcohol. However, advanced cases of alcoholic liver disease – whether severe alcoholic hepatitis or cirrhosis – renders the remaining liver capacity insufficient for carrying out normal, body functions.

Susceptibility
The relationship between drinking alcohol and developing alcoholic hepatitis is not necessarily linear. Only a small percentage of heavy drinkers develop alcoholic hepatitis, yet the disease can occur in people who drink only moderately or binge just once.

While the liver damage from alcoholic hepatitis has the potential to be reversed in people who stop drinking, this dangerous disease is likely to progress to cirrhosis and liver failure in those continuing to indulge. Because many people who drink heavily or binge drink never develop alcoholic liver disease, it’s likely that factors other than alcohol play a role:

· Genetic factors – Genetic mutations affecting alcohol metabolism may increase the risk of alcoholic liver disease as well as of alcohol-associated cancers. Genetic factors may account for half of any person’s susceptibility to alcohol-related disease.

· Other types of hepatitis – Long-term alcohol abuse worsens the liver damage caused by other types of hepatitis, especially Hepatitis C. If you have Hepatitis C and also drink (even moderately), the likelihood of developing cirrhosis is much greater than in someone who doesn’t drink.

· Other diseases – People who drink alcohol are more likely to develop alcoholic hepatitis if they also have another disease affecting the liver, such as diabetes or hemochromatosis.

· Obesity – Although most researchers agree that obesity makes alcoholic liver disease worse, the reasons are unclear. A likely cause is that alcohol causes fatty tissue to produce certain hormones and cytokines responsible for increasing inflammation throughout the body.

· Malnutrition – For one or both of the following reasons, many people who drink heavily are malnourished:

1. Because alcohol is often substituted for food, nutritional habits may be poor.

2. Because alcohol and its toxic byproducts prevent the body from properly absorbing and metabolizing nutrients, substances such as protein, vitamins and essential fats never make it to the body’s blood circulation.

In both cases, the lack of absorbed and metabolized nutrients contributes to liver cell damage. While it was previously thought that malnutrition – rather than alcohol – caused alcoholic liver disease, the relationship between the two appears more complicated.

· Alcohol use – Consistent heavy drinking or binge drinking is the primary risk factor for alcoholic hepatitis, though it’s hard to precisely define heavy drinking. Some experts believe that four or more drinks a day for men and two or more a day for women greatly increase the risk of liver damage. Moderate drinking is usually defined as no more than two drinks a day for men and one for women. However, because people vary greatly in their sensitivity to alcohol, these amounts can vary dramatically.

· Age – The effects of alcoholic hepatitis are likely cumulative, showing up after years of heavy drinking. However, symptoms of this disease can develop in people as young as 20.

· Gender – Women are two to three times as likely to develop alcoholic liver disease as men are. Experts believe this inequality is because it takes less alcohol to harm the liver in women, and liver disease progresses more quickly in women than in men. This disparity may result from genetic differences in the way alcohol is absorbed and broken down. Because women tend to metabolize alcohol more slowly, their livers are exposed to higher blood concentrations of alcohol for longer periods of time – with potentially greater toxicity. The slow rate of alcohol metabolism in women may be due to:

1. lower levels of stomach enzymes to break down alcohol
2. the effects of the female hormone estrogen
3. the typically smaller size of a woman’s liver

According to medical experts, even an occasional drinker is susceptible to developing alcoholic hepatitis. Since so many factors can contribute to the development of alcoholic liver disease, there is only one way to eliminate this threat. Making the monumental effort to quit drinking alcohol can return a liver to its pre-alcohol, healthy state. As long as abstinence occurs before the last stage of alcoholic liver disease begins, there is great hope for eradicating the perils of alcoholic hepatitis.

References:

Lederer, Sharon L., et al, Distinct cellular responses differentiating alcohol- and hepatitis C virus-induced liver cirrhosis, Virology Journal, November 2006.

www.gastroresource.com, Alcoholic Liver Disease, F. Wong, L. Blendis, First Principles of Gastroenterology, AstraZeneca Canada Inc., 2000.

www.hepatitis.org, Acute Alcoholic Hepatitis, Dr. Langlet Philippe, hepatitis.org, 2007.

www.mayoclinic.com, Alcoholic Hepatitis, Mayo Foundation for Medical Education and Research, 2007.

www.montana.edu, Alcohol and Liver Disease, Montana State University, 2007.

www.netdoctor.co.uk, Alcoholic Liver Disease, Dr. Matthew Warren, Professor Christopher P. Day, Netdoctor.co.uk, 2007.

Posted by Editors at 11:46 AM --- Printer-friendly version

December 11, 2008

Europe Approves Hepatitis C Re-Treatment Protocol

In response to a large, Roche-sponsored study, the European Commission approved Pegasys and Copegus for re-treating Hepatitis C non-responders.

Roche wins European approval for hepatitis drug

5th December 2008

By Staff Writer

Roche has announced that the European Commission has approved Pegasys plus Copegus for the re-treatment of hepatitis C patients who were not successfully treated with an initial course of interferon alpha, either alone or in combination with ribavirin.

The European approval provides a significantly broader indication for peginterferon alfa-2a and establishes a new standard of care for treatment-experienced patients with the most difficult-to-treat virus, the company said.

A large, Roche-sponsored study called REPEAT demonstrated that 72 weeks of re-treatment with peginterferon alfa-2a plus ribavirin doubled the chance of achieving a cure, compared to 48 weeks, in patients who were prior non-responders to PegIntron (peginterferon alfa-2b) and ribavirin. Furthermore, the study showed that 57% of patients who responded by week 12 (defined as HCV RNA levels of less than 50 IU/mL) went on to achieve a cure with 72 total weeks of re-treatment.

William Burns, CEO of Roche's pharmaceuticals division, said: "This new indication for Pegasys plus Copegus is another demonstration of Roche's commitment to extend the promise of a cure to as many chronic hepatitis C patients as possible.

"Our approach is to optimize and individualize treatment to increase patients' chance of success with Pegasys and Copegus, while establishing them as the backbone for combination with novel agents in development, both by Roche and through external partnerships and collaborations."

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December 08, 2008

Interferon Inappropriate for Long-Term Hepatitis C Treatment

The results are in from a 3-1/2 year study of long-term interferon treatment against the Hepatitis C virus. By examining clinical outcomes, researchers evaluated whether or not long-term use of interferon would be helpful or even appropriate for HCV patients.

Interferon As Long-term Treatment For Hepatitis C Not Effective

ScienceDaily (Dec. 8, 2008) — Use of the drug interferon as a long-term maintenance strategy to slow the progression of liver disease associated with the hepatitis C virus is ineffective, UT Southwestern Medical Center researchers and their colleagues from nine other institutions have found in a multicenter study.

Results of the 3½-year study, called the HALT-C (Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis) Trial, appear in today's issue of The New England Journal of Medicine. The researchers found no difference in the rate of progression of liver disease among patients who received interferon and those who did not.

"It wasn't that there was an insignificant difference; there was absolutely no difference whatsoever in the progression to cirrhosis and other disease complications," said Dr. William M. Lee, professor of internal medicine at UT Southwestern and a principal investigator for the study. "It is a negative study but an important one."

Dr. Lee said physicians should not expect any benefit from the long-term use of interferon by itself in slowing disease progression. By contrast, use of interferon with other drugs such as ribavirin can lead to viral eradication, or complete clearance of hepatitis C virus, a result that will "stop the disease in its tracks," Dr. Lee said.

Hepatitis C is a viral infection that causes liver inflammation and can progress over many years to cirrhosis, liver cancer, liver failure and death. The disease affects more than 3 million people in the United States and 170 million people worldwide. It is the most common reason for liver transplantation in the U.S.

There is no vaccine to prevent hepatitis C virus infection. The combination of interferon and ribavirin works for about 40 percent to 50 percent of people with the virus, while the other 50 percent to 60 percent of patients will continue to progress to later states of liver disease, Dr. Lee said.

In addition to interferon and ribavirin, new drug agents such as protease and polymerase inhibitors are being used in clinical studies at UT Southwestern to improve rates of virus eradication. Food and Drug Administration approval of these agents is likely to be three years away, Dr. Lee said.

In the HALT-C Trial, conducted between August 2000 and June 2007, 1,050 people with hepatitis C who did not respond to initial antiviral treatment were assigned randomly to either a group that received treatment with a type of interferon called peginterferon or to a group that did not. About 120 patients were enrolled at UT Southwestern.

Participants were monitored every three months and underwent liver scans and biopsies at specified intervals through the study period. Researchers found that although the level of hepatitis C virus in blood and certain enzymes in the liver decreased significantly with treatment, there was not a significant difference in ultimate clinical outcome.

"Currently, we use interferon only to clear the virus," said Dr. Lee. "If you cannot clear the virus with treatment, the idea that struggling long term through the side effects of interferon is somehow going to help you rid yourself of cirrhosis is just not plausible any longer."

Some patients cannot tolerate the side effects of the different types of interferon medication, which can cause extreme flu-like symptoms, such as fever, chills, fatigue, depression, muscle aches, chest pain, difficulty breathing, nausea, vomiting, and weight and hair loss.

Other researchers from UT Southwestern involved in the study were Dr. Thomas Rogers, professor of pathology, and Dr. Peter Malet, professor of internal medicine.

Also involved in the study were researchers from Saint Louis University School of Medicine; Virginia Commonwealth University Medical Center; University of Colorado School of Medicine; University of Southern California; National Institute of Diabetes and Digestive and Kidney Diseases; University of Michigan Medical Center; University of Connecticut Health Center; University of California, Irvine, and VA Long Beach Healthcare System; and University of Washington.

The study was funded by the National Institutes of Health. Pharmaceutical manufacturer Hoffman-LaRoche, through an agreement with the NIH, also provided funding.

Dr. Lee has received consulting fees from Eli Lilly, Fibrogen and Astra Zeneca, and grant support from Hoffmann-LaRoche, Schering-Plough, Vertex Pharmaceuticals, GlaxoSmithKline, Siemens, Globelmmune and Bristol-Myers Squibb.

Adapted from materials provided by UT Southwestern Medical Center.

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November 28, 2008

New Drug Finds Viral Hiding Spots

A new, experimental drug helps the immune system locate a virus by flagging cells that have turned inside out. Hepatitis C is among the viruses that could benefit from bavituximab's unique strategy of exposing a virus in hiding.

Inside-out cells offer target for antiviral drugs

By Julie Steenhuysen

CHICAGO, Nov 23 (Reuters) - An experimental drug cured guinea pigs infected with a fatal hemorrhagic fever virus, raising hope for its use in a broad range of viral diseases including influenza, hepatitis C, HIV, Ebola and others, U.S. researchers said on Sunday.

"This is a whole new strategy for making antiviral drugs," said Dr. Philip Thorpe, professor of pharmacology at the University of Texas Southwestern Medical Center at Dallas, whose research appears in the journal Nature Medicine.

Instead of attacking the virus directly, bavituximab, made by Peregrine Pharmaceuticals Inc (PPHM.O: Quote, Profile, Research, Stock Buzz), takes advantage of a defense mechanism used by the virus to hide from the immune system, Thorpe said.

When cells are under attack by a virus, this stress causes a fat molecule called phosphatidylserine, which normally lines the inside of the cell, to flip to the outside. "It's like wearing your clothes inside out," Thorpe, a scientific adviser to Peregrine, said in a telephone interview.

Bavituximab, a genetically engineered antibody, seeks out and attaches itself to these turncoat cells, flagging them for the immune system, which can then mount an attack,

"When injected into the bloodstream, bavituximab circulates in the body until it finds these inside-out lipids and then binds to them," Thorpe said in a statement.

"In the case of virus infection, the binding raises a red flag to the body's immune system, forcing the deployment of defensive white blood cells to attack the infected cells."

Thorpe said conventional antiviral drugs try to exploit some property of the virus, but these drugs are often quickly defeated as the virus mutates.

By targeting an aspect of infected cells in the host, he thinks bavituximab is less likely to lose effectiveness, which commonly happens when a virus mutates.

In the study, Thorpe and his colleagues tested the compound on guinea pigs in an advanced stage of infection with a form of the Lassa fever virus, a disease that affects parts of West Africa.

Half of the animals treated with the drug alone were cured. When the researchers tested it in combination with the antiviral drug ribavirin, a drug that keeps a virus from replicating, 63 percent of the guinea pigs lived.

Thorpe said the findings suggest the drug might be effective on other types of hemorrhagic viruses, such as Ebola and Marburg. But this lipid flipping also occurs in cells infected with many other viral infections, including influenza, smallpox and rabies.

Peregrine is conducting early phase clinical trials of the drug in people with hepatitis C and human immunodeficiency virus, or HIV, which causes AIDS. And it has more advanced trials under way in cancer.

"We think it has tremendous potential," Steven King, president and chief executive of Peregrine, said in a telephone interview. Peregrine funded the research along with the National Institutes of Health. (Editing by Will Dunham and Todd Eastham)

© Thomson Reuters 2008 All rights reserved

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November 21, 2008

Hepatitis C Patients: Drink More Coffee for a Healthier Liver

Demonstrating a hepatoprotective effect against Hepatitis C, the world's number one morning beverage lands a victory in the debate over its healthfulness.

by Nicole Cutler, L.Ac.

People living with Hepatitis C have had just about every aspect of their lifestyle analyzed to determine what could facilitate or impede the progression of liver disease. While most indulgences have been implicated in a worsening of Hepatitis C, drinking coffee may be an exception to this trend.

Over the past few years, several studies have encouraged people with chronic liver disease to be faithful to their preferred morning beverage. Research into its health benefits has revealed some surprising associations with coffee consumption including decreased risks of:

· alcoholic cirrhosis
· type 2 diabetes
· gallstone development
· liver damage in those with liver disease
· liver cancer

While the studies bearing such conclusions were encouraging to coffee drinkers with liver disease, there had been little evidence specific to advanced cases of Hepatitis C – until now. As reported at the 59th Annual Meeting of the American Association for the Study of Liver Diseases in November 2008, an increase in coffee consumption may slow the progression of liver damage caused by Hepatitis C. Pertinent details of the reported study are listed below:

· Over 800 people participated in this observational study
· Participants had Hepatitis C with an Ishak fibrosis score of 3 or higher
· Participants were unresponsive to standard drug therapies
· 88 percent of participants drank zero to two cups of coffee a day
· 12 percent of participants drank three or more cups of coffee daily
· Those who drank the most coffee also consumed the most alcohol and cigarettes

Considering the known dangers that drinking alcohol and smoking cigarettes pose to a person with Hepatitis C, one would expect those with the highest consumption rates to also have the most advanced cases of liver disease. However, this study found the reverse to be true. Compared to those who drank zero to two cups of coffee per day, the coffee drinkers who consumed three or more cups of coffee showed the following indicators of liver health:

· Less steatosis as determined by liver biopsy
· Lower bilirubin levels
· Lower α-fetoprotein levels
· Lower aspartate aminotransferase/alanine aminotransferase ratios

The calculations of liver damage in these Hepatitis C participants support the idea that consuming three or more cups of coffee per day may protect against the progression of liver disease.

Although this data is exciting for the coffee loving crowd, there are some uncertainties associated with this report. According to Neal D. Freedman, M.D., of the National Cancer Institute at the National Institutes of Health, Department of Health and Human Services, in Rockville, Maryland, “This is an observational study, so it may be that coffee is a marker for some other activity. It may be that people who are feeling sicker don’t drink as much coffee.” In addition, there were many details of coffee consumption omitted from the participants’ questionnaires such as:

· Coffee strength and preparation technique
· Caffeinated or decaffeinated
· Coffee additives like milk or sugar

The reason this study is so compelling is because the heavy coffee drinkers who consumed the most alcohol and cigarettes, both known liver toxins, had the least amount of liver damage. Likely due to the 1000-plus compounds in coffee, the jury is still out on why coffee appears to act as a liver protector. There is not enough evidence to conclude that drinking more than two cups of coffee a day fights Hepatitis C. However, there is sufficient proof that Hepatitis C on its own is not reason to abandon a daily coffee habit.

References:

http://www.liversupport.com/wordpress/2006/06/coffees-liver-benefits/, Coffee’s Liver Benefits, Nicole Cutler, Retrieved November 16, 2008, Natural Wellness, June 2006.

http://www.medscape.com/viewarticle/583121, AASLD 2008: High Coffee Consumption May Slow Hepatitis C Progression, Laurie Bouck, Retrieved November 16, 2008, Medscape, November 2008.

http://www.natap.org/2006/AASLD/AASLD_08.htm, Coffee Appears to Reduce Risk of Fibrosis in HCV+, Jules Levin, Retrieved November 16, 2008, AASLD, The Liver Meeting, October 2006.

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November 10, 2008

How to Afford HCV Treatment

Some Hepatitis C patients may choose not to attempt antiviral therapy for many different reasons. However, with the resources available today, financial reasons can be excluded from deciding whether or not to receive treatment.

by Nicole Cutler, L.Ac.

Some people are lucky enough to receive their Hepatitis C diagnosis while there is still time to do something about it. While absorbing the news that you are chronically infected with the Hepatitis C virus (HCV) may initially feel devastating, it beats not finding out until your liver is ready to shut down. Once a person discovers this virus lurking in their body, it is time to make decisions about receiving treatment. While many factors go into choosing whether or not to undergo antiviral therapy, its high cost may be less of an obstacle than most people think.

Choosing Anti-Viral Treatment
Aside from the financial burden, opting for the standard Western medical treatment consisting of pegylated interferon and ribavirin primarily hinges on two things: your state of health and your likelihood of progressing to cirrhosis or liver cancer in the future.

Anti-viral therapy is typically recommended if a person:

· Is at increased risk of developing cirrhosis due to elevated enzyme levels for over six months

· Has a high level of the virus in their blood, indicating an active infection

· Has had a liver biopsy which shows significant liver damage

Anti-viral therapy is typically NOT recommended if a person:

· Is not likely to develop cirrhosis, due to normal or only slightly elevated liver enzyme levels, and a liver biopsy showing little or no significant liver damage

· Has another serious medical condition such as diabetes, an autoimmune disease, depression, heart disease or active substance abuse

· Is pregnant

Best done in concert with your physician, deciding to try antiviral therapy for HCV involves many considerations. Some of the pros for this treatment are:

· Antiviral medicine is currently the only approved treatment for chronic HCV.

· The newer pegylated interferon medicine (combined with oral ribavirin) only needs to be injected once a week, rather than 3 times a week as is needed for standard interferon treatment.

· Research has shown that those who complete treatment and have no detectable virus in their blood six months following treatment appear to be “cured.”

· Approximately 50 percent of those with the most common HCV genotype in the United States, genotype 1, are able to achieve treatment success.

Some of the cons for this treatment are:

· Approximately 50 percent of those on the medicines develop significant side effects including fever, fatigue, muscle-aches, anemia and depression.

· Those who discontinue the treatment due to the side effects have a lower chance of treatment success.

· Studies on the effectiveness of anti-viral treatment have not been done on people who have other serious conditions.

· You will not be able to perform your job or take time off if you have significant side effects from the medicines.

· Approximately 50 percent of those with the most common HCV genotype in the United States, genotype 1, are able to achieve treatment success.

After weighing the treatment’s pros and cons, a decision to proceed is often met with concerns about how to pay for the high-priced medications. As it turns out, there is a way for most people who need and want the treatment to financially afford it.

Affording Treatment
Proper physician care and the cost of medications for HCV can both cost a lot of money. A representative from the pharmaceutical company Schering-Plough estimated the cost of antiviral medication averaged between $2,000 and $3,500 per month. While health insurance offsets this burden, data from the 2006 U.S. National Health Interview Survey show that 14.8 percent of Americans, or 43.6 million, do not have health insurance. Whether you do or do not have health insurance, there are many resources available in the United States for helping people afford HCV therapy. The more common options are listed below:

1. Private Health Insurance – Most private insurers provide coverage for all necessary care and medications. Depending on the company and plan, co-pays or deductibles may be necessary out-of-pocket expenses. Please note, if you must pay for a portion of your medication costs, shop around between pharmacies. The price of these drugs can vary widely between mail order companies, small pharmacies and big chain stores.

2. Medicaid – The federal and state public insurance program for low-income people meeting eligibility requirements, Medicaid programs cover HCV treatment in every state. However, the enrollment criteria, amount that you pay for prescription drugs, the number of drugs you can get in one month and the requirements to get drugs usually differ between states.

3. ADAP – For those co-infected with HCV and HIV, the AIDS Drug Assistance Program (ADAP) is a state and federal program that serves people living with HIV who are uninsured or underinsured. While eligibility criteria varies state to state, ten ADAPs provide access to both ribavirin and peg-interferon for those co-infected with HIV and HCV.

4. State Programs – Many states have HCV assistance for those in financial need. While it may take a bit of investigative work, a simple phone call to your state’s Department of Health and Human Services Department can reveal programs for helping afford the cost of physician care and HCV antiviral medications.

5. Patient Assistance Programs – If unable to access care through the previously described routes, both the manufacturers of the peg-interferon (Schering-Plough) and ribavirin (Roche Pharmaceuticals) have patient assistance programs. If a person meets these programs’ eligibility requirements, they may be able to receive the medications at a low-cost or for free. If in need, call the Schering-Plough Patient Assistance Program at 1-800-521-7157 and/or the Roche Patient Assistance Program at 1-877-757-6243.

Determining eligibility for one of the many programs will definitely involve paperwork. However, it can exclude financial need as a criterion for choosing to begin HCV antiviral treatment. Although antiviral treatment may not cure someone of the Hepatitis C virus, it proves worthy to some of those who can endure it.

Learning you have HCV before it progresses to the end stages of liver disease affords someone the option of choosing anti-viral therapy. If this route is chosen, there are many ways to finance the medications. Whether a person with HCV is insured, underinsured or uninsured – investigative effort, follow-up and filling out paperwork are sure to erase money from the anti-viral therapy pros and cons list.

References:

www.cdc.gov, Uninsured Americans: Newly Released Health Insurance Statistics, Center for Disease Control and Prevention, 2007.

www.schering-plough.com, Patient Assistance and Support Programs, Schering-Plough Corporation, 2007.

www.thebody.com, Access to Care and Treatment for HCV, WISE Words, The Body, August 2003.

www.webmd.com, Should I take antiviral therapy for hepatitis C?, WebMD, Inc., 2007.

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November 06, 2008

FDA Approves Roche's Hep C Viral Load Measurements Test

Roche's COBAS® AmpliPrep / COBAS® TaqMan® Test brings improved ease, speed and accuracy to Hepatitis C viral load measurements, and was just approved by the FDA.

Roche Receives FDA Approval for Hepatitis C Viral Load Test on Its Fully Automated Real-Time PCR Platform

Improved laboratory efficiencies and standardization to personalize patient care

PLEASANTON, Calif., Oct 30, 2008 /PRNewswire via COMTEX/ -- Roche Molecular Diagnostics today announced that the U.S. Food & Drug Administration (FDA) has approved the COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HCV Test for use in the United States. The test uses Roche's proprietary real-time PCR technology to quantify the amount of Hepatitis C RNA in a patient's blood. Physicians use Hepatitis C viral load testing results to establish a baseline level of hepatitis C infection and to serially monitor viral load levels and treatment effectiveness in patients on therapy.

"This new Roche test enables laboratories to deliver reliable healthcare information with ease and allows physicians to more efficiently monitor their patients and improve treatment outcomes," said Daniel O'Day, President and CEO of Roche Molecular Diagnostics. "We are pleased to offer this new solution for laboratories and physicians to optimize their turnaround time, workflow and patient care with simultaneous processing of HIV and HCV patient samples."

The new test offers a broad dynamic range from high levels of virus in a patients blood to the "undetectable" low levels of viremia -- the goal of therapy. To ensure accurate quantification, the test has been calibrated to World Health Organization (WHO) traceable standards and can detect down to 18 IU/mL with 100% certainty. In a 1,281 patient clinical trial, the COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HCV Test confirmed the importance of viral load testing to personalize Hepatitis C patient care by accurately predicting treatment response, from onset of therapy through end of treatment.

About the COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) System
The COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HCV Viral Load Test is designed for use on the first fully automated, FDA approved, real-time PCR platform, providing sample-in/results-out capability. The platform is flexible and customizable to meet the space and workflow needs of any laboratory. In the United States, more than 130 laboratories already utilize this fully automated platform for HIV testing.

The COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HCV Test is the third Roche COBAS(R) TaqMan(R) real-time PCR test approved by the FDA in the last eighteen months. The COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) System menu includes an FDA approved HIV viral load test, with continuous loading of samples in addition to parallel processing of HIV and HCV tests. In September 2008, Roche received FDA approval of the COBAS(R) TaqMan(R) HBV Test to monitor Hepatitis B viral load in patients on therapy.

About Hepatitis C
According to the Centers for Disease Control and Prevention, each year in the U.S. approximately 8,000-10,000 people die from hepatitis C-related liver disease.

An estimated 3.2 million persons in the United States have chronic hepatitis C virus infection. Most people do not know they are infected because they don't look or feel sick. However, approximately 75%-85% of people who become infected with hepatitis C virus develop chronic infection. (1)

Hepatitis C infections can range in severity from a mild or "acute" illness lasting a few weeks to a serious, lifelong or "chronic" illness. For most people, acute infection leads to chronic infection. Chronic hepatitis C infection is a serious disease that can result in long-term health problems, including liver damage, liver failure, liver cancer, or even death. Hepatitis C is the leading cause of cirrhosis and liver cancer and the most common reason for liver transplantation in the United States.

Hepatitis C virus is passed from person to person when infected blood enters the body of someone who is not infected. Different ways people can be infected with the hepatitis C virus include sharing contaminated needles, high risk sex with an infected partner, and from an infected mother to her infant during pregnancy and childbirth.

About Roche and the Roche Diagnostics Division
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totaled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at http://www.roche.com.
All trademarks used or mentioned in this release are legally protected by law.

(1) U.S. Centers for Disease Control. http://www.cdc.gov

For further information please contact:

Jessica E. Brillant
Molecular Diagnostics Communications
925.730.8503

Melinda Baker
Molecular Diagnostics Communications
925.730.8379

SOURCE Roche Molecular Diagnostics: http://www.roche.com

Copyright (C) 2008 PR Newswire. All rights reserved

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October 28, 2008

HCV Treatment for U.S. Prisoners

Despite the prevalence of Hepatitis C infection in the U.S. prison population, some inmates are denied treatment due to the medications' high cost. However, a UCLA study insists that treating all infected U.S. prisoners with the standard therapy would actually be cost-effective.

Hepatitis C Treatment Is Cost-effective For The US Prison Population

ScienceDaily (Oct. 25, 2008) — Treating all U.S. prisoners who have hepatitis C with the standard therapy of pegylated-interferon and ribavirin would be cost-effective, according to a new study.

U.S. prisons incarcerate more than 2 million inmates each year, and between 12 and 31 percent of them are infected with chronic hepatitis C (HCV), mostly related to high rates of intravenous drug use. The current standard treatment for HCV has been shown to be cost-effective in the general population and the Federal Bureau of Prisons recommends HCV treatment for those who meet the AASLD's criteria for treatment, as long as therapy is likely to be completed. However, each state adopts its own set of treatment guidelines, and many prisoners do not ultimately get treated.

Proponents for treatment argue that we have an ethical duty to provide prisoners with the best medical practices available, and treating HCV could reduce new infections as well as future medical expenses from advanced liver disease. Opponents point out that treatment is expensive and must be paid for by taxpayers, while many non-imprisoned HCV patients who don't have health insurance are denied access to this care.

Researchers, led by Sammy Saab of the David Geffen School of Medicine at UCLA, sought to determine if HCV treatment would be cost-effective in the male prison population (men make up over 87 percent of U.S. prisoners). They examined published literature for relevant studies and constructed a decision analysis model employing Markov simulation, using the generally accepted cost-effectiveness threshold of $50,000 per quality-adjusted life years.

"Our model found that treatment was cost-saving for prisoners of all age ranges and genotypes when liver biopsy was not a prerequisite to starting antiviral therapy," they report. "In other words, treatment resulted in both decreased costs and improved quality of life." Treatment was also cost-saving in most situations that included a pre-treatment liver biopsy.

The authors had not expected treatment to be cost-effective, because of the high re-infection rates and non-liver mortality rates in the prison population. However, they write, "our results demonstrate that pegylated-interferon and ribavirin is cost-saving in the prison population, both in strategies with and without biopsy. Incorporating a pre-treatment liver biopsy may be the most cost-effective approach, however, as one could potentially exclude certain patients with no fibrosis from therapy."

"If the decision to treat is based on pharmacoeconomic measures," the authors conclude, "the results of our analysis suggest that treatment is cost-saving and should not be withheld in U.S. prisoners with hepatitis C."

Since the efficacy of treatment would be diminished by relapse to injection drug use and re-infection, treatment should be coupled with educational and substance abuse programs, they suggest. And because mental illness is widespread in the prison population, and can often be exacerbated by treatment, careful mental health screening and follow-up would be required.

This research is published in the November issue of Hepatology, a journal published by John Wiley & Sons on behalf of the American Association for the Study of Liver Diseases (AASLD).

Adapted from materials provided by Wiley-Blackwell, via EurekAlert!, a service of AAAS.

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October 27, 2008

Caution: Hepatitis C and Vitamin D Deficiency

Although new research demonstrates vitamin D deficiency in those with Hepatitis C, make sure you don’t overreact by taking a toxic amount of this supplement.

by Nicole Cutler, L.Ac.

In addition to dietary recommendations for liver disease, a significant portion of people with the Hepatitis C virus (HCV) take vitamins and herbs to support their liver. Despite this trend, American researchers have confirmed that living with chronic Hepatitis C is usually accompanied by a vitamin D deficiency. Worried about the consequences of a vitamin D deficiency, those with the virus may choose to supplement with this vitamin. However, vitamin D is toxic in large doses and taking too much of it could end up being more harmful than not having enough.

About Vitamin D
Vitamin D is a fat-soluble vitamin that helps the body absorb calcium and plays a crucial role in the growth and maintenance of strong, healthy bones. A lack of vitamin D causes calcium-depleted bone, which can weaken the bones and increase the risk of fractures resulting from osteoporosis. While vitamin D is probably best known for its role in bone development and maintenance, it’s also involved in the brain, immune and reproductive systems. A lack of vitamin D can cause osteomalacia in adults and rickets in children, both of which are unwelcome additions to the burden of chronic liver disease.

Vitamin D is found in food, but can also be produced in the body after exposure to ultraviolet rays from the sun. Some forms of vitamin D are relatively inactive, with a limited ability to function as a vitamin. The liver and kidney help convert vitamin D to its active hormone form. But for those with advanced liver disease from Hepatitis C, a deficiency can conceivably develop from the liver’s inability to convert vitamin D into its active form.

The Research
Presented in October 2008 at the 73rd Annual Scientific Meeting of the American College of Gastroenterology, researchers from the University of Tennessee in Memphis measured the vitamin D levels in people with chronic liver disease. Of those evaluated, 85 percent of the study participants had chronic Hepatitis C. After dividing every vitamin D deficiency into three categories (mild, moderate and severe), the investigators found the following:

· 92.4 percent of those with chronic liver disease had some degree of vitamin D deficiency

· At least 33 percent of participants were severely deficient in vitamin D

· Severe vitamin D deficiency was more common among those with cirrhosis

Lead researcher Dr. Satheesh P. Nair commented, “Since deficiency is common among these patients, Vitamin D replacement may hopefully prevent osteoporosis and other bone complications related to end stage liver disease.”

Vitamin D Supplementation
For those with a documented vitamin D deficiency, supplementation can help prevent bone density problems from emerging. Established by the U.S. Institute of Medicine of the National Academy of Sciences, the recommendations for supplementing with vitamin D are as follows:

· 200 International Units (IU) for those between the ages of 19 and 50
· 400 IU for those ages 50 to70
· 600 IU for people over age 70

Increased dosages may be recommended as a person ages due to the skin’s declining ability to absorb the sun’s radiation and an inability of the liver or kidneys to transform vitamin D to its active form.

Vitamin D’s Danger
Between the newly released research connecting vitamin D deficiency with chronic HCV and the ease of obtaining vitamin D supplements, it seems that those with HCV would jump at the opportunity to supplement with vitamin D. However, too much vitamin D is dangerous for those with liver disease because it is toxic. Vitamin D toxicity can cause:

· Nausea
· Vomiting
· Poor appetite
· Constipation
· Weakness
· Weight loss

Too much vitamin D can also raise blood levels of calcium, causing mental status changes such as confusion and heart rhythm abnormalities. Another consequence of excess supplementation is calcinosis, the deposition of calcium and phosphate in soft tissues like the kidney.

The Food and Nutrition Board of the Institute of Medicine considers an intake of 1,000 IU for infants up to 12 months of age and 2,000 IU for children, adults, pregnant and lactating women, to be the tolerable upper intake level. Toxicity reports are associated with dosages above these levels.

While the results of the trial conducted in Memphis clearly link vitamin D deficiency with chronic HCV infection, those affected must beware. Supplementing with vitamin D could help prevent some of the consequences of insufficient vitamin D – but taking too much poses even greater dangers. A person’s best bet to make sure their vitamin D levels are adequate is to discuss their concerns with their physician and, if necessary, agree on the best way to supplement with vitamin D.

References:

http://healthlink.mcw.edu/article/982088787.html, Vitamin D, Retrieved October 12, 2008, Medical College of Wisconsin, 2008.

http://hepatitis.about.com/b/2008/10/06/are-you-getting-enough-vitamin-d.htm, Are You Getting Enough Vitamin D?, Charles Daniel, Retrieved October 12, 2008, About.com, October 6, 2008.

http://hepatitisc.va.gov/vahep?page=diet-02-09&pf=doc-pf&pp=pf, Diet and Nutrition, Retrieved October 12, 2008, United States Department of Veteran Affairs, 2008.

http://www.eurekalert.org/pub_releases/2008-10/acog-vdd100308.php, Vitamin D deficiency common in patients with IBD, chronic liver disease, Retrieved October 12, 2008, American College of Gastroenterology, October 6, 2008.

http://www.merck.com/mmpe/sec01/ch004/ch004k.html, Vitamin D, Retrieved October 12, 2008, Merck & Co., 2008.

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www
/story/09-25-2008/0004892578&EDATE=, Vitamin D Deficiency Reports May Be Causing Some to Overreact and Take Harmful Actions, Retrieved October 12, 2008, US Preventive Medicine, PR Newswire Association LLC, September 2008.

Posted by Editors at 03:36 PM --- Printer-friendly version

October 09, 2008

Combined Hepatitis Vaccine for Extra Protection

People with chronic Hepatitis C are more vulnerable to worsening of liver disease when burdened by an additional form of viral hepatitis. HCV patients will learn more about the Hepatitis A/B combination vaccine and possible side effects in this article.

by Nicole Cutler, L.Ac.

The various types of viral hepatitis vary widely in how they affect people’s health. One strain may cause a temporary, mild illness while others can lead to a lifelong battle with chronic liver disease. Regardless of which hepatitis virus you are exposed to, the prognosis is always more grim if you are already infected with some other form of chronic hepatitis. Therefore, taking advantage of the vaccinations available for Hepatitis A and Hepatitis B can help someone with another kind of hepatitis prevent a worsening of their condition by becoming infected with multiple hepatitis viruses.

Hepatitis C
Of particular concern are the four to five million Americans estimated to be living with chronic Hepatitis C. When burdened with an additional type of viral hepatitis, research has shown that those with chronic Hepatitis C experience more rapid progression of liver disease than those not infected by another form of hepatitis.

Hepatitis A and Hepatitis B are two of the three most common viral hepatitis strains found in North America. Fortunately, vaccines to prevent these two infectious diseases are readily available. Unfortunately, there is currently no vaccine to prevent the other prevalent viral hepatitis, Hepatitis C. Adding insult to injury, Hepatitis C’s low cure rate, high infectivity and likelihood to cause chronic liver disease makes it the most perilous strain of the three common types of viral hepatitis. Due to the greater chance of liver damage with more than one kind of hepatitis, those with Hepatitis C are always advised to get vaccinated for both Hepatitis A and Hepatitis B. Thanks to the marvels of Western medicine, a vaccine targeting both Hepatitis A and Hepatitis B have been combined into one series of injections.

Combination Vaccine
Luckily for those already infected with Hepatitis C, there is a preventative vaccine combining ammunition against both Hepatitis A and Hepatitis B. By uniting two separate vaccination series into one, the Hepatitis A/B combination vaccine has made preventing these illnesses much simpler. Those considering this vaccination must know that they cannot get hepatitis from it because it does not contain a live virus. The combination vaccine is created from whole, killed Hepatitis A virus and a genetically engineered piece of Hepatitis B virus.

The combination Hepatitis A/B vaccine is routinely recommended for those at high risk for acquiring infections such as:

· Health care personnel
· Laboratory workers who handle blood and patient specimens
· Police, fire and emergency medical personnel who give first aid treatment
· Hemophiliacs
· Dialysis patients
· Household and intimate contacts of those with chronic Hepatitis B or active Hepatitis A
· Persons with multiple sex partners
· Men who have sex with men
· Sex workers
· Injection drug users
· Those traveling to high-risk areas

To prevent a worsening of their condition and save them the time of two vaccination series, those already living with chronic Hepatitis C are also prime candidates for the Hepatitis A/B combination vaccine.

Considerations
While many receiving the Hepatitis A/B combination vaccine do not experience serious side effects, the most common problems include:

· soreness at the injection site
· headache
· fatigue

In addition, the combination vaccine is contraindicated in those with:

· a known hypersensitivity to neomycin
· a known hypersensitivity to yeast

Another consideration for the combination Hepatitis A/B vaccine is someone’s immune system strength. Vaccines work by bringing a tiny amount of infection into the body to stimulate an antibody response against it. Unfortunately, those with a weakened immune system (such as those with HIV) may not be able to illicit an antibody response strong enough to create immunity. While this is a concern for the Hepatitis A/B combination vaccine, new research has shown that administering a double dose greatly increases its efficacy for immune-compromised individuals.

Although medications free of flaws are virtually non-existent, the combination Hepatitis A/B vaccine is a blessing for those with chronic Hepatitis C. Especially if never vaccinated for either Hepatitis A or Hepatitis B AND diagnosed with Hepatitis C, the Hepatitis A/B combination vaccine saves the time and inconvenience of two separate vaccination schedules for preventing multiple hepatitis infections.

References:

http://aids.about.com/od/howtostayhealthy/p/twinrix.htm?p=1, Twinrix Vaccine, Mark Cichocki, RN, Retrieved September 5, 2008, About.com, 2008.

http://aids.about.com/od/vaccinesscreenings/a/hepbdd.htm?p=1, Double Dose Hepatitis B Vaccine For People Living With HIV, Mark Cichocki, RN, Retrieved September 5, 2008, About.com, 2008.

http://www.hivandhepatitis.com/hep_b/news/2008/082908_a.html, Prior Non-responders Respond Well to a Double Dose of Combined Hepatitis A and B Vaccine, Retrieved September 5, 2008, hivandhepatitis.com, 2008.

http://www.journals.uchicago.edu/doi/abs/10.1086/589722, Excellent Response Rate to a Double Dose of the Combined Hepatitis A and B Vaccine in Previous Nonresponders to Hepatitis B Vaccine, Kristina Cardell, et al, Retrieved September 5, 2008, The Journal of Infectious Diseases, 2008;198:299–304.

http://www.webmd.com/drugs/drug-21049-Twinrix+IM.aspx?drugid=
21049&drugname=Twinrix+IM, Twinrix IM, Retrieved September 5, 2008, WebMD, LLC, 2008.

Posted by Editors at 03:25 PM --- Printer-friendly version

Hepatitis C Transmission from Botox and Other Spa Treatments

Since medical spas are offering more treatments involving the use of needles, sometimes without the supervision of a medical physician or properly sterilized equipment, the potential for Hepatitis C transmission is rising. Learn about some of the spa treatment techniques that pose hepatitis transmission dangers, as well as five ways to increase your safety in a medical spa.

by Nicole Cutler, L.Ac.

Everyone wants to look good, and now there are more ways to do it. Medical spas are the fastest growing segment of the spa industry and the newest spin on the cosmetic surgery and anti-aging world – and may be contributing to the spread of Hepatitis C. Many medical spas offer services that blur the distinction between medical procedures and beauty treatments, creating a substantial void in regulation. When it comes to the transmission of the Hepatitis C virus, this lack of universal regulation poses an obscure danger.

The three primary destinations melding medical procedures with beauty treatments include:

1. Medical Spa Franchises – These businesses are becoming increasingly popular and are capitalizing on this growing market.

2. Existing Day Spas – More conventional spas are adding medical procedures to their list of offerings.

3. Cosmetic Surgery and Dermatology Offices – Many of these medical professionals are creating spa-like atmospheres to profit from this growing market.

With such varied types of businesses, government agencies are challenged to implement strict regulations or defined rules for the medical spa market. As Dr. Alexander Rivkin of Westside Medical Spa puts it, “the medical spa industry is the wild west at this point... It’s a buyer beware kind of field.”

Some say the problem with the medical spa industry is that their popularity has outpaced oversight. Some state laws say only doctors can botox injections, while California and New York only require doctor supervision. Still, others have no laws in place. And even where regulations exist, no one monitors medical spas until someone complains. CBS News went undercover in California and easily found a place willing to give botox injections by a technician only, which is against the law. “Oh, you don't need a doctor, or nurse,” says someone at the spa. “We've done this before.”

Hepatitis Transmission Dangers
As the number of people realizing they have the Hepatitis C virus continues to rise, so does the concern of how they were infected in the first place. Since Hepatitis C is only transmitted through the blood, a majority of infections occur through IV drug use or tainted blood transfusions. However, experts estimate that at least 10 percent of those infected cannot determine how they contracted Hepatitis C. The unregulated, burgeoning medical spa industry could be one of the culprits of mysterious Hepatitis C transmission cases.

Since medical spas are offering more treatments involving the use of needles, the potential for Hepatitis C transmission is rising. Anytime needles are involved, universal hygiene precautions must always be followed to prevent disease transmission. To maintain consumer safety, all licensed medical professionals who use needles are required to complete an approved course of study and pass an exam proving they fully understand and practice these precautions. Some of the techniques using needles in a spa environment include:

· Permanent Makeup – Called intradermal cosmetics or micropigmentation, this procedure is also known as cosmetic tattooing.

· Cosmetic Dermal Fillers – By injecting substances into wrinkles or folds, cosmetic dermal fillers such as Botox or Restylane are believed to restore volume and fullness to the skin.

· Mesotherapy – A type of body sculpting, small microinjections of medications, vitamins, minerals and amino acids into the skin’s middle layer is a new technique aimed at reducing cellulite.

· Derma Needle – Another type of body sculpting, a tattoo machine penetrates the skin with a small needle to create collagen formation, supposedly resulting in smoother, tighter skin.

While proper sterile practice eliminates the possibility of Hepatitis C transmission from any of these procedures, the lack of medical spa regulation removes this guarantee of consumer safety.

Making news in May of 2007, an incident in Ohio reminds us of the possibility of Hepatitis C transmission from a medical spa. Arrested for practicing medicine without a license, the owner of a medical spa in Westlake is accused of infecting a client with an improperly sterilized tool used in a spa procedure. It seems that a form of body sculpting was being conducted, using tiny needles on a roller. For this kind of procedure to be safe it is imperative that any needles used be in a sterile package for one-time use only – or – be properly sterilized in an autoclave.

What to Look For
When it comes to any kind of needle piercing the skin, a risk of Hepatitis C transmission exists if not properly sterilized, or is inappropriately used between clients. The Centers for Disease Control recommends that single-use instruments intended to penetrate the skin be used once, then disposed of properly. Reusable instruments or devices that penetrate the skin and/or contact a client’s blood should be thoroughly cleaned and sterilized between clients. Anything less creates the possibility of transmitting the highly contagious Hepatitis C virus.

Spa treatments utilizing needles can be safe (not transmit infectious disease) if the practitioner is following universal precautions. While the laws differ depending on the service and the spa location, here are five ways to increase your safety odds in a medical spa:

1. Research the spa first. Medical professionals say clients should do their homework: get references, check with local licensing agencies and ask questions before agreeing to any services.

2. Pay attention to the spa’s surroundings. Look for clues to their emphasis on safety and sanitation practices. Notice if customers are coming and going faster than instruments can be sterilized. Check to see if the staff changes the water in a footbath and sterilizes the tub between customers. If hygiene does not seem important – leave.

3. Never get an invasive spa treatment using needles from anyone other than a licensed medical practitioner. Confirm the status with your state’s medical board. Having a physician supervising your procedure is not the same as having one perform it.

4. When getting permanent makeup applied, make sure the technician uses a new, disposable needle for each person. Additionally, make certain they sterilize their hands and any other equipment before it touches your skin.

5. If not using sterile, single-use, disposable needles, ask the spa to see their sterilization equipment. The spa should be willing to show you their autoclave and accompanying spore test results. An effective autoclave is a device that properly sterilizes needles by using a combination of steam and pressure. A spore test confirms the autoclave is working properly.

Until regulation agencies catch up with the times and establish universal standards for medical spas, consumers need to be aware of the possible dangers. As technology races ahead finding new ways to make us appear more youthful and beautiful, we cannot lose sight of Hepatitis C transmission prevention. While a majority of medical spas in the U.S. pay scrupulous attention to hygiene practices, it only takes one non-sterile needle to pass on Hepatitis C. Be adamant about your own safety – and make certain that only a licensed professional is allowed to pierce your skin using only sterile needles.

References:

www.cbsnews.com, Medical Spa Makeovers Gone Wrong, CBS Broadcasting, Inc., 2007.

www.centredaily.com, Medical spas alluring, but lack of oversight worries some, Christy Arboscello, The Centre Daily Times, May 2007.

www.lindisima.com, Needling or Needle abrasion or Intradermabrasion, linidisima.com, 2007.

www.locateadoc.com, Inside the Medical Spa: What to Expect, Locateadoc.com, 2007.

www.medicalspaskincarehawaii.com, Restylane Filler, Medical Spa & Skin Care Hawaii, 2007.

www.milforddailynews.com, Nurses Say Many May Have Hepatitis C and Not Know It, Jennifer Lord, GateHouse Media, May 2007.

www.newhorizonsspa.com, Mesotherapy, New Horizons Medical Spa, 2007.

www.perfecttouchspa.com, Permanent Cosmetics, Perfect Touch LLP, 2007.

www.weathernet5.com, Bella Derm Patient Says She Got Ill From Spa Procedure, NewsNet5, May 2007.

www.webmd.com, Dying to be Beautiful, Coulette Bouchez, WebMD Inc., 2007.

Posted by Editors at 03:20 PM --- Printer-friendly version

August 26, 2008

Hep C Treatment: Comparing the Pegylated Interferons

Learn about the facts on pegylated interferon alfa-2a and pegylated interferon alfa-2b, the standard treatment for chronic Hepatitis C. Comparing and contrasting the pegylated interferons may help better explain a physician’s preference or indifference between the two when treating his or her Hepatitis C patients.

by Nicole Cutler, L.Ac.

Today’s standard treatment for chronic Hepatitis C is a combination of pegylated interferon and ribavirin. While the prescription might seem straightforward, there are actually two different kinds of pegylated interferon – pegylated interferon alfa-2a and pegylated interferon alfa-2b. A general review of their differences and what experts say about their comparison will help those with chronic Hepatitis C better understand the pegylated interferon debate.

What is Pegylated Interferon?
By attaching a protective barrier called polyethylene glycol (PEG) to interferon, pegylated interferon can survive in the body longer than the un-pegylated form, thus reducing dosing frequency. While regular interferon is injected three times a week, pegylated interferon is generally taken once a week. There are two types of pegylated interferons – peg-interferon alfa-2a and alfa-2b. The major difference between the two is how they are dosed:

· 2a – The dose of pegylated interferon alfa-2a (Pegasys) is the same for all patients, regardless of weight or size.

· 2b – The dosing of pegylated interferon alfa-2b (PegIntron) is based on an individual’s weight.

Which Pegylated Interferon is Better?
While there is no other currently approved therapy for chronic Hepatitis C, there is uncertainty among doctors, scientists and patients as to which pegylated interferon is supreme. An overview of the studies evaluating the pegylated interferons has provided conflicting results:

1. In the August 2006 Journal of Hepatology, a small Argentine study compared the pharmacokinetics, pharmacodynamics, and antiviral activity of Pegasys and PegIntron in participants with chronic Hepatitis C genotype 1. The researchers found that patients receiving PegIntron had greater decreases in HCV viral load after eight weeks of therapy, despite lower levels of interferon in the blood of these participants. Interestingly, this trial was sponsored by Schering-Plough, the manufacturer of PegIntron.

2. At the 38th annual Digestive Disease Week in May 2007, Roche announced results of a small study demonstrating that all patients who discontinued treatment with PegIntron and ribavirin due to adverse events within the first 12 weeks were able to complete 12 weeks of treatment with Pegasys and ribavirin. The researchers concluded that Pegasys may be an option for those who are unable to tolerate the side effects of PegIntron.

3. Three studies presented at the 43rd European Association for the Study of Liver Diseases (EASL) held in Milan, Italy in April of 2008 showed that Pegasys had a better cure rate for Hepatitis C than PegIntron. The results of two Italian and one German trial demonstrated that when the dosage of ribavirin was kept at a constant, the cure rate for Hepatitis C was greater in those treated with Pegasys than Pegintron.

4. Also presented at the 43rd EASL were the results of the IDEAL (Individualized Dosing Efficacy vs. flat dosing to assess optimal pegylated interferon therapy) trial sponsored by Schering-Plough. Over 3,000 participants with Hepatitis C genotype 1 were recruited. While relapse after the end of treatment was lower for participants receiving PegIntron, the end of treatment response was higher with participants taking Pegasys. In total, the IDEAL results demonstrated a similar sustained virologic response, safety and tolerability between the two pegylated interferons. This study is being criticized by experts because those receiving Pegasys received a different starting dose of ribavirin than those on PegIntron. In addition, ribavirin dose reduction protocol for side effects was not uniformly administered between these two treatment arms.

5. Published in the August 8, 2006 issue of the Journal of Viral Hepatitis, researchers from Oregon performed an adjusted indirect analysis of trials comparing dual therapy with Pegasys or PegIntron versus dual therapy with non-pegylated interferon. After analyzing 16 trials for sustained virological response and withdrawal due to side effect rates, no statistically significant differences between dual therapy with pegylated interferon alfa-2a and dual therapy with pegylated interferon alfa-2b were found. Despite their apparent similarity, the study authors stated, “Because estimates are imprecise, our results also do not rule out a clinically significant difference. Head-to-head trials are needed to verify the results of indirect analyses and provide additional guidance on optimal treatment choices.”

While logic might lead one to assume that a dosage customized for each individual would deliver safer and more effective results, the data does not completely support this view. The conflicting evidence already in existence clearly indicates that more adequately funded, large, impartial, well-designed studies comparing the two pegylated interferons are needed. Since the differences between Pegasys and PegIntron appear to be negligible, those doing combination therapy for the first time have little reason to be concerned about which pegylated interferon their physician has prescribed.

References:

http://www.bio-medicine.org/medicine-technology/Data-Suggest-that-
Pegasys-May-be-an-Option-in-Hepatitis-C-Patients-0AUnable-to-Tolerate
-Peg-Intron-700-1/, Data Suggest that Pegasys May be an Option in Hepatitis C Patients Unable to Tolerate Peg-Intron, Retrieved August 17, 2008, Bio-Medicine, May 2007.

http://www.hivandhepatitis.com/hep_c/news/2008/071808_a.html, Comparison of the Pegylated Interferons Pegasys and PegIntron for Treatment of Chronic Hepatitis C: Analysis of 16 Randomized Trials, Retrieved August 16, 2008, hivandhepatitis.com, July 2008.

http://www.hivandhepatitis.com/2006roberts/hcv/080906_c.html, Comparison of Pegasys vs Peg-Intron for Treatment of Chronic Hepatitis C, Liz Highleyman, Retrieved August 16, 2008, hivandhepatitis.com, August 2006.

http://www.medicalnewstoday.com/articles/105492.php, Final Results Of Ideal Study Presented At Annual Meeting Of The European Association For The Study Of The Liver (EASL), Retrieved August 16, 2008, MediLexicon International Ltd., April 2008.

http://www.natap.org/2008/HCV/011408_02.htm, IDEAL Study COMMENTARY- Doug Dieterich MD A Healthy Dose of Curiosity Clinical trial results require careful interpretation, Douglas T. Dieterich, MD, Retrieved August 16, 2008, Liver Health Today, January-March 2008.

http://www.ncbi.nlm.nih.gov/pubmed/18482285, Pegylated interferons for chronic hepatitis C virus infection: an indirect analysis of randomized trials, Chou R, et al, Retrieved August 16, 2008, Journal of Viral Hepatitis, August 2008.

http://www.pegasys.com/about-pegasys/what-is-pegasys.aspx, What is Pegasys?, Retrieved August 16, 2008, Hoffman-La Roche Inc., 2008.

http://www.roche.com/inv-update-2008-04-28c, Investor Update, Retrieved August 17, 2008, F. Hoffman-La Roche, April 2008.

http://www.thebody.com/content/art5176.html, HCV Treatment and Monitoring Guide, Retrieved August 16, 2008, The Body, August 2003.

Posted by Editors at 10:52 AM --- Printer-friendly version

August 15, 2008

Silymarin Improves Quality of Life During Hepatitis C Treatment

Although a large-scale study concluded long-term interferon therapy to be ineffectual for Hepatitis C management, it demonstrated improvements in quality of life for participants supplementing with silymarin.

by Nicole Cutler, L.Ac.

Over the past few decades, thousands of clinical studies have been conducted on the effectiveness of different types of complementary and alternative medicine (CAM) in combating chronic liver disease. As the CAM remedy most often advised and used to support liver health, silymarin supplementation has been the focus of a majority of these studies. Even though there is substantial evidence demonstrating silymarin’s benefits to a person with Hepatitis C, trial inconsistencies have prevented it from being totally accepted by the Western medical community. However, a recent result from a very large Hepatitis C clinical trial presents irrefutable evidence of silymarin’s value.

Silymarin
Milk thistle (Silybum marianum) has been used since Greco-Roman times as an herbal remedy for a variety of ailments, particularly liver problems. The active ingredient in milk thistle is known as silymarin. This substance, which actually consists of a group of compounds called flavonolignands, helps repair liver cells damaged by alcohol and other toxic substances. Silymarin also keeps new liver cells from being destroyed by these same substances, reduces hepatic inflammation and has potent antioxidant effects.

Most milk thistle products are standardized preparations extracted from the plant’s seeds. A majority of milk thistle preparations are standardized to contain 70 to 80 percent of silymarin. Since milk thistle products are dietary supplements in the U.S. and therefore not regulated, inconsistencies in concentration, purity and quality are the prime suspects for inconclusive clinical trial results.

CAM Frequency
As the aging population of Americans increasingly strives to take control of their health, their use of CAM rises correspondingly. Surveys show that in 1990, CAM was used by 34 percent of the U.S. population. In 1994, this frequency rose to 42 percent and up to 48 percent in 2004. Estimates show that Americans spend over $27 billion annually on CAM, a total that exceeds the amount spent on conventional medicines.

According to National Institutes of Health researchers, a significant portion of the subjects in the large-scale study evaluating Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) were taking silymarin. Among 1,145 of HALT-C’s participants, the following statistics were noted:

· 56 percent had never taken herbal supplements
· 23 percent were using herbal supplements during the study
· Silymarin constituted 72 percent of the 60 types of herbal supplements used by participants
· Among all participants, 16 percent had used silymarin in the past
· Among all participants, 17 percent used silymarin at the beginning of the study
· Silymarin use correlated strongly with higher education

HALT-C Findings on Silymarin
The large trial investigating the effectiveness of long-term pegylated interferon therapy on Hepatitis C previous non-responders, HALT-C was concluded ineffectual for Hepatitis C management. Even though long-term administration of pegylated interferon did not slow the worsening of liver disease, researchers learned about an advantage of taking silymarin with interferon. With such a large portion of people with chronic Hepatitis C taking silymarin, the researchers looked to see if these individuals demonstrated any differences from their counterparts who were not taking an herbal supplement.

When comparing silymarin users to non-silymarin users in the HALT-C trial, the following was discovered:

1. No beneficial effect of silymarin was found on ALT levels (serum alanine aminotransferases) – an enzyme often elevated with liver injury.

2. No beneficial effect of silymarin was found on Hepatitis C virus RNA levels.

3. Those on silymarin showed significantly fewer liver-related symptoms than non-users.

4. Those on silymarin scored higher on quality-of-life parameters than non-users.

5. After adjusting for age, race, education, alcohol consumption, exercise, body mass index and smoking, silymarin users showed significantly less fatigue, nausea, liver pain, anorexia, muscle and joint pain, and improvements in general health over non-users.

Confirming that silymarin has little direct effect on the Hepatitis C virus, the qualitative values generally used to evaluate virus severity were similar in silymarin users and non-users. However, there were other observable benefits to the silymarin users. By reducing the severity of common Hepatitis C symptoms and interferon side effects, silymarin use demonstrated an obvious advantage to people managing this virus.

Quality of Life
In reducing the liver symptoms of fatigue, nausea, liver pain, anorexia and muscle and joint pain, silymarin improves a person with Hepatitis C’s quality of life. In public health and in medicine, the concept of health-related quality of life refers to a person or group’s perceived physical and mental health. Physicians usually reference quality of life scales to measure the effects of how a chronic illness interferes with daily life.

Although quality of life is not a numerical measurement, many believe it to be the single most important factor in illness recovery.

A Pennsylvania study evaluated the importance of quality of life in patients with a specific type of advanced lung cancer. According to lead author Dr. Nicos Nicolaou, an attending physician in the radiation oncology department at Fox Chase Cancer Center in Philadelphia, “In the past, we've considered the stage of disease or tumor size along with other empirical data to predict how long a patient will survive, but now we know quality of life is a critical factor in determining survival.” Although this study focused on a different type of disease, a growing number of healthcare practitioners believe that enhancing a person’s quality of life improves the outcome of any type of chronic disease.

The most likely reason for CAM’s rising popularity is the increase in quality of life that many receive from its use. Although more research is required to prove that supplementing with silymarin improves the outcome of Hepatitis C infection, the mounting evidence leaves little room for doubt. The quality of life benefits that participants supplementing with milk thistle in the HALT-C trial experienced is enough to motivate most people managing this virus. If supplementing with this popular herb can significantly reduce fatigue, nausea, liver pain, anorexia, muscle and joint pain, and improve general health – it makes sense for people with chronic Hepatitis C to give it a try.

References:

Polyak, Stephen J., Inhibition of T-cell cytokines, hepatocytes NF-kappaB signaling, and HCV infection by standardized silymarin, Gastroenterology, May 2007.

Seeff LB, MD, et al., Herbal product use by persons enrolled in the hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) Trial, Hepatology, January 2008.

Tickerhoff, L., et al., Alternative therapy use in liver transplant recipients, Progress in Transplantation, September 2006.

www.bloodindex.com, Hepatitis C Treatment Reduces the Virus but Serious Liver Problems May Progress, Bloodindex, November 2007.

www.cdc.gov, Health-Related Quality of Life, National Center for Chronic Disease Prevention and Health Promotion, 2008.

www.haltctrial.org, Complementary and Alternative Medicine (CAM) for
the Treatment of Chronic Liver Disease, Leonard B. Seeff, MD, HALT-C News, New England Research Institutes, January 2007.

www.hcvadvocate.org, Health Related Quality of Life and Hepatitis C, David Bernstein, MD, FACP, FACG, Hepatitis C Support Project, 2008.

www.hepatitisneighborhood.com, Quality of Life Important in Hepatitis Management, Physicians Stress, John C. Martin, CuraScript, Inc., 2008.

www.nlm.nih.gov, Quality of Life Predicts Lung Cancer Survival, Robert Preidt, HealthDay, ScoutNews LLC, October 2007.

www.umm.edu, Milk Thistle, University of Maryland Medical Center, 2008.

Posted by Editors at 03:05 PM --- Printer-friendly version

August 12, 2008

Early Hepatitis C Treatment Increases Success

Currently approved treatment for chronic Hepatitis C is about 50 percent effective. New research from Canada claims that early treatment boosts its effectiveness up to 90 percent.

Early Treatment Is Key To Combating Hepatitis C Virus

http://www.sciencedaily.com/releases/2008/08/080808151715.htm

ScienceDaily (Aug. 11, 2008) — Canadian researchers have shown that patients who receive early treatment for Hepatitis C virus (HCV) within the first months following an infection, develop a rapid poly-functional immune response against HCV similar to when infection is erradicted spontaneously, according to a new study.

Therefore, early treatment can restore immune response against HCV and help eliminate the virus rapidly. This new discovery of the mechanisms of viral eradication could contribute to the development of new treatments.

About a quarter of infected individuals eradicate the infection spontaneously, without treatment. Led by Dr. Naglaa Shoukry and Dr. Julie Bruneau, affiliated to both the Research Centre of the Université de Montréal Hospital Centre and the Université de Montréal, as well as with researchers from the Institut national de la santé et de la recherché scientifique (Montréal branch), the study found that early treatment restores a rapid poly-functional immune response, characterized by the simultaneous production of multiple antiviral mediators.

HCV is transmitted through infected blood. Although a quarter of infected patients can eradicate the infection spontaneously, the majority develop persistent infection, a major cause of cirrhosis and cancer of the liver. The only approved treatment for HCV is an anti-viral drug known as pegylated interferon alpha. This drug is successful in only half of cases when administered during chronic infection. Success rates among those treated early after infection are significantly higher or around 90%.

In North America alone, most new HCV infections occur among intravenous drug users (IDUs), a vulnerable population that is often undiagnosed and untreated. In the study, researchers followed a group of IDUs at high risk of HCV infection before and immediately after exposure to HCV. Their findings clearly show the importance of early diagnosis and treatment of HCV – particularly in marginalized populations such as IDUs and aboriginal populations.

The study was funded by Canadian Institutes of Health Research and the Fonds de la recherché en santé du Québec.

Posted by Editors at 10:16 AM --- Printer-friendly version

July 31, 2008

Diabetes Prevention a Priority with Hep C

Diet and exercise are often quoted as the solution to most of our modern health problems. For reducing the risk of developing liver cancer, new research shows that these lifestyle changes are crucial to people with chronic Hepatitis C.

by Nicole Cutler, L.Ac.

Approximately 50 percent of the millions of people living with Hepatitis C are lucky enough to defeat the virus with interferon combination therapy. For the other half of people infected, the therapeutic goal remains to prevent their liver disease from progressing to cirrhosis or liver cancer. While stopping the worsening of liver disease constitutes approaches ranging from lifestyle changes to herbal supplements to unproven drug therapies, diabetes prevention appears to be more important than ever.

According to the American Diabetes Association, there are 20.8 million Americans living with diabetes. While an estimated 14.6 million have been diagnosed, experts estimate that about 6.2 million people are currently unaware that they have the disease. Although nobody wishes this increasingly common problem upon themselves new research points to another reason for practicing diabetes prevention. According to a recently published study from the Netherlands, having diabetes increases the risk of liver cancer for those with chronic Hepatitis C with advanced fibrosis or cirrhosis.

Study Details
Researchers at the Erasmus MC University Medical Center in Rotterdam analyzed data on 541 European and Canadian patients with advanced, chronic Hepatitis C. The researchers discovered that patients with more severe liver fibrosis were more likely to have diabetes. In addition, they concluded that individuals with advanced Hepatitis C and diabetes were at increased risk of developing liver cancer.

The severity of fibrosis was assessed by an Ishak fibrosis score, a system that measures the degree of scarring (fibrosis) of the liver:

· Stage 0 represents no fibrosis

· Stage 1 and 2 indicate degrees of fibrosis where there is minimal scarring around liver blood vessels

· Stage 3 indicates scarring extended out from liver blood vessels

· Stage 4 means that the scarring has formed bridges between blood vessels

· Stage 5 indicates nodular formation in the liver

· Stage 6 represents cirrhosis

According to researchers, the higher a person with Hepatitis C’s Ishak score, the more likely they were to have diabetes:

· Of those with an Ishak score of four, 10.5 percent had diabetes mellitus

· Of those with an Ishak score of five, 12.5 percent had diabetes mellitus

· Of those with an Ishak score of six, 19.1 percent had diabetes mellitus

Among the participants with diabetes, the study found an increased occurrence of liver cancer. As the primary test warning of diabetes (fasting glucose test) showed increased amounts of sugar in the blood, the risk of developing liver cancer also increased. The authors of the study postulated that hyperinsulinemia might explain the increased liver cancer risk among diabetic patients.

What is Hyperinsulinemia?
Although it does not necessarily equate to diabetes, hyperinsulinemia means having too much insulin in the blood. Unfortunately, hyperinsulinemia often leads to adult onset diabetes. Insulin is produced by the pancreas to help regulate blood sugar. The most common cause of hyperinsulinemia is insulin resistance, a condition where the body is resistant to insulin’s effects causing the pancreas to compensate by making more insulin.

Prevention
There is great hope for those who have hyperinsulinemia to prevent diabetes. The American Diabetes Association’s Diabetes Prevention Program (DPP) study conclusively showed that people with pre-diabetes can prevent the development of type 2 diabetes by making changes in their diet and increasing their level of physical activity. They may even be able to return their blood glucose levels to within normal range. Despite the DPP showing that some medications may delay the development of diabetes, diet and exercise had the most dramatic results. Just 30 minutes a day of moderate physical activity, coupled with a 5-10 percent reduction in body weight, produced a 58 percent reduction in diabetes.

Although the authors of this Dutch study do not explain why excessive amounts of insulin predispose someone to developing liver cancer, future studies are sure to investigate this established connection. In the meantime, this research warns people with chronic liver disease to take diabetes prevention seriously. It is now clearer than ever that those with Hepatitis C who don’t want liver cancer to be a part of their future must make diet and exercise their immediate priority.

References:

www.caringmedical.com, Condition: Hyperinsulinemia, Caring Medical & Rehabilitation Services, 2008.

www.diabetes.org, Diabetes Statistics, American Diabetes Association, 2008.

www.diabetes.org, How to Prevent or Delay Diabetes, American Diabetes Association, 2008.

www.idenix.com, Glossary of Terms, Idenix Pharmaceuticals, 2008.

www.mayoclinic.com, Hyperinsulinemia: Is it Diabetes?, Maria Collazo-Clavell, MD, Mayo Foundation for Medical Education and Research, 2008.

www.nlm.nih.gov, Diabetes Boosts Liver Cancer Risk in Hepatitis, Cirrhosis Cases, Robert Preidt, June 2008.

www.phoenixcme.org, Liver Fibrosis, phoenixcme.org, 2008.

Posted by Editors at 03:33 PM --- Printer-friendly version

July 29, 2008

Liver Donor Pool Expands For Hepatitis C Patients

Learn about the discovery made by St. Louis researchers that will expand the liver donor pool for HCV patients, and find out if Hepatitis C serology affects post-liver transplant survival rate.

Donor's Age Not Linked to Poor Outcomes in Liver Transplants

http://www.washingtonpost.com/wp-dyn/content/article/2008/07/22/
AR2008072201552.html

TUESDAY, July 22 (HealthDay News) -- Patients with hepatitis C who receive a liver from a donor over age 60 aren't at an increased risk for transplant failure, death or recurrent disease within five years after transplantation, say researchers at the Washington University School of Medicine, in St. Louis.

They analyzed data from 489 adults who had liver transplants at the school between 1997 and 2006. Of those patients, 187 (38.2 percent) had hepatitis C and 302 (61.8 percent) had other indications for liver transplant.

Of the patients with hepatitis C, 88.1 percent were still alive after one year, 78.3 percent survived three years, and 69.2 percent survived five years. Donor livers were still functioning in 85.6 percent of hepatitis C virus-positive recipients after one year, 75.6 percent after three years, and 65.6 percent after five years.

When they compared patients with hepatitis C and those without hepatitis C, the researchers found no differences in rates of patient survival and transplanted liver survival at one, three and five years.

"However, similar to other long-term transplant centers, we observed a negative effect from recurrent hepatitis C virus with a trend toward worsened long-term survival between years five and 10," the researchers wrote.

Among the patients in the study, 24 (12.8 percent) of those with hepatitis C and 48 (15.9 percent) of those without the virus received livers from donors age 60 and older. These recipients and those who received livers from younger donors had similar one-, three-, and five-year survival rates.

The findings were published in the July issue of theArchives of Surgery.

"In conclusion, overall patient and graft (organ) survival in hepatitis C virus-positive recipients is comparable with that in hepatitis C virus-negative patients, and there seems to be little, if any, adverse effect on short- and medium-term follow-up with the use of carefully selected older donor grafts in recipients with hepatitis C virus," the researchers concluded. "Data from this series suggest that the continued use of selected older donors is a safe method of expanding the liver donor pool, even for hepatitis C-positive recipients."

More information

The U.S. Centers for Disease Control and Prevention has more about hepatitis C.

SOURCE:JAMA/Archivesjournals, news release, July 21, 2008

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July 21, 2008

Natalie Cole Optimistic About Her Battle with Hepatitis C

Although currently recovering from combination therapy's side effects, the well-respected vocalist Natalie Cole may have conquered the Hepatitis C virus.

Natalie Cole says she has hepatitis C

The Associated Press
Published: July 16, 2008

http://www.iht.com/articles/ap/2008/07/16/arts/People-Natalie-Cole.php

NEW YORK: Grammy-winning singer Natalie Cole has been diagnosed with hepatitis C, her publicist said in a statement Wednesday.

Hepatitis C is a liver disease spread through contact with infected blood. The statement said the disease was revealed during a routine examination and was likely caused by her drug use years ago.

"I've been so fortunate to have learned so much from my past experiences," said Cole. "I am embraced by the love and support of my family and friends; I am committed to my belief in myself and in my abiding faith to meet this challenge with a heartfelt optimism and determination. This is how I intend to deal with this current challenge in my life."

Her physician at Cedars-Sinai Medical Center in Los Angeles, Dr. Graham Woolf, said Cole has had a "terrific response to her medication and is now virus negative."

"This gives her an increased chance of cure," he said. Woolf said Cole is recovering from side effects of the medicine she's taking, including fatigue, muscle aches and dehydration.

Cole, 58, the daughter of jazz legend Nat King Cole, has sold millions of records over her long career. She is due to release "Still Unforgettable," the follow-up to 1991's Grammy-winning, multi-platinum CD "Unforgettable ... With Love," on which she remade some of her father's classics, in September.

Posted by Editors at 10:06 AM --- Printer-friendly version

July 09, 2008

Hep C and Fatty Liver Disease Linked

Pittsburgh researchers have found an enzyme known to participate in fat production is elevated in those with Hepatitis C. Further exploration of this enzyme could help physicians better predict which HCV patients are at risk of developing fatty liver disease.

Hepatitis C Virus May Need Enzyme's Help To Cause Liver Disease

http://www.sciencedaily.com/releases/2008/07/080709091717.htm

ScienceDaily (July 9, 2008) — A key enzyme may explain how hepatitis C infection causes fatty liver -- a buildup of excess fat in the liver, which can lead to life-threatening diseases such as cirrhosis and liver cancer, report University of Pittsburgh Graduate School of Public Health and School of Medicine researchers.

The study shows that an enzyme known to play a major role in lipid production, fatty acid synthase (FAS), was highly elevated in human liver cells exposed to the hepatitis C virus. While preliminary, the research suggests that testing for elevated levels of FAS could help determine which patients with hepatitis C virus may go on to develop more serious, long-lasting health consequences brought on by fatty liver.

Nearly 200 million people worldwide are infected by hepatitis C, including 4 million Americans. Seventy percent of people with hepatitis C develop chronic liver disease, and the infection is the leading reason for liver transplantation in the United States.

Unlike hepatitis A and B, there is no vaccine to prevent hepatitis C infection. Since hepatitis C typically has no symptoms, many people do not know they have the infection until they develop signs of liver failure or fatty liver, sometimes decades after infection. The virus replicates and mutates quickly, helping it to evade discovery and attack by the immune system and allowing it to slowly wreak damage on the liver.

"Our study has provided new insight into how hepatitis C causes fatty liver. This has important implications for future studies and efforts to understand how the virus causes an increase in fatty acid levels that can lead to serious liver conditions," said Tianyi Wang, Ph.D., assistant professor, Department of Infectious Diseases and Microbiology, University of Pittsburgh Graduate School of Public Health, and the study's lead author.

To identify possible proteins in the hepatitis C virus linked to an increase in fatty acids, Dr. Wang worked with Thomas Conrads, Ph.D., co-director of clinical proteomics at the University of Pittsburgh Cancer Institute, and colleagues on a mass spectrometry-based proteomics approach in which they measured protein expression from liver cell cultures exposed to the hepatitis C virus. The approach sorted proteins based on their weight and electrical charge, looking for divergent patterns linked to the virus. Of the 175 proteins they identified, only FAS was highly elevated in cell cultures. Furthermore, when they blocked the expression of FAS, they noted a three to four times decrease in the level of the virus, indicating that FAS is directly linked to the virus's expression.

"Viruses are very complex, so it is challenging to determine what proteins may be at play in their survival and growth," said Dr. Wang. "The proteomic approach we used revealed many proteins linked to hepatitis C that may be worthy of further study, but FAS appears to be the protein most strongly associated with the production of fatty acids that can cause liver disease."

"Our next step in this research is to see how high the level of FAS is in tissue samples from hepatitis C patients and determine whether elevated FAS levels directly result in overproduction of fat in livers. If we learn that FAS is highly present in tissue, testing for it may be a way to predict those at risk for liver disease."

The study was published in the July 9 online issue of Hepatology. In addition to Drs. Wang and Conrads, other authors include Wei Yang, Ph.D., Sara Chadwick, B.S., and Shufeng Liu, Ph.D., University of Pittsburgh Graduate School of Public Health; Brian Hood, Ph.D., University of Pittsburgh Cancer Institute; Simon Watkins, Ph.D., University of Pittsburgh School of Medicine; and Guangxiang Luo, Ph.D., University of Kentucky College of Medicine.

The research was supported by a grant from the National Institutes of Health and University of Pittsburgh Central Research Development Funds.

Adapted from materials provided by University of Pittsburgh Schools of the Health Sciences, via EurekAlert!, a service of AAAS.

Posted by Editors at 03:29 PM --- Printer-friendly version

July 07, 2008

Popular Illegal Drug Extra Harmful with HCV

Scientists have found a popular street drug worsens Hepatitis C infection in two worrisome ways.

by Nicole Cutler, L.Ac.

Since an estimated 4.1 million Americans are infected with Hepatitis C, more people are concerned with which factors increase the damage this virus can cause. Considered to be a drug by healthcare professionals, alcohol is well-known to worsen Hepatitis C infection. As more research is conducted on the impact other types of drugs have on the Hepatitis C virus (HCV), it seems that an increasing number of controlled substances also encourage this virus to gain strength. In addition to causing neurological decline in people with HCV, methamphetamine has recently been charged with encouraging this virus to replicate.

About Methamphetamine
According to the 2005 National Survey on Drug Use and Health, 10.4 million Americans age 12 and older had tried methamphetamine at least once in their lifetimes. In many Western and Midwestern states, methamphetamine is second only to alcohol and marijuana as the drug most frequently used. A highly addictive central nervous system stimulant, methamphetamine’s low cost, ease to manufacture and variety of ways to take it make this substance a popular choice among those looking for a high.

In contrast to many other illicit drugs, methamphetamine can be made in small, homemade, illegal laboratories. Street methamphetamine is referred to by many names, such as “speed,” “meth” and “chalk.” Also referred to as “ice,” “crystal,” “glass” and “tina,” methamphetamine hydrochloride appears as clear chunky crystals resembling ice. Methamphetamine can be taken as a pill, injected, snorted, smoked or administered anally. Abusers may become addicted quickly, needing higher doses more often to feel its effects.

Meth’s Impact on the Body
While it is chemically related to amphetamine, methamphetamine’s effects are much more potent, longer lasting, and more harmful to the central nervous system. Methamphetamine increases the release of very high levels of the neurotransmitter dopamine, which stimulates brain cells, enhancing mood and body movement. Chronic methamphetamine abuse significantly changes how the brain functions. Taking even small amounts can result in:

· increased wakefulness
· increased physical activity
· decreased appetite
· increased respiration
· rapid heart rate
· irregular heartbeat
· increased blood pressure
· hyperthermia

Other effects of methamphetamine abuse may include irritability, anxiety, insomnia, confusion, tremors, convulsions, cardiovascular collapse and death. Long-term effects may include paranoia, aggressiveness, extreme anorexia, memory loss, visual and auditory hallucinations, delusions and severe dental problems.

Meth and Hepatitis C
Besides the possibility of acquiring Hepatitis C by using this drug, methamphetamine has been shown to wreck havoc on the body of a person already infected with the virus. Separate trials have shown that methamphetamine interacts with Hepatitis C in two damaging ways: cognition dysfunction and proliferation promotion.

1. Cognition Dysfunction – In a University of California at San Diego study, researchers examined how the Hepatitis C virus contributes to neurocognitive dysfunction in individuals with methamphetamine dependence. Investigators discovered that people with the Hepatitis C virus who had a dependence on methamphetamine had a higher likelihood of cognition issues, including overall neurocognitive performance deficits and problems in the specific areas of learning, abstraction, motor skills, speeded information processing and delayed recall.

2. Proliferation Promotion – In the April 2008 issue of Journal of Viral Hepatitis, researchers from the University Of Pennsylvania School Of Medicine reported on a laboratory study looking at whether methamphetamine lowered immunity in host cells, thus facilitating Hepatitis C replication in human liver cells. The researchers found that methamphetamine use affected the immune system in the following ways:

1. Methamphetamine inhibited natural intracellular interferon alpha expression.

2. Methamphetamine compromised the effect of recombinant interferon alpha as used for Hepatitis C treatment.

3. Methamphetamine inhibited expression of the signal transducer and activator of transcription 1 (STAT-1), a key modulator of interferon-mediated biological responses.

4. Methamphetamine also down-regulated expression of interferon regulatory factor 5 (IRF-5), a transcriptional factor that activates the interferon pathway.

Based on these findings, the investigators concluded that the manner in which methamphetamine compromises a person’s immune system encourages HCV viral load to rise.

As Hepatitis C infection rates climb, so does the effort to minimize the damage this virus inflicts. With its documented ability to favor central nervous system deterioration in people with HCV, methamphetamine use has an effect opposite of what many initially use this drug for – alertness. Additionally, new research presents evidence that methamphetamine’s effect on the immune system provides an ideal environment for Hepatitis C to replicate. Based on these two injurious effects of methamphetamine specific to HCV, people with the virus are hereby advised to avoid this illicit drug.

References:

L Ye, JS Peng, Z Wang, et al., Methamphetamine enhances Hepatitis C virus replication in human hepatocytes, Journal of Viral Hepatitis, April 2008.

www.hivandhepatitis.com, Methamphetamine Promotes Hepatitis C Virus Replication in Human Liver Cells, Liz Highleyman, hivandhepatitis.com, 2008.

www.neurology.org, Hepatitis C augments cognitive deficits associated with HIV infection and methamphetamine, M. Cherner, PhD, Neurology, April 2005.

www.nida.nih.gov, NIDA InfoFacts: Methamphetamine, National Institute on Drug Abuse, 2008.

www.usdoj.gov, Methamphetamine, United States Drug Enforcement Administration, 2008.

Posted by Editors at 12:19 PM --- Printer-friendly version

Hep C Long-Term Management Strategies

Since only about half of those on combination therapy beat Hepatitis C, the remaining people must strive to prevent their liver disease from progressing. Thus far, a liver wellness approach is a safer, more effective way to remain healthy compared to long-term interferon therapy.

by Nicole Cutler, L.Ac.

Over the past decade, clinical trials worldwide have been evaluating the effectiveness of Hepatitis C’s current standard of treatment, pegylated interferon and ribavirin. Most study results concur that approximately 50 percent of infected individuals are able to successfully clear the virus with the combination of these medicines. While this is good news for those who have been able to beat Hepatitis C, it leaves about half of those infected with a need for long-term management.

Sustained Viral Response
Successful Hepatitis C treatment is determined by the achievement of a sustained viral response (SVR). Considered to be the absence of detectable virus six months after the completion of treatment, SVR may even be a cure for those lucky enough to reach it. Although pegylated interferon and ribavirin have the potential to permanently get rid of Hepatitis C, it is a common occurrence for viral loads to rebound shortly after completing the medicine.

In the past, people with Hepatitis C who fail to achieve SVR have had few drug options for the continued battle against their liver disease. In general, Western medicine offers two choices for individuals in this position. They can:

1. repeat the pegylated interferon and ribavirin treatment with all of their side effects.

2. wait by the sidelines to see if new drugs are approved for Hepatitis C.

In lieu of curing the disease, those aiming to manage Hepatitis C share the goal of minimizing liver inflammation, thus reducing liver damage. Managing Hepatitis C has two distinct approaches – supporting liver wellness and using medications to slow down liver damage.

Liver Wellness for Hepatitis C Management
An increasing number of physicians and patients are recognizing the value of practicing liver wellness to delay disease advancement and enhance quality of life. Liver wellness is an approach that incorporates many daily aspects of living such as:

· Good nutrition
· Restful sleep
· Toxin avoidance
· Supplementing with milk thistle
· Alcohol abstinence
· Regular exercise
· Other liver supportive action

Despite being infected with Hepatitis C, combining the different facets of liver wellness has helped thousands of people live long, healthy lives.

Medications for Hepatitis C Management
In addition to practicing liver wellness, pharmaceutical companies also appreciate the value of keeping Hepatitis C viral loads to a minimum. Two U.S. studies have been conducted to determine if liver fibrosis progression caused by Hepatitis C can be stopped or significantly slowed with long-term, low-dose interferon treatment. The two studies, known as Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) and Colchecine versus Peg-Intron Long-term (COPILOT), evaluated approximately 1,600 people with Hepatitis C.

· HALT-C – The 517 patients randomized to the treatment arm in the HALT-C study received 90 micrograms of pegylated interferon in weekly injections for 3.5 years. Preliminary results from HALT-C looked promising, since pegylated interferon maintenance therapy led to improvements in liver enzymes, viral load and liver inflammation – markers typically assumed to predict liver disease progression. However, while these markers remained true, they ultimately did not translate into a lower likelihood of fibrosis progression, liver cancer, liver failure or death. Based on the HALT-C trial, maintenance doses of pegylated interferon are not an effective means of managing Hepatitis C.

· COPILOT – In this trial, patients are given a weekly injection of Peg-Intron or a twice-daily dosage of colchecine, an anti-inflammatory drug that has been found to help stave off the instance of liver cancer in cirrhotic patients. Differing from HALT-C, the COPILOT trial administers low dose Peg-Intron based on the patient’s weight. Given the side effects associated with standard doses of pegylated interferon, it was unclear whether lower-dose maintenance therapy would improve or impair quality of life. Thus far, the researchers have determined that treatment with weight-based, low-dose pegylated interferon does not adversely affect quality of life over a two-year period. Although it is too soon to determine the outcome of COPILOT, these preliminary results suggest that the weight-based low dosages of pegylated interferon may be tolerable by previous non-responders as maintenance therapy.

Major progress has been made in treating chronic Hepatitis C infection since the virus was isolated nearly 20 years ago. Since the current standard of therapy successfully eliminates the virus in approximately 50 percent of those affected, strategies to help people manage their illness is crucial for the remaining half of Hepatitis C infections.

At this time, no therapy is approved by the U.S. Food and Drug Administration for treatment failures of pegylated interferon and ribavirin. So far, the studies investigating low-dosage interferon as a maintenance therapy are inconclusive. However, preliminary results give us hope that a pharmaceutical concoction could delay liver disease advancement. Until an official approval for Hepatitis C maintenance therapy surfaces, liver wellness programs are an infected person’s best option for preserving their liver’s health. Often referred to as healthful lifestyle choices, investigating the many components of supporting the liver may help maintain hepatic health until a sustained viral response can be attained.

References:

Kelleher, T. Barry, et al., Maintenance Therapy for chronic hepatitis C, Current Gastroenterology Reports, June 2007.

www.hivandhepatitis.com, HALT-C Trial Shows Minimal Long-term Benefit of Pegylated Interferon Alfa-2a (Pegasys) Maintenance Therapy in Patients with Chronic Hepatitis C, Liz Highleyman, hivandhepatitis.com, November 2007.

www.hivandhepatitis.com, Treatment with Low-dose Pegylated Interferon Alfa-2b (PegIntron) Did Not Adversely Affect Quality of Life over a 2-year Period in Patients Staying on Therapy: The COPILOT Trial, hivandhepatitis.com, November 2007.

www.liverhealthtoday.com, Stalling Hepatitis C, Marc S. Botts, Liver Health Today, 2007.

www.nih.gov, Hepatitis C Treatment Reduces the Virus but Serious Liver Problems May Progress, US Department of Health and Human Services, November 2007.

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June 11, 2008

HCV Treatment Success: Early Response vs. Genotype

As presented at the April 2008 meeting of the European Association for the Study of the Liver, a rapid virological response can help clinicians customize the length of treatment for Hepatitis C – regardless of genotype.

by Nicole Cutler, L.Ac.

There is much debate among experts about the duration of treatment required for treating the Hepatitis C virus (HCV). As prescribed by physicians worldwide, the standard duration of a prescription for pegylated interferon (Pegasys or PegIntron) plus weight-based ribavirin differs depending on the patient’s genotype. However, recently announced research suggests that duration of treatment is best based on the individual’s virological response at specific intervals rather than their genotype.

The standard course of treatment is established by analyzing the results of large clinical trials. As determined by computational averages, these trials provide analysts with an ideal regimen for the population as a whole. In general, the standard duration of treatment is 24 weeks for HCV genotypes 2 and 3, and 48 weeks for HCV genotype 1. Despite this traditionally used model for determining treatment length, researchers have been finding that the best approach for Hepatitis C may veer away from this standardization and lean towards individual customization.

Historically, HCV genotype is the single most important predictor of a person’s outcome from treatment with pegylated interferon and ribavirin. Defined as a sustained viral response, a successful outcome is when the virus is undetectable in the blood six months after treatment ends.

The statistics consistently demonstrate that while about 50 percent of those with genotype 1 will achieve a sustained virologic response (SVR), between 70 and 90 percent of patients with genotype 2 or 3 will achieve SVR. Regardless of HCV genotype, experts have observed that patients who respond quickly to drug treatment are also more likely to be cured by them. Because pegylated interferon and ribavirin therapy is costly and carries the risk of serious side effects, scientists are continuously exploring new ways of predicting SVR so that the length of treatment can be customized for each patient.

The week of April 23-27, 2008, the 43rd annual meeting of the European Association for the Study of the Liver was held in Milan, Italy. Along with the myriad of revelations at this meeting, researchers presented a retrospective analysis of three randomized trials that demonstrated a rapid virologic response (RVR) to be superior to HCV genotype at predicting sustained virologic response.

Upon studying the outcomes of three trials, which, collectively, followed nearly 1,400 people receiving treatment for HCV, analysts compared these two factors for predicting SVR:

1. HCV genotype
2. RVR – defined as undetectable viral load after only four weeks of treatment

Among those achieving RVR in just four weeks of treatment, most (over 86 percent) achieved SVR independent of their HCV genotype. The value of this information applies to the scientists who calculate treatment time and to the physicians administering pegylated interferon and ribavirin treatment for HCV. The researchers recommended including RVR into the computations for treatment duration. In addition, they advise using an individual’s response to treatment after just one month to customize drug regimens regardless of genotype.

The debate over exactly how much medication for how long continues to churn in the Hepatitis C scientific community. By varying the treatment duration based on an individual’s early response, unnecessary side effects and costs of interferon and ribavirin can be spared. As factors other than genotype emerge as predictive of future treatment success, clinicians gain more insight into guiding their patients toward a customized, best possible outcome.

References:
Dalgard, Olav, et al., A Randomized Controlled Trial of Pegylated Interferon Alfa and Ribavirin for 14 vs. 24 Weeks in Patients with HCV Genotype 2 or 3 and Rapid Virological Response, Hepatology, January 2008.

Fried MW, et al., Rapid virological response is a more important predictor of sustained virological response (SVR) than genotype in patients with chronic hepatitis C virus infection, Program and abstracts of the 43rd Annual Meeting of the European Association for the Study of the Liver, Journal of Hepatology, April 2008.

http://clinicaloptions.com, RVR a Better Predictor of SVR Than HCV Genotype in HCV-Infected Patients With Peginterferon alfa-2a Plus Ribavirin, Clinical Care Options LLC, 2008.

Mangia, Alessandra, et al., Individualized Treatment Duration for Hepatitis C Genotype 1 Patients: A Randomized Controlled Trial, Hepatology, January 2008.

www.hcvadvocate.org, Adjustment of Treatment Duration Based on Early Response, Liz Highleyman, HCV Advocate, The Hepatitis C Support Project, March 2008.

www.hivandhepatitis.com, Duration of Pegylated Interferon plus Ribavirin May Be Tailored Based on Early Patient Response, Liz Highleyman, hivandhepatitis.com, 2008.

www.hivandhepatitis.com, HCV Genotype Is the Strongest Predictor of Sustained Virological Response after Retreatment of Hepatitis C Patients: Final Results of EPIC 3, hivandhepatitis.com, 2008.

www.natap.org, Virological response at 4 and 12 weeks predict high rates of sustained virological response in genotype 1 patients treated with peginterferon alfa-2a (40KD) plus ribavirin, Jules Levin, EASL, April 2007.

Posted by Editors at 12:26 PM --- Printer-friendly version

June 10, 2008

Fatty Liver Disease is a Major Health Concern

This liver disorder is incredibly common and its progression to a serious disease is usually preventable.

Health Watch: Fatty Liver Disease is a growing concern

By Brent D. Lemberg, MD • Special to The Journal • June 5, 2008

www.theithacajournal.com

Most Americans are aware that alcoholism and hepatitis C can lead to cirrhosis of the liver, but few people understand the risk of cirrhosis from fatty liver disease. An estimated 20 to 30 percent of all Americans have some degree of fatty liver disease, making it the most prevalent liver disease in this country.

Who is at risk?

Fatty liver disease is most common in people who are obese or who have the metabolic syndrome, which comprises a group of conditions including obesity, diabetes and high cholesterol. Ninety percent of all obese patients have fatty liver disease, as do 50 percent of all diabetics.

What causes this disease?

Normally, the liver helps to break down, process and remove fat, cholesterol and lipids from the body. However, when a person becomes overweight and/or develops insulin resistance, the liver becomes less efficient and begins to store fat rather than breaking it down. Stored fat in the liver can lead to inflammation, which in turn can cause permanent scarring and cirrhosis.
How serious is this problem?

While the majority of cases of fatty liver disease are fairly benign, about 30 percent of the time, fatty liver disease advances to a more serious condition known as nonalcoholic steatohepatitis (NASH). Of those, 10 percent develop cirrhosis. The number of people facing the risk of cirrhosis is increasing as the incidence of obesity rises in this country. The Centers for Disease Control (CDC) predict that by the year 2025, nearly 40 percent of Americans will be obese, including 20-30 percent of American children. This poses a very significant health problem in this country.
Cirrhosis of the liver

Cirrhosis is one of the top ten causes of death by disease in this country. It results from permanent scarring of the liver, caused by chronic disease or damage. A scarred liver cannot function properly and is no longer able to filter toxins from the blood or produce important enzymes and clotting factors. Cirrhosis puts you at risk for liver failure and may require a liver transplant.
How is it detected?

Because there are often no specific symptoms, fatty liver disease is usually detected when a routine blood chemistry profile shows elevated liver enzymes. In determining the cause of a person's elevated liver function, we check for risk factors for other reasons for liver disease such as viral hepatitis, autoimmune diseases, and medication-induced liver disease. A person in the latter stages of fatty liver disease may have pain in the right upper quadrant of his or her abdomen, and may experience fatigue. After ruling out other causes of liver disease, the doctor may order an ultrasound, CT scan, or MRI to look for signs of fat in the liver. A liver biopsy is rarely necessary to diagnose fatty liver disease, as long as other causes have been ruled out.
Recommended treatment

There is no quick fix. The optimal treatment is to lose weight, control diabetes, and lower your cholesterol. Losing 10 percent of your body weight is often enough to return liver function back to normal. There is ongoing research for medications to treat fatty liver disease, and there is some interest in the role of antioxidants, such as vitamins A and C.

However, at this time, the best treatment is weight loss. We have seen dramatic improvement of fatty liver disease in severely obese patients who have successfully undergone weight-loss (bariatric) surgery, such as gastric bypass.

People can and do live for a long time with fatty liver disease if it does not progress to a serious condition. The very best strategy is prevention, which starts by setting a healthy example for our children.

Dr. Lemberg is board-certified in gastroenterology/hepatology and internal medicine. He is on the medical staff of Cayuga Medical Center and in practice with Gastroenterology Associates of Ithaca, where he can be reached at 272-5011.

Posted by Editors at 02:29 PM --- Printer-friendly version

June 02, 2008

Marijuana Use Sparks Liver Transplant Controversy

Despite its legality in 12 states, learn why medical marijuana use may render a person with Hepatitis C ineligible for a liver transplant.

by Nicole Cutler, L.Ac.

Hepatitis C is not only the leading cause of chronic liver disease in the United States, it is also the most common reason for liver transplants in this country. Unfortunately, some with Hepatitis C are being denied access to liver transplants because of their use of a controversial type of symptom relief.

Although transplantation is considered a last resort for liver disease, the number of people waiting for a new organ far outnumbers the supply. Since donated livers are in such high demand, a complex system of prioritizing who gets transplant surgery has evolved. Obviously, great deliberation is involved in deciphering transplant eligibility and recipient ranking. However, the ethics of this process has been called into question for those using medical marijuana. Occasionally used to ease Hepatitis C symptoms, patients legally using medical marijuana are at high risk of being denied a spot on the liver transplant recipient queue.

UNOS
The United Network for Organ Sharing (UNOS) is a non-profit, scientific and educational organization that administers the nation's only Organ Procurement and Transplantation Network. UNOS is responsible for organ matching and placement throughout the United States. According to the UNOS website, over 98,000 people are currently on an organ transplant waiting list. Many people wait for years for a new liver, often not surviving the wait. According to the Scientific Registry of Transplant Recipients, less than a third of those waiting for a liver actually receive one.

The UNOS entrusts individual hospitals and transplant centers to develop their own criteria for transplant candidates. Some of these institutions automatically reject people who use "illicit substances" — including those legally prescribed medical marijuana. "Most transplant centers struggle with issues of how to deal with people who are known to use marijuana, whether or not it's with a doctor's prescription," said Dr. Robert Sade, director of the Institute of Human Values in Health Care at the Medical University of South Carolina. "Marijuana, unlike alcohol, has no direct effect on the liver. It is, however, a concern ... in that it's a potential indicator of an addictive personality."

Medical Marijuana
Marijuana has been used for medicinal purposes for approximately 4,000 years. Surviving texts from ancient India confirm that its psychoactive properties were recognized, and doctors used it for a variety of illnesses and ailments. These included a whole host of gastrointestinal disorders, nausea, low appetite, insomnia, headaches and as a pain reliever.

People with Hepatitis C have reported using marijuana (cannabis) to treat both symptoms of the disease as well as the nausea associated with antiviral therapy. An observational study by investigators at the University of California at San Francisco (UCSF) found that Hepatitis C patients who used cannabis were significantly more likely to adhere to their treatment regimen than patients who didn't use it. Despite this support for medical marijuana, several trials reported an association between daily cannabis use and the development of liver fibrosis in Hepatitis C. Aside from the question of legality, experts disagree on the therapeutic use of cannabinoids for Hepatitis C treatment.

The medical use of cannabis has been legalized in several countries including Canada, Belgium, Australia, the Netherlands, the United Kingdom, New Zealand and Spain. Since 1996, twelve U.S. states have legalized medical marijuana use: Alaska, California, Colorado, Hawaii, Maine, Montana, Nevada, New Mexico, Oregon, Rhode Island, Vermont and Washington. Doctors in these states can write a prescription for marijuana for a legitimate medical issue. However, the United States Supreme Court ruled that the federal government has the right to regulate and criminalize marijuana in these states, even for medical purposes.

Sad Outcome in Washington
The debate about medical marijuana’s impact on liver transplant eligibility jumped to center stage in May of 2008 when Washington state resident Timothy Garon passed away. To combat his Hepatitis C symptoms, Garon’s physician had authorized medical marijuana for alleviating his nausea and stomach pain and to stimulate his appetite. Legally authorized in Washington state since 1998, Garon’s attorney believes that his client’s medical marijuana use kept him off of the liver transplant list, a decision that ultimately cost Garon a chance for survival.

No one tracks how many patients are denied transplants over medical marijuana use. Pro-marijuana groups have cited a handful of cases, including at least two patient deaths, in Oregon and California, since the mid- to late 1990s, when states began adopting medical marijuana laws.

With the nation’s shortage of transplantable livers, some administrators may be using their moral judgment to decide who gets on an eligibility list. Thus, using medical marijuana to ease advanced Hepatitis C symptoms may put some people at a disadvantage. Until our nation’s lawmakers, physicians and administrators are all in agreement about the use of cannabis for certain illnesses, those in need of a liver transplant may wish to think ahead – and either choose a different medicine for symptom relief or consult with their chosen hospital about their view on medical marijuana as a factor in transplant eligibility.

References:

http://en.wikipedia.org, Medical Cannabis, Wikimedia Foundation Inc., 2008.

http://norml.org, Hepatitis C, The National Organization for the Reform of Marijuana Laws, 2008.

http://seattletimes.newsource.com, Is medical-marijuana use reason to deny someone an organ transplant?, Seattle Times Staff and Associated Press, The Seattle Times Company, May 2008.

http://stopthedrugwar.com, Marinol Death Sentence: Oregon Man Denied Liver Transplant Because of Prescription -- He's Not the Only One, stopthedrugwar.com, 2008.

Sylvestre, et al, Cannabis use improves retention and virological outcomes in patients treated for hepatitis C, European Journal of Gastroenterology & Hepatology, 2006.

www.cbhd.org, Liver Transplants: How Do We Choose Who Should Live When Not All Can?, Gregory W. Rutecki, The Center for Bioethics and Human Dignity, 2008.

www.drugwarfacts.org, Medical Marijuana, Common Sense for Drug Policy, 2008.

www.unos.org, Who We Are, United Network for Organ Sharing, 2008.

www.usatoday.com, Playing field for liver transplants is not level, studies find, Robert Davis, USA Today, 2008.

Posted by Editors at 11:28 AM --- Printer-friendly version

May 30, 2008

HCV Cure Associated with Early Drop in Viral Load

Australian researchers find that the suppression of Hepatitis C viral load within the first month of beginning treatment is a good predictor of defeating the virus - regardless of co-infection with HIV.

Overcoming virus early beats hepatitis

Adam Cresswell, Health editor | May 24, 2008

www.theaustralian.news.com.au

DRIVING down the number of circulating copies of the hepatitis C virus to undetectable levels in the earliest stages of infection makes it highly likely that the patient will eventually be cured - even among patients who are also infected with HIV.

The findings, the interim results from an Australian study presented to a recent international conference in Italy, suggest that rapid virological response - or RVR, the term used to indicate successful suppression of viral load within four weeks of starting treatment - is just as good a predictor of eventual cure among patients suffering acute hepatitis C infection as it is already known to be among chronically infected individuals.

In addition, the trial - which is still continuing - suggests new treatment options for difficult-to-treat groups such as people with HIV and injecting drug users. Unlike most hepatitis C treatment studies, this research included significant numbers of HIV patients and injecting drug users, and the findings showed RVR was just as good at predicting eventual cure in these as in other patients.

The Australian Trial in Acute Hepatitis C, known by its acronym ATAHC, was funded by the US National Institutes of Health. The interim findings were presented as a poster at the recent annual scientific meeting of the European Association for the Study of the Liver in Milan, where it was voted into the top 10 per cent of the more than 800 poster presentations at the meeting.

An estimated 264,000 Australians have been exposed to hepatitis C, a blood-borne virus that attacks the liver and left untreated can lead to liver inflammation, cirrhosis and eventually cancer.

Although 25 per cent of people clear the virus naturally, the prognosis for the remaining 75 per cent is more difficult as most will usually experience symptoms such as debilitating fatigue, pain and nausea.

While cure is possible with drug therapy, the drugs are quite toxic and hard to tolerate. Treatment also lasts a year and only works in fewer than 50 per cent of cases. Co-infection with HIV makes it even harder to eradicate hepatitis C.

Sydney-based hepatitis expert Greg Dore, a co-author of the study and who attended the Milan conference, said the message from the ATAHC findings was that if doctors could drive viral levels down to undetectable levels early "you can get incredibly good response rates".

While 107 patients in the study elected to have treatment for acute hepatitis C, 84 patients continued to the point where they had data on their progress after four weeks of treatment. Among the 26 patients infected with HIV as well as hepatitis C, RVR, or complete viral suppression, was observed in 10 people (45 per cent), and in 28 out of the 58 patients infected with hepatitis C alone (48 per cent).

Those with high hepatitis C viral loads at the start of treatment, with more than 400,000 international units per millilitre of blood, were less likely to achieve RVR.

Finally, 53 patients were assessed for both RVR and for sustained virological response, or SVR, a longer-term measure that is often taken to mean the patient has been cured. All the participants who achieved RVR went on to achieve SVR, and even 59 per cent of those who did not achieve RVR went on to be cured later.

The study's authors concluded that patients treated for acute hepatitis C infection and who achieved RVR "are highly likely to achieve SVR, irrespective of HIV status".

"This is the largest study ever of an injecting drug-user population with early infection," said professor Dore, who is head of the viral hepatitis clinical research program at the Sydney-based National Centre in HIV Epidemiology and Clinical Research.

"We have shown that it is feasible to treat this group, many of whom have been recent injecting drug users, and get remarkably good outcomes.

"What we are looking at now is to apply to the NIH for another five years' funding, to look at the different strategies to optimise treatment outcomes in this group."

Dore's colleague doctor Gail Matthews said the high proportion of HIV-positive cases in the study participants, about one-third, "probably reflects a current increase in acute HCV in this population - predominantly acquired through sexual transmission and mirroring what is being reported from many centres in Europe".

"This has potential implications for public health messages in this group," she said.

Adam Cresswell's trip to the EASL conference in Milan was organised as part of the prize for winning the Professor Geoff Farrell Medal, a journalism award organised by Hepatitis Australia for writing about hepatitis C. Funding for the award was provided by the drug company Schering-Plough.

Posted by Editors at 02:37 PM --- Printer-friendly version

May 27, 2008

Wine and Liver Health

Although a study emerging from San Diego claims that a small amount of wine may protect the liver, the researchers admit that this is not true for those already living with liver disease. In fact, there are several more caveats to this surprising claim.

A little wine can be beneficial to liver, UCSD research finds

By Cheryl Clark
UNION-TRIBUNE STAFF WRITER
www.signonsandiego.com

May 22, 2008

Alcohol and your liver: not a happy couple, right?

Well, not exactly. A new UCSD study challenges conventional wisdom by suggesting one small glass of wine a day can reduce the risk of early-stage liver disease by one-half compared with drinking no alcohol.

People who drank beer or hard liquor, though, had more than four times the odds of getting fatty liver disease.

“This is a whole paradigm shift in our way of thinking about this disease,” said Dr. Jeffrey Schwimmer, a UCSD liver disease expert who admits to drinking more wine now – preferably red – than before he conducted this study.

Moderate wine drinking previously has been linked with protecting the heart. Now, Schwimmer said, “if one is going to use alcohol in a modest fashion for heart protection, this study suggests wine is not only safe for the liver, but may in fact be beneficial.”

Schwimmer's study does not explain exactly how wine protects the liver, but he suggested in an interview that the benefit might come from an ingredient in wine called resveratrol, or from a process related to the fermentation of grapes.

His report is published in the current issue of the journal Hepatology and was funded by divisions of the National Institutes of Health.

The condition Schwimmer studies is called non-alcoholic fatty liver disease, a condition found in 20 percent of adults, even those who drink little alcohol. The condition has no symptoms, but can be diagnosed when the liver has around 5 percent abnormal fat deposits. The normal amount is 1 percent.

In a quarter of those with fatty liver disease, the condition worsens to hepatitis or liver inflammation. And in 10 to 20 percent of those with hepatitis, scarring associated with cirrhosis occurs.

Before one rushes to the discount wine store, the study has several caveats. For starters, one must limit consumption to only 4 ounces a day, a little more than two shots' worth.

Second, people who already have liver disease should avoid alcohol at all costs.

Third, the study does not suggest that drinking more than 4 ounces further reduces the chance of liver disease. In fact, for most people, drinking more alcohol could raise the risk of other illnesses, such as cirrhosis of the liver and heart disease.

Schwimmer's study also is vulnerable to reporting error. It was based on examination of answers given to researchers between 1988 and 1994 by 15,000 adult Americans who had undergone a liver enzyme blood test called ALT.

ALT is not as accurate as liver biopsies in diagnosing fat in the liver, he acknowledged.

“Now we need to take the next step,” Schwimmer said. He plans to study people who have more symptomatic liver disease, including hepatitis or cirrhosis, not linked to heavy use of alcohol.

Posted by Editors at 02:15 PM --- Printer-friendly version

May 14, 2008

What You Must Know About Alcoholic Hepatitis

If you think one must be a heavy drinker to suffer from this condition, you ought to read this article. Discover the causes, risk factors and complications of alcoholic hepatitis. Share this information with others. After reading this, anyone with liver concerns may want to abandon intoxicating beverages altogether.

Alert to Alcoholic hepatitis

Daily Mirror Health Line
Compiled by Naveen Jayawardena
www.dailymirror.lk

Monday, May 12, 2008

Alcohol has long been associated with serious liver diseases such as hepatitis - inflammation of the liver. But the relationship between drinking and alcoholic hepatitis is complex. Only a small percentage of heavy drinkers develop alcoholic hepatitis, yet the disease can occur in people who drink only moderately or binge just once. And though damage from alcoholic hepatitis often can be reversed in people who stop drinking, the disease is likely to progress to cirrhosis and liver failure in people who continue to drink. For them, alcoholic hepatitis may be fatal.

Causes

· Genetic factors. Having mutations in certain genes that affect alcohol metabolism may increase your risk of alcoholic liver disease as well as of alcohol-associated cancers. Genetic factors may account for half of any person's susceptibility to alcohol-related disease.

· Other types of hepatitis. Long-term alcohol abuse worsens the liver damage caused by other types of hepatitis, especially hepatitis C. If you have hepatitis C and also drink - even moderately - you are more likely to develop cirrhosis than is someone who doesn't drink.

· Other diseases. People who drink alcohol are more likely to develop alcoholic hepatitis if they also have another disease that affects the liver, such as diabetes or iron overload (hemochromatosis) - a disorder in which the body stores too much iron.

· Obesity. Although most researchers agree that obesity makes alcoholic liver disease worse, exactly why this is so isn't clear. It may be that alcohol causes fatty tissue to produce certain hormones and cytokines - immune system proteins that increase inflammation.

· Malnutrition. Many people who drink heavily are malnourished, either because they eat poorly - often substituting alcohol for food - or because alcohol and its toxic byproducts prevent the body from properly absorbing and metabolizing nutrients, especially protein, certain vitamins and fats. In both cases, the lack of nutrients contributes to liver cell damage. It was once thought that malnutrition, rather than alcohol, caused alcoholic liver disease. Now, the relationship between the two appears more complicated. But it's certain that drinking leads to malnutrition, which damages the liver and contributes to some of the serious complications of alcoholic liver disease.

Risk factors

· Alcohol use. Consistent heavy drinking or binge drinking is the primary risk factor for alcoholic hepatitis, though it's hard to precisely define heavy drinking. Some experts believe that four or more drinks a day for men and two or more a day for women greatly increase the risk of liver damage. Moderate drinking is usually defined as no more than two drinks a day for men and one for women. But because people vary greatly in their sensitivity to alcohol, that amount may not actually be moderate for everyone. Whether certain types of alcohol cause more harm than others also is a matter of debate. Some experts believe that wine is less damaging than hard liquor is, although it may be that wine drinkers generally tend to have healthier lifestyles.

· Age. The effects of alcoholic hepatitis are most likely to show up after years of heavy drinking, but symptoms of disease can develop in people as young as 20.

· Your sex. Women are two to three times as likely to develop alcoholic liver disease as men are. It takes less alcohol to harm the liver in women, and when liver disease occurs, it progresses more quickly than it does in men. This disparity may result from differences in the way alcohol is absorbed and broken down. Because women tend to metabolize alcohol more slowly, their livers are exposed to the higher blood concentrations of alcohol for longer periods of time - with potentially greater toxicity. The slow rate of alcohol metabolism in women may be due to lower levels of stomach enzymes that break down alcohol, the effects of estrogen or even the size of a woman's liver.

· Genetic factors. Researchers have discovered a number of genetic mutations that affect the way alcohol is metabolized in the body. Having one or more of these mutations may increase the risk of alcoholic liver disease and liver cancer.

Complications

· Increased blood pressure in the portal vein. Blood from your intestine, spleen and pancreas enters your liver through a large blood vessel called the portal vein. If scar tissue blocks normal circulation through the liver, this blood backs up, leading to increased pressure within the vein.

· Enlarged veins (varices). When circulation through the portal vein is blocked, blood may back up into other blood vessels in the stomach and esophagus. These blood vessels are thin walled, and because they're filled with more blood than they're meant to carry, they're likely to bleed.

· Fluid retention. Alcoholic liver disease can cause large amounts of fluid to accumulate in your abdominal cavity (ascites).

· Bruising and bleeding. Alcoholic hepatitis interferes with the production of proteins that help your blood clot and with the absorption of vitamin K, which plays a role in synthesizing these proteins. As a result, you may bruise and bleed more easily than normal. Bleeding in the gastrointestinal tract is particularly common.

· Jaundice. This occurs when your liver isn't able to remove bilirubin - the residue of old red blood cells - from your blood. Eventually, bilirubin builds up and is deposited in your skin and the whites of your eyes, causing a yellow color.

· Hepatic encephalopathy. A liver damaged by alcoholic hepatitis has trouble removing toxins from your body - normally one of the liver's key tasks. The buildup of toxins such as ammonia can damage your brain, leading to changes in your mental state, behavior and personality.

· Cirrhosis. This serious condition, which is an insidious and irreversible scarring of the liver. Cirrhosis frequently leads to liver failure, which occurs when the damaged liver is no longer able to adequately function.

Copyright © Wijeya Newspapers Ltd.

Posted by Editors at 09:25 AM --- Printer-friendly version

May 13, 2008

15 Tips for Managing Interferon-Ribavirin Side Effects

Many people abandon this challenging HCV treatment mid-course. Here are 15 ways to help manage the side effects of Hepatitis C combination therapy, to help patients' likelihood of completing the extremely challenging treatment. Share this article among patients contemplating and/or already undergoing chemotherapy for Hepatitis C, so they can help increase their likelihood of conquering the virus.

by Nicole Cutler, L.Ac.

Although it affects an estimated four to five million Americans, there is still no easy formula to eliminate the Hepatitis C virus (HCV). At best, infected individuals have a 50 percent chance of triumphing over the virus by enduring standard combination therapy, a notoriously challenging treatment with pegylated interferon and ribavirin medications. Most experts believe that the success rate of these drugs would be much higher without the burden of their potentially serious side effects. In cooperation with a physician, those with HCV who can manage standard combination therapy’s side effects are more likely to complete the drug regimen at full strength – and thus have a better chance of ridding the virus from their body.

Especially apparent in the first several weeks of treatment, the side effects of these drugs range from mild to severe. Managing these effects can be simple, involving lifestyle modifications, logical home remedies and taking some routine medications. Beyond these basics, working with a knowledgeable physician is important for customizing a plan to help someone manage their side effects.

The side effects from interferon and ribavirin therapy often lead to lowered dosages or even discontinuation of these drugs. Physicians agree that the more a dosage is reduced, the less of a chance the therapy has at successfully killing HCV. However, dose reduction or discontinuation of interferon or ribavirin may be indicated immediately if severe side effects develop.

Fifteen suggestions to discuss with your physician for managing the most common side effects of combination therapy are outlined below:

1. Getting a full night’s sleep helps the body recover from physical and emotional stressors. Being fully rested lessens the side effects of fatigue, headache, fever, myalgia (muscle pain), irritability and insomnia.

2. Keeping hydrated is helpful to counteract the drying properties of combination therapy. Keeping hydrated is advised to improve fatigue, headache, fever, myalgia and dry mouth.

3. Eating well-balanced meals helps the body bounce back from fatigue, headache, fever and myalgia.

4. Engaging in regular exercise keeps your circulation going and thus helps prevent fatigue, headache, fever and myalgia.

5. Taking a hot bath or using hot packs is recognized for helping relieve myalgia.

6. Taking acetaminophen (Tylenol) or NSAIDS can reduce fatigue, headaches, fever, myalgias or liver pain. However, dosage and safety considerations must be confirmed by your doctor since these drugs may place an additional burden on the liver.

7. Include ginger in your day by drinking it in tea, ale or snacking on ginger baked goods to relieve nausea.

8. Taking ribavirin with food and eating small, frequent meals helps ease ribavirin-related nausea.

9. Prochlorperazine (compazine) may stop nausea but should only be done under a physician’s guidance.

10. Avoiding stimulants like caffeine at night can reduce insomnia and irritability.

11. Practicing relaxation techniques, such as taking a deep breath and counting to ten, can significantly help reduce irritability.

12. Taking selective serotonin reuptake inhibitors (SSRIs) have been proven effective in treating the depression associated with interferon therapy for certain individuals. The additional side effects of SSRIs and treatment guidelines must be carefully evaluated by your physician.

13. Sharing feelings with friends, family or a support group can help many people cope with the irritability and depression often accompanying HCV therapy.

14. Being gentle with your hair can help minimize hair loss. This includes not pulling on or braiding the hair, avoiding vigorous combing or brushing and only using natural (not harsh) hair products.

15. Avoiding hot or spicy foods minimizes mouth irritation. For those dealing with the side effects of a dry mouth or mouth sores, avoiding these types of foods is a must.

Some of these tips for managing side effects are easily accomplished at home while others require collaboration with your physician. However it is accomplished, reducing side effect severity helps people endure a full course of combination therapy, a feat that increases their odds of eliminating the Hepatitis C virus.

References:

www.clevelandclinic.org, Managing Side Effects of Hepatitis C Treatment, The Cleveland Clinic Department of Patient Education and Health Information, 2008.

www.hepatitis.va.gov, Clinical Manual: Interferon and Ribavirin Treatment Side Effects, United States Department of Veteran Affairs, 2008.

www.hepcawareness.net.au, Treatment Side Effects, Australian Hepatitis Council, 2008.

Posted by Editors at 11:12 AM --- Printer-friendly version

May 12, 2008

New Mexico Offers Free Hepatitis C Hotline

Finally being recognized as the widespread, public health problem that it is, the New Mexico Department of Health has taken a giant step forward to help people with Hepatitis C. By launching a new, toll-free phone number, locals concerned about Hepatitis C can get some confidential, practical, expert advice.

Department of Health launches toll-free Hepatitis C number

Sun-News report
Article Launched: 05/06/2008 10:03:24 AM MDT

www.lcsun-news.com

SANTA FE -- The New Mexico Department of Health has launched a new toll-free number that will make it easier for patients with hepatitis C to access services and learn how to fight the disease. Department of Health staff answers the confidential, toll free number from 8 to 5 p.m. Monday through Friday at 1-888-DOH-HepC (364-4372). Callers can also leave a confidential message that will be returned by Department staff.

"The number will help providers connect patients with hepatitis C services," said Ray Stewart, the Department's director of public health services in southwestern New Mexico. "Individuals who are at risk for hepatitis C can also call to find out where they can get tested."

Project ECHO is a partnership between the Department of Health, the University of New Mexico Health Sciences Center, the New Mexico Corrections Department, and the New Mexico Primary Care Association. The project, which began in 2003, provides medical providers across the state with expert advice through telehealth sessions on treating their patients.

Telehealth uses live videoconferencing through the internet and has the potential to close gaps in healthcare access many New Mexicans face due to the lack of medical and behavioral health specialists in their area. Project ECHO also covers other chronic diseases such as asthma, arthritis, obesity, depression, and substance use disorders.

In recognition of World Hepatitis Day on May 19, the Department of Health has partnered with the University of New Mexico, New Mexico Hepatitis C Alliance, El Centro Family Health and New Mexico AIDS Service to host a series of events and raise awareness about the importance of viral hepatitis prevention and care:

On May 12, El Centro Family Health and Department of Health will host a health fair from 11 to 3 p.m. at the Wal-Mart, 1610 Riverside Drive in Española. Free viral hepatitis testing and vaccinations are available to those who qualify. Educational and treatment information are also available.

On May 19, New Mexico AIDS Services will extend testing hours from 5 to 7 p.m. to provide free hepatitis and HIV screening and hepatitis A and B vaccine at 625 Truman NE in Albuquerque. Eligibility will be determined based on risk assessment. Call 505-938-7100 for more information.

On May 23, Department of Health and the University of New Mexico will host a webinar presentation about the medical aspects of hepatitis C including treatment, surveillance, counseling, testing and harm reduction from 9 to noon. The webinar is open to the public. To register, e-mail Patrick.Stafford@state.nm.us.

On May 29, New Mexico AIDS Services will host a "Smart Steps" class from 1 to 3 p.m. for people infected with hepatitis C.

Posted by Editors at 12:52 PM --- Printer-friendly version

April 29, 2008

Hepatitis C Complications Helped by Maintenance Interferon

A four-year study confirms that low-dosage maintenance interferon therapy prevents disease progression in those with portal hypertension or cirrhosis from Hepatitis C.

Positive Findings In Treating Patients With Advanced Hepatitis C, Study Shows

www.sciencedaily.com

ScienceDaily (Apr. 25, 2008) — The hepatitis C therapy peginterferon alfa-2b, when given as low-dose maintenance therapy, can prevent disease progression in certain patients who failed previous interferon-based hepatitis C therapies and have advanced liver disease, according to findings from a large, four-year study presented April 24 at the 43rd annual meeting of the European Association for the Study of the Liver (EASL).

The study, called COPILOT (COlchicine versus Peg-Intron LOng-Term), showed that low-dose peginterferon alfa-2b was superior to colchicine in improving the disease-free survival of patients with cirrhosis and portal hypertension, especially in patients who stayed on treatment. In the study, more than 40 percent of patients had portal hypertension, a condition of high blood pressure in the major vessel going to the liver from the gastrointestinal tract and which often accompanies liver cirrhosis. However, peginterferon alfa-2b maintenance therapy was not superior to colchicine in patients overall.

"These findings make a strong case for considering low-dose peginterferon alfa-2b as a maintenance therapy in patients with cirrhosis and portal hypertension who have failed hepatitis C eradication therapy," said principal investigator Nezam Afdhal, M.D., Chief of Hepatology at Beth Israel Deaconess Medical Center (BIDMC) and Associate Professor of Medicine at Harvard Medical School. "While other interferon maintenance therapies have been studied in the past few years in previous interferon nonresponders, these findings show, for the first time, a clinical benefit in a specific population with advanced disease," he said.

Hepatitis C virus (HCV) infection is transmitted through exposure to infected blood and affects an estimated 4 million individuals in the United States. The current standard treatment, combination therapy with pegylated interferon plus ribavirin for 24 to 48 weeks, can eradicate the virus in about 50 percent of patients. Those who do not respond and have cirrhosis are at far greater risk for developing liver cancer or liver failure, so the development of treatment strategies for these nonresponders is a priority.

Conducted at approximately 40 sites in the United States, the COPILOT study compared weight-based low-dose peginterferon alfa-2b (subcutaneous injection of 0.5 mcg/kg/wk, one-third the dose used in standard HCV combination therapy) versus colchicine (0.6 mg orally, twice daily), an anti-inflammatory and antifibrotic medication, in 555 chronic hepatitis C patients with advanced liver fibrosis who previously failed interferon-based therapies. Patient baseline characteristics were well balanced between the two study arms.

Over the four years of the randomized study, investigators monitored the patients to determine how many reached a primary endpoint, defined as death, liver transplant, hepatocellular carcinoma (liver cancer), variceal bleeding, or liver failure (increase in Child-Pugh-Turcotte [CPT] by 2 points with ascites, jaundice or encephalopathy). They analyzed their findings for all 555 patients, who received at least one dose of their assigned drug, in two ways: based on all events that occurred during the entire four years of the study, regardless of whether a patient was still taking their assigned drug or not (the "intent-to-treat" or ITT analysis), and based on only the events that occurred while patients were taking their assigned drug (the "on drug" analysis).

The investigators found a primary endpoint was reached by 17.8% (51/286) of patients in the peginterferon alfa-2b group versus 20.4% (55/269) in the colchicine group in the ITT analysis, and by 12.2% (35/286) and 16.0% (43/269) patients, respectively, in the on-drug analysis (treatment differences were not statistically significant). Among patients who had portal hypertension (42.3% and 48.0% of patients in the peginterferon alfa-2b and colchicine groups, respectively), peginterferon alfa-2b therapy resulted in significantly improved event-free survival in both the ITT and on-drug analyses (Wilcoxon p = 0.041 and 0.028, respectively). Further, variceal bleeding, a specific complication of portal hypertension, was almost abolished with peginterferon alfa-2b in both the ITT (10 vs. 1 patients) and the on-drug (10 vs. 0 patients) analyses. In the ITT analysis, hepatocellular carcinoma occurred in 7.7% and 5.9% of patients in the peginterferon alfa-2b and colchicine groups, respectively, a non-significant difference.

Overall, 49% of patients discontinued their medication before the end of the four-year study, with 36% due to failure to comply and 13% due to side effects. Peginterferon alfa-2b was generally well tolerated. Among patients who discontinued due to interferon side effects (17.1%, 49/286), the most common reason (45%, 22/49 patients) was general intolerance to interferon (e.g., due to flu-like symptoms, malaise, and other common interferon side effects).

The COPILOT study was supported by Schering-Plough Corporation, manufacturer of peginterferon alfa-2b.

Adapted from materials provided by Beth Israel Deaconess Medical Center, via EurekAlert!, a service of AAAS.

Posted by Editors at 02:15 PM --- Printer-friendly version

April 18, 2008

Development of HCV Drug Candidate Ends

Due to phase II safety trial results, Wyeth Pharmaceuticals and ViroPharma Inc. agreed to discontinue developing their Hepatitis C drug HCV-796. Executives report that HCV-796's capacity to inflict liver damage was too great to maintain its candidacy.

ViroPharma, Wyeth end development of hepatitis C drug

Philadelphia Business Journal
www.bizjournals.com

Thursday, April 17, 2008

ViroPharma Inc. and Wyeth Pharmaceuticals have decided to discontinue the development of HCV-796, their new drug candidate being developed as a potential treatment for hepatitis C.

The companies said Wednesday night the decision was based on a previously announced safety issue -- an increased risk of liver damage -- that emerged during phase-II testing of the compound.

"Clearly, this is a disappointing outcome for patients suffering from this difficult disease," said Vincent Milano, president and CEO of ViroPharma (NASDAQ:VPHM) of Exton, Pa. "Significant activities were undertaken to determine a clear path forward for HCV-796; however, the risk associated with potential hepatotoxicity ultimately posed too high of a hurdle to merit further development."

ViroPharma and Wyeth Pharmaceuticals of Collegeville, Pa., a division of Madison, N.J.-based Wyeth (NYSE:WYE), said they do not expect to continue to collaborate on future development of hepatitis C treatment candidates.

Posted by Editors at 10:13 AM --- Printer-friendly version

April 17, 2008

Can Insect Bites Spread Hepatitis?

The warmer weather is here and so are those pesky flies and insects. Learn if you should be worried about being infected with viral hepatitis from insect bites.

by Nicole Cutler, L.Ac.

Regardless of how technologically advanced a culture is, the viral hepatitis epidemic seems to be enveloping the globe. Of particular concern to the healthcare community, the viruses that cause chronic hepatitis are the most troublesome. Chronic infection with Hepatitis B or Hepatitis C can progress to advanced liver disease, a fate involving cirrhosis, liver cancer or liver failure. A vehicle for transmitting some types of viruses, some people worry that an insect bite could pass on viral hepatitis. Since many cases of chronic viral hepatitis are incurable, hepatitis prevention takes center stage. However, even the most prepared have trouble preventing insect bites.

Because scientists know that Hepatitis B and Hepatitis C are primarily spread via blood- to-blood contact, all possible breaches of the skin have been suspected in viral hepatitis transmission. Occurring when blood from an infected person enters the body of a person who is not infected, Hepatitis B and Hepatitis C are mostly spread through:

· having unprotected sex with an infected person (more likely with Hepatitis B)
· sharing drugs, needles, or “works” when injecting drugs
· needle sticks or sharp exposures on the job
· from an infected mother to her baby during birth
· being tattooed with a contaminated needle (more likely with Hepatitis C)

Hepatitis B Virus (HBV) Transmission Risks
According to the Centers for Disease Control (CDC), those at highest risk for Hepatitis B infection include:

· Persons with multiple sex partners or diagnosis of a sexually transmitted disease
· Men who have sex with men
· Sex contacts of infected persons
· Injection drug users
· Household contacts of chronically infected persons
· Infants born to infected mothers
· Infants/children of immigrants from areas with high rates of Hepatitis B infection
· Healthcare and public safety workers with exposure to blood
· Hemodialysis patients

Hepatitis C Virus (HCV) Transmission Risks
According to the CDC, those at highest risk for Hepatitis C infection include:

· Injection drug users
· Recipients of clotting factors made before 1987
· Hemodialysis patients
· Recipients of blood and/or solid organs before 1992
· People with undiagnosed liver problems
· Infants born to infected mothers
· Healthcare/public safety workers – Low risk
· People having sex with multiple partners – Low risk
· People having sex with an infected steady partner – Low risk

Mosquito Transmission
Aside from the characteristic itching and swelling involved, fears of mosquito bites spreading disease are due to its contact with blood. The insect pierces the skin, siphons out a person’s blood then repeats on a different individual – all without sterilization in between victims. Although some say there is a theoretical risk of being infected with viral hepatitis from a mosquito bite, there are no known cases worldwide. If mosquito transmission of Hepatitis B or Hepatitis C were possible, many more millions of people would likely be affected. However, mosquito bites can transmit some viruses. Mosquito-born diseases include:

· Encephalitis
· Malaria
· Dengue fever
· Rift Valley fever
· Yellow fever

Bed Bug Transmission
Similar to a mosquito’s motive, bed bugs are also bloodsuckers. Bed bug bites can create considerable anxiety and localized and occasionally systemic reactions. Different from mosquitoes, bed bugs may be a suspected transmitter of viral hepatitis:

1. HBV – Hepatitis B viral DNA can be detected in bed bugs up to six weeks after they feed on infectious blood, but no transmission of Hepatitis B infection was found in a chimpanzee model.

2. HCV – Transmission of Hepatitis C is unlikely, since Hepatitis C viral RNA is not detectable in bed bugs after an infectious blood meal.

Regardless of the presence or absence of genetic material, these critters have never been proven to transmit disease. However, if concerned about the potential for getting Hepatitis B from this insect, make sure you are vaccinated. Some suggestions for detecting bed bugs include:

· Look around. Bed bugs are large enough to see.

· Look under the mattress and in the seams, in and around the bed frame and along any cracks or peeling paint in the wall or picture frames.

· Check in the cracks of any wooden furniture, particularly antiques.

· You can also spot bed bugs’ droppings, which may be tinged with blood.

Although the thought of mosquito or bed bug bites may be disconcerting, we do share this planet with them. Without invitation, these bugs break our skin and extract our blood, actions which logically cause concern. Thankfully, the risk of being infected with HBV or HCV through insect bites is just shy of impossible. So using mosquito repellant and checking for bed bugs will make you more comfortable and spare some itching, but it won’t make a difference in your susceptibility to acquiring viral hepatitis.

References:

Hwang, W. Stephen, et al., Bed Bug Infestations in an Urban Environment, Emerging Infectious Diseases, April 2005.

http://hotels.about.com, Bed Bugs, Charlyn Keating Chisholm, About.com, 2007.

www.cdc.gov, Hepatitis B: Fact Sheet, Centers for Disease Control, 2007.

www.cdc.gov, Hepatitis C: Fact Sheet, Centers for Disease Control, 2007.

www.emedicine.com, Bedbug Bites, Robert A Schwartz, MD, MPH, WebMD, 2007.

www.hepatitisc.org.uk, FAQ, Glasgow and Scotland Hepatitis C Charity, 2007.

www.whfhhc.com, Can Hepatitis B be transmitted by a mosquito or insect bite?, Centers for Disease Control, 2007.

Posted by Editors at 04:04 PM --- Printer-friendly version

Should You See a Specialist for Hepatitis C?

Even though you may be on a first name basis with your general practitioner, research from Germany proves that your chances for successfully eliminating the Hepatitis C virus are greater when treated by a hepatologist.

by Nicole Cutler, L.Ac.

Once diagnosed with Hepatitis C, a little research will eventually reveal that the current standard treatment is pegylated interferon with ribavirin. Despite the relatively low rate of success in eliminating the virus, many may mistakenly believe that it doesn’t matter who administers the treatment. However, new research demonstrates that it is well worth the effort to seek out a specialist for monitoring your therapy.

Successful Treatment
Known as sustained virological response (SVR), successful treatment for Hepatitis C is described as the inability to detect any of the virus in the blood six months after stopping therapy. Although it is currently the only viable option for Hepatitis C, estimates of those attaining SVR with pegylated interferon and ribavirin treatment vary widely.

Regardless of a study’s country of origin, large trials evaluating Hepatitis C treatment success have reported SVR rates ranging between 30 and 80 percent. However, close examination of people fighting Hepatitis C in the real world have led researchers to suspect that the type of doctor a patient seeks help from significantly impacts SVR likelihood.

German Study
In an attempt to realize the real world impact of the type of physician administering Hepatitis C treatment, researchers at the University of Dusseldorf conducted a landmark retrospective study. At their outpatient clinics, these German researchers analyzed the records of patients receiving at least one dose of interferon treatment for Hepatitis C over a span of seven years.

After analyzing over 300 people receiving Hepatitis C treatment for the first time, approximately two thirds consulted with an expert hepatologist on a regular basis while just over one third had their interferon treatment administered and supervised by a general practitioner. Even though the characteristics of infection were similar between those working with a hepatologist and those seeing a general practitioner, the outcomes of Hepatitis C treatment were significantly different between the two groups.

Right after interferon treatment, elimination of the Hepatitis C virus was more likely for those seeing a hepatologist:

· A viral load of zero was evident in 74 percent of those seeing a hepatologist.
· A viral load of zero was evident in 48 percent of those seeing a general practitioner.

At the six-month mark when SVR is measured, those seeing a hepatologist continued to have a definite advantage:

· SVR was attained by 66 percent of those seeing a hepatologist.
· SVR was attained by 34 percent of those seeing a general practitioner.

When broken down even more, those with genotypes 1 and 4 and those with advanced liver damage specifically benefited from expert care:

· For study participants infected with genotype 1 or 4, SVR was attained by 61 percent of those seeing a hepatologist.

· For study participants infected with genotype 1 or 4, SVR was attained by 27 percent of those seeing a general practitioner.

· For study participants with advanced liver damage, SVR was attained by 69 percent of those seeing a hepatologist.

· For study participants with advanced liver damage, SVR was attained by 25 percent of those seeing a general practitioner.

These results led the German authors to conclude “Patients with…genotypes 1 and 4 or with advanced liver damage benefit from HCV therapy supervision by a specialist, probably because of less frequent treatment interruptions or dose reductions.”

What Is An Expert?
A hepatologist is a physician who has obtained additional, specialized training in liver diseases. Initially, all hepatologists are trained in general internal medicine (adult medicine) or pediatrics (children’s medicine). Some pursue additional training in gastroenterology (which includes digestive disorders involving the esophagus, stomach, small and large intestines, pancreas, gallbladder and liver). However, to be a hepatologist, a fellowship focusing solely on the liver is typically mandated. Even though a hepatologist is the most qualified type of doctor to treat liver disease, there is currently no separate board certification examination in this highly specialized field.

The field of hepatology is a rapidly changing, emerging field. Even though the standard of care for Hepatitis C has been interferon-based treatment for many years, there are many factors involved in its administration. Hepatologists are up-to-date on the latest research and discoveries for treatment modifications, length of treatment, dosage adjustments, side effect management and all of the other details related to Hepatitis C treatment.

Although most people are comfortable with their general practitioner – and they may have been the physician who originally detected their infection – an expert may be more qualified to administer Hepatitis C treatment. Especially important for people who have genotypes 1 or 4, or who already have advanced liver disease, the chance of achieving SVR is much higher when an expert liver specialist manages treatment.

References:

http://depts.washington.edu, Sagir, A., et al., Therapy outcome in patients with chronic hepatitis C: role of therapy supervision by expert hepatologists, Journal of Viral Hepatitis, September 2007.

www.acponline.org, Hepatitis C, American College of Physicians, ACP Observer, April 2006.

www.annals.org, Update in Hepatology, Willis C. Maddrey, MD, Annals of Internal Medicine, February 2001.

www.hepatitiscounselor.com, Thoughts about Hepatitis C and Liver Disease, Hepatitiscounselor.com, 2007.

www.hepato-site.net, What is a hepatologist and why do I need one?, University of Cincinnati, 2007.

www.hivandhepatitis.com, Treatment Outcomes in HCV Patients Whose Therapy is Supervised by Expert Hepatologists, hivandhepatitis.com, October 2007.

Posted by Editors at 01:50 PM --- Printer-friendly version

April 07, 2008

Improving Response to HCV Treatment

Of special interest for those who have relapsed after Hepatitis C pegylated interferon therapy: Medical experts are gaining insight into why some courses of treatment are unsuccessful. By aiming to eliminate the likely causes for previous failures, more non-responders may be good candidates for re-treatment.

by Nicole Cutler, L.Ac.

In the United States, the Hepatitis C virus (HCV) is one of the leading causes of chronic liver disease. Accounting for about 15 percent of acute viral hepatitis, 60 to 70 percent of chronic hepatitis and up to 50 percent of cirrhosis, end-stage liver disease and liver cancer, HCV is a major threat to the health of our population. While it has undergone many improvements over the past decade, the current standard of therapy for HCV has a far way to go before this virus can be considered curable. Understanding why those with chronic HCV may not respond to treatment outlines the potential for successful re-treatment.

Sustained Virologic Response
The most common way to measure HCV treatment success is via the virologic response. To measure virologic response, doctors use a blood test to measure how much virus is in the blood. While Hepatitis C RNA may be undetectable immediately following treatment, this test must be repeated six months later to see if any of the virus remained and reproduced. Also referred to as viral load, the best outcome is a sustained virologic response (SVR). When the virus remains undetectable in the blood six months (or more) following HCV therapy, SVR is considered attained. So far, studies following those with HCV for two to three years after SVR have demonstrated a low relapse rate.

While the virologic response is primarily dependent on the action of the pegylated interferon, the prevention of relapse is mostly reflective of the action of ribavirin and the maintenance of its dosing. However, relapse prevention is also affected by the following variables:

· How quickly undetectable HCV RNA is attained after the start of treatment.

· How long the patient remains on treatment after achieving undetectable HCV RNA.

Broken down by the most common HCV genotypes, the following are estimates of how frequently SVR is attained with pegylated interferon and ribavirin therapy:

· Approximately 40 to 45 percent of those with chronic HCV genotype 1, the most common strain in the United States, achieve SVR.

· Approximately 75 to 80 percent of those with chronic HCV genotypes 2 and 3 achieve SVR.

Non-Responders
While those attaining SVR may be permanently free of HCV, the remaining people on pegylated interferon and ribavirin are non-responders. However, there is plenty of evidence that previous non-responders can be re-treated successfully, eventually achieving SVR. Identifying which HCV non-responders are appropriate candidates for re-treatment requires a complete understanding of the various virologic response patterns and the pitfalls associated with achieving and maintaining virologic response.

There are many reasons that a person may not achieve SVR. The individuals without any response to interferon-based therapies are poor candidates for re-treatment. These people have no significant decline in HCV RNA during treatment and are essentially immune to the effects of interferon. Aside from those without any virological response, the four most common reasons assumed responsible for continued HCV infection after treatment are missing doses, premature discontinuation of ribavirin, insufficient ribavirin dosage and infrequent viral load testing.

1. Missing a Dose – Recent studies highlight missing a dose of peg-interferon alfa and/or ribavirin as a leading contender for not achieving SVR. Missed doses can be a result of physicians instructing their patients to temporarily stop treatment because of significant treatment-related side effects, patients missing a dose by accident or intentional skipped doses in an attempt to self-treat side effects.

2. Premature Discontinuation of Ribavirin – Stopping ribavirin too soon increases the person’s chance of viral load rebound. In those who demonstrate a slow virologic response, several studies have demonstrated that relapse can be significantly reduced in those with HCV genotype 1 patients by prolonging the duration of treatment from 48 to 72 weeks.

3. Insufficient Ribavirin Dosing – Another frequently encountered reason for HCV relapse is initiating ribavirin treatment with an insufficient dosage. Three randomized trials have demonstrated that patients who initiate treatment with a higher dose of ribavirin have a lower relapse rate.

4. Infrequent Viral Load Testing – In addition, experts believe that SVR is attained by those who quickly recognize when viral load is undetectable and their current treatment regimen is adjusted swiftly. For this reason, viral load must be assessed periodically during treatment to identify this point as soon as possible.

By recognizing the patterns associated with a poor response to interferon-based therapy, physicians can better approximate why therapy failed and who might be a good candidate for re-treatment. If a non-responder attempts pegylated interferon and ribavirin treatment again, all efforts must be made to maintain adequate, sufficient dosing for the required time interval and frequently evaluate viral load. As long as there was some type of viral response to initial treatment, virologists estimate that a sizable percentage of previous non-responders are good candidates for HCV re-treatment.

References:

http://clinicaloptions.com, Understanding HCV Nonresponse and Identifying Candidates for Retreatment, Mitchell L. Shiffman, MD, Clinical Care Options LLC, 2008.

http://digestive.niddk.nih.gov, Chronic Hepatitis C: Current Disease Management, National Institute of Diabetes and Digestive and Kidney Diseases, 2008.

Posted by Editors at 02:32 PM --- Printer-friendly version

April 04, 2008

Hepatitis C Protein May Help Fight HIV

Scientists have discovered a unique property of a segment of one of Hepatitis C's proteins - inhibition of HIV. Continued research on this Hepatitis C component could lead to a new therapy capable of preventing HIV from being sexually transmitted.

Hepatitis May Be Ally Against HIV

April 1, 2008

www.sciam.com

A part of one of the proteins of the Hepatitis C virus shows anti-HIV activity in cell cultures. Cynthia Graber reports.

Podcast Transcript: The disease hepatitis C might provide a new tool in the fight against HIV/AIDS, say scientists at the Scripps Institute and in the Netherlands. The research was published March 31st online in the Proceedings of the National Academy of Sciences.

A segment of one of the proteins of the hepatitis C virus is called C5A. Ironically, this segment, or peptide, actually actually is deadly to the hepatitis virus. So scientists wondered if it could kill the HIV virus as well. They found that in cell cultures, C5A did indeed damage HIV. It also interfered with HIV’s ability to infect cells such as the immune system’s T cells. And C5A properties are in effect at low pH, which is important if any therapy based on it were to be used by women before sex.

The researchers say that C5A has a wider range of anti-viral activity than other antimicrobial peptides. Scientists hope that the Hep C peptide research will lead to the development of antiviral therapies that could help prevent the sexual transmission of HIV.

Posted by Editors at 03:47 PM --- Printer-friendly version

1-in-4 People Have Fatty Liver Disease

With a shocking 25 percent of Americans living with non-alcoholic fatty liver disease, California researchers claim that this condition is associated with a decline in cardiac and respiratory fitness levels.

1-in-4 U.S. Adults Have Fatty Liver Disease

www.redorbit.com

Tuesday, 25 March 2008, 12:00 CDT

One out of four U.S. adults suffers from non-alcoholic fatty liver disease — liver disease characterized by excessive fat in the liver, U.S. researchers said.

Non-alcoholic fatty liver disease, the most common cause of abnormal liver enzymes, is considered by many to be a manifestation of the metabolic syndrome — belly fat, elevated blood pressure, insulin resistance, high cholesterol — which result in an increased risk of coronary heart disease.

Study leader Joanne Krasnoff of the University of California San Francisco recruited 37 adult patients with a spectrum of non-alcoholic fatty liver disease severity measured by liver biopsy.

Patients had suboptimal cardiorespiratory fitness, muscle strength, body composition and physical activity participation. More than 97 percent had a body fat percentage that put them at increased risk for morbidity and mortality and less than 20 percent met recommended guidelines for physical activity.

The study, published in the April issue of Hepatology, demonstrated lower cardiorespiratory fitness in subjects with increasing non-alcoholic fatty liver disease severity.

However, the finding raised the question of a cause-or-effect phenomenon — does cardiorespiratory fitness attenuate non-alcoholic fatty liver disease, or does increasing non-alcoholic fatty liver disease severity result in a decline in cardiorespiratory fitness? the authors asked.

Posted by Editors at 02:15 PM --- Printer-friendly version

April 01, 2008

Gregg Allman, Co-Founder of Allman Brothers, Fighting Hepatitis C

Musician Gregg Allman is undergoing treatment for Hepatitis C. As one of the estimated five million Americans with this virus, Allman's fight against Hepatitis C reminds us that this disease affects people from all walks of life.

Gregg Allman has hepatitis C

Associated Press
www.news-journalonline.com
March 28, 2008

The Allman Brothers Band won't be peakin' at the Beacon for a while.

The rock band's annual spring run of concerts at New York City's Beacon Theatre has been postponed while co-founder Gregg Allman undergoes treatments for hepatitis C. The band also canceled their upcoming performances at the Wanee Festival, which they host every year in Live Oak.

"I'm getting better but I'm still tired," Allman said in a press release from Woody Graber, a public relations consultant for concert promoter Live Nation FL. "I need to be at 110% to do the shows the way we do them."

The Allman Brothers trace their roots to Daytona Beach, where Gregg and his late brother Duane first formed early incarnations of the band.

The Beacon dates, originally set for May 5-24, will be rescheduled. The Wanee Festival will go on as scheduled on April 11-12.

Posted by Editors at 09:20 AM --- Printer-friendly version

March 31, 2008

Do You Want to Participate in a Hepatitis-C Clinical Trial?

Presently, there are many clinical trials devoted to Hepatitis C. While participating in a study offers some people a chance at improved health, the decision to enroll must be carefully considered.

by Nicole Cutler, L.Ac.

A person living with Hepatitis C could have many reasons for participating in a clinical study. However, making the decision to be a subject in a trial is far from simple. Before deciding to sign up, make certain that you have all the facts. Understanding the pros and cons involved can help a person make this important decision.

What is a Clinical Trial?
A clinical trial is a research study using humans to answer specific health questions. When conducted carefully and thoroughly, clinical trials are the safest and fastest way to find effective treatments. Clinical trials for Hepatitis C could span many purposes, including:

· Finding ways to prevent the virus from proliferating
· Testing vaccines to protect someone from becoming infected
· Improving the existing treatment
· Testing a new treatment
· Investigating options for improving quality of life

Each clinical trial has its own protocol such as:

· What types of patients may enter the study
· What the schedule of tests and procedures are
· What drugs and specific dosages are administered
· The length of the study
· How the outcomes will be measured

These criteria help to reduce the amount of variation in the study without threatening the scientific integrity of the trial. Every protocol is designed to remove medical variations that might complicate analyzing the results. As a rule, each person participating in the study must agree to the rules set out by the protocol.

To see if it works as well or better, clinical trials for Hepatitis C often compare a new product or therapy to the current standard of treatment. In a blinded study, a participant is randomly assigned to one of three groups – and not informed of which group they were assigned to. In general the categories include those who:

1. Receive the product being tested
2. Receive the existing, approved therapy
3. Receive a placebo (a product such as a sugar pill that has no therapeutic action yet looks like the product being tested)

However, placebos are rarely used in Hepatitis C trials. This is because participants with serious illness are typically afforded some kind of assumed effective therapy.

Why Volunteer for a Clinical Trial?
Since clinical trials are the only way to test new ways to fight Hepatitis C, participating puts you on the cutting edge of medicine. Typically, people with Hepatitis C enroll in a study because they have already exhausted their treatment options. Either categorized as a non-responder to pegylated interferon therapy or unable to tolerate the current therapy’s side effects, clinical trials may provide additional hope.

It is important to realize that not everyone who applies for a clinical trial will be accepted. Volunteers could be excluded based on:

· the eligibility criteria
· the number of participants needed
· any number of additional complicating factors

If interested in a clinical trial, you should learn as much as possible about it. In addition to understanding what happens during the trial, the type of health care received and any costs involved, it is important to feel comfortable discussing your concerns with the facilitators of the trial.

Pro and Con Balancing
By weighing the potential benefits against the possible risks, the decision to volunteer in a study can be clarified. Benefits to being a trial participant may include:

· being actively involved in your own health care
· gaining access to potentially new research treatments
· receiving expert medical care since the investigators are likely to be Hepatitis C specialists
· helping others by contributing to medical research

It is also important to consider both the known and unknown risks. The hazards of participating in a clinical trial may include receiving ineffective treatment, suffering from serious or life-threatening side effects or even being overwhelmed by the time investment required for the study.

An additional consideration is whether or not medical care will continue after the trial’s conclusion. Some possible questions to ask include:

· If there are side effects that linger beyond the time of the trial, will the trial’s healthcare team offer you any support?

· If the treatment was beneficial, will it be continued after the trial is over?

Finding a Hepatitis C Trial
Clinical trials can be sponsored by an organization such as a pharmaceutical company, a federal agency (such as the National Institutes of Health or Veterans Administration) or an individual (such as a physician or health care provider). Determined by the sponsor, trial locations generally are at universities, medical centers, clinics, doctor’s offices, hospitals and other research sites.

You can find information about clinical trials currently being conducted by searching www.clinicaltrials.gov. This website is updated regularly and offers information on each trial’s purpose, who is eligible to participate, locations and phone numbers to call for more information. As of late March 2008, a search on this website revealed 184 interventional trials currently recruiting or about to recruit volunteers for a Hepatitis C study. Once on this site, there is an option to refine your search using various parameters, such as location of study, participant age range, conditions included and the intervention being studied. Since there is often a long list of eligibility criteria, make certain that you are a match before proceeding with an inquiry.

Participating in a clinical study is not for everyone. Taking part in an as yet, unproven therapy is frightening for some and exciting for others. However, being thorough in your evaluation of any clinical trial will help you make this potentially life-changing decision. Especially for those who feel as if they’ve run out of Hepatitis C treatment options, enrolling in a clinical trial can offer the right person another chance at returning to health.

References:

http://clinicalcenter.nih.gov, Are Clinical Studies for You?, National Institutes of Health, 2008.

www.clinicaltrials.gov, Search for Clinical Trials, US National Institutes of Health, 2008.

www.brightsurf.com, Hospitals that participate in clinical trials may provide better patient care, Journal of the American Medical Association, March 2008.

www.fda.gov, Basic Questions and Answers about Clinical Trials, US Food and Drug Administration, 2008.

Posted by Editors at 10:28 AM --- Printer-friendly version

March 27, 2008

Researchers Find a Way to Interrupt Hepatitis C Virus

Scripps researchers found the protein needed to assemble Hepatitis C by using technology borrowed from molecular genetics. By altering the protein NS5A, this discovery may have significant impact on the development of new therapeutic agents.

New Method Disrupts Hepatitis C Virion Production

www.sciencedaily.com

ScienceDaily (Mar. 24, 2008) — HCV is a significant human pathogen, infecting more than three percent of the world's population. The incidence of infection in the United States has been estimated to be as high as 4 million cases. In the March issue of the journal PLoS Pathogens, Timothy Tellinghuisen, an assistant professor in the Department of Infectology at Scripps Florida, and his colleagues describe how they used mutations of the viral NS5A phosphoprotein to disrupt virus particle production at an early stage of assembly. NS5A has long been proposed as a regulator of events in the HCV life cycle, but exactly how it orchestrates these events has been unclear.

"The interesting thing about this mutant is that while it triggers totally normal RNA replication, it causes severe defects in the output of infectious virus--in fact, it releases no infectious virus that we can detect," says Tellinghuisen. "And though this discovery isn't a cure for HCV, it is an important research tool that stops the assembly pathway." Total disruption of the replication process would be a cure for the disease, he adds, and that's the team's long-term goal.

HCV infection is roughly five to seven times more prevalent than HIV, underscoring the pandemic nature of HCV infection. HCV occurs when blood from an infected person enters the body of someone who is not infected. Most new HCV infections are due to illegal drug injections and sharing needles. However, those who had blood transfusions prior to blood donor screening in 1991, healthcare workers who had needle stick accidents, and hemodialysis patients are also at risk for developing HCV infection.

The virus predominantly infects the liver, and following many decades of virus reproduction serious disease such as hepatitis (liver inflammation), cirrhosis (liver scarring), and carcinoma (liver cancer) develop. Ultimately, HCV infection destroys the liver, resulting in death. Attempts at curing HCV infections with drug therapy have been only marginally successful.

Before more effective therapies can be developed, scientists need to understand, at the molecular level, the detailed mechanisms HCV uses to infect cells, replicate itself, assemble progeny virus, and exit the cell. Each of these processes could potentially be a target for a new drug to eliminate HCV infection. HCV, like all viruses, requires the normal cellular machinery for its replication and has developed strategies to utilize normal cell physiology for its own benefit (often to the detriment of the host).

The Tellinghuisen team, which includes Research Assistants Katie L. Foss and Jason Treadaway, has focused recent efforts on NS5A to understand the regulation of events used by the virus to assemble infectious copies of itself and exit the cell. NS5A is a three-domain protein, which means it is comprised of three compactly folded regions roughly 50 to 300 amino acids in length. The requirement of domains I and II for RNA replication is well documented. NS5A domain III, however, is not required for RNA replication, and the function of this region in the HCV life cycle is unknown.

Using standard molecular biology, the researchers removed from domain III of NS5A a coding sequence corresponding to roughly 15 amino acids. Then they generated a clone of the virus, transcribed the RNA from that clone, and purified the RNA. This RNA, which is directly infectious, was then transfected into a liver cell line where it produced all the HCV proteins that are encoded by that RNA genome.

"Those proteins assemble in the cell to make a structure called a replicase that then copies the viral RNA," Tellinghuisen explains. "We measured that RNA accumulation and observed no defect in RNA replication, but found, surprisingly, that no infectious viral particles were released from the cells." The team also found that no viral RNA nor nucleocapsid protein are released from cells, indicating that an early event in virus assembly had been affected.

Using genetic mapping and biochemical analyses, the authors were able to show that their deletion altered a phosphorylation signal controlling the switch from RNA replication to virus particle assembly. This signal was attributed to the activity of a cellular kinase that when inhibited by genetic or chemical means led to a reduction in infectious virus production without altering HCV RNA replication.

"These data provide the first evidence for a function of domain III of NS5A and implicate NS5A as an important regulator of the RNA replication and virion assembly of HCV," Tellinghuisen says. "The ability to uncouple virus production from RNA replication may be useful in understanding HCV assembly and may become therapeutically important."

Charles M. Rice, head of the Center for the Study of Hepatitis C at Rockefeller University, comments, "This is a spectacular advance linking a specific phosphorylation event by a cellular kinase to hepatitis C virus assembly. Remarkably, the target is a viral nonstructural protein, NS5A, and the data point to a pivotal role for this protein in regulating RNA amplification and infectious virus production. These new data make this multifunctional protein an even more attractive target for developing new anti-virals for treating hepatitis C."

This project was funded by a Career Development Award from the National Institutes of Allergy and Infectious Diseases of the National Institutes of Health, and by the State of Florida.

Adapted from materials provided by Scripps Research Institute, via EurekAlert!, a service of AAAS.

Posted by Editors at 04:21 PM --- Printer-friendly version

March 20, 2008

Taribavirin Showing Lower Anemia Rates than Ribavirin

When combined with pegylated interferon for Hepatitis C treatment, taribavirin may be a better option than ribavirin. Compared to ribavirin, preliminary results of a Phase IIb trial show that taribavirin is similar in viral load reduction yet superior with fewer incidences of treatment related anemia.

Valeant Pharmaceuticals Reports Encouraging Phase IIb Results at Treatment Week 12 for Taribavirin

March 17, 2008

www.businesswire.com

ALISO VIEJO, Calif.--(BUSINESS WIRE)--Valeant Pharmaceuticals (NYSE:VRX) today reported results at the treatment week 12 analysis point for the Phase IIb clinical trial for its antiviral compound, taribavirin, a prodrug of ribavirin in development for the treatment of chronic hepatitis C in conjunction with a pegylated interferon.

The Phase IIb trial is a U.S. multi-center, randomized, parallel, open-label study in 278 treatment-naïve, genotype 1 patients evaluating taribavirin at 20 mg/kg, 25 mg/kg, and 30 mg/kg per day in combination with pegylated interferon alfa-2b. The control group is being administered weight-based dose ribavirin (800/1000/1200/1400mg daily) and pegylated interferon alfa-2b. Overall treatment duration is 48 weeks with a post-treatment follow-up period of 24 weeks. The primary endpoints for this study are viral load reduction at treatment week 12 and anemia rates throughout the study.

The 12-week early viral response (EVR) data from the Phase IIb study showed comparable reductions in viral load for weight-based doses of taribavirin and ribavirin. The anemia rate was statistically significantly lower for patients receiving taribavirin in the 20mg/kg and 25mg/kg arms versus the ribavirin control arm.

Key Efficacy and Safety Data Table at Treatment Week 12 (ITT Population)

TBV 20 mg/kg

n = 67

TBV 25 mg/kg

n = 70

TBV 30 mg/kg

n = 68

RBV 800-1400mg

n = 70

Responders(a)
43 (64.2%) 40 (57.1%) 37 (54.4%) 36 (51.4%)

Undetectable(b)
28 (41.8%) 29 (41.4%) 17 (25.0%) 22 (31.4%)

Anemia rate(c)
6 (9.0%) 5 (7.1%) 10 (14.7%) 17 (24.3%)

(a) HCV RNA undetectable (less than 100 copies per mL) or ≥2-log decrease in viral load using the NGI SuperQuant Assay
(b) HCV RNA less than 100 copies per mL

(c) Anemia rate defined as percentage of patients with Hgb level < 10 g/dL. p=0.022 for 20mg/kg and p=0.009 for 25mg/kg

The most common adverse events were fatigue, nausea, flu-like symptoms, headache and diarrhea. The incidence rates among treatment arms were generally comparable except with respect to diarrhea, where diarrhea was approximately twice as common in taribavirin patients as ribavirin patients. However, the diarrhea was generally mild and not treatment limiting for taribavirin or ribavirin patients.

In 2006 Valeant released data from its Phase III VISER1 and VISER2 trials of taribavirin, administered in a fixed dose of 600 mg BID (approximately equivalent to 13-18 mg/kg), in which taribavirin did not meet its primary efficacy endpoint of comparable efficacy to weight-based dose ribavirin. In 2007, the company began this Phase IIb study to evaluate higher doses of taribavirin than used in the VISER trials, while also employing a weight-based dosing regimen, consistent with the dosing regimen for ribavirin.

“Ribavirin continues to be a necessary part of hepatitis C treatment, and clinicians would welcome a ribavirin prodrug with a profile of similar efficacy with decreased anemia,” stated Fred Poordad, M.D., Chief of Hepatology at the Center for Liver Disease and Transplant, Cedars-Sinai Medical Center, Los Angeles, CA. “A drug with fewer required dose reductions for anemia or a reduced need for adjunctive growth factor therapy may subsequently improve treatment adherence and overall response rate.”

“We are encouraged that these data suggest that weight-based dosing with taribavirin at higher doses may have a role in the treatment of patients infected with hepatitis C while continuing to produce lower anemia than ribavirin,” said J. Michael Pearson, Valeant’s chairman and chief executive officer. “However, we caution that these results only represent data from the first 12 weeks of a 72-week Phase II trial that was designed to identify appropriate doses for further development. We will use these data to explore the best options for taribavirin’s continued role in our portfolio, including consideration of partnering options.”

Patient Demographics

20 mg/kg

n = 67
25 mg/kg

n = 70
30 mg/kg

n = 68
Ribavirin

n = 70

Age (yrs, mean) 48.5 47.5 49.6 49.7
Gender (female) 52.2% 35.7% 36.8% 31.4%
Race (Caucasian) 74.6% 58.6% 61.8% 64.3%

Weight (>75 kg)(d)
64.2% 61.4% 63.2% 62.9%

Plasma HCV RNA ≥ 2 million copies(d)
73.1% 72.9% 72.1% 70.0%

(d) Study stratified patients by weight and viral load

In the study, the following percentages of patients completed 12 weeks of treatment in the taribavirin and ribavirin arms: 20mg/kg: 87.0%; 25mg/kg: 80.0%; 30mg/kg: 82.6%; ribavirin 74.3%. The following percentages of patients had adverse events leading to dose modification or interruption of taribavirin or ribavirin: 20mg/kg: 11.9%; 25mg/kg: 15.7%; 30mg/kg: 25.0%; ribavirin 28.6%.

In the Intent to Treat Analysis, the Rapid Virological Responses (RVR - virus undetectable at treatment week 4) in this study were 20mg/kg: 16.4%; 25mg/kg: 14.3%; 30mg/kg: 16.2 %; ribavirin: 11.4%.

Conference Call and Webcast Information:

Valeant will host a conference call and webcast on Thursday, March 27, 2008 at 12:00 p.m. EDT (9:00 a.m. PDT) to discuss the Company’s Strategic Plan as well as the results from this Phase IIb clinical trial. A webcast of this event will be available live over the Internet along with a slide presentation. The webcast may be accessed through the investor relations section of Valeant’s corporate Web site at www.valeant.com. The dial-in number to participate on this call is (877) 295-5743, confirmation code 39808652. International callers should dial (706) 679-0845, confirmation code 39808652. Interested parties will have access via the Internet and on the conference call to ask questions following the presentation. A replay will be available approximately two hours following the conclusion of the conference call and can be accessed by dialing (800) 642-1687, or (706) 645-9291, confirmation code 39808652.

About Taribavirin

Taribavirin is an investigational compound that has not been found by the Food and Drug Administration (FDA) or any other regulatory agency to be safe or effective in the diagnosis, mitigation, treatment or cure of any disease or illness. It may not be sold or promoted in the United States unless and until FDA has approved a New Drug Application. Similar restrictions apply in other countries.

About Valeant

Valeant Pharmaceuticals International (NYSE:VRX) is a global specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, including, but not limited to, statements regarding the potential efficacy and safety of taribavirin in the treatment of hepatitis C, and the continuing role of ribavirin or taribavirin in the treatment of hepatitis C, that are based on management’s current expectations and involve risks and uncertainties, including, but not limited to, risks and uncertainties relating to the clinical development of new products, regulatory approval processes, that results from treatment week 12 in a phase IIb clinical trial are not necessarily predictive of the entire phase IIb trial or a phase III trial, and other risks detailed from time to time in the company’s SEC filings. The company cautions the reader that these factors, as well as other factors described in its SEC filings, are among the factors that could cause actual results to differ materially from the expectations described in the forward-looking statements. The company also cautions the reader that undue reliance should not be placed on any of the forward-looking statements, which speak only as of the date of this press release. The company undertakes no responsibility to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.

Contacts

Valeant Pharmaceuticals
Laurie W. Little, 949-461-6002

Posted by Editors at 09:04 AM --- Printer-friendly version

March 17, 2008

3 Healthy Lifestyle Choices to Make Now

People with Hepatitis C can slow the liver's cycle of inflammation by making these three healthy lifestyle changes. By eliminating certain risk factors, one can live a long life with HCV.

by Nicole Cutler, L.Ac.

The number of people affected by Hepatitis C continues to grow. Unfortunately, the medicines used to treat this virus have not yet been able to defeat it. As of 2008, the current standard of treatment for the Hepatitis C virus (HCV), pegylated interferon and ribavirin, remains effective for approximately only half of all cases. Although pegylated interferon and ribavirin can’t help millions of people get rid of this virus, Hepatitis C doesn’t have to be a death sentence. Even though those living with chronic HCV are at a high risk of developing liver cirrhosis and/or liver cancer, eliminating three vices can prevent a worsening of liver health.

Understanding Liver Inflammation
Living with chronic HCV means constantly battling liver inflammation. If this inflammation rages unabatedly, it causes liver disease to progress. The progressive cascade of Hepatitis C and liver inflammation is as follows:

· HCV results in the death of liver cells.

· The death of liver cells triggers the dispatching of inflammatory cells to the affected area. Inflammation begins the processes that lead to fibrosis, the body’s response to liver damage.

· Inflammation triggers a reaction by a group of cells in the liver called stellate cells.

· Infected and inflamed liver cells release chemical signals (called cytokines), which activate leukocytes (white blood cells) from outside the liver to travel to the affected area.

· The cytokines and leukocytes team up with Kupffer cells to signal the stellate cells to produce and lay down collagen fibers between liver cells. A fibrous protein that forms scar tissue, collagen is the body’s attempt to limit the spread of infection to other cells.

· Normally, as an infection or injury resolves, the collagen matrix enclosing the injury is dissolved and activated stellate cells die off, allowing the tissue to return to normal. In chronic HCV, this matrix of collagen grows more rapidly than it can dissolve.

· The collagen builds up scar tissue around cells causing living liver cells to lose their access to the nutrient and oxygen rich blood flow.

· The restricted access to blood causes even more quarantined liver cells to die. As such, HCV progressively scars the liver.

This vicious cycle of inflammation causing scar tissue must be stopped to prevent a person’s chronic HCV from causing more and more liver damage.

Vice Elimination
According to Norah Terrault, MD, MPH, from the University of California, San Francisco, “Hepatitis C is a major public health concern and the number of patients developing complications of chronic disease is on the rise. It is essential that we identify risk factors that can be modified to prevent and/or lessen the progression of HCV to fibrosis, cirrhosis and even liver cancer. These complications of chronic HCV infection will significantly contribute to the overall burden of liver disease in the U.S. and will continue to increase in the next decade.”

By eliminating three unhealthful habits, people with HCV can single-handedly reduce the inflammation their liver must contend with. Although any toxin puts a greater strain on liver function, the following directly contribute to heightened inflammation with HCV:

1. Alcohol – There are many reasons why eliminating alcohol is imperative for living long with Hepatitis C. Researchers have demonstrated that alcohol promotes proliferation of Hepatitis C in human liver cells. Researchers at the Children’s Hospital in Philadelphia found that alcohol increases the activity of a protein called nuclear factor kappa B, which causes HCV to replicate. Aside from the cycle of inflammation that occurs with Hepatitis C, alcohol consumption on its own increases cytokine levels. Additionally, metabolized alcohol is believed to activate stellate cells directly. All of the chemical processes that occur when a person drinks alcohol exponentially worsen the damage that HCV does to the liver.

2. Marijuana – According to a study published in Clinical Gastroenterology and Hepatology, patients with HCV should not use marijuana (cannabis) daily. The researchers led by Terrault found that HCV patients who used cannabis daily were at significantly higher risk of moderate to severe liver fibrosis, or tissue scarring. Additionally, patients with moderate to heavy alcohol use combined with regular cannabis use experienced an even greater risk of liver fibrosis.

3. Fatty Food – Despite campaigns claiming that eliminating saturated fat from the diet preserves heart health, hepatologists agree that it also preserves liver health. Research from 2007 demonstrated that a high fat diet kills regulatory T cells in the liver. Less of these specialized immune cells allow a fatty liver to worsen to steatohepatitis, fatty liver with inflammation. This likely occurs because regulatory T cell death is associated with increased inflammatory cytokine production.

Although removing these three vices from one’s life may be a monumental life change for someone, it can also save their liver. The increase in inflammation that drinking alcohol, smoking marijuana and eating saturated fat can cause allows a liver with HCV to spiral into advanced liver disease. By abandoning these three unhealthful habits, the liver gets a respite from the inflammation cycle – perhaps enough for the body to break down some of the collagen matrix that contributes to the continuation of liver cell death.

References:

http://familydoctor.org, Hepatitis C, American Academy of Family Physicians, 2008.

http://pubs.niaaa.nih.gov, Alcohol and the Liver, National Institute for Alcohol Abuse and Alcoholism, 2008.

www.cdc.gov, Hepatitis C Fact Sheet, US Department of Health and Human Services, 2008.

www.hepctrust.org.uk, Liver damage and fibrosis during the chronic stage, Hepatitis C Trust, 2008.

www.medicalnewstoday.com, How Alcohol Use May Worsen Hepatitis C Infection, John Ascenzi, MediLexicon International, Ltd., 2007.

www.medicalnewstoday.com, Risk Of Hepatitis C-Related Liver Damage Increased By Regular Marijuana Use, MediLexicon International Ltd., 2008.

www.sciencedaily.com, High-fat Diet Makes Mice Susceptible To Liver Injury, ScienceDaily LLC 2008.

www.who.int, Hepatitis C, World Health Organization, 2008.

Posted by Editors at 02:00 PM --- Printer-friendly version

March 13, 2008

New, Interactive Internet Program Answers Hepatitis C Questions

A national, non-profit, public charity, the Caring Ambassadors Hepatitis C Program makes it easier for people with Hepatitis C to learn about the virus, its implications and up-to-date treatments. By utilizing the internet, people can get a customized response to their specific Hepatitis C concerns.

Caring Ambassadors Hepatitis C Program Launches Internet-Based Hep C Discussion PointTM to Assist People Living with Hepatitis C

www.marketwire.com

Mar 11, 2008

VANCOUVER, WA--(Marketwire - March 11, 2008) - The Caring Ambassadors Hepatitis C Program (CAP Hepatitis C), a national nonprofit organization, announces the Internet release of its new interactive medical management tool, Hep C Discussion Point™ at www.HepCChallenge.org. Hep C Discussion Point™ takes the user through a guided series of questions about their hepatitis C experience. Custom-built software analyzes the user's responses and generates a report with information and topics specific to the user's inputs. The report is designed to be used as both a learning tool for the patient and as a guide to facilitate communication and enhance the health care partnership between people living with hepatitis C and their doctors.

Hep C Discussion Point™ was developed by CAP Hepatitis C in conjunction with leading experts in the field of hepatology to help facilitate, inform, and enhance the therapeutic decision-making process by providing discussion points on state-of-the-art hepatitis C management. Hep C Discussion Point™ is a groundbreaking effort, and is the only tool of its kind designed exclusively for hepatitis C clients and their health care providers.

According to Lorren Sandt, the Hepatitis C Program Director, many of the calls CAP Hepatitis C receives are from patients who are confused by conflicting information they read or hear about regarding hepatitis C management. "When we designed Hep C Discussion Point™, we tried to address the most common and relevant questions we receive from those living with hepatitis C."

"We are excited about the launch of Hep C Discussion Point™ and are very pleased to offer this tool to the hepatitis C community, which includes both patients and their health care providers," said Dr. Tina St. John, Executive Director and Medical Director of the Caring Ambassadors Program. "Hep C Discussion Point™ represents a new and innovative approach to CAP Hepatitis C's commitment to ensuring that all persons living with hepatitis C have accurate and adequate information by which to make decisions that match their personal medical circumstances and health care goals."

Hepatitis C is the most common chronic, blood-borne viral infection in the United States. An estimated 5 million Americans are infected with the hepatitis C virus (HCV), the most common cause of chronic liver disease and adult liver transplantation in the U.S. No vaccine is available to prevent chronic hepatitis C but medications are available to clear the hepatitis C virus from the body in up to 50% of people treated.

About Caring Ambassadors Hepatitis C Program

The Caring Ambassadors Program is a 501(c)(3) nonprofit public charity dedicated to helping people with chronic and/or life-threatening diseases through information/education, awareness, public advocacy, and support. Founded in 2001, the organization is headquartered in Vancouver, Washington, U.S.A.

The Caring Ambassadors Hepatitis C Program (CAP Hepatitis C) is devoted exclusively to meeting the needs of the hepatitis C community. The CAP Hepatitis C mission is to improve the lives of people living with hepatitis C through information and awareness.

For additional information about the Caring Ambassadors Hepatitis C Program and Hep C Discussion Point™, contact Lorren Sandt at 360.816.4186 or Lorren@HepCChallenge.org.

Posted by Editors at 03:44 PM --- Printer-friendly version

March 07, 2008

Fast Food Likely to Accelerate Hepatitis C

According to new research from Sweden, grabbing a quick burger and fries is just as harmful to the liver as drinking alcohol. Since liver damage carries a graver risk to those living with Hepatitis C, eating low-fat meals is more important to this population than ever.

by Nicole Cutler, L.Ac.

New research from Sweden confirms that eating fast food can cause substantial liver damage. Luckily, the liver is one of our few organs capable of regenerating new, healthy cells. Thus, the injury inflicted from occasionally ordering dinner from a drive-through window can be reversed with a focused effort. Unfortunately, those battling Hepatitis C have a diminished ability to regenerate new liver cells and therefore have a harder time reversing liver damage. This means that the liver cell death incurred from eating the high-fat meals typical of fast food restaurants may be more detrimental to those already living with a chronic liver disease such as Hepatitis C.

The Hepatitis C virus (HCV) is one of the most common causes of chronic liver disease in the United States. Accounting for about 15 percent of acute viral hepatitis, 60 to 70 percent of chronic hepatitis and up to 50 percent of cirrhosis, end-stage liver disease and liver cancer, experts estimate that 4.1 million Americans are currently infected with HCV. While many more people live with HCV than die from it, the distinguishing factor between the two is learning how to prevent incurring further liver damage.

The HCV Disadvantage
The progression of liver disease is marked by a greater proportion of liver cell death than the creation of new, healthy liver cells. Due to a buildup of localized scar tissue, the following cascade of events demonstrates why those with HCV are prone to a worsening of their condition:

1. The Hepatitis C virus infects and kills liver cells.

2. In response to liver cell death, the body initiates an immune response, which causes inflammation.

3. In an attempt to limit the spread of infection, the immune system lays down collagen fibers between liver cells. These fibers are the building blocks of scar tissue.

4. Normally, as an infection or injury resolves, the collagen matrix enclosing the injury is dissolved and allows the tissue to return to normal. However, this web of collagen in people with chronic HCV grows more rapidly than it can dissolve.

5. As more collagen accumulates, the resulting scar tissue restricts living liver cells from access to nutrients and oxygen-rich blood.

6. The restricted access to blood causes even more quarantined liver cells to die. As such, HCV progressively scars the liver.

Since people living with HCV have this consistent battle being waged in their liver, they are more vulnerable to toxins that could damage this organ.

The Danger of Fast Food
Many things we breathe, ingest, swallow or otherwise absorb into our bodies pose a threat to the liver. A universally acknowledged cause of chronic liver disease, drinking alcohol is one of the most obvious ways to poison a liver. While most people might not categorize their lunch as toxic, millions of Americans are damaging their liver by eating fast food. A small Swedish study published in the February 2008 edition of the journal Gut found that even a brief fast-food binge combined with too little exercise can induce liver damage.

In this study, 18 slim, healthy participants stuck to a fast food diet, mostly consuming of hamburger meals from popular chains twice a day for four weeks while refraining from exercise. At the end of the experiment, participants not only gained an average of 16 pounds, but blood tests also showed evidence that those eating fast food incurred liver damage.

In the Swedish study, those gorging on fast food meals showed a dramatic increase in alanine aminotransferases (ALT) levels over a very short period of time. An enzyme produced in liver cells, ALT leaks into the bloodstream as liver cells are damaged. A result of liver cell damage, ALT elevations can be caused by any liver disease, hepatic inflammation or toxin.

Previous research has shown that a diet high in fat and calories, the hallmark of greasy, fast food, puts people at greater risk for obesity and type 2 diabetes, cardiovascular disease and heart failure. However, this Swedish study shows that doubling caloric intake without adding exercise also puts hepatic health in jeopardy. When excessive calories and fat overloads the liver’s ability to filter the blood, fat builds up in the liver cells and leads to liver damage. Considering that a majority of the study participants developed pathological ALT levels within just one week after eating fast food, this negative impact can occur relatively quickly.

Most people with HCV are aware that drinking alcohol causes liver cell death and can accelerate the severity of their liver disease. However, now their physicians must relay that alcohol is not the only thing they must navigate away from. Since eating a large quantity of high-fat foods (even for a short time period) while refraining from physical activity can damage the liver, people with HCV must avoid this combination. Since harboring the Hepatitis C virus makes recovery from liver damage a great challenge, hepatologists across the globe will be putting greater emphasis on sticking to a healthy, low-fat diet and adhering to an active lifestyle.

References:

http://abcnews.go.com, Fast Food: The Fast Track to Organ Damage, Radha Chitale, ABC News Internet Ventures, February 2008.

http://digestive.niddk.nih.gov, Chronic Hepatitis C: Chronic Disease Management, National Digestive Clearinghouse, 2008.

Diseases International http://en.wikipedia.org, Super Size Me, Wikimedia Foundatin Inc., 2008.

Kechagias, S, et al., Fast food based hyper-alimentation can induce rapid and profound elevation of serum alanine aminotransferase in healthy subjects, Gut, February 2008.

www.medpagetoday.com, Fast-Food Bender Can Convert to Liver Damage Swiftly, MedPage Today LLC, 2008.

Posted by Editors at 04:54 PM --- Printer-friendly version

Non-Invasive Testing for HCV Fibrosis Progression Improved

Michigan researchers have found that a new combination of markers may best predict the progression of cirrhosis for people with chronic Hepatitis C. Although requiring additional study for confirmation, these three serum fibrosis markers demonstrated a higher level of accuracy than other non-invasive tests.

Biomarker Panel May Improve Disease Staging in Chronic HCV

By Michael Smith, North American Correspondent, MedPage Today
Published: March 05, 2008
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

www.medpagetoday.com

ANN ARBOR, Mich., March 5 -- A panel of three biomarkers may be useful in identifying patients with chronic hepatitis C who have progressed to cirrhosis, researchers here found.

The three-marker panel was highly correlated to Ishak score in a prospective sub-study of the Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial, according to Robert Fontana, M.D., of the University of Michigan, and colleagues.

The biomarkers were also more accurate than other non-invasive tests that have been proposed, the researchers reported in the March issue of Hepatology.

The three markers evaluated by the researchers were serum tissue inhibitor of matrix metalloproteinase-1 (TIMP-1), hyaluronic acid (HA), and platelet count.

All were significantly associated with cirrhosis in a univariate analysis (as were several other markers) but in multivariate analysis, the three biomarkers had an area under the receiver operating curve of 0.81.

(A receiver operating curve measures the trade-off between sensitivity and specificity for a given test; if the area under the curve were 1.0, the test would correctly identify both positives and negatives.)

By comparison, Dr. Fontana and colleagues said, three other published models -- the Lok model, the AST-to-platelet ratio index, and the cirrhosis discriminant score -- had lower areas under the curve of 0.79. 0.73, and 0.70 respectively.

For this study, the researchers compared the model's predictions with the biopsy results of 513 patients with chronic hepatitis C and Ishak scores of between two and six. Those with Ishak scores of five and six (38%) were considered to have cirrhosis, while the remaining 62% had fibrosis.

Among those patients, the researchers found, the model would have correctly categorized 153 patients as having a low likelihood of cirrhosis with 86% accuracy.

An additional 146 subjects would have been categorized as having a high likelihood of cirrhosis with 73% accuracy.

The study was limited by the nature of the HALT-C patient population, the researchers said, which meant that there was no independent cohort of patients who also had stored serum available for testing for comparison.

Also, they noted, the model was not tested in an external validation cohort.

Nevertheless, the model "distinguished patients with non-cirrhotic (chronic hepatitis C) from those with cirrhosis" and "performed significantly better than other models based on routine laboratory tests," the researchers concluded.

The implication is that serum fibrosis markers "provide useful, incremental information in estimating disease stage" in chronic hepatitis C that can be obtained without biopsy, they said.

The study was supported by the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the National Center for Minority Health and Health Disparities, the National Center for Research Resources of the NIH, and Hoffmann-La Roche Inc.

Dr. Fontana reported being on the speakers bureau for Hoffmann-La Roche.

Posted by Editors at 02:52 PM --- Printer-friendly version

March 03, 2008

Re-Used Equipment at Nevada Clinic May Have Spread Hepatitis C

People treated at a Nevada Health Center may have been infected with Hepatitis C from an unsafe medical procedure. Thousands of people are being notified that they may have been exposed to this and other blood-borne viruses from the re-use of contaminated anesthesia equipment.

Nevada Hepatitis C Outbreak Tied to Las Vegas Clinic. Thousands Now At Risk for Hepatitis, HIV

Date Published: Thursday, February 28th, 2008

www.newsinferno.com

Hepatitis C and other blood borne diseases now threaten thousands of people in Nevada, thanks to the unsafe way anesthesia was administered at the Endoscopy Center of Southern Nevada in Las Vegas. At least six people who received treatment at the Endoscopy Center of Southern Nevada have already tested positive for Hepatitis C, but health officials in the state have urged another 40,000 to be tested for the virus, as well as HIV.

Hepatitis C is a blood disorder that is transmitted through blood-to-blood contact. Hepatitis C for the most part is asymptomatic and often leads to chronic, and long-term infection resulting in approximately 70% of those infected developing liver disease. Hepatitis C is a risk factor for liver cancer and can lead to the need for a liver transplant. HIV is the virus that causes AIDS, and is transmitted through the exchange of bodily fluids, including blood-to-blood contact.

The Endoscopy Center of Southern Nevada Health has been under investigation since early January, after health officials learned of three people who had been diagnosed with Hepatitis C. According to the Southern Nevada Health District, a total of six people contracted Hepatitis C after being treated at the Endoscopy Center of Southern Nevada. Five of them were treated the same day in late September; the sixth is believed to have been infected in July, the district said. The Southern Nevada Health District investigation revealed that “unsafe injection practices related to the administration of anesthesia medication might have exposed patients to the blood of other patients,” the statement said.

The Hepatitis C virus may have been spread when clinic staff reused syringes and used a single dose of anesthesia medication on multiple patients, the district said. A syringe would become contaminated by the backflow of blood when patients with a blood-borne disease were injected with medication, health officials said. That syringe, in turn, would be reused to withdraw medication from a different vial. That vial could become contaminated and result in infection.

The Southern Nevada Health District said that the unsafe practices had been in place for several years at the Endoscopy Center of Southern Nevada, and may have put others at risk. About 40,000 patients who received injections of anesthesia at the clinic will be told of the potential exposure in letters arriving next week. Anyone who received anesthesia at the clinic from March 2004 to Jan. 11 should be tested for the virus, along with Hepatitis B and HIV. The Southern Nevada Health Districts patient notification will be the largest of its kind in the country.

This is not the first time an outbreak of Hepatitis was blamed on medical practitioners who reused syringes or reused multidose vials of anesthesia on more than one patient. Late last year, the New York State Department of Health warned thousands of people treated by Long Island anesthesiologist Harvey Finkelstein that they were at risk for Hepatitis C, B and HIV. Finkelstein also was known to reuse syringes. At least one person is known to have contracted Hepatitis C as a result of Finkelstein’s unsanitary practices, and another six patients tested positive for the disease, although it is not absolutely certain that the virus was the result of Finkelstein’s treatment. Another six tested positive for Hepatitis B.

Posted by Editors at 09:22 AM --- Printer-friendly version

February 28, 2008

Update: What You Need to Know About Grapefruit and Hepatitis C

Even though there are more reasons than ever for those with chronic Hepatitis C to have a daily glass of grapefruit juice, there is a catch. Unfortunately, there is a long list of medications that can be dangerous when combined with this fruit.

by Nicole Cutler, L.Ac.

In the aftermath of recent research from Massachusetts, those with Hepatitis C are likely consuming more grapefruit than ever. By concluding that a compound in grapefruit likely prevents the Hepatitis C virus (HCV) from proliferating, this citrus fruit may accompany antiviral medication prescriptions in the future. However, anyone with a chronic illness considering adding grapefruit or its juice to their shopping list must be aware of the danger it could potentially inflict.

The Research
An investigative team from the Massachusetts General Hospital Center for Engineering in Medicine recently announced details about HCV propagation and the role grapefruit may have in hindering it. Apparently, Hepatitis C virus binds to a very low-density lipoprotein (vLDL) before it is secreted from liver cells to re-infect additional liver cells. Otherwise referred to as the bad cholesterol, vLDL functions as the body’s internal transport mechanism for lipids. According to lead author Yaakov Nahmias, Ph.D., “By finding that HCV is secreted from infected cells by latching onto vLDL, we have identified a key pathway in the viral lifecycle.”

Since HCV does not integrate its genetic material into the DNA of infected cells the way HIV does, totally clearing the virus is possible if new cells were not being infected. Therefore, interfering with the transport of HCV out of cells holds a great deal of therapeutic promise.

Scientists found that by blocking vLDL with a compound in grapefruit, Hepatitis C lost its vehicle and thus was stopped from expansion. Grapefruit's bitter taste is caused by the presence of the flavonoid naringin, which is metabolized into naringenin, an antioxidant known to reduce the secretion of vLDL from liver cells. The Massachusetts investigators confirmed that naringenin reduces the secretion of Hepatitis C from infected cells.

Another Grapefruit Advantage
Although focusing on a different component of the grapefruit, previous research supports the hepatic potential of grapefruit. Phytonutrients in grapefruit, called limonoids, inhibit tumor formation by promoting the formation of glutathione-S-transferase, a detoxifying enzyme. This enzyme sparks a reaction in the liver that helps to make toxic compounds more water soluble for excretion from the body.

Since those with chronic Hepatitis C are at a greater risk for developing cancer of the liver, inhibiting tumor formation is especially important. By helping the liver clear out cancer-causing toxins, limonoids’ promotion of detoxification enzymes is a simple way to ward off the development of cancer.

Grapefruit Warning
While just a few of grapefruit’s many health benefits are described above, there is a bittersweet side to this popular fruit. Grapefruit and its juice can be dangerous to people who take certain medications.

Amy Karch, RN, MS, of the School of Nursing at the University of Rochester Medical Center, an expert on drug interactions, explains that grapefruit juice is one of the foods most likely to cause problems with medications. The cytochrome P-450 3A4 enzyme breaks down grapefruit juice into useful components for the body, just like it breaks down dozens of medications. Grapefruit juice can block this enzyme, making it easier for medications metabolized by the same pathway to pass rapidly from the digestive system to the bloodstream. The result is blood levels of the drug rising faster and higher than normal. In some cases the abnormally high medication levels can be dangerous.

Consisting of more than 50 medications, interactions with grapefruit juice are well-known among researchers and clearly documented on warning labels. However, people commonly fail to comprehensively read the warning labels about drug-food interactions. In addition, it doesn’t take much grapefruit juice to boost the levels of drugs that are susceptible. A single glass can produce a 47 percent reduction of the intestinal enzyme that regulates absorption. Since the effect of grapefruit juice wears off slowly, a third of its impact is still evident after 24 hours.

While this list is not complete, some of the drugs interacting with grapefruit include:

· Anxiety: Xanax, Buspar, Versed, Halcion
· Depression: Luvox, Zoloft
· Allergies: Allegra
· Abnormal heart rhythm: Cordarone, quinidine
· Heart disease/stroke/blood clots: Coumadin
· Epilepsy: Tegretol
· Cancer: Cyclophosphamide, etoposide, ifosfamide,
tamoxifen, vinblastine, vincristine
· Cough: Dextromethorphan (found in many over-the-counter cold
medicines)
· HIV: Agenerase, Crixivan, Viracept, Norvir, Fortovase
· Prostate enlargement: Proscar
· Heart disease/High blood pressure: Coreg, Cardizem, Plendil, Cardene, Adalat, Procardia, Nimotop, Sular, Covera, Calan, Verelan
· Erectile dysfunction: Viagra, Cialis
· Asthma/Emphysema: Theophylline
· High cholesterol: Lipitor, Lescol, Mevacor, Zocor
· Pain: Alfenta, Duragesic, Actiq, Sufenta
· Infection: Biaxin, Sporanox, erythromycin, troleandomycin

As a person living with a chronic disease, those with HCV may have additional health issues warranting the use of medication. If unsure of a medication’s food interaction data, always contact a pharmacist to be sure.

The new evidence supporting the use of grapefruit in the fight against HCV is exciting, both because it may lead to viral elimination and because it can be done with an all-natural, well-known food source. However, before ordering your next case of grapefruit, make certain you don’t put yourself in jeopardy. If indulging in this sweet, tart member of the citrus family, be certain that any medications you take will not interact with your grapefruit.

References:

http://en.wikipedia.org, Very low density lipoprotein, Wikimedia Foundation, Inc., 2008.

www.health.harvard.edu, Grapefruit and medication: A cautionary note, President & Fellows of Harvard College, 2008.

www.peacehealth.org, Grapefruit Juice and Medication, Healthwise, 2008.

www.sciencedaily.com, Grapefruit Compound May Help Combat Hepatitis C Infection, ScienceDaily LLC, 2008.

www.sciencedaily.com, Grapefruit Juice And Medication Can Be A Dangerous Mix, ScienceDaily LLC, 2008.

www.whfoods.com, Grapefruit, The George Mateljan Foundation, 2008.

Posted by Editors at 09:44 AM --- Printer-friendly version

February 26, 2008

Agreement to Bring Rapid, Oral HCV Test Outside the U.S.

Two big pharmaceutical companies, Schering-Plough and OraSure, have agreed to work together to deliver a rapid, oral Hepatitis C test. In addition to their collaboration within the United States, this new agreement focuses on bringing this technology to additional markets.

AFX News Limited

Schering-Plough, OraSure Tech collaborate on oral hepatitis C test outside U.S.

www.forbes.com

02.11.08, 9:41 AM ET

NEW YORK (Thomson Financial) - Schering-Plough Corp. and OraSure Technologies Inc. Monday agreed to collaborate on the development and promotion of an oral hepatitis C virus (HCV) test outside the U.S.

The test will use OraSure's OraQuick technology platform.

Under the agreement Schering-Plough (nyse: SGP - news - people ) will reimburse OraSure for certain development costs and will provide payments to OraSure based on the achievement of certain regulatory and commercial milestones in international markets. Schering-Plough will provide promotional support while OraSure will make all sales and retain the rights to market and sell the test in all markets throughout the world.

The agreement builds upon the existing collaboration announced in January 2007 to develop and promote a rapid oral HCV test in the U.S. physicians' office market.

'We believe the global market opportunity for a rapid HCV test is significant and this expansion of our collaboration with Schering-Plough should help drive the adoption of this important product around the world,' OraSure said.

OraSure is a Bethlehem, Pa.-based company that specializes in oral fluid specimen collection devices and diagnostic products. Its stock closed Friday at $7.61.

Shares of Schering-Plough, a Kenilworth, N.J.-based advanced drug therapy company, closed Friday at $19.77.

Melinda Peer

mp/pc

Copyright Thomson Financial News Limited 2007. All rights reserved.

Posted by Editors at 09:55 AM --- Printer-friendly version

February 18, 2008

How Grapefruit Reduces the Spread of HCV

Massachusetts researchers have found that a compound in grapefruit blocks the Hepatitis C virus from infecting additional cells. Since the Hepatitis C virus depends on cholesterol metabolism to proliferate, future trials may prove that lipid-lowering drugs or supplements, such as that found in grapefruit, may inhibit the virus.

Grapefruit compound may help fight hepatitis C infection

www.tamilstar.com

Feb 14, 2008, 05:21

A compound naturally occurring in grapefruit and other citrus fruits may help get rid of hepatitis C virus, according to a study published in an upcoming issue of the journal Hematology.

The study led by researchers at the Massachusetts General Hospital Center for Engineering in Medicine showed naringerin, a flavonoid found in grapefruit, blocks the secretion of hepatitis C virus from infected cells.

Hepatitis C virus needs to latch onto a very low-density lipoprotein (vLDL, a so-called bad cholesterol) to pass on the infection to other cells in the liver.

The effect was observed in cultured cell lines.

"These results suggest that lipid-lowering drugs, as well as supplements, such as naringenin, may be combined with traditional antiviral therapies to reduce or even eliminate HCV from infected patients," said Yaakov Nahmias, PhD, of the MGH-CEM, the paper's lead author.

"Identifying the route by which HCV is released from cells introduces a new therapeutic target," said Martin Yarmush, MD, PhD, director of the MGH-CEM and the paper's senior author.

"That pathway's dependence on cholesterol metabolism could allow us to interfere with viral propagation to other cells and tissues, using tools already developed for atherosclerosis treatment."

Early studies showed hepatitis C virus needs vLDL to maintain its infection and naringenin can reduce secretion of vLDL from liver cells. The current study was meant to examine whether the compound might also lower HCV secretion from infected cells.

Hepatitis C virus is the leading cause of chronic viral liver disease in the United States that infects about 3 percent of the world population.

Eighty percent of persons with hepatitis C have no signs or symptoms but common symptoms include jaundice, fatigue, dark urine, abdominal pain, loss of appetite and nausea. Often it transmits from one person to another through contact of blood.

The current antiviral medications can treat 50 percent of cases, but 70 percent are expected to develop chronic infection, leading to cirrhosis or liver cancer in the end.

The researcher said naringerin or other lipid-lowering drugs could be used with other antiviral medications to treat hepatitis C infection if the effect is confirmed in human trials.

Posted by Editors at 01:45 PM --- Printer-friendly version

January 28, 2008

Hep C May Affect More than the Liver

A new study from Bulgaria proves that Hepatitis C infection is not only a liver disease, but affects many different parts of the body. Their research demonstrates that over three quarters of people with Hepatitis C have extra-hepatic manifestations and it helps physicians identify who is at the greatest risk.

Hepatitis C Virus Affects Many Organs And Tissues, Not Just Liver

www.sciencedaily.com

ScienceDaily (Jan. 18, 2008) — In 1994, the team of Tchernev and Petrova from Alexandrovska Hospital in Sofia examined a female patient with liver cirrhosis caused by chronic Hepatitis C virus (HCV). They were intrigued by the patient's many extra-hepatic manifestations -- vascular lesions on the lower limbs, acute pain in the joints, intense tingling of the fingers, and extreme labor-impairing fatigue. They were also intrigued by the presence of cryoglobulins in the patient's blood. Two years later, the patient developed enlarged lymph nodes on the neck. When one of the nodes was histologically tested, the patient was found to have lymphoma.

This case spurred the interest of the investigators in the extra-hepatic manifestations and complications of HCV infection, and for over a decade they studied the links between HCV infection, cryoglobulinemia, and lymphoma.

Hepatitis C virus is a major health problem worldwide, and more than 3 percent of the world's population is infected with HCV. Despite popular belief, HCV is not only a liver disease, but affects many organs, tissues, and systems.

In a new study of 136 Bulgarian patients with HCV, the team of Tchernev and Petrova found 76.5% of the patients had extra-hepatic manifestations. Common manifestations were fatigue (59.6%), renal impairment (25%), type 2 diabetes (22.8%), paresthesia (19.9%), arthralgia (18.4%), and purpura predominantly of the lower limbs (17.6%). Over 37% of the patients had cryoglobulins, and 8.8% had B-cell lymphoma.

The study found positive links between the presence of extra-hepatic manifestations and age, female gender, duration of the infection, infection by transfusion of blood and blood products, and extensive liver fibrosis. Therefore, elderly women with chronic HCV and advanced liver fibrosis, who were infected by transfusion during childbirth, are at the highest risk of developing extra-hepatic manifestations of HCV infection.

The study also showed most extra-hepatic manifestations of HCV infection are associated with the presence of cryoglobulins. In particular, the risks of developing B-cell non-Hodgkin lymphoma are much higher in cryoglobulin-positive than in cryoglobulin-negative patients. In the study, 17.6% of cryoglobulin-positive patients had lymphoma, whereas only 3.5% of cryoglobulin-negative patients did.

Given the prevalence of HCV around the world, it is important for physicians to recognize the extra-hepatic signs and symptoms of HCV infection. Patients who exhibit such manifestations should be tested for HCV infection. This can lead to prompt diagnosis and effective treatment of the infection before the development of cryoglobulinemia, when treatment gives poor results or is ineffective.

Journal reference: Stefanova-Petrova DV, Tzvetanska AH, Naumova EJ, Mihailova AP, Hadjiev EA, Dikova RP, Vukov MI, Tchernev KG. Chronic hepatitis C virus infection: Prevalence of extrahepatic manifestations and association with cryoglobulinemia in Bulgarian patients. World J Gastroenterol 2007; 13(48): 6518-6528 http://www.wjgnet.com/1007-9327/13/6518.asp

Adapted from materials provided by World Journal of Gastroenterology, via EurekAlert!, a service of AAAS.

Posted by Editors at 11:41 AM --- Printer-friendly version

Roche Stands By Their HCV Drugs Citing "IDEAL" Study Design Issues

Indicating patient preference for PegIntron™, Schering-Plough recently publicized their Hepatitis C trial, "IDEAL." However, competitor Roche indicates several IDEAL trial design issues that make for a poor comparison to their PEGASYS® with COPEGUS®.

Media Release

Contacts:
Brad Jenkins, Roche
+41 61 68 86404

Michelle Marchione
Axon Communications
+1 416 848 1419

Roche responds to announcement of “IDEAL” hepatitis C study

BASEL – January 14, 2008 – Following an announcement from Schering-Plough, Roche today affirmed the value of PEGASYS® (peginterferon alfa-2a) in combination with COPEGUS® (Roche’s brand of ribavirin) as the market-leading treatment for patients with hepatitis C. Despite clear biases in the design of the “IDEAL” study that potentially favoured patients taking PegIntron™ (peginterferon alfa-2b) regimens – particularly the ribavirin dose reduction protocol – the study results have shown that patients treated with a PEGASYS regimen had a similar chance of being successfully treated for hepatitis C.

“I do not expect that the results of the IDEAL study will meaningfully impact clinical practice, except to inform physicians on the appropriate dosing of PegIntron and to reinforce the already widely-accepted view that optimising ribavirin dosing throughout treatment is critical to achieving success and preventing treatment relapse in hepatitis C,” said Douglas Dieterich, M.D., Professor of Medicine in the Division of Hepatology at Mt. Sinai School of Medicine in New York, New York.

In 2001, the U.S. Food and Drug Administration (FDA) required Schering-Plough to conduct a post-approval commitment trial to determine if a lower dose of PegIntron (1.0 mcg/kg) was as effective as the approved dose of 1.5 mcg/kg, both in combination with identical ribavirin regimens.1 A third arm was added to the study in which patients received PEGASYS 180 mcg with a different ribavirin dosing schedule. This mismatch of ribavirin dosing introduces several potential biases into the study because experts agree that an optimised dose of ribavirin, with either pegylated interferon, is critical to achieving success in hepatitis C treatment. In particular, maintaining a full dose of ribavirin has shown an important ability to reduce relapse following the end of treatment.

“PEGASYS quickly became the market leader after its launch, based on robust clinical data and patient and physician preference. We are convinced that physicians and patients will continue to choose the PEGASYS plus COPEGUS combination therapy based on positive experience and sound clinical evidence,” said Rob Mitchell, Head of Viral Diseases Strategic Marketing at Roche. “Our current focus at Roche is on advancing the treatment of hepatitis C by optimising doses and duration of PEGASYS and ribavirin in patients with unmet medical need, while developing new compounds that have the potential to offer a successful outcome to even more patients.”

Roche believes that it is critical for patients and physicians to receive complete information to fully understand the results of “IDEAL” so that treatment decisions can be based on scientific data.
###

Please see below for additional information about the “IDEAL” trial, Roche and PEGASYS including important safety information.

“IDEAL” Trial Design Issues
· Starting doses of ribavirin were different in the PegIntron and PEGASYS arms of the study
· The design calls for a more drastic ribavirin dose reduction for side effect management in most patients in the PEGASYS arm compared to patients in the PegIntron arms; in some cases, ribavirin dose reductions for patients in the PEGASYS arm were three times greater than for patients in the PegIntron arms. This is important because a substantial number of patients being treated for hepatitis C require their ribavirin dose to be reduced to manage side effects, and this could have an impact on the efficacy of the regimen
· The PEGASYS arm was not blinded, meaning that patients and physicians knew which treatment was being administered. Many comparative studies are blinded to ensure that bias does not compromise the results
· Erythropoetin (EPO) is a medication that is often given to treat ribavirin-related anemia and help patients maintain a higher ribavirin dose. However, physicians could only prescribe EPO after the first dose ribavirin reduction in the “IDEAL” trial. Since patients in the PegIntron arms generally had smaller ribavirin dose reductions, this introduces another potential bias and means those PegIntron patients were potentially able to maintain a higher dose of ribavirin compared to PEGASYS patients

Efficacy of PEGASYS plus COPEGUS Combination Therapy
PEGASYS was launched by Roche in 2002 and quickly became the leading treatment for patients with hepatitis C. PEGASYS plus COPEGUS is the only pegylated interferon combination regimen to have demonstrated significantly superior benefits over conventional interferon combination therapy across all HCV genotypes, irrespective of viral load.2-4 The combination of PEGASYS and COPEGUS consistently shows high cure rates – up to 66% overall sustained virological response – across a number of large, randomised clinical studies including in patients with difficult-to-cure disease such as genotype 1 HCV, cirrhosis, and HIV-HCV co-infection.2-7

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

###

All trademarks used or mentioned in this release are protected by law.

References:

1. FDA letter to Schering-Plough, August 7, 2001. Accessed Nov. 26, 2007 at: http://www.fda.gov/cder/foi/appletter/2001/pegsche080701L.htm
2. Swan, T. Expediency, Cost-Cutting, Expediency Trump Science in Clinical Development Plan for Peg-Intron: The head-to-head that wasn’t. TAGLine 2003: 10(10)1-4. Also available at: http://www.aidsinfonyc.org/tag/taglines/0312.pdf
3. Raymond, D. The Real IDEAL: Peg-Intron vs. Pegasys. Hepatitis C Harm Reduction Project Web site. Accessed Dec. 17, 2007 at: http://hepcproject.typepad.com/hep_c_project/2004/05/the_real_ideal_.html
4. Hadziyannis SJ, Sette H, Jr., Morgan TR, et al. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med 2004;140(5):346-55.
5. Torriani FJ, Rodriguez-Torres M, Rockstroh JK, et al. Peginterferon Alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med 2004;351(5):438-50.
6. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002;347(13):975-82.
7. Marcellin P, Brillanti S, Cheinquer H. Peginterferon alfa-2a (40KD) (PEGASYS) plus ribavirin (COPEGUS) is an efficacious and safe treatment for chronic hepatitis C (CHC) in patients with compensated cirrhosis. . In: 38th Annual Meeting of the European Association for the Study of the Liver (EASL) July 3-6; 2003; Geneva, Switzerland; 2003.

Posted by Editors at 11:40 AM --- Printer-friendly version

Non-Hodgkin's Lymphoma Less Likely with Hepatitis C Treatment

After following participants for one year, a large Japanese study concludes that treating Hepatitis C aggressively reduces the occurrence of non-Hodgkin's lymphoma.

Treatment of Hepatitis C Reduces Incidence of Non-Hodgkin’s Lymphoma

http://professional.cancerconsultants.com

Researchers from Japan have reported that viral elimination in hepatitis C virus (HCV) infected patients reduces the incidence of non-Hodgkin’s lymphoma (NHL). The details of this study appeared in the December, 2007 issue of the American Journal of Medicine.

Hepatitis C affects approximately 170 million individuals worldwide. Following acute infection, the virus persists in many patients and a minority of patients develop chronic disease. Chronic hepatitis can progress slowly over many decades to chronic active hepatitis and cirrhosis, ultimately leading to end-stage liver disease or hepatocellular carcinoma. Studies from other countries, but not from the United States, have also shown an increased incidence of NHL in patients with HCV infection. Some researches suspect that this correlation can only be observed in populations where HCV is highly prevalent.

The current study was carried in 501 patients with HCV infection who had never received interferon and 2,708 patients who had received interferon. These authors reported that by one year, 0.6% of untreated patients had developed NHL which by 5 years had increased to 2.3% and by 10 years to 2.6%. In contrast, there were no cases at 5, 10 and 15 years for the 1,048 patients with HCV infection who had sustained virologic response. The remaining patients who were treated and had persistent viral infection had an incidence of NHL of 0.4% at the fifth year, 1.5% at the tenth year and 2.6% at the fifteenth year.

Comments: These data support the concept that treating HCV infection aggressively can reduce the incidence of NHL.

Posted by Editors at 11:39 AM --- Printer-friendly version

HCV Alert: Another Doctor Reuses Syringes

Unfortunately, another Long Island doctor put patients in jeopardy of acquiring Hepatitis C when it was discovered that he reused syringes between patients. Unlike the Finkelstein case, New York authorities are moving quickly to inform the public and notify patients.

Another Long Island Doctor Commits Malpractice By Reusing Syringes

www.newsinferno.com

Date Published: Wednesday, January 16th, 2008

It’s been revealed that another Long Island doctor has reused syringes when administering injections to patients. Dr. E. Jacob Simhaee, a Manhasset-based obstetrician-gynecologist reused syringes when administering flu shots to at least 36 patients last fall. Simhaee is not the first Long Island doctor to commit such medical malpractice. Late last year, it was learned that Dix Hills doctor Harvey Finkelstein had infected several of his patients with blood borne diseases after reusing syringes.

According to the New York State Department of Health, Simhaee is contacting these patients in writing. The state Department of Health composed the letter for the physician. Simhaee was asked to sign the letter and is also contacting patients by telephone. The state initiated its investigation of Simhaee’s practice in December following a complaint filed with the Nassau County Department of Health.

The state’s release of information yesterday contrasts sharply with its handling of the Dr. Harvey Finkelstein case. It waited three years before telling the public last fall and notifying nearly 11,000 patients that Finkelstein had reused syringes—exposing thousands of patients to blood-borne pathogen infections—resulting in transmission of hepatitis C. As of Tuesday, 13 of Finkelstein patients have tested positive for hepatitis B and nine for hepatitis C. The state said it is impossible to determine whether Finkelstein’s office was the source of these infections. Finkelstein has more malpractice settlements than any other pain-management specialist on Long Island and, was sued, on average, once or twice yearly. Fifteen suits concerned epidural injections; at least 10 led to settlements. On his resume—posted on his now offline Web site—Finkelstein was described as a 1985 fellow in pediatric and cardiac anesthesia and a 1986 fellow in pain management via Stony Brook Hospital. A hospital spokeswoman said they were not accredited to offer fellowships in pain management until 1994, in pediatric anesthesia until recently, and are not accredited in cardiac anesthesia.

Mary Curtis, Nassau’s deputy executive of health and human services said, regarding the Simhaee investigation, “It’s amazing that in this amount of time, they conducted an investigation and made a notification,” adding, “The state and Nassau County did a great job. We’ve really learned from the past.” State senator Kemp Hannon (R-Garden City) feels the discovery of a second such case might warrant legislative action. “We’re going to have to look into the prohibition of multiple-use vials or limiting the use of syringes to single-use syringes,” he said.

As with Finkelstein, the department determined Simhaee used a single syringe, which held up to six doses, on multiple patients; infection-control procedures require a new syringe be used for each patient. The state said no diseases have been transmitted and Simhaee has cooperated fully. Simhaee’s patients who received the flu shot between September and December are being urged to be tested for hepatitis C, hepatitis B, and HIV and to be revaccinated against the flu.

According to Simhaee’s attorney, Craig Schaum of Garden City “This is a very highly respected doctor who has been cooperating in every way with state and county officials and will continue to do so.” Simhaee graduated in 1982 from the Albert Einstein School of Medicine at Yeshiva University in the Bronx, according to the state health department Web site; completed his graduate medical education at Maimonides Medical Center in the Bronx in obstetrics and gynecology; and is board certified in obstetrics and gynecology.

Posted by Editors at 11:35 AM --- Printer-friendly version

January 17, 2008

Fibrin Glue May Have Transmitted HCV

Used in Japan in the 1980s, a surgical adhesive made from fibrin is another suspect for the transmission of Hepatitis C. Primarily utilized for treating burns, nosebleeds and to aid in plastic surgery, fibrin glue may have been tainted with HCV-infected fibrinogen before proper testing was conducted.

Fibrin glue used for burns, facelifts

The Yomiuri Shimbun

www.yomiuri.co.jp

Fibrin glue, a surgical adhesive linked to the transmission of the hepatitis C virus, was used in a wide variety of areas, such as dealing with burns, stopping nosebleeds or in plastic surgery, according to doctors and other sources.

The tainted glue is estimated to have been used on about 79,000 patients, and those infected with the virus via the glue are eligible for relief under a law enacted Friday offering blanket relief to HCV suffers who contracted the disease through tainted blood products.

However, many patients do not realize the wide extent of the glue's use, causing delays in the investigation into how many patients have been infected with the virus via the glue. "The Health, Labor and Welfare Ministry should alert the public by announcing the names of hospitals that used the glue and for what kind of treatment the glue was often used," said Shiro Iino, former health ministry official in charge of research into issues concerning hepatitis.

The contaminated glue was made from a combination of substances including HCV-tainted fibrinogen manufactured by the defunct Green Cross Corp. mainly between 1981 and 1987. The glue was mostly used for stopping bleeding or as an adhesive during surgery. While it was not formally approved under the Pharmaceutical Affairs Law, Green Cross promoted the glue by issuing a booklet that gave details of how the glue could be used, resulting in many hospitals using it.

A private hospital in western Japan started using the glue from around 1982 as a surgical adhesive when it conducted major skin grafts on patients who had suffered severe burns. "As the glue had hemostatic and adhesive properties, we could conduct surgery quickly. I think we used the glue in treating between 10 to 20 patients a year," a doctor at the hospital said.

The hospital stopped using the glue in the late 1980s, when the risk of hepatitis infection came to light. They have not confirmed any cases of HCV infection via the glue.

"We no longer have the medical records of the patients as the storage term has already expired. But I think it's possible some patients will have contracted HCV via the glue as it was applied directly to the surface of the burned skin," the doctor said. "What has happened to those patients subsequently is a concern."

Meanwhile, a doctor in the ear, nose and throat department of another hospital in western Japan used the glue in the mid-1980s to treat patients suffering from nosebleeds. When it was difficult to identify from which part of the nose a patient was bleeding, the doctor filled the nose with the glue to stop the bleeding. The treatment was conducted on about 20 patients.

Several years ago, the doctor informed patients about the possibility of infection, and recommended them to undergo medical tests. But results obtained did not show any infection.

"As the glue was removed from the nose after treatment, that might have lowered the infection risk," the doctor said.

In the 1980s, the glue was also used in plastic surgery. According to an academic journal, an aesthetic plastic surgeon in Tokyo used the glue as a hemostatic agent or as a surgical adhesive in facelift operations.

According to a report submitted in 2001 to the Health, Labor and Welfare Ministry by the then Welfide Corp., which took over Green Cross, the glue was used in about 270 medical procedures, including some related to the treatment of pneumothorax and stomach ulcers.
(Jan. 15, 2008)

Posted by Editors at 03:15 PM --- Printer-friendly version

Proteomic Profiling Improves Liver Cancer Identification

Boston researchers have demonstrated that proteomics demonstrates a higher specificity and sensitivity for detecting liver cancer than traditional methods. This breakthrough may detect liver cancer tumors earlier, when they are easier to treat.

Proteomic profiling shown more accurate than traditional biomarkers in identifying liver cancer

Contact: Bonnie Prescott
bprescot@bidmc.harvard.edu
617-667-7306
Beth Israel Deaconess Medical Center

www.eurekalert.org

BOSTON – As the incidence of liver cancer continues to grow-- fueled in large part, by rising rates of hepatitis C infections – so too does the need for tests to help diagnose the disease at an earlier stage. A study appearing in the January 15 issue of Clinical Cancer Research demonstrates that a novel mass-spectrometry based form of proteomic profiling is more accurate than traditional biomarkers in distinguishing liver cancer patients from patients with hepatitis C liver cirrhosis, particularly with regard to identifying patients with small, curable tumors. Led by researchers at Beth Israel Deaconess Medical Center (BIDMC), the study could help lead to earlier diagnostic methods – and subsequent treatments -- for liver cancer.

“Proteomics represents a potentially powerful tool for the serologic recognition of protein profiles associated with cancer,” explains co-senior author Towia Libermann, PhD, Director of the Genomics Center at BIDMC and Associate Professor of Medicine at Harvard Medical School.

“Although this particular proteomics technology, SELDI-TOF MS [surface enhanced laser desorption/ionization time of flight mass spectrometry] had already proven capable of identifying liver cancer in some limited studies, this was the first time that the technology was compared side-by-side with the clinical standard biomarker in a cohort of patients at risk for developing the disease,” adds Liebermann, who is also Director of the Dana-Farber/Harvard Cancer Center Proteomics Core in the Division of Interdisciplinary Medicine and Biotechnology at BIDMC.

Over a single decade, the incidence of liver cancer (hepatocellular carcinoma) increased from 1.8 to 2.5 per 100,000 patients, in large part due to a rise in the spread of hepatitis C virus.

“Hepatitis C has become a tremendous public health problem,” explains co-senior author Nezam Afdhal, MD, Director of the Liver Center at BIDMC and Associate Professor of Medicine at Harvard Medical School. “And a significant number of hepatitis C-infected patients will go on to develop liver cirrhosis.” Cirrhosis results when healthy tissue is replaced by scar tissue, preventing the liver from properly functioning. Cirrhosis itself is responsible for more than 25,000 deaths each year. But, adds Afdhal, secondarily, cirrhosis greatly increases a person’s chances of developing liver cancer.

“Each year, cirrhosis patients have a two to five percent chance that their condition will escalate to cancer,” he explains. “And the problem is that, right now, there is no reliable means of detecting liver cancer at an early stage, when surgical treatment is an option. Typically by the time the disease is discovered, the cancer has advanced and treatment options become much more limited.”

The best hope for early detection is cancer biomarkers, serum proteins found in altered amounts in blood or other body fluids. The current biomarker for liver cancer in clinical use is alpha fetoprotein (AFP). In many cases, patients with hepatitis C undergo routine monitoring for AFP levels as an indicator of whether tumors may have developed in their livers.

But, as Libermann explains, the AFP biomarker has a number of shortcomings, including false positives and false negatives. “AFP not only fails to detect many early tumors, but it also lacks specificity. Consequently, elevated AFP levels could be indicators of not only cancer, but also of other liver diseases or even benign conditions, while on the other hand, many patients with small tumors will test negative for AFP.”

The authors, therefore, decided to evaluate the sensitivy and specificity of SELDI-TOF MS for the detection of liver cancer and to compare its effectiveness with AFP.

Examining serum samples of 92 patients – including 51 patients with liver cirrhosis and 41 patients with liver cancer, and among the cancer patients, individuals with both large and small (less than 2 cm) tumors -- by SELDI-TOF mass spectrometry, the investigators were able to identify an 11-protein signature that accurately discriminated between the cirrhosis and cancer patients, first in a training set (made up of 26 cirrhosis and 20 liver cancer patients), and then again in an independent validation set (consisting of 25 cirrhosis and 19 liver cancer patients). The resulting diagnostic value – 74 percent sensitivity and 88 percent specificity – compared favorably with the diagnostic accuracy of AFP (73 percent sensitivity and 71 percent specificity) as well as with two other biomarkers currently in clinical development for liver cancer, AFP-L3 and PIVKA-IL.

“Most strikingly,” notes Libermann, “in patients with small tumors (less than 2 cm), where AFP identified only three, and AFP-L3 and PIVKA-II only one each, the 11-protein signature correctly identified seven of eight patients at this early stage of disease.

“Biomarkers play a major role in all aspects of personalized medicine, not only in early disease detection, but also in outcome prediction and evaluation of therapeutic responses,” he adds. “This study provides strong evidence that serum contains early detection biomarkers and supports the notion that a combination of multiple biomarkers may prove more effective than individual biomarkers for diagnosis of liver cancer, as well as other cancers.”

###

This study was funded by grants from the National Institutes of Health.

In addition to Libermann and Afdhal, study coauthors include BIDMC investigators Noah Zinkin MD, and Franck Grall, PhD, (joint first authors), Killimanagalam Bhaskar, MD, Hasan Otu, PhD, Dimitrios Spentzos, MD, Brett Kalmowitz, MD, Meghan Wells, Manuel Guerrero, BSc, and John Asara, PhD.

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and consistently ranks among the top four in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit www.bidmc.harvard.edu.

Posted by Editors at 03:11 PM --- Printer-friendly version

Japan Offers Aid to Recipients of HCV Tainted Blood

Lawmakers in Japan have publicly recognized the government's responsibility in Hepatitis C transmission from tainted blood products. While a recently passed bill will offer compensation to those affected, it will be interesting to see if other administrations follow suit.

Saturday, Jan. 12, 2008

Hepatitis C bill offering aid, apology clears Diet
Compiled from staff, Kyodo reports

http://search.japantimes.co.jp

The House of Councilors voted unanimously Friday to enact a law to give uniform relief to people who contracted hepatitis C from tainted blood products.

With the passage of the hepatitis C bill, about 1,000 people, including the 207 hepatitis C plaintiffs who sued the government and drugmakers, will receive an apology and compensation from the government.

In a statement issued following the law's enactment, Prime Minister Yasuo Fukuda said: "We must frankly admit the state's responsibility for causing huge harm to the victims and for failing to prevent the harm from spreading. I express my apologies from my heart."

With the enactment, the plaintiffs plan to conclude a basic agreement Tuesday with the government to pave the way for the pending lawsuits nationwide to be settled out of court.

Watching the Upper House approve the legislation in the chamber, plaintiffs smiled and some wiped away tears. Michiko Yamaguchi, who leads the plaintiffs' group, said, "I feel that the five years of fighting (since the lawsuit was filed in 2002) have at last paid off."

Fukuda plans to meet with the plaintiffs Tuesday.

Stalled negotiations on out-of-court settlements saw a breakthrough after Fukuda announced Dec. 23 his decision as president of the ruling Liberal Democratic Party to seek a lawmaker-sponsored bill to provide blanket relief to the sufferers.

The bill was submitted Monday to the Diet, was passed unanimously Tuesday by the Lower House and was sent to the Upper House for final legislative approval.

Under the law, people who contracted hepatitis C from contaminated blood products, including fibrinogen, will receive compensation ranging from ¥12 million to ¥40 million per person depending on the severity of the case.

The government will provide around ¥20 billion to set up a fund at the Pharmaceuticals and Medical Devices Agency to pay the relief. The drugmakers will also be required to offer contributions.
Gist of hepatitis C relief law

The following is the gist of a law enacted Friday to offer blanket relief for people with hepatitis C caused by tainted blood products:

* The government admits responsibility for causing huge harm to victims and failing to prevent the harm from spreading.

* The law will provide relief to those who contracted hepatitis C from contaminated blood products, such as fibrinogen.

* Victims entitled to relief are required to submit certification as hepatitis C sufferers, such as court rulings.

* Compensation ranging from ¥12 million to ¥40 million per person will be paid depending on the severity of the case and the balance will be paid if the condition worsens within 10 years.

* A fund will be set up to ensure payments, with the government providing the resources.

* The fund will call for drugmakers to provide contributions.

Posted by Editors at 03:08 PM --- Printer-friendly version

January 14, 2008

Hepatitis C, Liver Fibrosis and Marijuana

According to a recently published California study, daily use of marijuana may increase the risk of fibrosis in people with Hepatitis C.

Chronic Marijuana Use May Increase Fibrosis for Hep C Patients
Sunday, January 06 2008 @ 11:05 PM EST
Edited by: Michael Hess

Daily cannabis use increases the risk of liver fibrosis in patients with hepatitis C

http://bbsnews.net

BBSNews 2008-01-06 -- (IACM) According to research at the University of California at San Francisco daily cannabis use was associated with moderate to severe liver fibrosis in 204 patients with hepatitis C. Between 2001 and 2004, participants underwent interviews to assess demographic data, risk factors for HCV, and use of cannabis and alcohol. In addition, virologic testing and liver biopsy was performed.

The median age of the group was 46.8 years, 69 per cent were male, 49 per cent were white. Cannabis use frequency within prior 12 months was daily in 13.7 per cent, occasional in 45.1 per cent, and never in 41.2 per cent. There was no fibrosis in 27.5 per cent, mild fibrosis in 55.4 per cent and moderate to severe fibrosis in 17.2 per cent of subjects.

Current daily cannabis use increased the odds of moderate to severe fibrosis by nearly 7-fold. There was no association between current daily cannabis use and mild fibrosis. A major limitation of the study is the method, since only one examination was performed, which limits the ability to establish a temporal relationship between cannabis use and fibrosis stage.

However, the study confirms an earlier French study of 2004, in which daily cannabis use was also associated with an increased risk for liver fibrosis. Authors conclude that "HCV-infected individuals should be counseled to reduce or abstain from cannabis use."

(Source: Ishida JH, Peters MG, Jin C, Louie K, Tan V, Bacchetti P, Terrault NA. Influence of cannabis use on severity of hepatitis C disease. Clin Gastroenterol Hepatol 2008;6(1):69- 75)

Posted by Editors at 10:38 AM --- Printer-friendly version

January 10, 2008

An Updated Report on Hepatitis C Genotypes

The importance of learning your Hepatitis C genotype is crucial in determining a recommended treatment plan. As researchers discover yet another genotype, prescribed medicines will become increasingly tailored to each individual's Hepatitis C infection.

by Nicole Cutler, L.Ac.

As more detailed information becomes known about any illness, treatment strategies can be increasingly focused on that specific ailment. Treating viral hepatitis exemplifies the advantage of increasing therapeutic specificity. Because higher success rates are associated with how well the hepatitis strain is matched with its prescribed therapy, differentiation between infections is paramount.

Brief History of Viral Hepatitis
Although outbreaks of epidemic jaundice were known in both Greek and Roman times, viral hepatitis was first recognized as a distinct clinical entity in the United States and Europe during the late 18th and early 19th centuries. Originally, viral hepatitis was classified by its route of transmission:

· Through oral and/or fecal route (infectious)
· Through the blood (serum)

During World War II, these two types of viral hepatitis were officially acknowledged; infectious hepatitis was designated as Hepatitis A and serum hepatitis became known as Hepatitis B.

In 1977, the Hepatitis D virus was detected and the development of serological assays for Hepatitis A and Hepatitis B proved that additional hepatitis viruses existed. Hepatitis due to viruses other than the Hepatitis A, Hepatitis B or Hepatitis D viruses were referred to as non-A, non-B hepatitis. In the late 1980s, those infected with non-A, non-B hepatitis were further differentiated with the identification of two more viruses: Hepatitis C and Hepatitis E.

Hepatitis C Classification
Although discovering the root of someone’s liver disease as Hepatitis C is a task in and of itself, there is much more differentiation required to properly address this virus. As of late 2007, the number of known genotypes for Hepatitis C (the genetic make-up of the virus) grew from six to seven distinct viruses. In addition to being classified by genotype, there are over 50 known subtypes of Hepatitis C. As of the end of December 2007, the newly acknowledged genotype 7 has been associated with three separate subtypes.

Hepatitis C genotypes are most common in the following locations:

· Genotypes 1, 2 and 3 = North America and Western Europe
· Genotype 4 = Africa, Egypt and the Middle East, but is increasingly seen in some parts of Europe
· Genotype 5 = Africa and the Middle East
· Genotype 6 = Southeast Asia
· Genotype 7 = Central Africa

In order to prescribe a treatment plan with the highest chances of success, a person must have their particular Hepatitis C genotype and subtype identified. Additionally, knowing the exact strain of Hepatitis C virus is helpful in defining its epidemiology. Once the genotype is identified, it need not be tested again; genotypes do not change during the course of infection.

While the therapeutic responses between Hepatitis C subtypes are not disclosed here, some of the differences among genotypes include:

1. Those with genotypes 2 and 3 are almost three times more likely than patients with genotype 1 to respond to therapy with alpha interferon or the combination of alpha interferon and ribavirin.

2. A 24-week course of combination treatment is typically adequate for those with genotypes 2 and 3.*

3. A 48-week course of combination treatment is typically adequate for those with genotype 1.*

4. Data are mixed concerning genotype 4, though its response to combination treatment seems to be somewhere in between the response of genotypes 2 and 3, and genotype 1.

5. Recently published research on treating genotype 5 shows that its response to combination treatment is similar to those with genotype 1. However, previous results show that genotype 5 appears to be an easy to treat virus with response rates similar to those of genotypes 2 and 3 after a 48-week course of therapy.

6. Preliminary study results show that the response to treatment in those with genotype 6 lies at an intermediate level, between that seen with genotype 1 and genotypes 2 or 3.

7. Since it has just recently been discovered as having a distinct genetic make-up, the response to standard combination therapy is not yet established for genotype 7.

*Although some studies claim this duration of time to be ‘typically adequate,’ other trials have demonstrated that longer courses of treatment have lower relapse rates.

Our understanding of the various strains of the Hepatitis C virus is exponentially greater than the knowledge of viral hepatitis just a few decades ago. As more specificity about each type of viral infection is discerned, treatment approaches can be individually tailored. The one-size-fits-all method of prescribing medications is continually shown to be outdated, causing our medical practices to become more advanced. Accompanying this more advanced evolution of infectious hepatology, people fighting Hepatitis C stand their best chance ever of ridding themselves of their particular viral strain.

References:

M. H. Nguyen, E. B. Keefe, Prevalence and treatment of hepatitis C virus: genotypes 4, 5, and 6, Clinical Gastroenterology and Hepatology, October 2005.

www.abbottdiagnostics.com, Hepatitis Learning Guide, Abbott Laboratories, 2006.

www.cdc.gov, Frequently Asked Questions About Hepatitis C, Centers for Disease Control and Prevention, 2007.

www.hivandhepatitis.com, Epidemiology and Treatment Response of Genotype 5 HCV: Researchers Find New Seventh Genotype, Liz Highleyman, hivandhepatitis.com, 2007.

www.stanford.edu, The History of Hepatitis, Tiffany Chang, Stanford University, 1999.

Posted by Editors at 03:04 PM --- Printer-friendly version

January 02, 2008

Cirrhosis to Liver Cancer: Progression May be Genetic

Collaboration between French and American researchers has uncovered a possible genetic link among those who progress from cirrhosis to liver cancer. If this genetic variation is confirmed to be behind the development of hepatocellular carcinoma, this gene will be evaluated in cirrhotic patients and may be the basis for future therapies.

Gene Variation May Elevate Risk Of Liver Tumor In Patients With Cirrhosis

www.sciencedaily.com

ScienceDaily (Jan. 2, 2008) — A particular gene variation appears to significantly increase the risk that individuals with cirrhosis of the liver will go on to develop hepatocellular carcinoma (HCC), a liver tumor that is the third leading cause of cancer death. Researchers from Massachusetts General Hospital (MGH) Cancer Center and colleagues in France describe finding that a single alteration in the epidermal growth factor (EFG) gene may greatly increase the risk of developing HCC.

"If these results are confirmed, this EGF variation could be used to determine which cirrhotic patients should be screened more intensively for tumor development," says Kenneth Tanabe, MD, chief of Surgical Oncology at the MGH Cancer Center, the study's lead author. "In addition, the molecular pathway controlled by EGF and its receptor EGFR -- which is known to be important in several types of cancer -- appears to be an excellent target for chemoprevention studies. This is a deadly cancer and so progress in prevention and early detection is critically important."

HCC is the sixth most common solid tumor worldwide and most commonly develops in individuals with cirrhosis, which may be caused by infection with the hepatitis B or C viruses. There are currently no effective treatments for most HCC patients, so there is considerable interest in strategies that may prevent development of the tumor.

EGF's normal function is to stimulate tissue growth. Animal studies have shown that elevated levels of this protein in the liver lead to tumor development and that blocking the protein's receptor can prevent development of liver cancer. The current study was designed to determine whether cirrhotic patients with higher EGF levels are at greater risk for liver cancer and to determine the influence of a particular inherited gene on EGF levels in cirrhotic patients.

The researchers focused on a known variation in the EGF gene -- the presence of the nucleotide guanine (G) instead of the more common adenine (A) in a particular location -- which has been shown to increase EGF secretion in blood cells and raise the risk for malignant melanoma. Individuals inherit one copy of the gene from each parent and therefore have this gene with either two copies of A (A/A), two copies of G (G/G), or one copy of each (A/G). Genetic analysis of liver tumor cell lines showed that messenger RNA transcribed from DNA strands with the G allele was more stable that that transcribed from the A version, which could explain why cells with two G copies tend to secrete higher levels of EGF.

The researchers then studied tissue samples from all patients in the MGH Cancer Center Tumor Bank who had cirrhosis. Among the 207 patients with cirrhosis, most of whom were infected with the hepatitis C virus, 59 also had HCC. Patients with at least one copy of the G nucleotide had a significantly higher risk of developing HCC than did A/A patients -- ranging from a more than twofold increase for those with one G to an over fourfold increase for those with two G alleles. In all three genotypes, tissue analysis showed that EGF levels were highest in the G/G patients, as was activation of the EGFR receptor. In addition, blood levels of EGF were highest in those with two copies of the G allele.

To confirm these finding in a different patient population, the MGH team worked with colleagues from the Paul Brousse Hospital in Paris. Samples from this group, all of whom had alcoholic cirrhosis, also showed that patients with the G/G version of the EGF gene had a significantly greater risk of developing the liver tumor than did the A/A patients, in this instance an almost threefold risk increase.

In both the MGH and French study groups, controlling for factors such as age and gender did not change the increased risk associated with the G allele. While both groups primarily consisted of Caucasian patients, in the MGH group, it was noted that the G allele was more common among Asian patients; and it is well known that more than half the cases of HCC worldwide occur in China.

"We now need to prospectively study EGF levels in cirrhotic patients, to see if elevated levels will correlate with a greater risk of developing HCC, and look at factors such as diet, drugs or ethnicity that may modulate EGF levels," Tanabe says. "I think this is a terrific opportunity to see if targeting a specific pathway will prevent HCC in this group of patients, who are at risk for liver cancer because of their cirrhosis." Tanabe is an associate professor of Surgery at Harvard Medical School.

This research was published in the January 2 issue of JAMA.

The study was supported by grants from the National Institutes of Health, the MGH Department of Surgery, Tucker Gosnell Gastrointestinal Cancer Center, and the Fund for Medical Discovery. Co-authors of the JAMA article are Dianne Finkelstein, PhD, Hiroshi Kawasaki, Tsutomu Fujii, MD, PhD, Raymond Chung, MD, Gregory Lauwers, MD, Yakup Kulu, Alona Muzikansky, Darshini Kuruppu, PhD, Michael Lanuti, MD, Jonathan Goodwin and Bryan Fuch, PhD, of the MGH; and Antoinette Lemoine, MD, and Daniel Azoulay, MD, PhD, Paul Brousse Hospital, Paris.

Adapted from materials provided by Massachusetts General Hospital.

Posted by Editors at 04:08 PM --- Printer-friendly version

December 26, 2007

Hepatitis C and the Health Benefits of Eating Oatmeal

By eating a hot breakfast in the winter, a person with Hepatitis C can begin their day with a healthy start. Although most hot breakfast foods are not good for you, eating oatmeal in the morning offers a number of liver-specific health benefits.

by Nicole Cutler, L.Ac.

We’ve all heard it before – breakfast is the most important meal of the day. While this sounds like a straightforward concept, most of us are unaware of what kind of breakfast is in our best interest. Sadly, the majority of American breakfast foods are not ideal for a person working to preserve liver health. Especially important for those living with the Hepatitis C virus (HCV), there are many benefits to starting the day with a nutritious breakfast.

Eating a healthy breakfast takes on additional importance throughout the cold winter months. Requiring a strong body to deflect troublesome pathogens, an array of hearty colds and viruses make their presence during this frigid time of year. Thankfully, there are breakfast options providing us with vitamins, minerals, protein and fiber that can help the body successfully fight off winter’s worst illnesses.

Appetite Changes
Complicating breakfast selections are the appetite changes typically accompanying HCV infection or its treatment. The symptoms of nausea and vomiting can easily deter a person from eating well in the morning. Additionally, some foods once enjoyed may no longer taste the same. People with HCV often report that certain protein-rich foods, especially red meat, taste bitter. These phenomena may be due to HCV medications causing a bad taste in the mouth or it could be a consequence of liver disease harming certain chemical pathways in the body.

Warm Food
When cold outside, the body naturally craves warming foods to maintain its ideal, internal temperature for maintaining immunity. People who are in tune with this desire typically veer away from ice cream, cold cereal, and anything else straight out of the refrigerator or freezer in the winter. According to dietician Dr. Sharon Madigan, “As we approach the time of year when we all seem to succumb to the cold, one way of boosting our immune system is by eating a variety of foods which give you different nutrients that may help the body fight infection.”

Ribavirin
In today’s fast paced lifestyle there is a trend toward eating little or no breakfast. However, those on anti-viral therapy with ribavirin have an additional reason to consume breakfast. This oral medication is mostly taken by mouth twice daily. Clinical studies have indicated an increase in its effectiveness when taken with a substantial meal. Since most physicians advise taking ribavirin in the morning and evening, it is important for those on ribavirin therapy to take this medicine with an ample breakfast.

Troublesome Choices
While eating a hot breakfast is the best way to start a wintry day, not all hot foods are created equally. Unfortunately, many morning hot foods do not contribute to your health. Some of the top offenders include:

· Breakfast meat – Bacon and sausage are usually highly preserved, loaded with salt, and high in saturated fats. Preservatives require extra effort for a challenged liver to break down, lots of salt can stress the kidneys and cause water retention (bad for ascites), and saturated fat contributes to fatty liver disease and can worsen portal hypertension. If opting for bacon or sausage, consider chemical-free, low-fat and low-sodium varieties.

· Eggs – Although providing a good dose of protein, eating eggs daily can cause a steep hike in cholesterol levels. Additionally, the cheese used in omelets adds saturated fat, which contributes to clogged blood vessels, fatty liver disease, and portal hypertension. A healthier option is consuming egg whites or egg substitutes.

· Pancakes or waffles – Although these foods can provide a decent breakfast, many people load up on their not-so-good toppings. Powdered sugar, butter, margarine and gobs of syrup add sugar and fat to pancakes or waffles. Additionally, restaurants may cook these tasty dishes in shortening – a top contributor to atherosclerosis. However, multi-grain and low-fat options are healthful ways to enjoy pancakes and waffles. Just limit your toppings to a small amount of low-calorie syrup and you can enjoy a decent hot breakfast.

· Biscuits and gravy – This Southern favorite of two white biscuit halves smothered in gravy speckled with sausage bits is a nutritionist’s nightmare. High in saturated fat and salt, this dish is sure to worsen hypertension, heart, liver and kidney disease.

Hot Breakfast Savior
Despite the discouraging news of the most popular hot breakfasts, a bowl of hot cereal offers hope. According to Dr. Madigan, oatmeal is the ideal winter breakfast food. Oatmeal contains whole grains, which are good sources of protein, fiber, vitamin E and B, zinc, antioxidants, and phytochemicals. Like fruit and vegetables, oatmeal provides a package of nutrients that can help keep the immune system strong to fight bacteria and viruses – including HCV.

Bernadette Speer, Marketing Manager of White’s, maker of Speedicook Porridge Oats said, “eating a large breakfast in the winter has been shown to increase the blood level’s gamma interferon by 450 percent.” As the body’s natural anti-viral compound, gamma interferon is crucial to maintaining health when exposed to viruses.

Often referred to as “breakfast that sticks to your ribs,” eating oatmeal in the morning is healthful when it is not laden with sugar. However, most of the flavored packages of instant hot cereal have high portions of sugar. Nutritionists agree that plain oatmeal is best. According to the American Cancer Society, some of the reasons oatmeal’s soluble and insoluble fibers are beneficial are:

· By attacking certain bile acids, insoluble fiber reduces the toxins that need to be filtered by the liver.

· Soluble fiber may reduce LDL cholesterol (the bad one) without lowering HDL cholesterol (the good one). By improving the cholesterol ratio, soluble fiber can reduce atherosclerosis, fatty liver disease, and portal hypertension.

· By slowing down the digestion of starch, soluble fiber helps keep a stable blood sugar level. This feature benefits anyone at risk for insulin dependence or diabetes – two problems commonly associated with HCV infection.

· The phytochemicals in oats are believed to have cancer-fighting properties. In addition, they are a good source of many nutrients including protein, vitamin E, zinc, selenium, copper, iron, manganese, and magnesium.

While oatmeal may be too bland for your taste, below are five ways to make it delicious:

1. To add richness while adding calcium and protein, make the oatmeal with milk instead of water.

2. Sweeten oatmeal with honey or Stevia.

3. Add flavored protein powder after it’s been cooked.

4. Mix in fresh or frozen fruit like bananas, blueberries or peaches to give your oatmeal great flavor while adding the nutrients found in fruit.

5. Top your oatmeal with some nuts to add flavor and boost protein levels.

Iron Caution
A specific dietary concern for those with HCV is iron consumption. Since those with chronic liver disease must restrict their dietary iron intake, be certain to skip oatmeal fortified with iron. Because most oatmeal contains a small amount of iron, it is worth the effort to search for oatmeal with a low percentage of this mineral.

While consuming oatmeal offers many benefits including aiding toxin elimination, reducing cholesterol, improving blood sugar levels, and preventing cancer, it does not pose the health threats of more popular American hot breakfasts. Starting a winter morning with your liver’s health in mind is as easy as consuming a bowl of oatmeal. Besides warming us from the inside, oatmeal provides an array of nutrients to help a person with HCV overcome their daily challenges.

References:

http://health.learninginfo.org, Six Health Benefits of Eating Oatmeal, Ryan Cote, 2007.

http://quakeroatmeal.com, Oats and Cholesterol Lowering - Summary of Studies, The Quaker Oats Company, 2007.

Hurley, Jayne, Bonnie Liebman, Stephen Schmidt, Bad news breakfasts - nutritional value of restaurant breakfast foods, Nutrition Action Newsletter, March 1996.

www.allabouthepatitisc.com, Overcoming Obstacles to Eating, Schering Corporation, 2007.

www.belfasttelegraph.co.uk, A bowl of porridge a day keeps doctor away, Claire Regan, Independent News and Media, November 2007.

www.healthnewsdigest.com, Oatmeal, A Magical Food?, Healthnewsdigest.com, 2007.

www.medicinenet.com, Ribavirin – Oral Capsules, MedicineNet Inc., 2007.

Posted by Editors at 10:05 AM --- Printer-friendly version

Twelve More Finkelstein Patients Test Positive for Hepatitis

While most doctors are vigilant about disease transmission prevention, Long Island physician Dr. Harvey Finkelstein violated this vigilance when he reused syringes on his clientele. Although nearly impossible to determine where the infection originated, twelve more of Finkelstein's patients have just tested positive for Hepatitis.

Twelve test positive for hepatitis B and C
www.newsday.com

By Ridgely Ochs | ridgely.ochs@newsday.com
December 5, 2007

As state Sen. Kemp Hannon prepares to convene a hearing Thursday on the Dr. Harvey Finkelstein case, patients of the Dix Hills physician continue to stream into Nassau County clinics to be tested for blood-borne infections.

As of Wednesday, six of 119 Finkelstein patients tested in the past few weeks were positive for hepatitis B, and six have been found with hepatitis C, according to the Nassau County Health Department. A total of 149 so far are scheduled to be tested by Nassau. More than 1,200 people have been notified by the state that they should be tested.

State health department spokeswoman Claudia Hutton cautioned that because the virus may have mutated in people's bodies since 2004, when Finkelstein was found to be re-using syringes in multi-dose vials, it's impossible to determine whether the infections stemmed from his improper practices.

"The cases may not trace back to Dr. Finkelstein," Hutton said. "Hepatitis B and hepatitis C do exist in society and people do have them. Getting them from a health care exposure is rare; getting them any number of other ways is not so rare," she said.

Hepatitis C is the most common chronic bloodborne viral infection in the U.S., according to the Centers for Disease Control and Prevention. About 4.1 million Americans have been infected with the virus, of whom 3.2 million have a chronic infection that can last for the rest of their lives. One in 20 Americans will get hepatitis B at some point in their lives, according to the CDC; about 1.25 million Americans have a chronic hepatitis B infection.

Hannon (R-Garden City), the head of the Senate's health committee, decided to hold the hearing as the Finkelstein controversy unfolded last month.

The health department came under fire because it took almost three years to notify hundreds of patients of the transmission and to urge them to be tested.

Hutton made it clear Wednesday that the state's investigation of specific cases involving Finkelstein patients is done: "The epidemiological investigation is over," she said. "We do not intend to do anything about test results. The reason we notify people is to urge them to get tested and to seek appropriate care."

The state used genetic fingerprinting to confirm in early 2006 the transmission of hepatitis C in Finkelstein's office. But because viruses mutate over time, it's too late to use that technique now.

"At this point we are not trying to do a mosaic of every patient of Dr. Finkelstein," Hutton said.

Although she said the health department "cared intimately" about each patient's disease diagnosis, "what would be the purpose to figure out a second or third transmission except to sue Dr. Finkelstein? That's not the health department's job. That's why people hire attorneys," she said.

Posted by Editors at 09:32 AM --- Printer-friendly version

December 24, 2007

Trial to Test Potential HCV Triple Combination Therapy

GI-5005 Tarmogen is under consideration as the third drug in a cocktail for treating chronic Hepatitis C. In an international Phase II trial just getting underway, GI-5005 will be paired with the current standard of therapy - pegylated interferon and ribavirin.

GlobeImmune Begins Trial With Hepatitis C Candidate

Dec. 20, 2007 | Vol. 5 No. 248
http://fdanews.com

GlobeImmune has started a Phase II trial to evaluate GI-5005 Tarmogen for the treatment of patients with chronic hepatitis C infection.

The drug is being evaluated as a potential therapy in combination with the standard of care, pegylated interferon plus ribavirin.

The randomized, open-label, multi-arm, multicenter trial is evaluating GI-5005 in combination with full duration standard of care versus standard of care alone in patients who are either treatment-naive or unresponsive to previous therapy.

This study will enroll 120 patients in the U.S., India and Europe, GlobeImmune said.

Posted by Editors at 12:34 PM --- Printer-friendly version

New HCV Drug Prospect Gets Good Marks for Safety

Already approved in the Russian Federation for treating Hepatitis B and C, NOV-205 has just demonstrated its safety in a U.S. Phase 1b trial. As we progress into 2008, look for reports on the efficacy of this drug.

Novelos ends safety trial of hep C drug on good news

Mass High Tech: The Journal of New England Technology

Thursday, December 13, 2007
www.bizjournals.com

Novelos Therapeutics Inc. reports concluding its initial U.S.-based Phase 1b trial for a hepatitis C therapy with good safety results.

The Newton-based biopharmaceutical company was evaluating NOV-205 as a therapy in chronic hepatitis C genotype 1 patients who had previously failed treatment with interferon plus ribavirin.

Based on favorable safety data in the 14-dose trial with 18 subjects, Novelos said it plans to initiate a longer proof-of-concept trial in hepatitis C nonresponders during the second half of 2008.

NOV-205 has been approved in the Russian Federation, based on a longer duration of dosing in treating hepatitis B and C patients who have not yet received other treatments. NOV-205 was also tolerated well in those studies, officials said.

According to the World Health Organization, chronic hepatitis C affects 170 million people worldwide and up to 4 million people are newly infected each year. Chronic infection can progress to cirrhosis, end-stage liver disease and hepatocellular carcinoma.

Posted by Editors at 12:06 PM --- Printer-friendly version

December 12, 2007

Antibody Isolation May Prevent or Slow HCV

American and Canadian scientists unite in studying a novel approach for reducing the scope of Hepatitis C infection. Their isolation and injection of specific antibodies into liver tissue demonstrates potential in preventing or slowing the Hepatitis C virus.

Treatment could slow hep C

U of A researchers, California scientists team up against global menace

Bill Mah, The Edmonton Journal; With files from Bloomberg News
Published: Friday, December 07

EDMONTON - Researchers at the University of Alberta have teamed up with California scientists to devise a potential treatment that could, for the first time, head off hepatitis C -- especially in patients who have had liver transplants.

Hepatitis C affects about 240,000 Canadians and an estimated three per cent of the world's population. The number of people infected is increasing rapidly in Canada and around the world, according to Health Canada. The disease is spread by contact with infected blood and needles.

Treatments are costly and help just half of patients, according to the World Health Organization. The virus causes chronic infections in most patients, leading to liver damage in some and cancer in others. It's the leading cause of liver transplants in the U.S. and Canada.

Several thousand people each year across North America and Europe who don't respond to drug treatment and need liver transplants. These patients are particularly at risk, since the virus comes back in 100 per cent of the cases.

"This may give us insight into how we can move forward to develop ways to prevent re-infection in patients who have hepatitis C who are going to get a transplant," said Norman Kneteman, a professor of surgery at the U of A and the director of transplantation for Capital Health.

Kneteman is referring to a set of immune proteins that, when injected into laboratory mice bred with human cells in their livers, either protected the rodents from the infection or delayed its onset.

Researchers Mansun Law and Dennis Burton at the Scripps Research Institute in La Jolla, Calif., isolated a set of antibodies that attack a part of the virus that is less susceptible to changes in its DNA.

The U.S. scientists showed that the antibodies could fight two different mutations of the hepatitis C virus, Kneteman said.

The Americans approached Kneteman, whose lab had produced mice with human liver cells.

The hep C virus only lives in human and chimpanzee liver cells.

"So we took the antibodies that they developed ... and we put them into some of our mice with human liver cells," Kneteman said.

"We gave these mice a big dose of the antibody and then we followed that up by injecting the mice with hepatitis C virus from a patient."

Four control mice that didn't get the antibody became infected quickly.

One form of the antibody delayed the infection in three of five mice, while two never were infected.

In another group, a different antibody protected three of four mice and delayed infection in the fourth.

The antibodies open up new possibilities for preventing and treating hepatitis C.

"This is the first time that we've been able to demonstrate the ability of an antibody preparation to block hep C infection for a substantial period of time in a living animal," Kneteman said.

But he said much more work needs to be done to confirm the findings, improve the antibodies and come up with "clinical-grade" forms in partnership with biotech or pharmaceutical companies. Then the antibodies would have to undergo clinical evaluation.

Law said the antibodies might be given to people who think they've been exposed, either from drug use or accidental needle sticks, to avoid chronic infection. "It would be similar to shots for rabies that are used in exposed people."

Law said that while he has been contacted by companies interested in developing a drug from the antibodies, no deal is in place. Further tests in animals, perhaps in chimpanzees, might be needed before the antibodies are tried in people, he said.

The study's findings were released Thursday in the journal Nature Medicine.

Posted by Editors at 12:14 PM --- Printer-friendly version

November 23, 2007

Extended Interferon Treatment Not Helpful for Hepatitis Delta

While most cases of chronic viral hepatitis present a treatment challenge, treating the Hepatitis Delta virus is even harder. Soured by its high relapse rate, the only approved treatment for this infection is one year of interferon therapy. In their search for better solutions, Turkish researchers found that doubling the treatment length has no effect on this viral strain's response rates.

Interferon for the Treatment of Chronic Hepatitis Delta
www.hivandhepatitis.com

By Liz Highleyman

Hepatitis delta virus (HDV) is a defective virus-like pathogen that can only replicate in the presence of hepatitis B virus (HBV). HDV is transmitted through the same routes as HBV (direct blood contact, sexual contact, mother-to-child). People may either become coinfected with HBV and HDV at the same, or may acquire HDV while already infected with HBV.

A 1-year course of high-dose interferon alpha is the only established treatment for chronic HDV infection, but it has a high relapse rate after therapy is completed.

As reported in the November 2007 Journal of Viral Hepatitis, researchers from the University of Ankara in Turkey conducted a study to determine whether treating HDV for 2 years would improve sustained response rates.

In this study, 23 patients were treated with 10 million unit (MU) of interferon alpha-2b (Intron-A) 3 times weekly for 2 years. Treatment response was assessed as follows at the end of treatment (24 months) and after a 6-month follow-up period (30 months total):

• Virological response: undetectable HDV RNA;

• Biochemical response: normal alanine aminotransferase (ALT);

• Histological response: at least 2-point decrease in the Knodell score (histological activity index measuring liver necroinflammation and fibrosis).

Results

• 15 patients completed the 2-year course of treatment and 6-month follow-up period.

• Out of these patients, 7 (47%) had a biochemical response, but only 2 (13%) still had normal ALT at the end of follow-up.

• ALT decreased from the mean baseline value of 143.1 to 39.7 IU/L at the end of treatment.

• 6 patients had a virological response at the end of treatment, but only 2 had sustained virological response at the end of the follow-up period.

• 2 patients lost hepatitis B surface antigen (HBsAg).

• Among the 12 patients with paired liver biopsies, 8 experienced histological improvement.

Conclusion

Based on these findings, the authors concluded, "Interferon treatment leads to a complete or partial response in a substantial number of patients, but 2 years of treatment does not appear to increase sustained response rates over 1 year treatment."

10/26/07

Reference
C Yurdaydin, H Bozkaya, H Karaaslan, and others. A pilot study of 2 years of interferon treatment in patients with chronic delta hepatitis. Journal of Viral Hepatitis 14(11): 812-816. November 2007.

Posted by Editors at 02:22 PM --- Printer-friendly version

October 31, 2007

Can Carbs Harm the Liver?

Researchers have proven carbohydrates with a high glycemic index cause fat to accumulate in the liver. By stabilizing blood sugar levels, suggestions are given to reduce the risk high glycemic foods pose, thus minimizing the growing threat of fatty liver disease.

by Nicole Cutler, L.Ac.

For those of us living with liver disease, there appears to be an endless supply of warnings against which foods to avoid, habits to break and activities to dodge. It seems the healthy lifestyle revolution was created exclusively for those with an impaired liver, giving no mercy to people with cravings or personal preferences. Although a common food category in the American diet has been added to our list of things to avoid, healthcare experts have assembled some tips to help people minimize their intake of certain carbohydrates.

Nutritionists have known for a long time that foods with a high glycemic index foster weight gain, and when dominant in the diet may even spawn adult onset diabetes. Confirming their negative impact on health, researchers from Children’s Hospital Boston have recently demonstrated a linear relationship between carbohydrates with a high glycemic index and a fatty liver.

Glycemic Index
Over the last 30 years, research into food and blood glucose response has completely changed our carbohydrate classification system. By measuring how quickly foods are digested and absorbed, the glycemic index measures the body’s response to carbohydrates. The rate at which carbohydrates elevate blood sugar defines a food’s glycemic measurement:

· High – Carbohydrates with a high glycemic index are absorbed quickly into the blood stream and cause a rapid rise in blood glucose levels. This demands a quick response from the pancreas to release insulin for the metabolization and storage of the sugar. Over time, consumption of high glycemic foods stresses the pancreas and the immune system by causing the blood sugar highs and lows endemic to diabetes and hypoglycemia. A glycemic value of 70 or more is considered high.

· Low – Foods with a low glycemic index are broken down more slowly into simple sugars, keeping blood glucose levels more stable. The absorption of these foods is therefore more gradual and does not contribute to blood sugar highs and lows.

The Research
Associate professor of pediatrics and director of the Optimal Weight for Life program, David Ludwig, MD, PhD of Children's Hospital in Boston led the research suggesting that high glycemic foods pave the way for fatty liver disease. “Our experiment creates a very strong argument that a high-glycemic index diet causes, and a low-glycemic index diet prevents, fatty liver in humans,” stated Ludwig.

Published in the September 2007 issue of Obesity, this study investigated the effect of feeding mice either a high or low glycemic index diet containing a type of cornstarch that was either quickly or slowly digested. Diets were then controlled to contain equal calories, fat, protein and carbohydrates. Ludwig and co-workers report that, after six months, the mice weighed the same. However, the differences between the mice were as follows:

· Those on the low glycemic index diet were lean, with normal amounts of body fat.

· Those fed the high glycemic index diet had double the normal amount of fat in their bodies, blood and livers.

According to Ludwig, the mechanism behind the apparent damage of consuming a high glycemic index diet is the increased production of insulin. Instructing the body to make and store fat, insulin is most concentrated in the liver. Fat in the liver increases a person’s risk for liver inflammation, which can ultimately cause liver damage.

Preventing a Fatty Liver
While many lifestyle adjustments are touted for improving liver health, two ways of preventing fat accumulation in the liver are choosing low glycemic instead of high glycemic foods and supplementing with milk thistle to reduce insulin resistance.

By choosing low glycemic foods, sharp swings in blood sugar are avoided, thereby naturally decreasing the body’s production of insulin. Some popular high glycemic foods to restrict in your diet are:

· Potatoes
· Corn
· White flour
· Rice – white or brown
· Refined sugar – white or brown
· Watermelon
· Most refined breakfast cereals

Some popular low glycemic foods to increase in your diet are:

· Apples or pears
· Yams
· Nuts
· Legumes
· Whole grains (especially barley and oats)
· Agave or stevia

In addition to choosing your carbohydrates carefully, supplementing with milk thistle offers an additional level of protection against fat accumulation in the liver. The regular use of milk thistle decreases insulin resistance, where normal amounts of insulin are inadequate to normalize blood sugar.

According to a study published on October 30, 2006 in Phytotherapy Research, Iranian researchers demonstrated that milk thistle seed extract helped control blood sugar for people with type 2 diabetes. In this double-blind study, diabetics taking milk thistle for four months showed better blood sugar control, cholesterol and triglyceride levels than the control group. This research shows that milk thistle can help stabilize swinging blood glucose levels to prevent the accumulation of insulin and therefore fat in the liver.

In order to thwart the burgeoning numbers of people with fatty liver, a better understanding of beneficial carbohydrates is needed. Since consuming lots of high glycemic foods such as bread, cake and rice contributes to a fatty liver, those concerned with liver health are better off choosing low glycemic foods. The more we protect our liver’s health by supplementing with milk thistle and eating low glycemic carbohydrates, the further away a fatty liver disease epidemic becomes.

References:

http://naturalmedicine.suite101.com, The Who’s Who of Sugars, Victoria Anisman-Reiner, August 2006.

http://ukpress.google.com, Diet Link to Liver Disease, The Press Association, 2007.

www.bodybuildingforyou.com What is the Glycemic Index (GI)?, Gary Matthews, bodybuildingforyou.com, 2007.

www.childrenshospital.org, Quick-Burning Carbs May Cause Fatty Liver, Children’s Hospital Boston, September 2007.

www.ehow.com, How to Avoid High Glycemic Foods, eHow Inc., 2007.

www.foodnavigator.com, High GI Diets May Increase Fatty Liver – Study, Decision News Media SAS, September 2007.

www.nccam.nih.gov, Milk Thistle, National Institutes of Health, 2007.

www.nursingpractice.com, Liver Disease Link to Carbohydrates, Campden Publishing Limited, September 2007.

www.webmd.com, Milk Thistle May Help Treat Diabetes, Miranda Hitti, WebMD Inc., 2007.

Posted by Editors at 02:23 PM --- Printer-friendly version

MRI Could Replace Liver Biopsy

Although just a preliminary study, New York researchers have discovered a new use for a well-known diagnostic tool. Useful for evaluating more than just soft tissue injuries, this recent study supports MRI technology as an effective non-invasive method to replace or supplement liver biopsy.

MRI Predicts Liver Fibrosis, Study Says

www.sciencedaily.com

ScienceDaily (Oct. 29, 2007) — Moderate to severe chronic liver disease can be predicted with the use of diffusion-weighted MRI (DWI), according to a recent study conducted by researchers at New York University Medical Center in New York, NY.

"Due to the increased incidence of chronic hepatitis in the United States, particularly hepatitis C, there is a strong need for non-invasive methods to replace or supplement liver biopsy, which is relatively invasive and limited by interobserver variability and sampling error," said Bachir Taouli, MD, lead author of the study. "DWI appears promising in that purpose, although it needs validation in larger series," he said.

The study included 23 patients with chronic hepatitis and 7 volunteers. The researchers compared apparent diffusion coefficients (ADCs) or the quantification of water diffusion in a tissue between patients who had stage 2 or greater versus stage 1 or less fibrosis and stage 3 or greater versus stage 2 or less fibrosis. In liver fibrosis and cirrhosis, decreased ADC (i.e. restricted water diffusion) is possibly related to increased collagen deposition and decreased perfusion. The study showed that hepatic ADC was a significant predictor of stage 2 or greater and stage 3 or greater liver fibrosis.

"At this point, this is an experimental method that needs to be tested in a larger series. It should also be compared with other methods such as FibroTest (a score based on a combination of basic serum markers) or FibroScan (an ultrasound based method to measure liver stiffness) in order to be validated," said Dr. Taouli. "However, diffusion imaging does show potential for decreasing the number of biopsies and decreasing the number of antifibrogenic drug trials," he said.

"We did not expect to have such good results in terms of detection of significant fibrosis, partly because this is an investigational study and we did not have any prior experience with such application," said Dr. Taouli.

"This preliminary study was funded by a grant from the Society of Gastrointestinal Radiologists and we are now in the process of applying for extramural funding from National Institutes of Health," said Dr. Taouli. "The goal is to validate diffusion and perfusion imaging as a replacement of liver biopsy in chronic viral hepatitis," he said.

The full results of this study appear in the October issue of the American Journal of Roentgenology, published by the American Roentgen Ray Society.

Adapted from materials provided by American Roentgen Ray Society.

Posted by Editors at 11:27 AM --- Printer-friendly version

October 30, 2007

Living with Hepatitis C: Is an Occasional Drink Okay?

Learn about the effect of alcohol on Hepatitis C, and whether or not its consumption, in any moderation, poses risks for people managing the virus.

by Nicole Cutler, L.Ac.

Conflicting research about alcohol’s benefits has cast a shadow of doubt over advice to completely abstain from drinking alcohol. For every article about the benefits of alcohol consumption, another seems to warn of its risks. The debate gets even trickier when deciding to drink an occasional glass of wine while managing Hepatitis C. Although there is no doubt that heavy alcohol use worsens Hepatitis C infection, many social drinkers wonder if this same warning applies to them.

Hepatitis C Progression
The majority of people with chronic Hepatitis C will never develop a major complication related to this disease. Because Hepatitis C is a slowly progressing virus, signs of hepatic inflammation don’t typically appear until 10-20 years after initial exposure. However, if undetected, ignored or untreated, Hepatitis C is more likely to develop into cirrhosis or liver cancer.

Once infected with Hepatitis C, the most prominent risk factor for developing cirrhosis and liver cancer is drinking alcohol. Compared to non-drinkers, regular alcohol consumption significantly raises the risk of developing cirrhosis and liver cancer from Hepatitis C. It is now known that alcohol use, even in socially accepted amounts, accelerates the course of liver disease.

Benefits
Confusing the issue of social drinking, published studies are increasingly supporting consumption of alcoholic beverages. The touted health benefits of moderate alcohol consumption, defined as two drinks a day if you’re a male under 65, or one drink a day if you’re a female or a male over 65, include:

· Reduces risk of developing heart disease, peripheral vascular disease and intermittent claudication
· Reduces the risk of dying of a heart attack
· Possibly reduces risk of strokes, particularly ischemic strokes
· Lowers risk of developing gallstones
· Possibly reduces risk of diabetes

No Justification
With such fantastic health benefits, even a person with Hepatitis C can find justification for infrequent or moderate drinking. However, these benefits do not apply to a person with any kind of chronic liver disease, especially Hepatitis C! If you identify with taking an occasional alcoholic drink with Hepatitis C, consider this perspective – being infected with Hepatitis C is like harboring smoldering coals in your liver. A sip of alcohol is like putting a drop of lighter fluid on those coals. While repeated dumping of lighter fluid will fuel an increasingly raging inferno, even a small amount can fan the fire. Drinking just a little bit of alcohol can push a low Hepatitis C viral load into the far upper registers.

The Evidence
Immunology researchers have demonstrated that alcohol promotes the proliferation of the Hepatitis C virus in human liver cells. By studying molecular mechanisms in cell cultures, Philadelphia researchers revealed the role of alcohol in aggravating Hepatitis C infection and interfering with drug treatment. “It was already known that habitual alcohol drinkers have higher blood levels of Hepatitis C virus, compared to infrequent drinkers, even when both are infected with the virus,” said Wen-Zhe Ho, M.D., the director of retroviral research at The Children's Hospital of Philadelphia.

Three discoveries resulted from studying alcohol’s effect on the Hepatitis C virus:

1. Nuclear factor kappa B – Ho’s research team clarified why alcohol consumption parallels high Hepatitis C viral loads. The researchers found that alcohol increases the activity of a protein called nuclear factor kappa B. Increasing the activity of this specific protein causes the Hepatitis C virus to replicate. Additionally, nuclear factor kappa B plays a role in hepatic inflammation.

2. Interferon-alpha therapy – On a molecular level, the researchers found that alcohol interferes with the antiviral activity of interferon-alpha. By making interferon less effective against the virus, alcohol defeats the purpose of attempting viral eradication with medication therapy.

3. Naltrexone – Another finding with potential implications for Hepatitis C treatment was that naltrexone, a drug used to help alcoholics avoid relapse, blocks the deleterious effects of alcohol in promoting Hepatitis C infection. According to Dr. Ho, both alcohol and morphine activate opioid systems present in liver cells. These systems produce natural opiates, which play a crucial role in drug and alcohol addiction. This process may explain why naltrexone, which blocks opiates from binding to their receptors on cell membranes, reduced the effects of alcohol on Hepatitis C viral replication. “These data strongly suggest that activation of the endogenous opioid system is implicated in alcohol-induced Hepatitis C expression,” the authors conclude.

Thanks to the research team at the Children’s Hospital of Philadelphia, there is no longer any confusion as to what amount of alcohol is acceptable for a person with Hepatitis C. Even though moderate alcohol consumption has been associated with some health benefits, any advantages are far overshadowed by alcohol’s acceleration of Hepatitis C viral replication. Unless you are deliberately trying to increase your viral load, no amount of alcohol is okay with Hepatitis C. While the virus is present in your body, avoid alcohol altogether.

References:

Stoller, Eleanor Palo, et al., Alcohol Consumption within the Context of Hepatitis C, Alcohol and Alcoholism, July 2006.

www.alcoholism.about.com, Drinking May Worsen Hepatitis C Infection, University of Philadelphia News Release, About, Inc., 2007.

www.gastro.org, Hepatitis C, American Gastroenterological Association, 2007.

www.hepnet.com, Hepatitis C and Alcohol, Eugene R. Schiff, MD, Schering Canada, Inc., 2007.

www.mayoclinic.com, Alcohol and Your Health: Weighing the Pros and Cons, Mayo Foundation for Medical Education and Research, 2007.

www.nih.gov, Alcohol Increases Hepatitis C Virus in Human Cells, National Institutes of Health, 2007.

www.patients.uptodate.com, Hepatitis C and Alcohol, Sangik Oh, MD, Sanjiv Chopra, MD, UpToDate, Inc., 2007.

www.webmd.com, Bad Mix: Alcohol and Hepatitis C, Jeanie Lerche Davis, WebMD, Inc., 2007.

Posted by Editors at 12:29 PM --- Printer-friendly version

October 16, 2007

10 Helpful Tips: Reducing Dry Mouth for Hepatitis C

Patients with Hepatitis C often experience a chronic dry mouth. Learn ten safe and valuable ways to reduce this uncomfortable symptom.

by Nicole Cutler, L.Ac.

Although sources disagree on how many people are affected, health care professionals recognize that many people with Hepatitis C experience the chronic discomfort of a dry mouth. Known clinically as xerostomia, not having enough saliva to keep the mouth wet can be a serious problem. Luckily, there are some solutions for xerostomia that are safe for those with Hepatitis C.

Xerostomia
Possibly causing problems with tasting, chewing, swallowing and speaking, a chronic dry mouth is often due to inadequate function of the salivary glands. In addition to lubricating the mouth to permit speech, taste and chewing food, saliva also prevents bacteria, viruses and fungi from causing mouth infections. Besides having a mouth that feels like it is stuffed with cotton, xerostomia patients may experience a sore tongue, gums or cheeks, frothy or foamy saliva, bad breath or sensitive teeth.

Gone untreated, a severe case of xerostomia can lead to increased levels of tooth decay and mouth infections. According to Dr. Martin Greenberg, chairman of the department of the School of Dental Medicine at the University of Pennsylvania, “If a patient has a dry mouth, the chance of dental caries (cavities) climbs.”

Drugs and Depression
Whether due to the physical aspects of Hepatitis C, its emotional associations, social impact or the virus’ treatment regimen, many people living with Hepatitis C confront depression. A common side effect of antidepressant medication, xerostomia is often seen in people battling depression. Additionally, depression can have its own influence on personal hygiene. According to Richard Darling, DDS, “One-third of hepatitis patients on medication suffer depression and, thus, impaired perception of self-care. They may take less care of their teeth, and problems will occur.”

While most antidepressants can cause xerostomia, drugs with significant anticholinergic activity are most likely to lead to oral complications. Anticholinergics such as tricyclic antidepressants are frequently implicated in dental problems because they have a prolonged effect on salivary function. Antipsychotic medications and antiparkinsonian drugs are other classes of drugs with anticholinergic properties likely to cause dry mouth. Newer antidepressants such as venlafaxine, reboxetine and the selective serotonin reuptake inhibitors (SSRIs) can also cause dry mouth, but this is likely to be mild and temporary. For those with Hepatitis C on a methadone treatment program, methadone is another substance known to cause xerostomia.

Hepatitis C Specific
For the most part, people with Hepatitis C do not have to worry about dental problems any more than the average person. “A hepatitis patient has the same responsibility to his or her teeth as every other citizen out there,” says Darling. “They simply need to keep their teeth clean and free of plaque.” However, one study published in the Australian Dental Journal in 2000, indicated some evidence showing that people with hepatitis are slightly more prone to tooth decay.

For a person with Hepatitis C who is at the end stage of liver disease, the poor dental health accompanying xerostomia can result in being rejected for a liver transplant. If you are on the transplant list, you already know that you have to be completely free of any dental disease undergoing an operation. “At the Department of Oral Medicine here at the University of Pennsylvania, we have a service where all transplant patients get a full dental evaluation,” says Dr. Greenberg. “We must eliminate any possible oral influences on infection. While dental problems are not as serious with a liver transplant as they might be with a bone marrow transplant, for instance, it is still an important issue.” All transplant centers offer some kind of dental care for their patients, from the smallest sign of infection to having every tooth removed.

10 Tips for Helping Xerostomia
Since saliva acts to protect your teeth from bacteria, there is plenty of reason to avoid a chronic dry mouth. While your doctor and dentist should be aware of your oral health issues, below are ten ways to help restore moisture in your mouth:

1. Regularly sip water and sugarless drinks.
2. During meals, sip water to help with chewing and swallowing.
3. Chew sugarless gum or suck on hard sugarless candy to help stimulate saliva flow.
4. Avoid caffeine, tobacco and alcohol because they all dry the mouth.
5. During the night, use a humidifier.
6. Avoid spicy and salty foods as these can exacerbate a dry mouth.
7. Reduce bacteria and plaque in your mouth by brushing your teeth at least twice a day with fluoride toothpaste and flossing daily.
8. Minimize sugary, sticky foods, and brush immediately after their consumption.
9. Visit your dentist at least twice a year.
10. Discuss a salivary substitute with your healthcare provider.

Even if a liver transplant is not in your near future, the importance of reducing xerostomia goes beyond the motive to minimize bad breath. By recognizing the possible consequences of a chronic dry mouth, you can work towards improving oral health. Taking such an initiative will save you from liver transplant rejection and from the added burden of oral diseases.

References:

Coates EA, et. al., Hepatitis C infection and associated oral health problems, Australian Dental Journal, June 2000.

Henderson L., et al., Oral health of patients with hepatitis C virus infection: a pilot study, Oral Diseases, September 2001.

http://panicdisorder.about.com, What to do About My Dry Mouth, Cathleen Henning Fenton, About, Inc., 2007.

www.australianprescriber.com, Psychotropic Drugs and Dentistry, Michael M Page et al., Australian Prescriber, 2007.

www.hepccouncilsa.asn.au, Hepatitis C and Dental Health, B. Scopacasa BDS FRACDS, E. Coates MDS FADI FICD, R. Logan BDS MDS, Hepatitis C Council of SA, 2007.

www.liverhealthtoday.org, Open Wide, Tamra B. Orr, Liver Health Today, 2007.

www.medterms.com, Definition of Xerostomia, MedicineNet Inc., 2007.

Posted by Editors at 03:03 PM --- Printer-friendly version

October 15, 2007

Hepatitis C Less Severe with Hemophilia

The lack of clotting factor in hemophiliacs' blood reduces their ability to form clots in the liver, therefore reducing their liver's ability to scar. Israeli researchers propose this to be the reason that Hepatitis C infection is less severe in hemophiliacs.

Is Chronic Hepatitis C Virus Infection More Benign in Patients With Hemophilia?

www.hivandhepatitis.com

Hemophiliacs, who have a bleeding disorder that requires the administration of donated clotting factor, have a high rate of infection with blood-borne viruses including HCV, HBV, and HIV. Such infections were much more common before routine implementation of infection-control measures including donor screening and treatment of blood products.

Liver cirrhosis is associated with the development of thromboses (blood clots) of the intrahepatic vasculature. Because hemophiliacs lack clotting factor, this raises the possibility that HCV-related liver disease progression in hemophiliacs may differ from that of non-hemophiliac patients with hepatitis C.

As reported in the August 2007 American Journal of Gastroenterology, Israeli researchers analyzed liver biopsies from 12 hemophiliacs and 20 non-hemophiliac control subjects with chronic hepatitis C matched for age and sex. The mean ages of the hemophiliacs and the controls were 35 and 40 years, respectively. Biopsy samples were compared for inflammatory activity and fibrosis.

Results

• 6 of the 7 hemophiliac patients (86%) but only 8 of 17 control subjects (46%) were infected with HCV genotypes 1a or 1b, with the remainder having 2b, 3a, or 3b.

• Serum aspartate aminotransferase (AST) levels were lower (44 +/- 13 vs 70 +/- 43 U/L) and partial thromboplastin times (PTT) were longer (49.2 +/- 16.9 vs 31.2 +/- 1.2 s.) in the hemophiliac patients compared with the control subjects.

• Biopsy results showed that histological activity scores (1.9 +/- 0.6 vs 3.6 +/- 2.7) and fibrosis scores (0.3 +/- 0.2 vs 1.5 +/- 1.5) were significantly lower in the hemophiliacs compared with the control subjects.

• None of the hemophiliacs had histological evidence of advanced liver disease (bridging fibrosis or cirrhosis), compared with 30% of the control subjects.

Conclusion

Based on these results, the authors concluded, "HCV infections in hemophiliacs may be less severe than in HCV infected patients without hemophilia."

09/25/07

Reference
N Assy, N Pettigrew, SS Lee, and others. Are Chronic Hepatitis C Viral Infections More Benign in Patients With Hemophilia? Am J Gastroenterol 102(8): 1672-1676. August 2007

Posted by Editors at 09:30 AM --- Printer-friendly version

October 12, 2007

Hepatitis C Complication: Breast Cancer

New research shows that people undergoing treatment for breast cancer have a greater mountain to climb when also infected with Hepatitis C. Breast cancer affects both men and women. Note: October is designated as both Breast Cancer Awareness Month and Liver Awareness Month.

by Nicole Cutler, L.Ac.

Considering how many people are diagnosed with chronic Hepatitis C, along with the likelihood of someone developing breast cancer, treatment for these two illnesses must be compatible. Because Texan researchers have discovered that Hepatitis C infection may impair breast cancer treatment and increase the complications of chemotherapy, improved communication between hepatologists and oncologists is crucial.

Gender and Breast Cancer
Although predominantly occurring in women, breast cancer can also affect men. Many do not realize that just like women, men have breast tissue. At puberty, a girl's ovaries make female hormones (estrogen), causing breast ducts to grow, lobules to form at the ends of ducts and the amount of stroma to increase. During a boy’s puberty, male hormones (testosterone) made by the testicles typically prevent further growth of breast tissue. Although men's breast tissue is mostly composed of ducts, these cells can undergo cancerous changes. In addition, each individual produces varying amounts of hormones that can encourage breast cancer development; women produce varying amounts of testosterone and men produce varying amounts of estrogen.

Breast Cancer Prevalence
Excluding cancers of the skin, breast cancer is the most common type of cancer in women in the United States, accounting for one of every three cancers diagnosed. The chance of developing invasive breast cancer at some time in a woman’s life is about one in seven. It is one of the leading causes of cancer mortality among women in the United States.

One in every 100 people with breast cancer is a man. Unfortunately, breast cancer’s gender preference typically leads to dangerously late detection in men.

Aside from the gap between men and women in initial diagnosis, early detection, intervention and postoperative treatment have decreased breast cancer mortality. The use of mammography for screening has largely contributed to early detection, and aggressive treatments have allowed many people to survive breast cancer.

Hepatitis C Prevalence
Most Hepatitis C diagnoses come as a surprise because of how long a person can live without any indication of this illness. A study by the Centers for Disease Control and Prevention suggests that 4.1 million individuals in the United States are infected with Hepatitis C, and most have chronic infections. However, most academics agree that the current Hepatitis C statistics are underestimated due to the number of new diagnoses that occur each day.

University of Texas Research
Assistant Professor at the University of Texas department of breast medical oncology, P. K. Morrow, MD is a medical oncologist specializing in the treatment of breast cancer patients. As the lead researcher in a study presented at the 2007 American Society of Clinical Oncology Breast Cancer Symposium, Morrow warned, “Hepatitis has wide-ranging effects on treatment of breast cancer.” The researchers indicated in their presentation that poor outcomes of breast cancer treatment are endemic to those also infected with Hepatitis C.

In the small retrospective study of breast cancer patients, Texan researchers found chemotherapy dose delays or required dose reductions in those with Hepatitis C:

· Neoadjuvant Chemotherapy – Given prior to a surgical procedure to shrink the cancer, neoadjuvant chemotherapy effectiveness was reduced by 27 percent in the study’s participants with Hepatitis C.

· Adjuvant Chemotherapy – Given to destroy leftover (microscopic) cells that may be present after the known tumor is removed by surgery, adjuvant chemotherapy effectiveness was reduced by 30 percent in the study’s participants with Hepatitis C.

Although the reason for this effect is not fully understood, Morrow postulated two reasons for a poorer outcome in breast cancer treatment in those dually affected by chronic Hepatitis C:

1. Poor drug metabolism – A person with chronic Hepatitis C is likely to have decreased liver function, thereby making it more difficult to metabolize the toxic chemotherapy drugs used in breast cancer treatment.

2. Myelosuppression – A common side effect of chemotherapy, myelosuppression occurs when bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets. The current treatment standard for Hepatitis C, interferon and ribavirin combination therapy is also known to initiate myelosuppression. With a decrease in bone marrow activity, recovery becomes an immense challenge.

In addition, participants with Hepatitis C undergoing chemotherapy for breast cancer had a drastically increased likelihood of treatment complications.

Study Analysis
It makes sense that chemotherapy would be the ultimate challenge for a person with chronic liver disease. Essentially, chemotherapy is the administration of toxic medications to kill cancerous cells. Of course, a person with chronic Hepatitis C must do all they can to protect their liver from any additional toxic burdens. This is likely to explain why a prior study demonstrated that breast cancer treatment for patients with Hepatitis B increased the chance of viral reactivation, early discontinuation of chemotherapy, and treatment delay.

Dr. Morrow urged doctors who treat breast cancer to closely monitor their patients living with Hepatitis C. She even suggests that oncologists do a full hepatitis panel on their patients with elevated liver enzymes. It is important to note that there is hope for those dually diagnosed with breast cancer and Hepatitis C. When extra cautionary measures are taken, these individuals have the potential for regaining their health.

With so many people being diagnosed with breast cancer and Hepatitis C, the primary item needing attention in such cases is the integration between the fields of hepatology and oncology. According to Morrow, “I think what we need to do is to cooperate with hepatologists to see if we can act at the onset and see if we can reduce the type of risks that we're seeing in these patients’ therapy.” Although modern medicine is often fragmented into specialties, this research urges healthcare workers to work together in search of their common goal – patient wellness.

References:

P.K.H. Morrow, et al., Clinical outcomes of breast cancer patients with hepatitis C: A case series, Journal of Clinical Oncology, June 2005.

http://jama.ama-assn.org, Hepatitis C Prevalence, Tracy Hampton, PhD, Journal of the American Medical Association, June 2006.

www.cancer.org, What is Breast Cancer in Men?, American Cancer Society, Inc., 2007.

www.chemocare.com, Chemotherapy Terms, The Cleveland Clinic Foundation, 2007.

www.docguide.com, Breast Cancer Patients With Hepatitis C Require Surveillance to Avoid Poor Outcomes, P/S/L Consulting Group Inc., September 2007.

www.emedicine.com, Breast Cancer, Mammography, Nagwa Dongola, MD, FRCR, WebMD, 2007.

www.mdanderson.org, Who We Are, The University of Texas M. D. Anderson Cancer Center, 2007.

www.medpagetoday.com, ASCO Breast: Hepatitis C Impacts Breast Cancer Treatment, Crystal Phend, MedPage Today, LLC, September 2007.

www.websters-online-dictionary.org, Myelosuppression, Philip M. Parker, INSEAD, 2007.

www.menstuff.org, Breast Cancer in Men, Gordon Clay, 2007.

Posted by Editors at 10:20 AM --- Printer-friendly version

September 19, 2007

HCV's Gene Unraveling Secret Discovered

Revealing new potential for future vaccine possibilities, University of Illinois professors have unlocked one of Hepatitis C's propagation mysteries. By using biochemical dye technology, their research demonstrates how the virus gathers enough energy to dismantle RNA and DNA to create new genetic material.

Hepatitis-promoting protein caught in the act

By Greg Kline
Sunday, September 16, 2007 10:29 AM CDT
www.news-gazette.com

When your body, or a nasty virus invading it, cooks up a batch of genes, helicases – an enzyme, or type of catalyzing protein molecule – appear to be bigger than Betty Crocker in the kitchen.

The tasks performed by the proteins apparently include the unwinding of the tightly coiled ribbonlike DNA and RNA molecules containing the instructions for gene making.

Those chains of nucleic acids – the "N" and "A" in DNA and RNA and the basic building blocks of life – are then read by another type of protein molecule, called a polymerase.

But the genetic cookbook has to be cracked open by helicases first, and scientists have been of two minds on how that happens.

Some structural studies of helicases frozen in place seemed to suggest they work one page – or base pair, the basic unit of DNA and RNA strands – at a time.

Meanwhile, biochemical studies indicated that helicases sometimes work over three base pairs at once.

University of Illinois Professors Sua Myong and Taekjip Ha might have resolved the conflict. Their theory, backed by research using a technique developed by Ha to capture the movement of single molecules, is that it's both.

Helicases have three domains, or legs, as Myong described it recently. Two of those legs step along the acid chains, a base pair at a time during the unwinding process. The third leg remains anchored behind and gets stretched out until enough tension builds that it snaps lose and ahead three pairs. Ha, a UI physics professor, likened its movement to a spring.

"When we saw it, it made a lot of sense," said Myong, a professor at the UI Institute for Genomic Biology and the lead author of a paper on the study in the journal Science.

While interesting biologically, the information also has the potential to play into medical breakthroughs.

The UI researchers and collaborators at Yale University and the Maryland-based Howard Hughes Medical Institute looked at a helicase from the hepatitis C virus, which affects hundreds of millions of people worldwide – and for which there is no vaccine.

The helicase and its unwinding job are necessary for the virus to replicate, which makes the protein a potential target for new hepatitis C treatments.

That is undoubtedly a ways off and presents some challenges. For one thing, it appears that many helicases, including those of benefit in the human body, might function in a similar manner. A treatment would need to hone in on the hepatitis C helicase while leaving others alone, said Ha, a biological physicist who's also an affiliate of the Institute for Genomic Biology and of the Hughes Institute.

Besides their role in hepatitis C propagation, helicases have been implicated in human maladies such as cancers and in premature aging diseases, Ha said.

"If they don't function properly, then you can get into trouble," he said.

In their study of the hepatitis C helicase, the researchers found that the protein is powered by a lot of energy – and plenty of a cellular fuel called adenosine triphosphate, or ATP, to generate it. Ha said that makes a helicase more like an SUV than an economy car in this instance.

But gas guzzling could be a good thing here, Ha and Myong said. The nucleic acid chain road is a rough one, full of bumps and twists and turns and possibly obstacles to be cleared, such as other proteins interacting with the DNA or RNA molecules. The helicases might need an SUV's power and off-road capability, a lot more than most SUV owners do, to get their job done.

To track the tiny protein as it moves, Ha's lab uses a method called fluorescence resonance energy transfer, FRET for short, in which the researchers attach, through a biochemical process, fluorescent dye markers at various locations.

The sample is exposed to laser light, which makes the dye glow, and glow in different colors depending on its proximity to another marker.

Those light signals can be captured and interpreted to understand how a helicase is moving, at a resolution that allows not only pictures but animations to be created from the data.

The study was funded by the National Institute of General Medical Sciences at the National Institutes of Health.

Next, the researchers need to look at other helicases in action, Ha said. Myong has a plan to contrast the hepatitis C helicase with a helicase involved in putting the body's immune system on a battle footing in response to invaders like the hepatitis virus.

Posted by Editors at 11:53 AM --- Printer-friendly version

September 18, 2007

Body Shop Founder's Legacy

Body Shop founder Anita Roddick died last week at the age of 64. She had announced to the media earlier this year that she had Hepatitis C, which the disease apparently had led to a previous diagnosis of liver cirrhosis. Ms. Roddick had made new inroads in social and environmental awareness and responsibility in business, while advocating for green cosmetics, animal rights, Community Trade and establishing organizations such as Children on the Edge as well as promoting the work of the Hepatitis C Trust following her diagnosis.

www.cnn.com

(CNN) -- The founder of The Body Shop, which grew from one shop in southern England to an international chain, has died, the chairman of Body Shop International confirmed Monday.

Anita Roddick, 64, died after suffering a major brain hemorrhage, her family said in a statement to the UK Press Association. Her husband, Gordon, and daughters, Sam and Justine, were all with her at St Richard's Hospital in Chichester, England.

Roddick had revealed in February that she contracted hepatitis C through a blood transfusion while giving birth to a daughter in 1971, according to The Associated Press.

Roddick and her husband stepped down as co-chairmen of the company in 2002, according to the AP. Still, she continued to contribute as a consultant.

The Body Shop chain became a massive success selling "green" cosmetics as customers were becoming environmentally aware.

Adrian Bellamy, chairman of Body Shop International, said in a written statement: "All of us in The Body Shop family are deeply shocked and saddened to hear the news of Anita's passing.

"Anita was not only our founder but she was also the heart and passion of The Body Shop and with her we achieved so much, whether on animal rights, human rights, Community Trade, or through the founding of organizations like Children on the Edge.

"It is no exaggeration to say that she changed the world of business with her campaigns for social and environmental responsibility.

"But for everyone who knew Anita, it was about much more than that: you couldn't help but be inspired by her love of life, her vision of the world and her passion for changing it.

"Anita leaves us with an enduring legacy which will long guide the affairs of The Body Shop. Our heartfelt condolences are with the Roddick family at this sad time."

Roddick had said her business ethics were partly inspired by women's beauty rituals that she discovered while traveling in developing countries, and lessons that her mother passed on from life during the hard years of World War II. Watch CNN Boardroom interview with Roddick. Video

Roddick's business opposed product testing on animals and tried to encourage development by purchasing materials from small communities in the Third World. According to AP reports, the Body Shop also invested in a wind farm in Wales as part of its campaign to support renewable energy, and it set up its own human rights award.

The Body Shop has grown into a global phenomenon with nearly 2,000 stores in 50 countries and remains independently run despite being owned by L'Oreal Group.

In recognition of Roddick's contribution to business and charity, Queen Elizabeth II made her a dame, the female equivalent of a knight, in 2003.

Posted by Editors at 09:17 AM --- Printer-friendly version

September 17, 2007

HCV Genotype 3 and Fatty Liver

Infection with Hepatitis C genotype 3 carries a greater chance of a fatty liver than other genotypes. Although this relationship is likely due to the strain's molecular structure, successful treatment can erase this extra burden.

by Nicole Cutler, L.Ac.

All of Hepatitis C’s genotypes are not created equally. Aside from differences in treatment response, one Hepatitis C strain carries a concern above and beyond damage from the virus itself. According to researchers, Hepatitis C genotype 3 (HCV3) is most likely to be accompanied by steatosis, or fatty liver.

Steatosis
As the most common liver disease in the United States, non-alcoholic fatty liver disease often accompanies Hepatitis C infection. Liver steatosis describes the accumulation of fat in liver cells. For those with Hepatitis C, steatosis is associated with more severe fibrosis progression.

Past studies have shown that various Hepatitis C virus (HCV) genotypes are associated with different forms of steatosis. In patients with genotype 1 and 4, steatosis is primarily due to metabolic factors such as obesity and diabetes. For those with genotype 3, the viral strain itself is suspected to cause fat accumulation in the liver cells.

The prevalence of steatosis is reported by a broad range of people, affecting anywhere from 34 to 81 percent of people with HCV. Variables predisposing someone with HCV to develop steatosis include:

· Alcohol consumption
· Obesity
· Diabetes
· Hyperlipidemia (high cholesterol)
· Viral type

Genotype 3 Dominance
By pooling together various bodies of research collectively examining over 6,400 people with HCV, those infected with HCV3 have a much higher chance of developing steatosis. Some statistics relating hepatitis with steatosis include:

· Overall, approximately 56 percent of those with HCV have steatosis.
· Approximately 17 percent of those with autoimmune hepatitis have steatosis.
· Approximately 27 percent of those with Hepatitis B have steatosis.
· Approximately 48 percent of those with HCV of a genotype other than 3 have steatosis.
· Approximately 74 percent of those with HCV3 have steatosis.

In the March 2004 issue of Gut, French researchers reported on the relationship between steatosis and HCV clearance after antiviral treatment. This study examined the liver biopsies before and after antiviral treatment of 151 participants. According to the authors:

· Steatosis improvement was seen significantly more often in patients who achieved HCV clearance from treatment.

· Among those who were successful in eliminating the virus with treatment, steatosis improvement occurred more often in those with HCV3 than those with other genotypes.

· Among those who were not successful in eliminating the virus with treatment, steatosis improvement did not differ by genotype.

Also published in the March 2004 issue of Gut, an internationally-based group of researchers confirmed that Hepatitis C genotype affects steatosis. By analyzing data from 755 people with chronic HCV, the authors advised that those with HCV3 and diagnosed steatosis should receive antiviral treatment.

As published in the March 2004 issue of the Journal of Hepatology, researchers from Scripps Clinic reported on the impact of steatosis on liver disease progression and treatment response in patients with chronic Hepatitis C. The researchers evaluated liver biopsies from 574 patients, and found the following:

· Steatosis severity was associated with body mass index, HCV3, older age and longer duration of infection.

· Among those with genotype 3, higher HCV viral load was associated with more severe steatosis.

· Steatosis improved markedly in genotype 3 patients who achieved viral clearance from treatment.

From a laboratory perspective, scientists agree about the association between HCV3 and liver steatosis. In an in vitro model published in the January 2007 issue of Gut, Hourioux and colleagues compared lipid levels in sections of cells producing genotype 1a or genotype 3 core proteins. They found that the cumulative lipid droplet area was significantly greater in cells producing genotype 3 core proteins; lending this strain more amenable to fat accumulation. Another study comparing HCV proteins found that the genotype 3a core protein induced significantly greater enzyme activity that is required for the development of hepatic steatosis.

To further understand this pathological difference between HCV genotypes, scientists have been closely examining each genotype’s molecular structure variances. One possible explanation may involve HCV3’s obstruction of the liver’s release of very low density lipoprotein (VLDL) particles to the bloodstream. This theory rests on the foundation that dietary fat becomes trapped in the liver of those with HCV3.

When cumulatively examined, the evidence supports the premise that Hepatitis C genotype 3 exerts a specific effect on the genesis of hepatic steatosis independent of metabolic risk factors such as obesity. Although linking steatosis to genotype 3, the evidence also shows that those with this strain who are successful with antiviral treatment have a greater chance of liver recovery. It is clearer now than ever that the divergence between HCV genotypes exert more disparities than previously thought, and is likely due to the virus’ molecular structure.

References:

C Hourioux, et al., The genotype 3-specific hepatitis C virus core protein residue phenylalanine 164 increases steatosis in an in vitro cellular model, Gut, January 2007.

Hissar SS, et al., Hepatitis C virus genotype 3 predominates in North and Central India and is associated with significant histopathologic liver disease, Journal of Medical Virology, April 2006.

http://clinicaloptions.com, Insulin Resistance and Hepatic Steatosis in Patients With Chronic Hepatitis C, Stephen A. Harrison, MD, LTC, MC, Clinical Care Options LLC, 2007.

J. Westin, et al., Impact of Hepatic Steatosis on Viral Kinetics and Treatment Outcome During Antiviral Treatment of Chronic HCV Infection, Journal of Viral Hepatology, March 2007.

Sharma, Pratina, et al., Hepatic Steatosis in Hepatitis C Virus Genotype 3 Infection: Does It Correlate with Body Mass Index, Fibrosis, and HCV Risk Factors?, Digestive Diseases and Sciences, October 2004.

www.hcvadvocate.org, Liver Steatosis, Liz Highleyman, Hepatitis Journal Review, March 2004.

www.hivandhepatitis.com, Liver Steatosis in Genotype 4 Patients Is Mainly Due to Metabolic Factors, Liz Highleyman, hivandhepatitis.com, 2007.

www.medscape.com, Hepatitis C and Steatosis: A Reappraisal, A. Lonardo, et al, Journal of Viral Hepatology, March 2006.

Posted by Editors at 10:40 AM --- Printer-friendly version

September 14, 2007

The First Liver Transplant to Erase Hepatitis C

Although re-infection with Hepatitis C usually recurs rapidly following a liver transplant, a Japanese woman has beaten the odds. This 60-year-old with Hepatitis C, cirrhosis, liver cancer and diabetes, is the first reported case where a liver transplant led to a complete recovery from Hepatitis C.

Hepatitis C gone after liver transplant

Posted : Fri, 31 Aug 2007 12:51:49 GMT

Author : Health News Editor
www.earthtimes.org

NAGASAKI, Japan, Aug. 31 A Japanese woman is the first reported case in which a complete recovery from hepatitis C-RNA was achieved after liver transplantation.

The 60-year-old woman with liver cirrhosis and liver cancer caused by hepatitis C had been diagnosed diabetic since 1995; and previous chemotherapies to remove cancer didn't bring any satisfactory result.

Dr. Tatsuki Ichikawa of the Nagasaki University Hospital, in Japan, was hesitant to give the woman a donated piece of the liver offered by her daughter fearing the new liver would get reinfected and progress rapidly to liver cancer. Previous data indicated that complete clearance of hepatitis C is necessary for a good outcome of a liver transplant.

To save the life of the patient, Ichikawa used a more powerful drug -- PEGylated IFN -- before liver transplantation and five weeks after the PEG-IFN treatment, the hepatitis antigen was no longer detectable from the patient but hepatitis-RNA persisted, even after 18 weeks of treatment, so liver transplantation was performed.

Unexpectedly, clearance of hepatitis C-RNA was achieved just one month after the successful liver transplantation and HCV was never detected in this patient thereafter, reported the case study published in the World Journal of Gastroenterology.

Posted by Editors at 09:52 AM --- Printer-friendly version

September 05, 2007

Factors Influencing Self-Recovery from Hepatitis C

As reported in the August 21, 2007 edition of the World Journal of Gastroenterology, researchers investigated why some people are able to spontaneously recover from the Hepatitis C virus. This study found the following factors responsible for a person's ability, or inability, to self-recover from the virus - quantity of Hepatitis C antibody, co-infection with Hepatitis B, and the active use of IV drugs.

Source: World Journal of Gastroenterology
Date: August 29, 2007

www.sciencedaily.com

Who Will Recover Spontaneously From Hepatitis C Virus Infection?

Science Daily — More than 3% of world population is infected with hepatitis C virus (HCV). The outcome of HCV infections is either self recovery or chronic hepatitis, and many of the chronic infections will develop into liver cirrhosis or liver cancer. Since there is no cure for chronic hepatitis C, nor is there any approved vaccine for this virus, hepatitis C is currently a major health problem worldwide.

Twenty to fifty percent of HCV infected patients recovers spontaneously. The hepatitis C patients and their relatives like to know if his/her infection would fall into the category for self recovery.

A research article to be published on August 21 in the World Journal of Gastroenterology addresses this question.

The research team led by Dr. Mihm from Georg-August-Universität spent more than 8 years working with a cohort of 67 patients who spontaneously recovered from HCV infection. In addition to these, the researchers included a similar number of patients with chronic HCV infection. Large sample size allowed these investigators to obtain results with great statistical significance, and to draw very reliable conclusions.

One conclusion reported by the investigators is, patients who self recovered usually have lower levels of HCV antibody. Thus patients with lower HCV antibody titer may have a brighter clinical outcome. However, for a practical standard to be established to define a low HCV antibody titer, more effort is needed by investigators in the future.

Another interesting conclusion reached by these investigators is, co-infection by hepatitis B virus (HBV) is associated with a higher possibility of self recovery. The investigators suggested that the infection of HBV interferes with the HCV replication, which would finally lead to virus eradiacation.. HCV patients co-infected by hepatitis A virus also have a better chance of self recovery, possibly by a similar mechanism.

Active iv drug users are less likely to self recover, for a couple of reasons: 1, they have a higher incidence of re-infection; 2, drugs have been shown to inhibit the expression of antiviral cytokines such as IFN-a and IFN-g; 3, HCV replication has been shown to be enhanced both by morphine use and morphine withdrawal.

Several different genotypes of HCV were discovered. The HCV genotype studied by Dr. Milm¡¯s group is type 1b, which is the prevalent genotype in Germany, and in China.

Note: This story has been adapted from a news release issued by World Journal of Gastroenterology.

Posted by Editors at 10:20 AM --- Printer-friendly version

August 15, 2007

Tattoo, Piercing Shop Creates HIV and Hepatitis Risk

Learn why the Durham Region Health Department is concerned that nearly 2,000 people may have been exposed to diseases such as Hepatitis B, Hepatitis C and HIV over an eight-month time span at a tattoo and body-piercing shop in Oshawa, Ontario (Canada).

Tattoo, piercing shop put up to 2,000 at risk
Warned to undergo tests for HIV, hepatitis

CanWest News Service
Published: Saturday, August 11
www.canada.com

The Durham Region Health Department is looking for 1,500 to 2,000 people who were customers at an Oshawa tattoo and body-piercing shop because of concerns about communicable diseases.

The department recently closed Longhorn Custom Body-art after inspectors determined during a routine visit that a sterilizer was malfunctioning and that contaminated equipment may have been used between Nov. 17, 2006, and Aug. 1, 2007.

While describing the risk as low, the department is still concerned that such diseases as hepatitis B, hepatitis C and HIV could have been spread to customers. It is urging them to visit a doctor for blood tests.

Ross MacEachern, manager of environmental health for Durham Region, said, "At this time, we have no evidence of transmission of infectious diseases, but because of the potential use of non-sterile equipment, there is a risk."

The operators of the business kept records on every customer and are co-operating with health officials in trying to track them down.

It has yet to be determined whether charges will be laid against the business.

© The Gazette (Montreal) 2007

Posted by Editors at 12:18 PM --- Printer-friendly version

Drinking Coffee May Reduce Risk of Liver Cancer

Discover the results of a recent study in Italy that examined the relationship between coffee consumption and the risk of liver cancer, as well as the favorable effects of some of coffee's components.

Coffee and liver cancer

Medical Studies/Trials
Published: Sunday, 5-Aug-2007
www.news-medical.net

After lung and stomach cancer, liver cancer is the third largest cause of cancer deaths in the world.

A new study on the relationship between coffee drinking and the risk of hepatocellular carcinoma (HCC) confirmed that there is an inverse association between coffee consumption and HCC, although the reasons for this relationship are still unresolved.

The results of this study appear in the August 2007 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). Published by John Wiley & Sons, Inc., Hepatology is available online via Wiley InterScience at http://www.interscience.wiley.com/journal/hepatology.

At least eleven studies conducted in southern Europe and Japan have examined the relationship between coffee drinking and the risk of primary liver cancer. The current study, led by Francesca Bravi of the Istituto di Ricerche Farmacologiche Mario Negri in Milan, Italy, was a meta-analysis of published studies on HCC that included how much coffee patients had consumed. Researchers combined all published data to obtain an overall quantitative estimate of the association between coffee consumption and HCC.

The results showed a 41 percent reduction of HCC risk among coffee drinkers compared to those who never drank coffee. "Moreover, the apparent favorable effect of coffee drinking was found both in studies from southern Europe, where coffee is widely consumed, and from Japan, where coffee consumption is less frequent, and in subjects with chronic liver diseases," the researchers state.

They point out that animal and laboratory studies have indicated that certain compounds found in coffee may act as blocking agents by reacting with enzymes involved in carcinogenic detoxification. Other components, including caffeine, have been shown to have favorable effects on liver enzymes. Coffee has also been related to a reduced risk of liver diseases and cirrhosis, which can lead to liver cancer.

"Despite the consistency of these results, it is difficult to derive a causal inference on the basis of the observational studies alone," the authors note. It may be that patients with digestive tract diseases, including liver disorders, naturally reduce their coffee consumption, even though avoidance of coffee is not routinely recommended. Also, they note that the assessment of coffee intake was based on patients self-reporting, although recall of coffee drinking has been shown to be accurate. The fact that the inverse relationship between coffee drinking and HCC was shown in both southern Europe and Japan suggests a lack of bias in these studies. Allowance for other confounding factors, such as hepatitis B and C, cirrhosis, social class indicators, alcohol use and smoking, also suggests that such factors did not influence the results.

"In conclusion, the results from this meta-analysis provide quantitative evidence of an inverse relation between coffee drinking and liver cancer," the authors state. "The interpretation of this association remains, however, unclear and the consequent inference on causality and worldwide public health implications is still open for discussion."

http://www.interscience.wiley.com/journal/hepatology

Posted by Editors at 11:35 AM --- Printer-friendly version

August 14, 2007

Hepatitis Transmission and Swimming Pools

Learn why a certain hepatitis virus can pose trouble in communal waters, as well as ways to prevent and minimize this swimming pool risk.

by Nicole Cutler, L.Ac.

For millions of overheated Americans, the perfect summer activity involves a swimming pool. According to U.S. census data, swimming ranks as the second most popular exercise activity in the country. In the age of seemingly mysterious illnesses infecting every age, sex, race and income bracket, sharing the same body-enveloping fluid as strangers can initiate fear of communal waters. Whether in the backyard, local recreation center, fitness club, neighborhood pool or vacation hotel, swimming is a healthy pursuit deserving of an equally healthy, water-filled basin.

As one of the most prevalent infectious disease categories today, a growing number of people are concerned about exposing themselves to a hepatitis virus by swimming in a pool. However, there is only one hepatitis-related danger to swimming in a pool, and infection is preventable.

Hepatitis Risk
Although approximately 10 percent of people infected with a hepatitis virus are unsure of how they contracted it, scientists do know which bodily fluids can transmit the different strains of hepatitis illnesses. While there are three prevalent hepatitis viruses, only one has the potential to contaminate a maintained pool.

· Hepatitis A – Since this virus is primarily transmitted via fecal matter, this is the hepatitis strain that could become a problem in a swimming pool.

· Hepatitis B – Transmitting this strain of hepatitis is not a concern for swimmers because it involves blood-to-blood contact.

· Hepatitis C – Transmitting this strain of hepatitis is not a concern for swimmers because it involves blood-to-blood contact.

Hepatitis A
A self-limiting viral infection of the liver, hepatitis A typically does not cause chronic disease. While hepatitis A causes liver inflammation, most people’s livers can fully recover without any long-term damage. However, people already afflicted with chronic liver disease are more susceptible to serious illness as a result of hepatitis A infection. Since this disease is caused by a virus, it does not respond to antibiotics.

The most common symptoms of hepatitis A include:

· Nausea, vomiting, diarrhea
· Low-grade fever and loss of appetite
· Rash
· Fatigue
· Jaundice and dark urine
· Liver pain

Transmitted primarily by the fecal-oral route, hepatitis A infection can occur by swallowing pool water containing feces. Additionally, hepatitis A is a potential problem when large numbers of people congregate and where overcrowding and inadequate sanitation exist. Because hepatitis A is easily spread by raw sewage, it can become a danger in the recreational swimming environment when:

· a person accidentally has a bowel movement in the pool
· sewage systems become overburdened from heavy rainfall or flooding and infects swimming waters.

Once someone has hepatitis A, lifelong immunity is established preventing re-infection with this disease. For those who have never contracted this virus, the hepatitis A vaccination provides immunity.

Prevention
In addition to getting vaccinated for hepatitis A, there are ways to minimize swimming pool risks. Proper chlorination to kill waterborne germs, good sanitation practices and suitable personal hygiene in and around the swimming area can make the difference between a healthy and unhealthy swimming experience. According to CDC epidemiologist Dr. Michael Beach, "It's crucial that public health professionals, pool operators and the general swimming public work in partnership to increase everyone's chances for healthy swimming experiences."

· Disinfecting – Water filtration is not an effective means of removing contamination from a pool in a timely manner. The ability to kill pathogens in the water is based on the contact time a pathogen has with a disinfectant and the concentration of the disinfectant. While a majority of systems rely on chlorine, there are a few disinfectant alternatives. Considered to be moderately chlorine-resistant, experts approximate it takes chlorine at least 16 minutes to kill hepatitis A in pools that do not use stabilizers such as cyanuric acid. Additionally, all pools should maintain a stringent policy for water disinfection in case any fecal matter is detected.

· Evaluate the Pool – Before diving in, first evaluate the pool’s hygiene. The water should appear clean and clear, with painted stripes on the bottom clearly visible. The pool walls should feel smooth, not sticky or slippery. Listen for pump and filtration system noise to confirm the pool equipment is working. Lastly, smell the pool. Contrary to popular belief, a well-chlorinated pool has little odor. A heavy chemical odor is typically due to chloramines, not chlorine. The well-known strong chlorine odor means that unhealthy chloramines have formed in the water, created from the mix of chlorine and contaminants. Chloramines are not as effective in disinfecting swimming pool water.

· Don’t Swallow – Since hepatitis A is spread through the fecal-oral route, infection typically involves swallowing contaminated pool water. Teach children and train yourself not to swallow pool water – and even avoid getting it in your mouth.

As swimming continues its popularity as a preferred summer activity, people can take control of their health by being a hepatitis A prevention advocate. Make sure your swim spot is well maintained. Inform pool personnel about any concerns you have. Especially important for people already living with some other form of liver disease, refrain from getting pool water in your mouth. In addition, make sure you are protected with the hepatitis A vaccine in case you are exposed. By being educated about the potential for hepatitis A infection in a swimming pool, you can avoid being affected by this liver illness.

References:

www.cdc.gov, Chlorine Disinfection Time Table, Centers for Disease Control and Prevention, 2007.

www.cdc.gov, Pool User Information, Centers for Disease Control and Prevention, 2007.

www.ehagroup.com, Diseases Acquired via Recreational Bathing (Public Swimming Pools), EHA Consulting Group, Inc., 2007.

www.havuz.org, Waterborne Pool Illnesses, Larry Katz, 2007.

www.healthstate.mn.us, Public Swimming Pools, Minnesota Department of Public Health, 2007.

www.healthypools.org, What You Think You Know and What You Should Know About Healthy Pools, U.S. Centers for Disease Control and Prevention, the National Consumers League, the Water Quality and Health Council, the Chlorine Chemistry Council and the National Spa & Pool Institute, 2007.

www.medicalnewstoday.com, Make a splash for public health this summer - Swimming pool health, MediLexicon International Ltd., 2007.

www.pponline.co.uk, A quick look at the medical hazards of swimming in pools, P2P Publishing Ltd., 2007.

Posted by Editors at 02:51 PM --- Printer-friendly version

August 06, 2007

The Skinny on Fatty Liver Disease

Visceral fat, or "internal flab" associated with fatty liver disease, is manifesting into a big liver problem. Learn about fatty liver disease, lifestyle factors that may increase the likelihood of developing this liver condition, as well as why being thin does not guarantee having a healthy liver.

A "Growing" Liver Problem: Thin Outside, Fat Inside

www.prweb.com/releases

"Internal flab" associated with fatty liver disease is becoming a bigger liver problem than cirrhosis in the United States and Canada, and most people have no idea that they're at risk.

San Antonio, TX (PRWEB) July 30, 2007 -- Thin is in, but being thin on the outside doesn't necessarily mean you're thin on the inside, especially where your liver is concerned.

That's the conclusion of a team on researchers including Professor Jimmy Bell of the Imperial College, London.

A recent 14-year study revealed that even people who would be described as "thin" could have invisible "internal flab" that might pose a danger to their health, and could be an especially dangerous liver problem.

Fatty liver disease is a liver condition that occurs when there's a buildup of fat cells in the liver. The buildup can grow unnoticeably but could eventually lead to a range of liver problems, including enlarged liver, cirrhosis and liver cancer. Symptoms are rare in the early stages, so most people don't even know the problem is developing.

Fatty liver disease usually occurs in people with a poor diet and a sedentary lifestyle. Excessive alcohol use can also be a factor.

Professor Bell recently told the Daily Telegraph that many people who look normal and healthy on the outside may actually be obese on the inside, especially where the liver is concerned.

Bell's research used MRI scans to map the "internal flab" or visceral fat people carry inside the body, especially in the liver. Such visceral fat can be much more of a problem than fat that is more obvious on the outside.

Bell noted that "thin" women can actually carry more than twice the amount of visceral fat of someone who is considered to be "heavy" or "obese."

"If you maintain your weight through diet alone, you'll probably have higher levels of visceral fat," Bell adds. "You need to burn visceral fat away with activity." In other words, exercise is necessary.

Canadian health authorities recently said obesity and fatty liver disease have overtaken cirrhosis as the number one liver problem in Canada. According to Gary Fagan, president of the new Canadian Liver Foundation, fatty liver disease is now the fastest growing and most common liver ailment in Canada.

Posted by Editors at 01:51 PM --- Printer-friendly version

Development Suspended for Hepatitis C Drug

After two, 13-week long toxicology studies, Anadys Pharmaceuticals, Inc. and Novartis have decided to halt the development for ANA975, a phase 1b compound for the treatment of infections due to the Hepatitis C virus.

Development Discontinued for ANA975, an Early Stage Compound for Treatment of Hepatitis C Virus Infection

http://ir.anadyspharma.com

SAN DIEGO, July 26, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) today announced that it and Novartis have decided to discontinue the development of ANA975, a phase 1b compound for the treatment of hepatitis C virus (HCV) infection. The parties have determined that the results received to date from the ongoing 13 week toxicology study together with the results observed in the previous 13 week toxicology study do not support further clinical evaluation of chronic daily dosing of ANA975 in hepatitis C patients.

"Although we are disappointed to discontinue development of ANA975, our animal toxicology results have convinced us that chronic daily dosing of this compound is inappropriate for further clinical development," said Lawrence C. Fritz, Ph.D., president and chief executive officer of Anadys. "However, we remain optimistic that TLR7 agonists offer therapeutic potential as effective immunomodulators in multiple disease areas, albeit using alternative dosing schedules, and our plans to develop ANA773 for cancer treatment continue unabated," Dr. Fritz said.

Anadys continues its development of ANA773, another TLR7 agonist prodrug distinct from ANA975, and expects to file an IND by the end of 2007. Anadys plans to evaluate ANA773 in Phase 1 clinical trials for the treatment of advanced cancer. This program is independent of the Novartis collaboration and is not affected by the decision to discontinue development of ANA975.

First and Second Toxicology Study Results

In June 2006, Anadys and Novartis suspended dosing in their 28-day phase 1b clinical trial of ANA975 in HCV infected patients due to then recently obtained information from pre-clinical 13-week toxicology studies. No clinical observations contributed to this decision. Preliminary analysis of the toxicology information revealed various new observations which appeared consistent with intense immune stimulation in animals. Subsequently, the FDA put the ANA975 IND on full clinical hold. In November 2006, Anadys and Novartis initiated a second 13-week toxicology study to understand better the observations from the first toxicology study and to assist in determining a future course of action for the program.

Analysis of available data from the second 13-week toxicology study, together with the results from the initial 13-week toxicology study led the parties to determine that: 1) chronic daily dosing of ANA975 was unlikely to provide an adequate therapeutic index; and 2) additional preclinical evaluation would be necessary to determine if alternate dosing schedules of ANA975 would support a safety margin sufficient for further development of this compound for the treatment of patients chronically infected with hepatitis C.

About TLR-7

Toll-like receptor 7 (TLR7) is a pattern-recognition receptor that activates the innate immune response. Stimulation of TLR7 induces the release of interferon-alpha and other type I interferons from immune cells, the release of various pro-inflammatory cytokines, the upregulation of co-stimulatory molecules and the development of an adaptive immune response. Small-molecule TLR7 agonists have been shown to have broad antiviral and anticancer effects in preclinical models and in some clinical settings.

Webcast of Conference Call

Anadys will host a conference call tomorrow at 8:30 a.m. Eastern Daylight Time to discuss the discontinuation of ANA975 development in HCV. A live webcast of the call is available online at http://www.anadyspharma.com. A telephone replay will also be available approximately one hour after completion of the call. To access the telephone replay, dial 888-286-8010 (domestic) or 617-801-6888 (international), passcode 38857175. The webcast and telephone replay will be available through August 10, 2007.

About Anadys

Anadys Pharmaceuticals, Inc., http://www.anadyspharma.com, is a biopharmaceutical company committed to advancing patient care by discovering, developing and commercializing novel small molecule medicines for the treatment of viral diseases and cancer. The Company's programs focus on Toll-Like Receptor-based small molecule product candidates and direct antiviral compounds that inhibit key steps in viral proliferation. The Company has core expertise in medicinal chemistry coupled with cell biology and structure-based drug design, and is developing compounds for the treatment of hepatitis C infection, hepatitis B infection and cancer.

Safe Harbor Language

Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to the belief that TLR7 agonists offer therapeutic potential as effective immunomodulators in multiple disease areas, the believed effect of using alternate dosing schedules, as well as the timing and plans for filing an IND for ANA773 and pursuing development activities with ANA773 in advanced cancer. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys' actual results to be materially different from historical results or from any results expressed or implied by such forward- looking statements. In particular, the results of in vitro studies and initial in vivo studies may not be predictive of future results, and Anadys cannot provide any assurances that any of its product candidates will not have unforeseen safety issues, will have favorable results in future clinical trials or will receive regulatory approval. In addition, Anadys' results may be affected by other factors. In particular, there is no guarantee regarding Anadys' future involvement with, or value recognition from, the ANA380 program. Anadys' results may be further affected by risks related to its collaborative relationships with Novartis and LG Life Sciences, competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to successfully develop and market products, the level of effort that its collaborative partners devote to development and commercialization of its product candidates, difficulties or delays in its pre-clinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments involving future products and its ability to obtain additional funding to support its operations. Risk factors that may cause actual results to differ are more fully discussed in Anadys' SEC filings, including Anadys' Form 10-K for the year ended December 31, 2006 and the "Risk Factors" section of Anadys' Form 10-Q for the quarter ended March 31, 2007. All forward-looking statements are qualified in their entirety by this cautionary statement. Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

SOURCE Anadys Pharmaceuticals, Inc.

James Glover, Chief Financial Officer of Anadys Pharmaceuticals, Inc., +1-858-530-3763

Posted by Editors at 12:16 PM --- Printer-friendly version

August 02, 2007

Popular Restaurant Causes Hepatitis Scare

A well-known restaurant in Arizona created a hepatitis alarm in late July. Immune globulin (IG) injections were offered to all patrons of the restaurant who might have been exposed.

Cheesecake Factory in Arizona May have Exposed Diners to Hepatitis A

Jul. 30, 2007
www.newsinferno.com

Patrons of a Biltmore, Arizona Cheesecake Factory Restaurant may have been exposed to Hepatitis A, a potentially dangerous food borne infection. Last week, the Maricopa County Health Department announced that a worker at the restaurant had tested positive for the disease, and there is a chance that Hepatitis A could have been transmitted to some customers who ate at the Cheesecake Factory on July 20. So far, no other cases of Hepatitis A have been reported, and health officials in Arizona believe that the chance of transmission is low.

Hepatitis A is a contagious liver infection. The virus is found in the stool of infected people, and can be spread if they do not wash their hands thoroughly after using the bathroom. Symptoms of Hepatitis A include low-grade fever, nausea, vomiting, diarrhea, rash, yellowing of the skin, dark brown urine, loss of appetite and fatigue. Symptoms of Hepatitis A can last from two to nine months. Most people who contract Hepatitis A make a full recovery, however, in some rare instances the disease can progress to the point of causing liver failure or even death.

Once someone has been infected with Hepatitis A, there is no real treatment. Usually, bed rest is prescribed, and efforts are made to make the patient’s symptoms more tolerable until the disease runs its course. In some instances, a patient will be hospitalized to treat dehydration or liver problems. Sometimes patients with a severe case of Hepatitis A will require a liver transplant.

Immune globulin (IG), a preparation of antibodies can prevent Hepatitis A if it is administered within two weeks of exposure. The Maricopa County Health Department is offering IG injections to anyone who ate at the Biltmore Cheesecake Factory on July 20. The vaccinations will be available at the Maricopa County Public Health Clinic on July 30 and 31. Anyone with questions can call the Health Clinic at 602-747-7500.

Outbreaks of Hepatitis A have been linked to popular restaurants in the past. The largest Hepatitis A outbreak in US history occurred in Pennsylvania in 2005. More than 500 people contracted Hepatitis A, and three died after eating at a Chi-Chi’s Mexican Restaurant. That outbreak was linked to tainted green onions. Generally restaurant-related outbreaks of Hepatitis A infect between 25 and 200 people.

Posted by Editors at 04:17 PM --- Printer-friendly version

July 30, 2007

Can Hepatitis C Be Transmitted Through Sexual Contact?

Learn how likely it is to sexually transmit the Hepatitis C virus, as well as what are considered to be high risk sexual transmission factors.

by Nicole Cutler, L.Ac.

Responsible, sexually active people are educating themselves on safe sex, and this education includes learning about Hepatitis C’s potential for transmission during sexual contact. Creating confusion and instilling mystery, conflicting reports about whether this virus is contracted sexually continues to circulate throughout our society. Although not exclusively considered a sexually transmitted disease, the Hepatitis C virus (HCV) has the potential to be spread through sexual contact.

According to the Centers for Disease Control, HCV is the most common blood borne infection in the United States. Since newly infected individuals rarely demonstrate specific symptoms, Hepatitis C infection is typically detected by routine blood tests. As such, more and more people are surprised to learn that they have been living with this infection, likely for a long time. Presently, an estimated 4 million Americans have Hepatitis C, with new diagnoses occurring every day.

As the number of people realizing they have HCV continues to rise, so does the concern of how they were originally infected with this disease. Since medical experts agree that Hepatitis C is only transmitted through the blood, a majority of cases are contracted through IV drug use or tainted blood transfusions. However, an estimated 10 percent of those infected cannot determine how they contracted Hepatitis C in the first place.

With such a significant percentage of people infected with HCV unsure of how their disease was acquired, just about every possibility becomes suspect. Some physicians reassure their patients that sexual transmission of Hepatitis C is rare, and that their infection likely has other origins. Other doctors flat out assume that sexual activity is the culprit of a person’s Hepatitis C infection.

Truthfully, the evidence indicating HCV is spread through sexual activity is inconclusive. However, researchers have uncovered those at higher risk of transmitting Hepatitis C through sex.

Monogamous Heterosexuals
A majority of published studies about monogamous heterosexuals have concluded an extremely low incidence of sexually transmitting Hepatitis C. While someone in a long-term, monogamous relationship with a partner infected with HCV is at risk, the risk of sexual transmission ranges from 0 to 0.6 percent per year. This risk of transmission is slightly higher — about 1 percent per year — if involved in a short-term sexual relationship with someone who has Hepatitis C. This risk increases if your partner is also infected with HIV.

1. According to the HCV Partner Study completed by the Centers for Disease Control in 2004, the risk of sexual transmission in the United States is 2.2 percent in monogamous heterosexual relationships where one partner has Hepatitis C.

2. As reported in the May 2004 American Journal of Gastroenterology, Carmen Vandelli and colleagues concluded that, “the risk of sexual transmission of Hepatitis C within heterosexual monogamous couples is extremely low or even null.”

3. V. Tahan and colleagues reported in the April 2005 American Journal of Gastroenterology that none of 216 HCV negative individuals with opposite-sex HCV positive spouses seroconverted during an average follow-up period of about three years.

HIV Co-Infection
While the reasons remain unknown, it appears that people already infected with HIV, the virus that causes AIDS, have a higher percentage of sexually transmitting HCV.

1. Roel Coutinho and Thijs van de Laar reported on a retrospective study of sexual transmission of HCV among 1,836 HIV positive and HIV negative gay men in the Amsterdam Cohort Study. The authors concluded, “HIV infection and/or mucosal trauma caused by extreme sexual techniques and concurrent STD might facilitate sexual transmission of HCV.”

2. As reported in the November 4, 2005 issue of AIDS, Aureliea Briat and colleagues from Paris analyzed HCV RNA levels in the semen of 82 HIV/HCV co-infected and 38 HCV mono-infected men. They detected HCV genetic material more often in the seminal fluid of co-infected men than men with HCV alone (38 percent vs. 18 percent).

3. As published in the November 1, 2005 Journal of Infectious Diseases, M.J. Nowicki and colleagues measured HCV RNA levels in the cervicovaginal lavage fluid from 58 HIV/HCV co-infected and 13 HCV mono-infected women. HCV RNA was detected in the genital fluid of 29 percent of the co-infected women, but none of the HCV mono-infected women.

Higher Risk
With all of the research on the sexual transmission of HCV, various factors have been repeatedly recognized as constituting a higher risk. Rates of transmission are higher:

· When a person has an acute HCV infection

· When the infected individual has a high viral load

· Individuals who have frequent sexual encounters and/or multiple sexual partners

· When mucosa is damaged from potentially vigorous sexual techniques such as anal intercourse, fisting and use of certain sex toys.

While the risk of transmitting HCV through sexual contact is low, it remains a possibility. Factors increasing this risk include concurrent HIV infection, sexual techniques that damage mucosa, acute HCV infection, high HCV viral load and those with multiple sexual partners. Even though studies have yielded conflicting data, there is enough evidence to conclude that sexual transmission of HCV does occur. Until medical researchers provide us with more concrete guidelines, practicing safe sex is the only reliable method of preventing sexual transmission of HCV.

References:

Buffington, J, et al, Low Prevalence of Hepatitis C Antibody in men who have sex with men who do not inject drugs, Public Health Reports, 2007.

www.cdc.gov, Hepatitis C: FAQ, US Department of Health and Human Services, 2007.

www.hcvadvocate.org, HCV Sexual Transmission Revisited: A Look at the Latest Research, Liz Highleyman, HCV Advocate Newsletter, April 2006.

www.hcvadvocate.org, Prevention of Spread of HCV, Miriam J. Alter, PhD, Hepatitis C Support Project, 2007.

www.hcvadvocate.org, Sexual Activity as a Risk Factor for Hepatitis C Infection, Norah A. Terrault, MD, MPH, Hepatitis C Support Project, 2007.

www.mayoclinic.com, Hepatitis C: How Common is Sexual Transmission?, Mayo Foundation for Medical Education and Research, 2007.

www.mysanantonio.com, Cay Crow: Although rare, hepatitis C can be transmitted through sex, KENS 5 and the San Antonio Express-News, July 2007.

Posted by Editors at 03:51 PM --- Printer-friendly version

July 27, 2007

Rare Liver Transplant with Child is Successful

Last month, doctors at Children's Hospital of Pittsburgh performed a domino transplant, a rare liver transplant operation, on a 9 year-old boy. Learn more about this successful operation, as well as what a domino transplant is and why it's so rare.

Pittsburgh hospital performs rare liver transplant

www.phillyburbs.com

The Associated Press

PITTSBURGH - A 9-year-old boy suffering from a rare liver disease received a donor liver and then had his old liver transplanted into a 24-year-old man in a rare operation known as a domino transplant.

Doctors at Children's hospital of Pittsburgh said the surgery performed late last month was a success and marked the first time the hospital has performed a domino transplant with a child.

The procedure gets its name because the transplants are done sequentially, with the first recipient getting an organ from a deceased donor and then his organ being transplanted into a second recipient.

Johnathan Devantier, 9, of St. Louis, was diagnosed as a newborn with maple syrup urine disease, in which the body can't process certain amino acids. He received a donor liver and his old liver was transplanted into Ali Al-Garni, of Saudi Arabia, who suffers from a genetic disease that can cause liver failure.

Devantier's maple syrup urine disease was not passed to the other recipient in the surgery, said Dr. George V. Mazariegos, director of pediatric transplantation at the hospital's Hillman Center for Pediatric Transplantation. The disease does not originate in the liver, but instead is caused by a lack of enzymes in the body, making a domino transplant possible, he said.

"Domino transplants are rare because there are very few conditions for which you can cure one patient with a transplant and then transplant his or her organ into someone else without passing on the disease," Mazariegos said. "MSUD is one such disease."

The procedure was the third domino transplant ever involving a patient with maple syrup urine disease, according to the United Network for Organ Sharing. More than 65 domino liver transplants have been performed in the U.S.

Posted by Editors at 04:58 PM --- Printer-friendly version

July 25, 2007

Bishop of Athens to Undergo Liver Transplant

Millions of people worldwide are affected with hepatitis infections and, as people who are familiar with hepatitis know, the disease can affect anyone. After recovering from his intestinal cancer operation, it has been recommended to Orthodox Archbishop Christodoulos of Athens that he undergo a liver transplant because of his end-stage liver disease, chronic hepatitis and cirrhosis. Learn more about the liver transplant set to take place, as well as what the risks are for the surgery.

Bishop of Athens to undergo treatment in Miami

Orthodox Archbishop Christolodoulos of Athens will undergo a treatment for end-stage liver disease. Dr. Andreas Tzakis of the University of Miami medical school will perform surgery on August 15.

www.speroforum.com
by George Gilson
Friday, July 20, 2007

Greek-American liver transplant expert Andreas Tzakis announced that Archbishop Christodoulos has agreed to undergo a liver transplant to try to cure his end-stage liver disease, which includes a four-centimetre malignant cancer, chronic hepatitis and cirrhosis.

Tzakis, flanked by Christodoulos' attending doctors at Athens' Aretaieion hospital, told a July 12 news conference that Christodoulos will be taken to the University of Miami's Miller School of Medicine after August 15.

He said the archbishop's medical team, including surgeon Dionysios Voros who operated on Christodoulos' intestinal cancer on July 13, unanimously agreed that a transplant should be undertaken "as soon as possible", and specifically in the next six weeks, after full recovery from the intestinal cancer operation. Voros said that Christodoulos was informed after he entered hospital on June 9 that he would likely undergo a liver operation.

After pre-operative screening in August, the archbishop will be placed on an organ waiting list. Tzakis said that Christodoulos scores a high 22 points on the Model for End-Stage Liver Disease (MELD) scoring system, placing him at the top of the list.

Aretaieion doctors said that Christodoulos is now off all intravenous medication, walks about the hospital and could be released within days.

Tzakis said that the decision to expedite the transplant is intended to minimise the risk of metastasis to other parts of the body. He maintained that the large size of the archbishop's tumour will put him at the top of the organ waiting list in the United States. He admitted that in Europe patients with such large liver tumours, and with two types of cancer, are not considered candidates for transplantation.

Asked by the Athens News what the risks are for the surgery given the 68-year-old Christodoulos clinical profile, which includes two types of cancer and diabetes, Tzakis appeared exceedingly optimistic about the prospects of success. He said that the intestinal cancer was successfully treated by removing a large portion of the intestine, though he admitted there are "no guarantees" that there cannot be a recurrence, and stressed that Christodoulos' liver is "at a point where it is ready to lose its balance".

"The hepatitis is not active, and of the two cancers one was removed. Now he has cirrhosis and diabetes, which may be connected with the liver diseases and is being treated with insulin," Tzakis told this newspaper.

But he conceded that the diabetes "burdens the clinical profile somewhat" and requires extremely comprehensive clinical screenings of the heart, kidney and other organs. The screening process, which will begin in Athens, will also seek to make certain that the intestinal and liver cancer (which the Aretaieion team said was not a metastasis) has not spread to other parts of the body.

Tzakis noted that German transplant surgeon Christoph Broelsch, who pioneered liver transplants at the University of Chicago in the mid 1980s and examined Christodoulos on July 4, also recommended a transplant after preparation.

As for Christodoulos' age, Tzakis said it is not a counter-indication for a transplant and noted that an octogenarian liver transplant patient of his is now over 90 years old and is doing well.

Stressing that pre-operative condition is the key measure of transplant success, Tzakis said the post-transplant prognosis for Christodoulos is good, as he was extremely active and fit until now. "His heart and kidney function are totally normal. If he had full mental and physical capacities before, with all these illnesses, after a transplant you'll see him better than he has been for years," he said.

The Greek-American surgeon also ruled out various types of chemotherapy that were previously discussed as options - such as chemoembolism, which targets large doses of chemotherapy directly at the liver - as these "could burden the function of the liver and the body overall".

Tzakis conceded that the lifelong immunosuppressive drugs required by liver transplant patients could conceivably lead to a recurrence of intestinal cancer, but only if some of the intestinal cancer tumour has remained in the body. Thus, he indicated that the risk-benefit analysis clearly favours a transplant. He said immediate recovery (walking etc) would take weeks, while full recovery is a matter of months and continues gradually. "Longterm recovery is clinically complete," he said.

George Gilson is a writer for the Athens News, Greece.

Posted by Editors at 04:45 PM --- Printer-friendly version

July 16, 2007

Getting Easier: Predicting Hepatitis C Treatment Success

Just released by Veteran Affairs, new research has identified several factors to help predict Hepatitis C treatment success. In addition to race, cholesterol level, the presence of cirrhosis and ALT enzyme elevation, this report also suggests that specific viral genotypes respond best to different types of pegylated interferon.

Key Factors Spur Hepatitis C Treatment Success
07.06.07, 12:00 AM ET

www.forbes.com

FRIDAY, July 6 (HealthDay News) -- Successful treatment of hepatitis C may depend on the type of interferon given to patients and the viral strain, researchers say.

The study also confirmed that other factors, such as Caucasian race, the absence of cirrhosis and elevated levels of the liver enzyme ALT, all predict successful treatment.

More than 3 million people in the United States are chronically infected with hepatitis C, experts say. Infection is spread by contact with the blood of infected individuals, primarily through injection drug use. Without treatment, hepatitis C results in liver disease and death. It is the leading cause of liver transplants in the United States. Interferon, combined with additional drugs, is the primary treatment.

Researchers in the Veterans Affairs Palo Alto Health Care System analyzed data from almost 6,000 patients who received treatment for hepatitis C in system clinics. The researchers tested their blood three months after treatment ended to find out if the virus was no longer detectable, indicating successful treatment.

The research showed that patients treated with pegylated interferon form 2A, rather than 2B, were 40 percent more likely not to have any detectable virus in their blood. Pegylated interferon is a man-made version of interferon, a substance made by the body to fight viruses. The term pegylated refers to additional elements that keep the medicine in the body longer.

The results also indicated that patients with hepatitis C virus genotype 2 were more likely to respond to treatment than those with genotype 3, both of which are known to be more successfully treatable than genotype 1.

Low cholesterol levels also predicted a lack of treatment success. The researchers theorize that low cholesterol may indicate more severe liver disease.

In the article, published in the July issue of Hepatology, the experts suggest that a better understanding of the varying factors that affect the success of hepatitis C treatment can help physicians and patients develop a strategy for success.

Posted by Editors at 11:19 AM --- Printer-friendly version

Shortened Hepatitis C Treatment Increases Relapse Rate

Researchers from Virginia Commonwealth University confirm that shortened treatment times negatively impact cure rates for Hepatitis C genotype 2 or 3. These new study results warn us that treatments shortened to three or four months have higher relapse rates than the average six-month interval for these genotypes.

Longer Hepatitis C Treatment Best?
Cure Rates Are Higher With Longer Treatment Of 6 Months, Research Suggests

July 11, 2007
www.cbsnews.com

(WebMD) Shortening treatment to less than six months does not appear to be a good strategy for patients with the most curable types of hepatitis C virus infection, new research suggests.

Patients with hepatitis C genotypes 2 and 3 who were treated for four months had lower cure rates and higher relapse rates than those treated for six months.

The study, which appears in Thursday's New England Journal of Medicine, shows that longer treatment benefits even those with highly treatable hepatitis C, researcher Mitchell L. Shiffman, MD, tells WebMD.

"I tell patients if they can tolerate treatment and can stay on it for 24 weeks, they have a better chance of achieving the best possible outcome, which is a cure," he says.

Hepatitis C Treatment Strategies
Long-term infection with hepatitis C virus (HCV) is a leading cause of cirrhosis, liver cancer, and liver transplants in the United States. As many as 4 million Americans are infected, but most don't know it, experts say.

About 70 percent of infected Americans carry the genotype 1 form of hepatitis C, which tends to be less responsive to treatment than genotypes 2 and 3.

With aggressive treatment, nearly 80 percent of people with genotypes 2 or 3 achieve complete and sustained viral eradication, or cures, compared with about 40 percent to 45 percent of people carrying genotype 1 virus.

These days, most patients are treated with a long-acting version of the injected drug interferon along with the antiviral drug ribavirin.

The standard course of treatment for patients with the more treatable types of hepatitis C infection is half that of patients with genotype 1 hepatitis C — 24 weeks compared with 48 weeks.

In several recent studies, it was reported that shortening treatment to four months and even three months had no impact on cure rates in hepatitis C genotype 2 or 3 patients.

In an effort to test these findings, Shiffman and colleagues from Virginia Commonwealth University compared outcomes among genotype 2 or 3 patients treated for four months and six months.

They report that 31 percent of patients treated with the shorter course of therapy eventually relapsed, compared with 18% of patients who got the full six months of treatment. Relapse was defined as having detectable levels of virus in the blood at follow-up despite complete viral eradication at the end of treatment.

Overall, 62 percent of patients treated for four months achieved sustained viral responses, compared with 70 percent of patients treated for six months.

Among patients who achieved complete viral responses within a month of starting treatment, 79 percent of those treated for four months achieved complete, sustained responses, compared to 85 percent of the patients treated for six months.

Individualized Hepatitis C Treatment
Shiffman understands the desire of patients and doctors to shorten treatment. The drugs used to treat hepatitis C are very expensive and they can cause severe fatigue, fever, depression, and other hard-to-tolerate side effects.

But he says a better strategy than shortening treatment is lowering drug dosage in patients who have trouble tolerating hepatitis C treatments.

He adds that rapid response to treatment has become as important as viral genotype for predicting response to treatment.

Patients who show no signs of hepatitis C infection within a month of beginning treatment have a 90 percent cure rate, regardless of genotype, he says.

"We are learning that the optimal way to treat hepatitis C is to monitor the virus during treatment, no matter what the genotype, and adjust treatment duration based on response."

T. Jake Liang, MD, of the National Institutes of Health, says this individualized approach to hepatitis C treatment will become more common as more is learned about the virus.

Liang is chief of the liver disease branch of the National Institute of Diabetes and Digestive and idney Diseases.

"As our technology improves we will be more able to identify patients who will benefit from a shorter course of treatment," he tells WebMD. "For now, though, genotype 2 and 3 patients who can tolerate the treatment should remain on it for a full six months."

By Salynn Boyles
Reviewed by Louise Chang
B)2005-2006 WebMD, Inc. All rights reserved.

Posted by Editors at 10:24 AM --- Printer-friendly version

How to Detect Liver Fibrosis without Liver Biopsy

Biotech company IQur's new blood test for evaluating liver fibrosis has been approved in the UK. The 'Enhanced Liver Fibrosis Test' detects and monitors liver damage without the need for an invasive liver biopsy.

Blood test to detect liver damage
11 July 2007

www.mlwmagazine.com

A new blood test that detects and monitors liver damage has now received regulatory approval to be used in the UK.

The ‘Enhanced Liver Fibrosis Test’ (ELF), produced by IQur, a biotech company in the field of liver disease, detects liver problems without the need for invasive biopsies.

Liver damage, or fibrosis, may occur without causing any symptoms so many people remain unaware for decades that they have liver disease. Deaths due to liver disease currently stand at 7,500 a year in the UK.

“This is a massive shift in the area of liver disease,’’ said Professor William Rosenberg, one of the pioneers behind the test. “Liver disease is one of the most common causes of death in the UK and anything that we can do to stem the rise has huge significance for patients and those treating the disease.’’

The new test is available through GP surgeries, health clinics and hospitals. The analysis of samples is undertaken by iQur’s specialist diagnostic service, and the test can be repeated at appropriate intervals to monitor disease progression and response to therapy.

ELF test has been developed by iQur in association with the University of Southampton and Siemens Medical Solutions in the US.

Posted by Editors at 10:17 AM --- Printer-friendly version

July 13, 2007

HCV and the Body's Most Important Antioxidant

Humans have a potent chemical within every cell for protection against dangerous substances. Learn why one particular antioxidant is considered the be the body's most important, and what makes it so vital to the health of your liver.

by Nicole Cutler, L.Ac.

Composed of three amino acids (glutamine, cysteine and glycine), glutathione is a well-known chemical that benefits individuals with Hepatitis C. It is an enzyme found in all tissues protecting against potential damage from wastes and toxins. Due to its constant battle to defend itself against Hepatitis C, a liver dealing with this virus can use all the help it can get to resist injury from toxic compounds.

Antioxidants are important for health preservation because they neutralize free radicals, which can build up in cells and cause damage. “Glutathione is a very interesting, very small molecule that’s [produced by the body and] found in every cell,” says Gustavo Bounous, MD, director of research and development at Immunotec and a retired professor of surgery at McGill University in Montreal, Canada. “It's the [body's] most important antioxidant because it's within the cell.”

Because glutathione resides within the cells, it is in the best position to neutralize free radicals. It also has potentially widespread health benefits because it can be found in all types of cells, including the cells of the immune system, whose primary responsibility is to battle disease.

Glutathione Deficiency
Clinical studies have demonstrated that the level of glutathione is significantly depressed in many people with Hepatitis C. Glutathione deficiency can be the result of:

· diseases that increase the need for glutathione
· deficiencies of the amino acids needed for synthesis
· diseases that inhibit glutathione formation

Regardless of how it was caused, glutathione deficiency is an important factor contributing to liver damage. Glutathione levels decline naturally as people age, fight a chronic disease or are exposed to excessive amounts of toxins. Insufficient glutathione levels reduce the liver’s ability to break down drugs, chemicals and other toxins, enhancing the probability of liver damage.

Glutathione Supplementation
The cellular consumption of glutathione is greater by those with chronic Hepatitis C than those without the virus, increasing the demand for this chemical. Although glutathione is available as an over-the-counter pill, its absorption into cells has been repeatedly questioned. A majority of experts on glutathione supplementation suggest people with chronic Hepatitis C take its amino acid building blocks, which are then converted by the body into glutathione.

N-acetyl cysteine (NAC) is a building block of glutathione which helps boost its levels in the body. In the case of an acetaminophen overdose, NAC is administered by physicians to detoxify the drug before it destroys too many liver cells and becomes fatal. NAC has been shown to increase blood glutathione in HIV-infected patients with low levels of glutathione due to their chronic infection.

One study of 24 Hepatitis C patients with low glutathione showed that 600 mg of NAC taken three times daily along with interferon therapy led to a normalization of ALT liver enzymes in 41 percent of patients. In addition, the viral loads of participants on NAC were significantly lowered. NAC appeared to have the significant effect of bringing glutathione levels back to normal inside white blood cells after six months of combined therapy. While not every study evaluating NAC with Hepatitis C has confirmed these results, most healthcare practitioners value this relatively inexpensive supplement to boost glutathione and protect the liver from incurring further damage.

Dietary Influences
Glutathione occurs naturally in many foods, and people who eat well probably have enough in their diets, says Dean Jones, PhD, professor of biochemistry and director of nutritional health sciences at Emory University in Atlanta. Glutathione is found in fruits and vegetables, including:

· Watermelon, grapefruit, strawberries, oranges, cantaloupe, and peaches

· Avocadoes, asparagus, potatoes, acorn squash, tomatoes, broccoli, okra, zucchini, and spinach

· Herbs such as cinnamon and cardamom contain compounds capable of restoring healthy levels of glutathione

· Cyanohydroxybutene, a chemical found in broccoli, cauliflower, brussel sprouts and cabbage, is also thought to increase glutathione levels

When equipped with the raw ingredients, the body is more apt to manufacture glutathione. High protein foods are rich in the three amino acids found in glutathione:

1. Cysteine – is found in ricotta cheese, cottage cheese, yogurt, pork, sausage meat, chicken, turkey, duck, wheat germ, granola, and oat flakes.

2. Glutamine – is found in fish, meat, beans, and dairy products.

3. Glycine – is found in fish, meat, legumes, and dairy products.

Most people with chronic Hepatitis C are aware of the potential damage toxins can inflict on their liver. In support of this effort, being sure to get enough antioxidants into their body has become routine. Glutathione and its precursor (NAC) should have a place on the healthcare considerations of every person with chronic Hepatitis C. Since this powerful antioxidant actually protects liver cells from the inside, glutathione is an invaluable ally in maintaining liver health. By increasing glutathione-rich food intake or by supplementing with NAC, you can fortify your liver cells against the Hepatitis C virus.

References:

www.au.health.yahoo.com, Glutathione, Healthpoint Technologies, 2007.

www.hepcchallenge.org, Nutritional Supplementation, Lark Lands, PhD, Lyn Patrick, ND, Hepatitis C Caring Ambassadors Foundation, 2007.

www.liversupport.com, How One Man Uses Natural Remedies to Live a Full Life with Hepatitis C, Natural Wellness, 2007.

www.medicinenet.com, Glutathione: New Supplement on the Block, Alison Palkhivala, MedicineNet, Inc., 2007.

www.raysahelian.com, Glutathione: A Practical Guide, Ray Sahelian, MD, 2007.

www.thebody.com, Liver Dinner, Sandra Goldsmith, MS, RD, Body Positive, September 2000.

www.vitamins-supplements.org, Glutathione, Vitamin Supplements Guide, 2007.

Posted by Editors at 02:43 PM --- Printer-friendly version

June 22, 2007

Non-Invasive and Inexpensive Fibrosis Evaluation for HCV

By combining standard liver blood tests with a patient’s age, French researchers have developed a reliable and inexpensive method to determine the extent of liver fibrosis in people with Hepatitis C. While the accuracy of this calculation is only valid within a narrow window of liver injury, it may save many patients from undergoing costly and invasive liver biopsies.

FIB-4: An inexpensive and accurate marker of fibrosis in HCV infection. comparison with liver biopsy and fibrotest.

Vallet-Pichard A, Mallet V, Nalpas B, Verkarre V, Nalpas A, Dhalluin-Venier V, Fontaine H, Pol S.

www.ncbi.nlm.nih.gov

Université Paris‐Descartes, Paris, France.

To optimize the management of patients with chronic hepatitis C virus (HCV) infection, noninvasive tests to determine the degree of hepatic fibrosis have been developed. The aims of this study were (1) to validate a simple, inexpensive, noninvasive test called FIB-4, which combines standard biochemical values (platelets, ALT, AST) and age, in a series of 847 liver biopsies performed in HCV-monoinfected patients; and (2) to compare the results of 780 FIB-4 and FibroTests performed the same day in a series of 592 HCV-infected patients. The FIB-4 index enabled the correct identification of patients with severe fibrosis (F3-F4) and cirrhosis with an area under the receiver operating characteristic curve of 0.85 (95% CI 0.82-0.89) and 0.91 (95% CI 0.86-0.93), respectively. An FIB-4 index <1.45 had a negative predictive value of 94.7% to exclude severe fibrosis with a sensitivity of 74.3%. An FIB-4 index higher than 3.25 had a positive predictive value to confirm the existence of a significant fibrosis (F3-F4) of 82.1% with a specificity of 98.2%. Using these ranges, 72.8% of the 847 liver biopsies were correctly classified. The FIB-4 index was strongly correlated to the FibroTest results for a score <1.45 or >3.25 (kappa = 0.561, P < 0.01). A FIB-4 value <1.45 or >3.25 (64.6% of the cases) was concordant with FibroTest results in 92.1% and 76%, respectively. Conclusion: For values outside 1.45-3.25, the FIB-4 index is a simple, accurate, and inexpensive method for assessing liver fibrosis and proved to be concordant with FibroTest results. (HEPATOLOGY 2007.).

Posted by Editors at 10:49 AM --- Printer-friendly version

June 21, 2007

New Hepatitis C Cases Connected to NYC Anesthesiologist

According to the Department of Health and Mental Hygiene, it was recently discovered that a NYC anesthesiologist might have transmitted Hepatitis C to at least three patients. With over 4,500 other people treated by this same doctor being made aware of their potential risk of exposure, find out how common transmission of the disease is within a medical setting.

3 Hepatitis C Cases Linked to NYC Doctor
www.cfnews13.com

NEW YORK(AP)

Authorities urged 4,500 people who were treated by an anesthesiologist to get tested for hepatitis C, saying three patients may have been infected as the doctor gave them anesthesia.

The city Department of Health and Mental Hygiene said Thursday it was mailing letters to everyone at risk and noted that the liver-damaging disease cannot be spread by casual contact.

Three people treated by the doctor in August were diagnosed with hepatitis C in recent months, the health department said. Laboratory tests suggest they were infected while getting intravenous anesthesia drugs during outpatient procedures, according to the agency.

Authorities have not identified the anesthesiologist. A state Health Department spokeswoman, Claudia Hutton, said the agency had not established "that the doctor is guilty of doing anything wrong."

The doctor has had a medical license since 1977 and "does not have a history of spreading infection," Hutton said.

City authorities said they were contacting everyone treated by the anesthesiologist while he or she practiced at 10 different medical offices in New York City, from Dec. 1, 2003, to May 1, 2007. The doctor has stopped practicing during the investigation, the city health department said.

"Transmission of hepatitis in a medical setting is rare, but as a precaution we are reaching out to anyone who could have potentially been exposed," Dr. Marci Layton, the agency's assistant commissioner for communicable disease, said in a statement.

She stressed that intravenous medications are "very safe when standard infection-control procedures are followed," and that patients should not avoid important procedures because of worries about infections.

Hepatitis C is a chronic, blood-borne virus that that can cause scarring or other damage to the liver. It often does not cause noticeable symptoms, although some people experience flu-like symptoms, a yellowing of the skin and the whites of the eyes, dark urine and pale feces. It is treatable, but many people who have the disease do not even know they are infected.

---

Since making headlines, the number of possible Hepatitis C cases linked to the anesthesiologist in New York has nearly doubled. The doctor, whose identity has finally been revealed, now faces a lawsuit from one of his victims.

Doctor sued in spread of hepatitis C
www.upi.com

NEW YORK, June 24 (UPI) -- Two more people have contracted hepatitis C after receiving intravenous anesthesia from a doctor in New York who is under investigation.

Dr. Brian Goldweber, 64, is accused of spreading the disease by failing to follow proper infection control protocols, The New York Post reported Sunday.

A 45-year-old woman with a prominent corporate post filed a lawsuit last week against Goldweber and three other doctors at the Manhattan practice, where she underwent a colonoscopy in 2004.

She filed her suit as "Jane Doe" due to what she called the "stigma, discrimination and embarrassment" of a hepatitis C infection, which typically affects drug addicts and the sexually promiscuous.

Another woman has notified the city Health Department after contracting hepatitis C after an outpatient procedure. That notification brings the number of possible victims to at least five, the Post said.

Posted by Editors at 02:51 PM --- Printer-friendly version

June 20, 2007

Pros and Cons of Medical Marijuana with Hepatitis C

A 2006 report demonstrated the benefits of marijuana for people undergoing interferon and/or ribavirin treatment for Hepatitis C. On the other hand, recent studies have shown the use of marijuana may increase the acceleration of the disease process and possibly cause decreased immune function. The information presented in this article is not intended to encourage or discourage illegal activity, but rather to provide the reader with proven facts about marijuana's impact on the liver.

by Nicole Cutler, L.Ac.

Despite its illegality in most cases, Cannabis Sativa, commonly known as marijuana, remains a popular recreational drug throughout the world. Now, an increasing amount of proposed legislation is seeking to maintain the legality of medical marijuana, allowing for people with certain medical ailments to legally continue using this illicit drug. As of May 2007, 11 U.S. states host medical marijuana programs that allow for the chronically ill and their caregivers to possess and use marijuana for pain relief or other therapeutic purposes.

Pros
The basis of any argument in favor of medical marijuana claims that it can relieve pain, reduce nausea, and increase appetite in those with chronic disease. While illnesses such as cancer and HIV are approved for some medical marijuana legislation, Hepatitis C has been largely ignored. However, a 2006 report demonstrated a positive use of marijuana for people with HCV.

While therapy for chronic Hepatitis C is most often based on interferon medication, its value is limited due to the uncomfortable side effects it can induce, such as flu-like symptoms, fatigue, insomnia, loss of appetite, nausea, muscle and joint pain, and depression. These symptoms often lead to interferon therapy’s poor adherence, which manifests either in a dose reduction or discontinuation of treatment—both of which hinder interferon’s potential effectiveness against HCV.

Published in the October 2006 European Journal of Gastroenterology and Hepatology, a Northern California study involving 71 participants demonstrated that moderate marijuana use may relieve interferon’s side effects, helping people with Hepatitis C stick with the full treatment regimen.

Without any evidence of killing the virus, researchers assume that marijuana’s influence on Hepatitis C is due to side effect management, rather than an antiviral effect. Lead researcher, Diana Sylvestre, MD, of the University of California at San Francisco emphasized that the benefit of marijuana was primarily due to improved ability to stay on adequate doses of interferon and/or ribavirin. Sylvestre told HIVandHepatitis.com that the researchers could not judge whether marijuana had a direct antiviral effect.

Unfortunately for heavy users, this study did not examine a direct dose-response relationship between the amount of marijuana consumed and the likelihood of successful interferon therapy. In fact, participants who used the largest amounts of marijuana had less success with Hepatitis C interferon therapy. Because the researchers did not perform pre and post-treatment histological assessments using paired liver biopsies, and did not measure immune parameters, the claim of marijuana’s value in Hepatitis C therapy remains limited.

Cons
Ever since the results of the 2006 California study were published, experts have been expressing concern about the health implications of Hepatitis C patients using marijuana. A French study of untreated individuals with Hepatitis C (those not taking interferon therapies) showed that, compared with occasional or non-users of the drug, people who used marijuana daily were:

· more likely to have severe liver fibrosis
· at a higher risk for rapid fibrosis progression.

At the 2007 42nd Annual Meeting of the European Association for the Study of the Liver in Barcelona, Spain, the same French research team reported on a study linking marijuana use and liver steatosis. These researchers noted that marijuana binds to two receptors, CB1 and CB2. Recent experimental data suggests that activation of CB1 receptors increases steatogenesis (liver fat accumulation). Stimulation of the CB1 receptor is assumed to be the reason daily marijuana smoking is associated with the development of significant hepatic fibrosis.

In addition to the discovery that smoking marijuana accelerates liver fibrosis, concerns remain about its impact on the immune system. Experts explain that the use of marijuana may suppress immune function. Cannabinoid receptors are confirmed to be present on the surface of immune cells, and when the cannabinoid molecules from marijuana bind to these receptors, the person’s resistance to disease is compromised. Therefore, various studies have concluded that using marijuana can enhance the disease process.

To Use or Not to Use
While the decision to use marijuana with Hepatitis C is highly personal, taking these facts into consideration can help clarify its proven impact on those living with this disease. In particular, advocates suggest that medical marijuana laws and programs who specify its use for patients with specific conditions such as AIDS and cancer should also include people with Hepatitis C. Additionally, if you have Hepatitis C and are currently struggling with side effects of interferon therapy, it may be worth your while to investigate medical marijuana use in your area. Whether it’s breaking the law or not, any person with Hepatitis C considering smoking this drug should be aware that marijuana has been linked with increased liver fibrosis and possibly with decreased immune function. Whatever you choose to do, make your decisions based on what you believe will enhance your odds at fighting the infectious virus, not on what will hamper them.

References:

Cabral GA, et al., Effects on the Immune System, Handbook of Experimental Pharmacology, 2005.

Klein, TW, et al., Marijuana, immunity and infection, Journal of Neuroimmunology, March 1998.

www.boston.com, Senate votes to allow medical marijuana permanently, Ray Henry, The New York Times Company, May 2007.

www.hivandhepatitis.com, Cannabis Use Predicts Severe Liver Steatosis in Patients with Chronic Hepatitis C, Liz Highleyman, hivandhepatitis.com, 2007.

www.hivandhepatitis.com, Moderate Cannabis Use Associated with Improved Treatment Response in Hepatitis C Patients on Methadone, Liz Highleyman, hivandhepatitis.com, 2007.

www.medscape.com, Hepatitis C -- Current State of the Art and Future Directions, David Bernstein, MD, Medscape, 2007.

www.natap.org, Daily Cannabis Smoking as a Risk Factor for Fibrosis Progression in Chronic Hepatitis C, natap.org, 2007.

www.washingtonpost.com, Marijuana Aids Therapy, Rick Weiss, washingtonpost.com, September 2006.

Posted by Editors at 12:55 PM --- Printer-friendly version

May 31, 2007

Nurses Review Hepatitis C Prevalence and Transmission Routes

Healthcare workers confirm that the Hepatitis C virus does not discriminate and lurks everywhere. While it is only transferred through blood, two nurses from Massachusetts review the many possible routes of Hepatitis C transmission and admit that most people have no idea they are infected.

Nurses say many may have hepatitis C and not know it

www.milforddailynews.com

By Jennifer Lord/Daily News staff
May 23, 2007

In their years treating patients at MetroWest Medical Center, nurses Kelly Lindebald and Lynn Dempsey have learned there is no such thing as a typical hepatitis C patient.

Drug users who have shared needles may have it. So might a suburban stay-at-home mom who had a blood transfusion before 1990.

"It's the most common blood-borne illness in the country - more than 4 million are infected," said Dempsey, coordinator for the hospital's hepatitis C clinic.

"And most don't know," added Lindebald, the co-coordinator. "There are probably many more people walking around that have absolutely no idea they have it."

Hepatitis C is a virus that causes inflammation of the liver, leading to chronic liver disease and cirrhosis. It is the most common cause of liver transplants. The virus is transmitted when blood from an infected person enters the body of a person who is not infected, most commonly through sharing drug needles, needle sticks in health workers or from mother to child during childbirth.

Some patients may have contracted hepatitis C by getting a tattoo or a body piercing under non-hygenic conditions or even sharing a razor or toothbrush with an infected person. Sexual transmission is also possible but considered rare.

"About 10 percent of the population doesn't even know how they got it," Lindebald said. "They're starting to suspect snorting drugs may be a risk factor as well. Anything that can transfer blood-to-blood."

To help determine who might be infected with hepatitis C, the hospital is offering free testing tomorrow beginning at 2:30 p.m. as part of an all-day hepatitis C awareness event. The test requires a simple blood draw and results will be sent to patients' primary care doctors or the hospital's clinic if the patient does not have a main doctor.

"A lot of people don't find out (they have it) until they give blood and get a letter in the mail," Lindebald said. "It's a horrible way to find out."

Symptoms typically don't appear until 10 to 20 years after infection and about 80 percent never have signs or symptoms. Some symptoms may include jaundice, fatigue, dark urine, abdominal pain, loss of appetite and nausea.

Unlike hepatitis A and B, there is no vaccine against hepatitis C and it is considered incurable, although treatment with interferon and ribavirin can bring the viral load down to an undetectable level, Dempsey said.

The number of new infections each year declined from an average of 240,000 in the 1980s to about 26,000 in 2004, the latest year for which statistics are available. The number of hepatitis C-related deaths could increase to 38,000 a year by 2010, surpassing annual HIV/AIDS deaths, according to the U.S. Centers for Disease Control and Prevention.

While the typical patient is over the age of 40, figures released recently by the state Department of Public Health found hepatitis C cases on the upswing among 15- to 25-year-olds, rising from 254 in 2001 to 784 in 2005. The jump was attributed to an increase in young people experimenting with injectable drugs.

"It's important to say it's not passed on by casual contact," Dempsey said. "Hepatitis C carries the same kind of stigma as HIV - in fact, hepatitis C and HIV often go hand-in-hand."

(Jennifer Lord may be reached at 508-626-3880 or jlord@cnc.com.)

Posted by Editors at 11:31 AM --- Printer-friendly version

Declaration of Hepatitis C Cure is Misleading

Here is an example of an article on the recent claims of a Hepatitis C "cure." Readers should take note that the study included those who have already beaten the virus with interferon combination therapy (ICT). The good news is that once you beat the virus with ICT, you are likely to remain virus-free. The bad news is that ICT only helps approximately one quarter of those infected with the most common strain of the virus, when you take into account those who had to stop or adjust their treatment due to the severe side effects.

Drug combination found effective against hepatitis C, but there's a catch

www.kentucky.com

By Bob Lamendola

SOUTH FLORIDA SUN-SENTINEL

FORT LAUDERDALE, Fla. --
Doctors and researchers almost never use the word "cure," but they came as close as they ever do Monday when describing a combination of two drugs used to treat the severe liver disease hepatitis C.

Among some patients, the drug cocktail of pegylated interferon and ribavirin completely kills the virus that causes hepatitis C, and keeps it from coming back, doctors said in reporting their new study at a Digestive Disease Weekly conference in Washington, D.C.

The catch is, the drug combo does not work in about half of people with hepatitis C, and researchers still are not sure why it works so completely for some but fails in others. Also, the combo has difficult side effects.

"I call it a cure. It doesn't work for everyone but it has the ability to eradicate this virus, and this study is the best evidence to prove that," said Dr. Eugene Schiff, director of the center for liver diseases at the University of Miami medical school, who was attending the conference but not involved in the study.

The findings of the six-nation study, headed in the United States by Virginia Commonwealth University, solidifies the drug combination as the top treatment for the virus, which has infected about 4 million Americans.

The virus spreads only via direct contact with infected blood. Most cases stem from blood transfusions before 1992 and intravenous needle use, but the virus also can occasionally be passed through sex.

Long-term infection of hepatitis C has caused a leap in the incidence of liver cancer and liver damage, and is the leading cause of people needing liver transplants. The virus kills more people than HIV/AIDS.

The new study followed 997 patients who had cleared the virus from their systems while taking the drug combo for almost a year. Of those, 99 percent remained virus-free an average of four years after they stopped taking the drugs, and as long as seven years later.

That kind of success is not seen with other viruses, such as hepatitis B and HIV, which hide in the body and come back strong if the patient stops taking the medicine, said Dr. John Vierling, a Baylor College professor and past president of the American Association for the Study of Liver Diseases.

"This is a virus we can beat," said Vierling, who was not associated with the study.

But the drug combo only defeats the virus in about 40 percent of those infected with the most common strain of hepatitis C, which accounts for two-thirds of cases. Blacks and those with serious cirrhosis of the liver are less likely than average to do well. The drugs succeed about 80 percent of the time against other strains of the virus.

The side effects from the drugs can be serious. Most people experience little more than flulike symptoms, but small numbers report hair loss, depression, moodiness, sharp anemia, and in rare cases, heart and kidney failure, suicidal thoughts and even death.

"People don't like to take it if they don't have to," Schiff said.

Plantation, Fla., patient Andi Thomas, who founded the nationwide advocacy group Hep-C Alert, said she has been virus-free since taking the combo in 2004, with only headaches as a side effect. The group is funded in part by Roche Inc., which makes the interferon drug.

"I would like to hope I am cured forever and ever," Thomas said. "I would like for them to have better drugs, but right now they don't. It's the best tool we have."

Are you looking for further clarification on genotypes and success rates of combination therapy? Be sure to also read the article, A Cure for Hepatitis C posted on Hepatitis-Central.com

Posted by Editors at 11:28 AM --- Printer-friendly version

May 10, 2007

Pain Relievers and Hepatitis C

People with chronic Hepatitis C suffer from the same sprains, strains, and body aches as everyone else. In addition, Hepatitis C symptoms can include musculoskeletal pain, joint pain, headache, episodic abdominal pain and liver pain. However, many typical, over-the-counter pain medications can damage an already vulnerable liver. For those with Hepatitis C, finding a way to ease their pain without encouraging liver injury can feel like an uphill battle.

by Nicole Cutler, L.Ac.

According to a 2005 ABC News/USA Today/Stanford University Medical Center poll, more than 50 percent of Americans live in chronic or recurrent pain. Fortunately, the pharmaceutical industry has provided a variety of solutions to relieve many painful conditions. Despite this, a significant number of people with Hepatitis C who experience periodic or chronic pain are limited in their pain relief options.

Prior to attempting to self-treat pain or discomfort, Hepatitis C patients must discuss symptoms and pain management with their doctors. Because all drugs exert some type of strain on the liver and can also suppress the immune system, a well-informed physician will assess each individual situation and advise their patients appropriately. When living with Hepatitis C, it is a good idea to discuss pain relief medication with your physician as soon as possible so that when pain strikes, you will be ready with appropriate medicine on hand.

Alternatives
Chronic or recurrent pain is typically your body’s way of alerting you that a problem exists. Only attempt self-treatment with alternatives if you are sure your pain is not an emergency. When in doubt, always check with your physician first.

Since every medication taken can jeopardize an already struggling liver, many people with Hepatitis C rely on non-medication options. Before opening a bottle of pills, try these seven, safe alternatives first:

1. Apply a heat pack on sore muscles, joints or over the liver for pain relief.

2. Soak in a warm bath with Epsom salts.

3. Following all directions, rub a natural, topical pain reliever onto the area of pain.

4. Make sure you have adequate rest. Fatigue always worsens pain.

5. For muscular pain, gentle stretching or mild physical activity can deliver the oxygen and blood flow needed for relief.

6. Find a credentialed massage therapist with experience in Hepatitis C and chronic pain. Massage therapy enhances circulation, helping to reduce physical pain.

7. Some patients achieve pain relief with complementary and alternative therapies, such as herbal medicine, chiropractic or acupuncture. Only seek advice or treatment by a qualified professional, and be sure to discuss any of these therapies with your physician and liver specialist.

Medications
The most common way to manage pain in our society is with over-the-counter painkillers. Also known as analgesics, these drugs may place additional liver strain on people with Hepatitis C. Anyone with chronic hepatitis should discuss the use of analgesics first with their doctor. Always follow your doctor’s suggestions and the manufacturer’s advice when using over-the-counter pain medication. Never exceed the recommended dosage and never combine medications.

The primary over-the-counter painkillers contain acetaminophen, ibuprofen or aspirin. All three of these have some impact on the liver, and can cause liver damage when taken in excess. While occasional, restricted use may be safe for those with Hepatitis C, a doctor will choose the drug based on which is least likely to adversely affect you.

1. Acetaminophen – (Tylenol, Anacin 3, Panadol, Paracetamol and others) is a common, mild to moderate pain reliever and fever reducer. A liver afflicted with Hepatitis C may not be able to metabolize this drug. High doses of acetaminophen can cause liver injury, even to a healthy liver. In limited dosages, a physician will generally only suggest this class of analgesic to a person whose hepatic metabolism is fully functioning.

2. Ibuprofen – (Motrin, Advil, Nuprin and others) reduces high body temperature, is an anti-inflammatory and inhibits normal platelet function. A non-steroidal anti-inflammatory drug (NSAID), ibuprofen can cause gastrointestinal upset and bleeding. Those at risk of portal hypertension are already at risk for gastrointestinal bleeding, intensifying this risk. Studies have demonstrated that at certain dosages, ibuprofen can stress the liver and elevate liver enzymes in people with Hepatitis C. Ibuprofen must be used with extreme caution in the later stages of liver disease and for those on interferon therapy.

3. Aspirin – (Bayer, Anacin, Excedrin and others) reduces fever, relieves pain, and acts as an anti-inflammatory and blood thinner. In addition to influencing liver test results, aspirin’s effect on blood platelets temporarily limits the clotting process and prolongs bleeding. In chronic liver disease where the body’s production of clotting factors is naturally decreased, aspirin can increase the risk of bleeding. Although there is no actual drug interaction between aspirin and the drugs used in interferon therapy, both can disrupt blood clotting, which must be monitored if used together. When taken in high doses (more than 2,000 mg per day) aspirin can cause liver injury.

While relieving aching muscles requires little thought for those without liver disease, it is obviously a complex process for someone with Hepatitis C. Since no one wants to purposefully worsen the condition of his/her liver, having a plan to deal with pain wisely serves people with Hepatitis C. Make sure to discuss your options with your doctor and consider alternatives to medication. Because many people with Hepatitis C experience pain at one point or another, experiment with the seven alternatives listed above. If you are lucky, you may not need analgesics after all.

References:
www.hepatitismag.com, Balancing Act: Drugs that can Help and Hurt, Jason E. Moore, hepatitismag.com, 2007.

www.hepatitis-central.com, Hepatitis C & Drug Use, Hepatitis-Central.com, 2007.

www.hepcawareness.net.au, Pain Management, Australian Hepatitis Council, 2007.

www.hcvadvocate.org, A Guide to Hepatitis C Treatment Side Effect Management, Hepatitis C Support Project, 2007.

www.medicinenet.com, Common Cold, William C. Shiel, Jr., MD, FACP, FACR, MedicineNet, Inc., 2007.

www.medicinenet.com, Pain Poll: Many Americans in Pain, Miranda Hitti, WebMD Inc., 2007.

www.pkids.org, Ibuprofen vs. Acetaminophen: Which Painkiller is better for Children with Viral Hepatitis?, Thomas R. Riley III MD, Jill P. Smith, MD, Parents of Kids with Infectious Diseases, 2007.

Posted by Editors at 09:04 AM --- Printer-friendly version

April 27, 2007

Can New Protein Lead to New Hepatitis C Medications?

Researchers' recent discovery of a protein may lead to the development of new Hepatitis C drugs. Learn what protein is involved in stopping the virus from replicating, making it critical in the search for medications capable of preventing infection.

New Protein Controls Growth Of Hepatitis C Virus

www.sciencedaily.com

Date: April 24, 2007

Science Daily — Researchers reveal a new protein that prevents the hepatitis C virus from replicating, which could help devise new drugs against hepatitis C.

Hepatitis C is a blood-borne, infectious disease that can cause liver inflammation, fibrotic scarring of the liver -- or cirrhosis -- and liver cancer. The virus spreads within its host by replicating its RNA and using it to build proteins that form new viruses and by inhibiting various antiviral proteins inside host cells. By understanding both mechanisms, scientists hope to prevent the virus from replicating, thus stopping the infection.

Stanley M. Lemon and colleagues discovered a new protein involved in stopping the virus from replicating. Called p21-activated kinase 1, the protein is known to play a role in several cellular signaling pathways, but it has not been shown previously to be involved in regulating the replication of hepatitis C virus.

Article: "p21-activated Kinase 1 Is Activated through the Mammalian Target of Rapamycin/p70 S6 Kinase Pathway and Regulates the Replication of Hepatitis C Virus in Human Hepatoma Cells" by Hisashi Ishida, Kui Li, MinKyung Yi, and Stanley M. Lemon

Note: This story has been adapted from a news release issued by American Society for Biochemistry and Molecular Biology.

Posted by Editors at 02:43 PM --- Printer-friendly version

April 19, 2007

Quick Response to Combination Therapy Signals Hope for HCV Patients

An analysis of several recent clinical trials shows how important early responses to treatment are for clearing the Hepatitis C virus. Now doctors can tell earlier than ever, the chances patients can be cured. Find out just how soon doctors can now determine the success of treatment and what this means for newly diagnosed patients.

Treatment Optimisation With PEGASYS Plus COPEGUS Offers Patients With Hepatitis C an Excellent Chance for a Cure

www.presseportal.de

High Response Rates Confirmed in 'Real-Life' Study and Clinical
Trials

BASEL, Switzerland, April 13 /PRNewswire/

Patients with hepatitis C who respond quickly to treatment have an
excellent chance of being cured of the disease, according to data
presented today at the 42nd Annual Meeting of the European
Association for the Study of the Liver (EASL). Patients with genotype
1 hepatitis C (HCV) who clear the virus within a month of starting
treatment with PEGASYS (peginterferon alfa-2a (40KD)) plus COPEGUS
(ribavirin) have up to a 91% chance of achieving a sustained
virological response (SVR), considered a cure by researchers.

"Now we can tell earlier than ever - at just week 4 of treatment -
whether a patient has a good chance to be cured." said Professor
Patrick Marcellin, Hôpital Beaujon, Clichy, France. "Knowing their
virus levels in the first and third months of treatment helps
patients take ownership of beating the disease and helps motivate
them to stay on treatment. This information should be made available
for everyone starting therapy."

Early Response to Treatment Means Patients Have an Excellent
Chance for a Cure

An analysis of six different clinical trials highlights the value
of checking how well patients with genotype 1 HCV have responded to
treatment at weeks 4 and 12 of therapy(1). The results of the
analysis showed that of those patients treated with PEGASYS 180 mcg
weekly plus COPEGUS 1,000-1,200 mg daily:

- Up to one in five cleared the virus by week 4 of therapy
(called rapid viral response)

- 83-91% of patients with a rapid viral response went on to be
cured of their hepatitis C

- About 40% of patients who did not achieve a rapid viral response
managed to clear the virus by week 12 of therapy (called complete
early virological response); 65-67% of these patients were cured

Excellent Chance for a Cure for Rapid Viral Responders Confirmed
in 'Real-Life' Study

A large real-life study involving 4,377 patients conducted by the
Association of German Independent Gastroenterologists confirms that
these results can be replicated in clinical practice(2):

- One quarter of patients with 'difficult-to-cure' genotype 1
or 4 HCV who had their viral levels tested at week 4 of treatment
achieved a rapid viral response

- While the study is not yet complete, over 70% of those who have
finished their 6-month post-treatment follow-up period were cured

"These are really important results," said Dr Elmar Zehnter,
Gastroenterologist and Hepatologist, Dortmund, Germany, and
researcher in the study. "This study confirms that the high cure
rates reported for rapid viral responders in clinical trials
translate into clinical practice and are relevant to the patients we
see every day. At the moment, testing viral levels at 4 weeks of
treatment is not standard practice. Based on these results, however,
testing viral levels at 4 weeks of therapy should become a routine
test."

About Hepatitis C

Hepatitis C, the most common chronic blood-borne infection, is
transmitted primarily through blood or blood products. Hepatitis C
chronically infects 180 million people worldwide, which makes it more
than four times more prevalent than HIV(3,4). Alarmingly, many people
infected with hepatitis C don't even know they carry the virus. For
example, it is estimated that 80-90% of people with hepatitis C in
the UK are unaware that they are infected(5). Hepatitis C is a
leading cause of cirrhosis, liver cancer and liver failure, despite
the fact that many patients can be cured with treatments that are
available today.

About PEGASYS

PEGASYS, the market leader worldwide in hepatitis C therapy,
provides significant benefit over conventional interferon therapy in
HCV patients of all genotypes. The benefits of PEGASYS are derived
from its large 40 kilodalton (KD) branched-chain polyethylene glycol
(PEG) construction, which allows for sustained drug levels over the
course of a full week. PEGASYS also distributes more readily to the
liver (the primary site of infection) than conventional interferon.
PEGASYS is the only pegylated interferon available as a
ready-to-administer solution. Each weekly subcutaneous injection
contains 180 mcg of pegylated interferon alfa-2a (40KD), which is the
approved dose for all patients, regardless of body weight.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of
pharmaceuticals and diagnostics. As the world's biggest biotech
company and an innovator of products and services for the early
detection, prevention, diagnosis and treatment of diseases, the Group
contributes on a broad range of fronts to improving people's health
and quality of life. Roche is the world leader in in-vitro
diagnostics and drugs for cancer and transplantation, a market leader
in virology and active in other major therapeutic areas such as
autoimmune diseases, inflammation, metabolism and central nervous
system. In 2006 sales by the Pharmaceuticals Division totalled 33.3
billion Swiss francs, and the Diagnostics Division posted sales of
8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and
has R&D agreements and strategic alliances with numerous partners,
including majority ownership interests in Genentech and Chugai.
Additional information about the Roche Group is available on the
Internet at www.roche.com.

All trademarks used or mentioned in this release are protected by
law.

Film footage is available for broadcast journalists from The
NewsMarket at www.thenewsmarket.com. Video is compressed in MPEG2 and
is available for download to your FTP server.

References

1. Marcellin P, Hadziyannis S, Berg T, et al. Virological response
at 4 and 12 weeks predict high rates of sustained virological
response in genotype 1 patients treated with peginterferon alfa-2a
(40KD) plus ribavirin. In: 42nd Annual Meeting of the European
Association for the Study of the Liver; 2007 April 11-15; Barcelona,
Spain; 2007.

2. Zehnter E, Mauss S, Boeker K, et al. Potential relevance of
rapid viral response for SVR and optimisation of the treatment of
hepatitis C (CHC) with peginterferon alfa-2a (PEG) and ribavirin
(RBV). In: 42nd Annual Meeting of the European Association for the
Study of the Liver; 2007 April 11-15; Barcelona, Spain; 2007.

3. AIDS Epidemic Update. 2006. (Accessed February 27, 2007, at
http://www.who.int/hiv/mediacentre/2006_EpiUpdate_en.pdf.)

4. Initiative for Vaccine Research, Viral Cancers, Hepatitis C.
World Health Organization, 2006. (Accessed July 24, 2006, at http://w
ww.who.int/vaccine_research/diseases/viral_cancers/en/index2.html.)

5. The hepatitis C scandal. London: All-Party Parliamentary Group
on Hepatology; 2004.

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact: Janet Kettels, Roche, +1-862-596-9084; Natalie Henson, Axon
Communications, +44(0)20-843-99-406

Posted by Editors at 09:25 AM --- Printer-friendly version | Comments (0)

April 18, 2007

Hepatitis C and Damp Heat

Symptoms of Hepatitis C and damp heat both include jaundice, fever and thirst. Learn how to determine if you're suffering from damp heat accumulation, as well as foods you should add to or eliminate from your diet that will make a profound difference in your health.

by Nicole Cutler, L.Ac.

One of the reasons acupuncturists and Chinese herbalists have success in helping people with chronic Hepatitis C is because they approach each client as an individual. As practitioners of Traditional Chinese Medicine (TCM), these professionals see past the medical diagnosis to the pattern of imbalance blocking each person’s wellness.

There are approximately ten, very different, major TCM imbalances responsible for progression of the Hepatitis C virus. According to this system of medicine, damp heat accumulation is commonly seen in individuals with Hepatitis C. While the best way of benefiting from TCM is to visit one of its practitioners, here is a general guide for deciding if damp heat accumulation is part of your imbalance and how to approach it nutritionally.

Basic Theory
According to TCM, health is largely dependant upon the continual transformation and movement of various energetic and material substances throughout the body. When the body’s fluids are prevented from being properly transformed and moved to their destination, dampness ensues. Treating dampness is challenging because it is sticky, heavy and tends to further clog all surrounding avenues. This is why imbalances diagnosed by TCM as damp are often long-term, chronic conditions. Additionally, people with Hepatitis C are encouraged to reduce dampness because infections thrive in damp environments.

Dampness is usually accompanied by a weakness in the body’s digestive system. Responsible for separating food into nutrition and waste, a weak digestive system causes the excretion of nutritional elements, and allows unhealthy substances to remain in our systems. When a weak digestive system allows material that should be excreted to circulate, proper fluid movement is hampered, causing dampness.

Heat is generated when dampness resides in the body for any extended period of time. The accumulation of damp heat in the body can be compared to an overheated engine. As sludge builds up in the moving parts of an engine, there is increased resistance to its proper functioning. With increasing resistance, the parts get hotter and hotter, drying up any remaining lubricants. If nothing is done to break the cycle, this unfortunate chain of events ends in an overheated engine.

Damp Heat Manifesting
Although diagnosing damp heat as the predominant imbalance requires a knowledgeable practitioner’s evaluation, those aware of what is happening with their bodies can get a general idea if they are living with this disharmony. Since TCM diagnosis is based on pattern differentiation, every given symptom of an imbalance will not fit each person. Interestingly, many classic symptoms of acute Hepatitis C are synonymous with symptoms of damp heat. These include:

· Jaundice – Bright yellow coloring of the eyes or face. While jaundice can be a dull or pale yellow, bright yellow is more characteristic of a damp heat disharmony.

· Nausea, vomiting and/or reduced appetite – It is important to separate a love of food from listening to the food desires communicated by your body. Nausea, vomiting and low appetite are all signs that dampness may be obstructing the digestive system.

· Fever – Whether it is high or low grade, fever is a manifestation of heat.

· Abdominal or rib-area pain – In TCM, sharp or intense pain is characteristic of stagnation. As damp heat is a type of fluid stagnation, this is one explanation behind this type of pain.

· Thirst – Damp heat characteristically involves thirst (as a result of the heat), but with actual little to no desire to drink (as a result of the dampness).

Dietary Balancing
One branch of TCM is using dietary therapy to help balance the body. In the case of damp heat, there are four primary goals to accomplish: cool the heat, dry the dampness, move the congestion, and strengthen digestion. The following foods perpetuate stagnation, heat and dampness, and should be avoided:

· Oily and fatty; these qualities perpetuate dampness

· Raw; this takes more energy for an already weak digestive system to break down

· Sugary; refined sugar and other concentrated sweeteners contribute to dampness’ sluggish quality

· Spicy; perpetuates heat

· Alcohol; anything containing alcohol worsens both heat and dampness

In general, foods that are bitter, cooling and alkalizing help neutralize damp heat conditions. When experiencing an acute bout of damp heat-related symptoms, the following dietary advice will make the person more comfortable and headed in a healthy direction:

· Focus your food choices around light soups, broths and herbal teas.

· Include aduki beans, mung beans, lima beans, celery, carrots, winter squash, potatoes with skins, asparagus, mushrooms, dandelion leaves, lemons, cranberries, and huckleberries in your food selection.

· Lightly cook vegetables (instead of a raw salad) to help your digestive system extract nutrients.

Symptoms dominated by a TCM damp heat imbalance can be turned around with dietary therapy. While this dietary advice may seem limiting, remember that it is only intended to get you through the rough times. By including some of the food suggestions and avoiding some of the contributors to damp heat, your body will get a break from the self-perpetuating cycle dampness encourages. Just because an engine has accumulated some sludge, and is working harder to drive around, doesn’t mean it is doomed to overheating. The beauty of the human body is that by paying attention to what it is telling you, you can use something as simple as your diet to reset it in order to live a long, healthful life.

References:

Cohen, Misha, OMD, L.Ac., Hepatitis C Virus: The Silent Epidemic, Part Two, Acupuncture Today, October 2002.

Pitchford, Paul, Healing with Whole Foods, North Atlantic Books, Berkeley, CA, 1993.

www.acupuncture.com, Dampness and the Circle of Wellness, Aram Akopya, Cyber Legend, Ltd., 2007.

Posted by Editors at 04:37 PM --- Printer-friendly version

April 05, 2007

Sexual Transmission of Hepatitis C

Important research examining the risks of Hepatitis C transmission through heterosexual relationships has recently been conducted. Discover whether heterosexual couples were found to be at an increased risk for acquiring HCV in consideration of additional risk factors.

Lack of evidence for the heterosexual transmission of hepatitis C

http://qjmed.oxfordjournals.org

G. Neumayr, A. Propst, H. Schwaighofer, G. Judmaier and W. Vogel

From the Division of Gastroenterology, Department of Internal Medicine, University of Innsbruck, Austria

Received 14 April 1999 and in revised form 5 July 1999

Dr G. Neumayr, Department of Internal Medicine, University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria

Summary

The importance of sexual transmission in the epidemiology of hepatitis C virus (HCV) infection is still controversial. To assess the risk of heterosexual HCV transmission, we examined eighty patients with chronic HCV-associated liver disease and their spouses in a cross-sectional clinical and serological cohort study. Serum samples from index patients and their spouses were assayed for HCV antibodies and HCV RNA. In the couples positive for both, further HCV genotyping was done. A questionnaire addressing points such as additional risk factors for HCV infection, sexual behaviour or duration of partnership was completed by all couples. HCV antibodies were detected in four (5%) spouses, of whom three (4%) were also positive for HCV-RNA. HCV genotyping revealed concordance (genotype 1) in two couples, indicating a risk of interspousal HCV transmission of 2.5%. Spouses of patients with HCV viraemia and chronic liver disease have a low risk for acquiring HCV. Even long-term spouses seem not to be at increased risk. We therefore suggest that the risk of HCV transmission between monogamous sex partners does not depend on the duration of sexual exposure.

Introduction

The use of advanced gene technology made possible the characterization of hepatitis C virus (HCV) by Choo and coworkers in 1989. Soon HCV was identified as the major cause of non-A, non-B hepatitis worldwide.1–4 Epidemiological studies showed that its most efficient route of transmission is parenteral, by transfusion of blood or blood products, by intravenous drug abuse, occupational needle-stick injuries, haemodialysis and organ transplantation. Parenteral transmission is well established, and accounts for the high rates of HCV among haemophiliacs and intravenous (i.v.) drug users. In about 30–40% of HCV cases, the routes of transmission remain unknown.5,6 Sexual transmission or other close human contact could play a role in these sporadic or community-acquired infections.

Many studies have addressed this question and achieved somewhat conflicting results. The high prevalence of HCV found in prostitutes,7 male homosexuals,8–10 sex partners of patients infected with both HCV and human immunodeficiency virus11 and patients attending sexually-transmitted-disease clinics,9,12,13 suggests that sexual transmission may occur. Other studies, however, having investigated monogamous sex partners of HCV-infected transfusion recipients and of patients with acute or chronic hepatitis C, reveal infrequent or no sexual HCV transmission.14–20,25,26

Results from Asian countries indicate that interspousal transmission becomes more important with longer duration of partnership.21–23 Similar data from Western countries are rare.24–26 To evaluate the prevalence of interspousal transmission of HCV for Central Europe, we investigated the heterosexual partners of 80 referred patients with HCV viraemia and chronic liver disease in a cross-sectional study, and compared the HCV genotype among the infected couples.

Methods

From January to September 1998, spouses of 80 patients with chronic HCV-associated liver disease were screened for HCV infection at our Division of Gastroenterology at the University of Innsbruck. Chronic HCV-associated liver disease was defined as elevated liver enzymes for at least 6 months and a positive reaction in a second-generation anti-HCV assay. A total of 80 patients were enrolled: 43 men (54%) and 37 women (46%) with a mean age of 47.1 years (range 24–83). Forty-six (57.5%) had chronic persistent hepatitis, six (7%) chronic active hepatitis, 24 (30%) cirrhosis, and four (5%) hepatocellular carcinoma. The diagnoses were confirmed by liver biopsy in 54 patients (68%). In the majority of cases the aetiology and duration of HCV infection were unknown; in 38 (48%), parenteral exposure was considered to be the source of infection.

The couples completed a questionnaire addressing the occurrence of premarital non-A, non-B hepatitis or other liver diseases, history and timing of blood transfusion or injuries by needle stick, use of illicit intravenous drugs, tattoos and piercings, duration of their present marriage, sexual activity, such as weekly frequency of intercourse, various sexual practices, the use of condoms, extramarital relationships, sharing of personal hygiene implements such as toothbrush or razor, and at least weekly alcohol intake and nicotine consumption.

Serum samples from study patients and their spouses were collected and assayed for anti-HCV with a second-generation assay (Abbott Laboratories). Serum HCV RNA was detected by reverse-transcription nested polymerase chain reaction (PCR) with primers deduced from the 5'-noncoding region (Amplicor, Roche Diagnostic Systems). HCV genotypes in spouses and corresponding patients were determined by a PCR typing assay (Inno-Lipa HCV 2, Innogenetics).

Frequencies between groups were compared using the {chi}2 test and Fisher's exact test. A p value of <0.05 was considered significant.

Results

Forty-three (54%) of the 80 spouses were female, 37 (46%) were male. Their mean age was 44.6 years (range 24–81). All had a sexual relationship with the study patient. The couples were divided into six groups according to the duration of partnership: 0–5 years (n=8); 6–10 years (n=17); 11–20 years (n=17); 21–30 years (n=14); 31–40 years (n=14); and >40 years (n=10). The mean length of sexual relationship was 21.4 years; 75 couples (94%) remained sexually active, and five (6%) did not. The average rate of sexual intercourse was 1.6 times per week, estimated for the whole period of partnership. All but three couples (96%) conducted unprotected sexual intercourse (without condom), 33 (41%) reported practicing oral sex, and four (5%) anal intercourse. Nicotine consumption was recorded in 33 cases (41%), former i.v. drug abuse in nine (11%) and the mean intake of alcohol per week was about 70 g. Five partners (6%) had received blood transfusions, seven (9%) had tattoos and/or piercings, and one woman reported having suffered several needle-stick injuries in her occupation as a nurse.

Of the 80 spouses negative for hepatitis B surface antigen, four (5%) were positive for anti-HCV antibodies, of whom three (4%) were positive for HCV RNA as well. The characteristics of these study patients and their spouses are summarized in the table. One female partner tested positive for HCV antibodies but negative for HCV RNA several times; she was a former i.v. drug user, had normal levels of liver enzymes, and had no clinical or biochemical evidence of liver disease. All other spouses positive for anti-HCV had no history of premarital hepatitis or extramarital relationship. All were sexually active with the study patient, and denied using condoms or sharing personal hygiene implements.

Of the three spouses positive for HCV antibodies and HCV RNA, one suffered from cirrhosis, one from chronic persistent hepatitis and the last, although not biopsied, was considered to be an healthy HCV carrier. Their HCV genotypes were analysed and compared with those of the study patients. In two couples (2.5%) the genotypes were concordant (genotype 1b, the predominant type in Western Europe) and in one discordant. In the latter case, the partner, a nurse who had suffered several needle-stick injuries, was infected with genotype 2b, while her partner, a former i.v. drug user, was infected with genotype 3. Analysis of the questionnaires completed by the two couples with concordant HCV genotypes showed that one case involved an additional risk factor for HCV infection, namely a blood transfusion in 1996 that tested negative for anti-HCV. The other case showed no additional risk factors. A male spouse reported having had bloody sexual intercourse with his wife several times over many years. He had suffered from phimosis, which was later treated by circumcision.

There was no statistical difference in sex distribution, mean age, mean peak serum ALT level, stage of liver disease, duration of marriage, sexual behaviour, amount of alcohol and nicotine consumption or risk factors for acquiring HCV infection between study patients with anti-HCV-positive and anti-HCV-negative spouses.

Discussion

Our study finds no convincing evidence for the heterosexual transmission of hepatitis C. The HCV seroprevalence in spouses of patients with chronic HCV infection and viremia is 5%. Sexual transmission, however, appears possible in only 2.5%, due to the results of HCV genotyping. The real risk of interspousal transmission may even be half that (1.25%) when excluding spouses with concordant but additional independent risk factors for HCV infection.

During the last few years, some shifts in the epidemiological patterns of HCV transmission have been observed. In the past, transfusion of blood and blood products was the classical source of infection, but it is believed that currently, high-risk drug and sexual exposures accounts for most HCV transmissions. The source of infection is unknown in 30–40% of all HCV infections. Sexual and intrafamilial transmission have been discussed as possible routes of transmission. So far, discordant results have been reported, and the importance of sexual HCV transmission remains unclear. The controversy of previous reports is probably due to the small sample size of many studies investigating heterogeneous groups at varying risk, to the various means of testing, especially the lack of genotyping, and to geographic differences. The reported risk for heterosexual transmission is estimated at between 0% and 27%.14–18,21–28 The highest rates were reported in studies conducted in the Far East or Southeast Asia,21,22 citing a risk of between 17% and 27% for heterosexual transmission, and emphasizing older age and longer duration of marriage as the most evident risk factors. In Southeast Asia, however, the prevalence of HCV is much higher, and common external sources, such as dentistry, acupuncture or medical injections, may interfere with interspousal transmission of concordant genotypes.

In Western societies, there is little evidence to show that sexual transmission of HCV is of epidemiological importance. The few studies27,28 reporting high rates of 11% to 14% were performed with small sample sizes (n=21) and unreliable screening methods (first-generation ELISA). In contrast, there are many reports documenting a low or absent risk of sexual transmission.14–20,25,26 Some of the discrepancies in the literature among reported seroprevalence rates for groups with sexual risk factors may also be due to missing or inadequate information about additional parenteral exposure. Particularly in studies investigating the sexual risk of prostitutes, homosexual men and STD clients, accurate histories of former i.v. drug abuse may not be available.

Our study does not find an increased risk for couples for acquiring HCV. This finding is all the more significant with a view to the high percentage of long-lasting sexual partnerships (the median sexual relationship was 21.4 years) and to the high frequency of unprotected sexual intercourse. Evaluation of the questionnaires and statistical analysis revealed no risk factors for HCV transmission in the everyday life of couples. Neither sex, stage of liver disease, duration of marriage, sexual behavior nor condom use had an influence on the risk of interspousal transmission. Further special risk factors like phimosis or other conditions causing bleeding during intercourse, seem to be needed to cause sexual transmission. An example of this is couple 2 (Table 1Go) with concordant HCV genotype 1b, absent additional risk factors for HCV infection, but bleeding during intercourse.

The sample size of our trial is small, and studies on larger samples are needed to be able to draw more conclusions. However, the findings are significant and confirmed by recent results from Italy25,26 where similar HCV seroprevalences (7.3%) were found in larger sex partner studies, and sexual transmission did not seem to play a role in the intrafamilial spread of HCV infection. The risk of heterosexual HCV transmission calculated in this study is 2.5%. In the USA, the United States Public Health Service estimates that the risk of sexual transmission is approximately 5%, well below the risk of sexual transmission of hepatitis B or human immunodeficiency virus.29

In conclusion, the heterosexual transmission of HCV is possible but infrequent in monogamous sex partners of patients with HCV viraemia and chronic liver disease. The risk of sexual transmission does not seem to correlate with intensity and duration of sexual exposure.

References

1. Choo QL, Kuo G, Weiner AL, Overby LR, Bradley D, Houghton M. Isolation of a cDNA clone derived from blood-borne non-A, non-B hepatitis genome. Science 1989; 244:359–62.[Abstract/Free Full Text]

2. Kuo G, Choo QL, Alter HJ, Gitnick GL, Redecker AG, Purcell RH, et al. An assay for circulating antibodies to a major etiologic virus of human non-A, non-B hepatitis. Science 1989; 244:362–4.[Abstract/Free Full Text]

3. Alter MJ, Hadler SC, Judson FN, Mares A, Alexander WJ, Hu PY, et al. Risk factors for acute non-A, non-B hepatitis in the United States and association with hepatitis C virus infection. JAMA 1990; 264:2231–5.[Abstract]

4. Dienstag JL. Non-A, non-B hepatitis. I. Recognition, epidemiology and clinical features. Gastroenterology 1983; 85:439–62.[ISI][Medline]

5. Alter MJ. Transmission of hepatitis C virus: Route, dose, and titer. N Engl J Med 1994; 330:784–6.[Free Full Text]

6. Neumayr G, Judmaier G, Stöffler G, Dietze O, Vogel W. Die Bedeutung der Infektionswege für die Hepatitis-C-Virus-assoziierte Lebererkrankung. Z Gastroenterol 1994; 32:338–41.[ISI][Medline]

7. Nakashima K, Kashiwagi S, Hayashi J, Noguchi A, Hirata M, Kajiyama W, et al. Sexual transmission of hepatitis C virus among female prostitutes and patients with sexually transmitted diseases in Fukuoka, Kyushu, Japan. Am J Epidemiol 1992; 136:1132–7.[Abstract/Free Full Text]

8. Osmond DH, Charlebois E, Sheppard HW, Page K, Winkelstein W, Moss AR, et al. Comparison of risk factors of hepatitis C and hepatitis B virus infection in homosexual men. J Infect Dis 1993; 167:66–71.[ISI][Medline]

9. Tedder RS, Gilson RJC, Briggs M, Loveday C, Cameron CH, Garson JA, Kelly GE, Weller IVD. Hepatitis C virus: evidence for sexual transmission. Br Med J 1991; 302:1299–302.[ISI][Medline]

10. Melbye M, Biggar RJ, Wantzin P, Krogsgaard K, Ebbesen P, Becker NG. Sexual transmission of hepatitis C virus: cohort study (1981–9) among European homosexual men. Br Med J 1990; 301:210–12.[ISI][Medline]

11. Eysters ME, Alter HJ, Aledort LM, Quan S, Hatzakis A, Goedert JJ. Heterosexual co-transmission of hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Ann Int Med 1991; 115:764–8.[ISI][Medline]

12. Weinstock HS, Bolan G, Reingold AL, Polish LB. Hepatitis C virus infection among patients attending a clinic for sexually transmitted diseases. JAMA 1993; 269:392–4.[Abstract]

13. Thomas DL, Zenilman JM, Alter HJ, Shih JW, Galai N, Carella AV, et al. Sexual transmission of hepatitis C virus among patients attending Sexually Transmitted Diseases Clinics in Baltimore—an analysis of 309 sex partnerships. J Infect Dis 1995; 171:768–75.[ISI][Medline]

14. Bresters D, Mauser-Bunschoten ED, Reesink HW, Roosendaal G, van der Poel CL, Chameleau RA, et al. Sexual transmission of hepatitis C. Lancet 1993; 342:210–11.[ISI][Medline]

15. Everhart JE, Di Bisceglie AM, Murray LM, Alter HJ, Melpolder JJ, Kuo G, et al. Risk for non-A, non-B (type C) hepatitis through sexual or household contact with chronic carriers. Ann Int Med 1990; 112:544–45.[ISI][Medline]

16. Brettler DB, Mannucci PM, Gringeri A, et al. The low risk of hepatitis C virus transmission among sexual partners of hepatitis C infected hemophilic males: an international multicenter study. Blood 1992; 80:540–3.[Abstract/Free Full Text]

17. Shev S, Wejstal R, Wahl M, Hermodsson S, Norkrans G. The lack of transmission of NANB/C hepatitis between acute and chronically infected patients and their heterosexual partners. Scand J Infect Dis 1991; 23:407–11.[ISI][Medline]

18. Kao JH, Chen PJ, Yang PM, Lai MY, Sheu JC, Wang TH, et al. Intrafamilial transmission of hepatitis C virus: The important role of infections between spouses. J Infect Dis 1992; 166:900–3.[ISI][Medline]

19. Silva M, Findor A, Roach K. Prevalence of HCV infection in stable sexual partners of patients with chronic hepatitis C (CAH-C). Gastroenterology 1991; 100:A797.

20. Gordon SC, Patel AH, Kulesza GW, Barnes RE, Silvermann AL. Lack of evidence for the heterosexual transmission of hepatitis C. Am J Gastroenterol 1992; 87:1849–51.[ISI][Medline]

21. Akahane Y, Kojima M, Sugai Y, Sakamoto M, Miyazaki Y, Tanaka T, et al. Hepatitis C virus infection in spouses of patients with type C chronic liver disease. Ann Int Med 1994; 120:748–52.[Abstract/Free Full Text]

22. Kao JH, Hwang YT, Chen PJ, Yang PM, Lai MY, Wang TH, et al. Transmission of hepatitis C virus between spouses: The important role of exposure duration. Am J Gastroenterol 1996; 91:2087–90.[ISI][Medline]

23. Chayama K, Kobayashi M, Tsobuta A, Koida I, Arase Y, Saitoh S, et al. Molecular analysis of intraspousal transmission of hepatitis C virus. J Hepatol 1995; 22:431–9.[ISI][Medline]

24. Guadagnino V, Stroffolini T, Foca A, Caroleo B, Loiacono L, Giancotti A, Menniti-Ippolto F, Piazza M. Hepatitis C virus infection in family setting. Eur J Epidemiol 1998; 14:229–32.[ISI][Medline]

25. Caporaso N, Ascione A, Stroffolini T. Spread of hepatitis C virus infection within families. Investigators of an Italian Multicenter Group. J Viral Hepatol 1998; 5:67–72.[ISI][Medline]

26. Comandini UV, Tossini G, Longo MA, Ferri F, Cuzzi G, Noto P, Zaccarelli M, Visco G. Sporadic hepatitis C virus infection: a case-control study of transmission routes in a selected hospital sample of the general population in Italy. Scand J Infect Dis 1998; 30:11–15.[ISI][Medline]

27. Benamouzig R, Ezratty V, Chaussade S. Risk for type C hepatitis through sexual contact. Ann Intern Med 1990; 113:638.

28. Tor J, Llibre JM, Carbonell M, Muga R, Ribera A, Soriano V, et al. Sexual transmission of hepatitis C virus and its relation with hepatitis B virus and HIV. Br Med J 1990; 301:1130–3.[ISI][Medline]

29. Dienstag JL. Sexual and perinatal transmission of hepatitis C. Hepatology 1997; 26 (3 Suppl.1):66S–70S.[Medline]

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April 04, 2007

Fatigue and Hepatitis C

Chronic fatigue, the most commonly reported symptom of Hepatitis C infection, affects between 65 and 75 percent of those diagnosed with the disease. Learn what factors contribute to excessive tiredness and lack of energy associated with Hepatitis C, and discover what steps you can take to help manage fatigue.

by Nicole Cutler, L.Ac.

Although Western medicine has yet to find the reason behind the excessive fatigue associated with Hepatitis C, research has uncovered several contributing factors:

· Poor sleep and lack of rest
· Drug and alcohol use
· Stress and depression
· Other diseases
· Chronic pain
· Lack of exercise
· Poor nutrition
· Not drinking enough water and fluids
· Impaired immune system
· Certain medical treatments (such as interferon therapy)

The following four reasons likely play a part in HCV-related fatigue:

1. Energy Storage - Understanding the liver’s role in energy production clarifies how HCV can result in fatigue. One of its many physiological functions, the liver is intimately involved in supplying the body with energy. In addition to its well-known responsibility for filtering the blood, the liver also converts food into glucose, storing it for later use. When the body needs energy, the liver releases stored glucose to provide fuel for creating a burst of energy. By producing, storing and supplying the body with glucose, the liver is a key player in preventing fatigue. A liver unaffected by disease releases glucose between meals, or whenever the cells need nourishment and energy. While a healthy liver maintains a steady level of energy throughout the day, one hampered by advanced disease and scarring has a reduced ability to produce glucose, and less space to store it.

2. Interferon - In addition to being the preferred drug treatment for HCV, interferon therapy causes fatigue. This drug is synthesized to match one of the immune system’s naturally occurring interferons. Part of the protection mechanism against infection, interferons are proteins that help the body recognize a foreign substance. Interferon is believed to cause flu-like symptoms, including fatigue, which typically disappears once the treatment is over.

3. Ribavirin - As those who have undergone treatment with ribavirin are aware, this medication can cause anemia. A condition where the body does not have enough oxygen-carrying red blood cells, anemia causes substantial fatigue. All the cells in the body need oxygen from red blood cells to maintain their health. During HCV therapy with ribavirin, additional medications may be administered to prevent anemia from occurring.

4. Neurotransmitter-Immune Dysfunction - The continued, long-term response of the immune system to chronic Hepatitis C contributes to fatigue. The release of neurotransmitters (chemicals in the brain) is part of a healthy immune system response. When the body is physically or emotionally stressed, the immune system activates, causing the brain to release the appropriate substance for self-protection. Liver disease causes a chronic, uncontrollable stress to the patient, weakening the immune system and decreasing the release of certain neurotransmitters.

In a study led by Steven M. Kerfoot of the Immunology Research Group at the University of Calgary in Canada and published in the January 2006 issue of Hepatology, researchers determined that certain types of liver damage are associated with an immune response affecting the central nervous system. The researchers found that rats with a specific type of liver disease had decreased levels of hypothalamic corticotropin-releasing hormone (CRH), an essential neurotransmitter for activating a stress response. Implicated as a cause of clinical fatigue, scientific studies have found a defect in CRH in people with chronic fatigue syndrome.

Managing Fatigue
Fatigue is a very real and problematic symptom of HCV. While certain lifestyle factors can reduce its impact, most people with Hepatitis C must learn how to manage their fatigue. Being informed about the detrimental effects of alcohol, drug use, poor sleep, dietary habits and a highly stressful life can empower the individual to make positive lifestyle changes. In addition to making healthful lifestyle decisions to reduce fatigue, these changes will also support the liver and strengthen the immune system.

By stepping outside the confines of Hepatitis C’s possible causes of fatigue, scientists have teamed with nutritionists to develop a novel approach to this problem. Through evaluating how to best support the body’s production of energy on a cellular level, researchers found that the energy-producing parts of a cell, the mitochondria, function best when their membrane is fully intact. Combining several nutritional ingredients capable of restoring the mitochondria membrane, NT Factor has been proven to improve energy levels. While taking an all-natural nutritional product for energy restoration must be discussed with a physician, this effective approach has helped many exhausted Hepatitis C sufferers.

In addition to traditional healthful lifestyle approaches, balancing daily activities can help manage fatigue. The following are some helpful tips:

· Try to avoid overloading your day with a busy schedule by prioritizing necessities.
· Work at the time of the day when you feel your best and arrange to do things then.
· When possible, conserve your energy by sitting down to perform activities you typically do while standing.
· Rather than trying to sleep when you are fatigued, rest or do a lighter, easier activity since you will regain more energy from this sort of break.
· Pace yourself by including regular breaks in your day.
· Pass on large, heavy meals in favor of smaller, more frequent ones.
· Since hot temperatures can be draining, take warm showers.
· Establish a pre-sleep routine at night to wind-down and prepare your body for sleep.

If you have HCV and are fatigued, you are not alone. Fortunately, you do have options. Reclaim your energy by supporting your liver and immune system through healthful lifestyle changes and be sure to discuss nutritional supplements containing NT Factor with your physician. While the power to rid yourself of HCV may be just beyond your grasp, you do have the ability to help your body overcome fatigue.

References:

Piche, T, et al., Fatigue is associated with high circulating leptin levels in chronic hepatitis C, Gut, 51, 2002.

www.eurekalert.org, Understanding Fatigue in Chronic Liver Disease, AAAS, 2007.

www.hcvadvocate.org, Easy C Facts, Hepatitis C Support Project, April 2005.

www.hcvadvocate.org, Hepatitis C and Fatigue, Peter Hauser, MD, Hepatitis C Support Project, 2007.

www.healthlink.mcw.edu, Hepatitis C – Or Its Treatment – Can Cause Fatigue, Julie L. Mitchell, MD, MS, Medical College of Wisconsin, 2007.

www.hepatitisc.org.au, Fatigue and HCV, Hepatitis C Council of NSW, March 2004.

www.hepnet.com, Fatigue as a Symptom of Liver Disease, Mark G. Swain, MD, Schering Canada, Inc., 2007.

www.hepnet.com, Understanding how your Liver Works, John Lauerman, Schering Canada, Inc., 2007.

www.natap.org, Fatigue, HCV/HIV Coinfection, Transmission, Disease Progression & Interferon, David Bernstein, MD, National Aids Treatment Advocacy Project, 2007.

www.webmd.com, Managing Hepatitis C, WebMD, Inc., 2007.

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March 29, 2007

How Mothers May Infect Their Children with HCV

Studies show that up to one in ten mothers infected with the Hepatitis C virus are likely to transmit the infectious disease to their children. Learn how much the risk of transmission increases when the mother is also infected with HIV.

Derek Thaczuk, Thursday, March 29, 2007

http://www.aidsmap.com

A new meta-analysis has confirmed that the mother-to-child transmission risk for hepatitis C virus (HCV) nearly doubles for mothers who are HCV/HIV coinfected. In coinfected mothers with detectable HCV viremia, the risk is nearly tripled. The results, published in the April 15th issue of Clinical Infectious Diseases, confirm those of a 2003 meta-analysis by another researcher.

Rates of vertical (mother-to-child) transmission of HCV range from 4 to 10%; mothers coinfected with HIV are more likely to transmit HCV to their child. An earlier meta-analysis (Pappalardo, 2003) determined the odds ratios for HIV-coinfected compared to HIV-negative mothers as 2.82 (95% CI, 1.78 to 4.45, p=.00001) for HCV antibody-positive women, and 1.97 (95% CI, 1.04 to 3.74, p=.04) for women with HCV viremia (detectable HCV in the blood).

Researchers from Johns Hopkins University School of Medicine have now performed a similar meta-analysis including two large studies not published at the time of the Pappalardo review. One of these – the European Pediatric Hepatitis C Virus Network (EPHN) study – is the largest such cohort to date, including 1479 babies.

The team’s conclusions were drawn from a restricted analysis that they believed provided the most reliable estimate (details below). According to this analysis, vertical transmission was 1.9 times more likely for HIV/HCV coinfected mothers than for HCV-infected mothers without HIV (95% confidence interval, 1.36–2.67). For coinfected mothers with detectable HCV viremia, the risk was 2.82-fold greater (95% CI, 1.17 to 6.81) than for HIV-negative mothers without HCV viremia.

Much of the Johns Hopkins report details the methodology of how studies were selected for the meta-analysis. The original literature review found 243 “potentially relevant” published articles (conference abstracts were not considered). From these, the team selected only results published in English which (among other criteria) presented original data, compared coinfected with HCV-monoinfected women, and included at least 20 coinfected women. This left only ten (mostly European) studies, published between 1993 and 2005 (Lam, 1993; Zanetti, 1995; Paccagnini, 1995; Zuccotti, 1995; Tovo, 1997; Zanetti, 1998; Granovsky, 1998; Resti, 2002; Rerrero, 2003; EPHN, 2005). All but one of these were prospective cohorts, yielding a total of 4424 mother/child pairs, 19.4% of which included coinfected mothers.

However, the investigators felt that the “most reliable estimate” came from an even more restricted pool – the five studies with sample sizes of at least 50. The odds ratio for coinfected mothers, calculated from the ten originally selected studies, was 2.75 (95% CI, 1.51 to 4.99). However, analysis indicated that the estimates in this group were “heterogeneous and ideally should not be pooled”. The lack of comparability was ascribed to “a lack of standardised HCV diagnostic criteria and the inability to control for known confounders” – such as selection bias, loss to follow-up, and means of delivery (Caesarean vs. live birth). The researchers therefore analysed various subgroups of the ten studies, leading to the 1.9-fold odds ratio drawn from the five studies (Paccagnini, Tovo, Granovsky, Resti, and EPHN) which “showed low heterogeneity, and were of better overall quality.”

Despite the similarity to the 2003 findings, the report concludes that more research is still required, particularly calling for “large studies that control for potential known confounders, use clear selection criteria … and employ standardized HCV testing[.]”

References
Polis CB et al. Impact of maternal HIV coinfection on the vertical transmission of hepatitis C virus: a meta-analysis. Clin Inf Dis 44:1123-1131, 2007.

Pappalardo BL. Influence of maternal human immunodeficiency virus (HIV) co-infection on vertical transmission of hepatitis C virus (HCV): a meta-analysis. Int J Epidemiol 32:727-734, 2003.

Posted by Editors at 11:24 AM --- Printer-friendly version

How Your Immune System Can Help Defeat Hepatitis C

Eighty-five percent of HCV patients develop chronic Hepatitis C. The remaining 15 percent have acute Hepatitis C, which spontaneously resolves within weeks or months. Learn how the health of your immune system determines whether the virus progresses to advanced liver disease and what you can do to help support your immune system.

by Nicole Cutler, L.Ac.

Our defense against bacteria and viruses, the immune system is essential in maintaining health. The strength of our immune system is one factor that determines whether Hepatitis C becomes of an acute case or develops into a chronic illness.

Hepatitis C’s extraordinary ability to evade the body’s immune system has been the focus of countless medical studies. Researchers at Johns Hopkins University School of Medicine have discovered how the genetic changes resulting from Hepatitis C infection allow it to avoid destruction by the body’s immune system.

Two Ways, Two Sites
Scientists have found that HCV is programmed to change form in two different ways, at two different sites. The genetic material under attack by immune cells evolves to weaken the immune system, while genetic material at different sites reverts back to an ancestral, or original, genetic code. This dual morphing capability of the Hepatitis C virus is why it is so challenging for the immune system to destroy. The infection becomes chronic when the virus evades immune cells and establishes itself in the body. At this point, the immune system becomes weakened and ineffective against Hepatitis C. For the millions of people in this position, their best defense against progression of the disease is by supporting and strengthening their immunity.

According to Hopkins study investigator, associate professor and infectious disease specialist, Stuart Ray, MD, "We think this piecemeal exchange is helping the virus evade the body's immune system. In a newly infected person, the virus may need to adopt new mutations to escape recognition by the immune system's T cells, which fight infection, but it may need to lose the mutations that had protected it in someone else. Despite pressure to change, the virus is always restoring its shape."

Ancestral Genetic Sequence
Hepatitis C demonstrates amazing self-modification capability. When the danger dissipates, the virus returns to its original form. The Johns Hopkins investigators found that when the immune response weakened, the Hepatitis C virus naturally mutated back to its preferred state. During the acute phase of infection, the virus is under severe pressure from the body’s immune response, forcing it to mutate. However, this change appears to be reversible. Once the virus successfully evades a particular immune cell, its amino acids revert back to its original sequence.

Fast Reproduction
According to the lead author of one of the studies, assistant professor at Hopkins and infectious disease specialist, Andrea Cox, MD, PhD, “The Hepatitis C virus naturally mutates, or alters its genome, very rapidly. For example, its strains have two to three times more genetic variability than HIV, the virus that causes AIDS, and Hepatitis C reproduces over 100 billion times per day, 100 times faster than HIV. Compounding the problem, Hepatitis C infection is asymptomatic in the early stages, making it less likely that diagnosis will be made early, when it is easiest to treat.” The speed at which Hepatitis C is capable of reproducing poses an additional challenge to stopping the virus dead in its tracks.

Darwin’s Prodigy
Charles Darwin, the father of evolution comprehension, put forth the concept that the Hepatitis C virus closely follows. The well-known phrase, “survival of the fittest,” is applicable to this virus’ lifecycle. The Hepatitis C virus' genetic material changes in ways that make it more reproductively "fit" in the face of each immune system it encounters. The virus changes to evade the immune system in one host, then restores itself when the pressure is off.

Good News
The silver lining in discovering Hepatitis C’s mastery of transformation is the insight it provides researchers working to defeat the virus. In response to this research, scientists have identified Hepatitis C’s chain of amino acids, its ancestral genetic code. Having this code is a critical to genetic biologists in developing a potential vaccine.

Maintaining strong immunity means paying attention to your body and incorporating healthful lifestyle choices into your routine. In general, experts recommend the following tips for a healthy immune system:

· Get Sufficient Sleep – The immune system is replenished during the deep stages of sleep.

· Wash Your Hands – Keeping your hands clean will reduce stress on the immune system by minimizing the microbes it must constantly battle.

· Follow a Balanced, Nutritious Diet – Eating well provides your immune system with the tools it needs to be in tip-top shape. Avoid sugar and the processed foods that harm immunity by suppressing crucial immune cells. If need be, consult a nutritionist for proper guidance.

· Avoid Toxins – Items toxic to your immune system include alcohol, cigarettes, chemicals and pollution. Toxins slow down and weaken the immune response. Consider an antioxidant and natural detoxifier such as Liv.52 to neutralize the toxins you encounter every day.

· Reduce Stress – Finding ways to minimize stress reduces stress-related hormones from weakening the immune system.

· Supplement – Consider supplementing your diet with a safe, energy enhancement solution product such as Fatigue Relief Plus. In addition to naturally replenishing energy to overcome the fatigue associated with HCV, it provides vitamins, minerals and probiotics to strengthen the body’s immune system.

Keeping your immune system as strong as possible is the key to longevity. Whether you are virus-free or not, fortifying your defenses can make the difference between developing acute or chronic viral hepatitis, as well as preventing liver disease progression.

References:

Gremion C, Cerny A, Hepatitis C Virus and the Immune System: A Concise Review, Reviews in Medical Virology, July/August 2005.

www.businessweek.com, Waging War on Hepatitis C, John Carey, McGraw Hill Companies, February, 2006.

www.hcvadvocate.org, The Role of the Immune System in Determining Viral Outcome After Hepatitis C Viral Infection, Jose Azocar, MD, DS, Hepatitis C Support Project, 2006.

www.medicinenet.com, Hepatitis C, MedicineNet, Inc., 2006.

www.medicalnewstoday.com, How Hepatitis C Virus Evades Immune System in Acute and Chronic Infections, Johns Hopkins Medical Institutions, June 2005.

www.sciencedaily.com, Study Details Hepatitis C Ability to Block Immune System Response, Scripps Research Institute, May 2006.

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March 23, 2007

Night Sweats: Another Approach to this Common HCV Symptom

Night sweats are a common symptom of chronic Hepatitis C infection. Though Western medicine has neither a concrete explanation nor a solution, Traditional Chinese Medicine has ways of dealing with this uncomfortable symptom. Learn more about the causes of night sweats and what you can do to manage and minimize their impact.

by Nicole Cutler, L.Ac.

Chronic Hepatitis C presents many different symptoms in its patients, such as fatigue, abdominal pain, nausea, jaundice, muscle aches, and night sweats. Individuals who suffer from night sweats may awaken in the middle of the night either feeling too cold or too hot, their palms clammy and their bed sheets wet with perspiration. Night sweats can disrupt sleep, causing stress and insomnia. For an illness without a cure, the only resolution of night sweats for people with Hepatitis C is the eradication of the virus. A common symptom for people with chronic Hepatitis C and a wide range of other health disorders, Western medicine does not have a cure for night sweats. However, Traditional Chinese Medicine (TCM) recognizes night sweats as a specific dysfunction and addresses it accordingly.

Perspiration is how the body regulates its temperature. Controlled by the sympathetic nervous system, sweating can occur with any bio-thermal activity. The quantity of sweat and the speed it is expired through the body’s 200-500 million pores depends primarily on these five factors:

1. Temperature
2. Moisture
3. Wind
4. Physical health
5. Emotional status

Proposed Causes
While the physiological explanation for night sweating is widely debated, most experts believe the cause to be one of the following:

· Infectious Diseases – Hepatitis C falls under this category, as does HIV and tuberculosis. Any infectious disease bringing on a fever can cause night sweats.

· Menopause – The hormonal changes causing menopause in women is the most common cause of night sweats. However, some men also suffer from night sweats during the male menopause (andropause).

· Diabetes Insipidus – Night sweats are often a symptom of diabetes. Other metabolic conditions have also been associated with night sweating.

· Sleep Apnea – When accompanied by severe snoring and excessive daytime sleepiness, night sweats can be a sign of sleep apnea.

· Alcohol, drugs and spicy foods – Consumption of any of these can cause night sweats. Some recreational and prescription drugs can both potentially cause night sweats.

· Hot and humid environment – Sleeping in a hot room or with blankets that are too warm can cause overheating, resulting in night sweats.

Approaches
Western medicine advises approaching night sweats based on their cause. Since HCV is currently an infectious disease without a cure, this approach provides little relief. Below are some practical tips on managing night sweats:

· Avoidance – Avoid alcohol (this is a given with liver disease), cigarettes, recreational drugs, spicy foods, caffeine and sugar. All of these can raise body temperature.

· Drug check – Talk with your doctor about your medications to see if they could be contributing to night sweating.

· Cool down – Keep your bedroom cool. If weather permits, keep a window open, or try using a fan. However, avoid a draft directly on you.

· Shower – Taking a cool shower before bed may lower body temperature enough to prevent an attack of night sweats.

Traditional Chinese Medicine perceives night sweating as an indication of a person’s state of health. According to Chinese medical theory, night sweats are associated with an imbalance of yin, where body fluids and nutrients are depleted.

In TCM, the well-known yin-yang symbol is the embodiment of balance. Although they represent opposite forces, there can be no yin without yang, and vice versa. Yin is the material basis for yang. Yang is the functional manifestation of yin. The three most relevant properties of yin are as follows:

1. Cools – Due to its fluidity, yin cools the body and maintains an even body temperature.

2. Nourishes – Yin supplies nourishment to the body at all levels.

3. Provides rest – When in balance with yang, yin enables us to use our energy efficiently, recover easily from fatigue and preserve health.

In cases of chronic disease, particularly when the liver is affected, the proportion of yin to yang diminishes. Symptoms of yin deficiency include night sweats, fatigue, restlessness, insomnia, flushed cheeks, warm palms and soles, a dry mouth, red lips, and low-grade afternoon fevers. Therefore, TCM approaches night sweats by fortifying yin. Those trained in TCM utilize a variety of techniques and/or herbal prescriptions to tonify the yin. Countless case studies document night sweats disappearing under the care of a TCM practitioner. Although less potent than acupuncture or Chinese herbs, consuming the following foods can also help fortify yin:

· Grains – barley, millet
· Beans – adzuki beans, kidney beans, black beans, black soya beans, mung beans
· Protein – eggs, beef, pork, duck, oyster, clams, crab, octopus, fish
· Flavorings – sesame seeds, black sesame seeds, walnuts
· Vegetables – asparagus, artichokes, peas, regular and sweet potatoes, seaweed, yams, tomatoes
· Fruits – apples, pears, pomegranates, watermelon, bananas, avocadoes

Approximately 50 percent of people with Hepatitis C can successfully rid themselves of the virus with current western medical treatments. TCM can provide a new approach to those who continue to experience night sweats as a result of the disease. Although Traditional Chinese Medicine does not claim to rid the body of HCV, seeing a qualified practitioner or following TCM dietary advice as outlined here can put an end to this uncomfortable symptom.

References:

www.acupuncturetoday.com, Hepatitis C Virus: The Silent Epidemic, Part Two, Misha Cohen, OMD, L.Ac., Acupuncture Today, October 2002.
www.digitalnaturopath.com, Night Sweats, The Analyst, 2007.

www.comoxvalleyacupuncture.com, Dietary Principles According to Traditional Chinese Medicine, Comox Valley Acupuncture, 2007.

www.patients.uptodate.com, Approach to the Patient with Night Sweats, Gerald W. Smetana, MD, UptoDate, 2007.

www.sleepdisorders.about.com, How to Cope with Night Sweats, About, Inc., 2007.

www.sleepingdisorder-abc.com, Sweating Sleep: What It Means When You Have Night Sweats, Sleeping Disorder ABC, 2007.

www.thebody.com, Treating Night Sweats with Herbs, Dr. Qingcai Zhang, The Body, 2007.

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March 20, 2007

Update to Previous News Item: Politician Passes Away

Immediately upon sending the most recent Research and Treatment News Update earlier today, we learned of the unfortunate news that New York Assemblyman Kenneth Zebrowski passed away Sunday morning. Join us in sending our heartfelt condolences to the Assemblymen's family during this difficult time. In addition to learning more about Mr. Zebrowski's public service career, read on to find information regarding funeral arrangements for those who wish to pay their respects to this honored politician.

www.thejournalnews.com
Assemblyman Zebrowski dies at 61
By Suzan Clarke

Assemblyman Kenneth P. Zebrowski died yesterday morning at Nyack Hospital after a battle with hepatitis C.

The cause was a combination of liver and kidney failure, according to the family.

Zebrowski, 61, was "a force of nature," said Rockland County Legislature Chairwoman Harriet Cornell, who knew him for more than 35 years.

"I think his family was just so important to him, and he really was very, very loyal to friends and ... he really loved the art of governing," Cornell said. "It was just something he really loved, and I think he'd been very, very happy in the New York state Assembly."

Zebrowski, of New City, was first elected to the county Legislature in November 1973 at age 29 and was then the youngest member of the body. That began a 33-year career in elected office.

Representing the 5th District, which includes New City and part of the Mount Ivy area in Haverstraw, he served in the county Legislature for 21 years, including four years as chairman and two years as majority leader.

During his tenure, he was chairman of the Budget and Finance Committee and led a panel of legislators that investigated alleged misuse of authority by trustees at Rockland Community College.

In 2003, when Zebrowski was running for his fifth term on the county Legislature, he cited among his accomplishments co-sponsoring a law that banned the sale of ephedra in Rockland and helping pass laws to protect open space and waterways.

Zebrowski was first elected to the Assembly in 2004, representing the 94th District, which covers Clarkstown, Haverstraw and parts of Ramapo.

He ran unopposed after former Assemblyman Alexander Gromack left the race to take the Clarkstown town supervisor position.

While running for his second term in the Assembly, the senior Zebrowski said that the health and welfare of senior citizens were his top priority and that he was working with state Sen. Thomas Morahan, R-New City, on getting help for those affected by the Mirant tax challenge.

One bill he sponsored allows seniors to bypass automated telephone menu systems when dealing with medical insurance companies.

He served on the Assembly's Aging, Codes, Corporations, Authorities and Commissions, Governmental Employees, Judiciary, and Racing and Wagering committees.

Zebrowski twice ran unsuccessfully for state senator - once in a special election in 1999 and again in 2000. Both times were against Morahan.

In spite of their respective political affiliations, the men had a long friendship that began when both were Rockland County legislators.

"We served on two different sides of the aisle in the local Legislature, but it was always with respect for each other, and we always strove for a consensus and a compromise, so that we could get a result, and working together we got much done," Morahan said.

"When he came to Albany, we worked together on bills. ... We did a lot together. He was a pleasure to work with, and this is a very, very sad day.

"I think Rockland County lost a great spokesperson, a man who loved his job and loved being a legislator and loved writing laws. He was a wonderful man, and we'll miss him."

Morahan talked with Zebrowski a few days ago. The conversation was jocular, reflecting their need to keep their spirits up, Morahan said.

"It's hard to describe the emotion and the words that may have passed between us," he said. "They were from my side, encouragement, and from his side, he was fighting. He was fighting to get better."

Jeffrey Adams of Haverstraw called Zebrowski a mentor, colleague and friend who was always willing to help everyone.

"I'm numb, because even though I heard he was in ill health, and I spoke with him several days ago, Kenny was going to be back, and everything was going to be fine, and he was a battler, and he never quit," said Adams, an attorney.

In an interview with The Journal News in 1975, Zebrowski described having worked, while as a high school and college student, as a busboy, then waiter, then dining room manager, at Dellwood Country Club in New City.

He had complained to his father about how hard he labored and what little recognition he got.

"You get paid to do a good job, not a bad one," he recalled his father, Vincent, saying to him.

"I really am in love with the law," he said later during that interview. "I know that's about as corny as you can get, but I really think it gives you perspective on people's lives."

In 1973, he underwent surgery to remove a benign tumor from his brain lining.

A Roman Catholic who has supported funding for Planned Parenthood, Zebrowski has said his views on abortion were "his own" and that he didn't believe he had a right to legislate other people's outlook on the issue.

Zebrowski began missing Assembly votes in late February and was listed as "EOR," meaning he was excused for other reasons than legislative business.

The last session for which he was present for all votes was Feb. 14.

He underwent a procedure March 2 to treat the hepatitis and also was being treated for a blood clot in his leg.

Vince Monte, the chairman of the Rockland Democratic Committee, said he was saddened by Zebrowski's death.

"Quite frankly, I'm going to miss the discussions of politics and government," Monte said. "I'm really going to miss him, and reminiscing about our time when we came up as young Democrats."

Zebrowski was born on Nov. 12, 1945, in Brooklyn.

He is survived by his wife, Linda; children Kristen, Kevin, Kenneth P. Jr., Kristopher, Kraig and Kathryn; his mother, Jean Zebrowski; and a sister, Ronnie Horn.

His father, Vincent, died in 1989.

Calling hours will be from 2 to 4 and 7 to 9 p.m. Wednesday and Thursday at Michael J. Higgins Funeral Home, 321 S. Main St., New City.

A funeral Mass will be at 10 a.m. Friday at St. Augustine's Church, South Main Street, New City.

Zebrowski's local Assembly office will remain open today, spokesman Keith Braunfotel said.

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March 15, 2007

How Hepatitis C Can Affect a Patient's Sex Life

While some chronic Hepatitis C patients maintain normal sexual function and a healthy interest in sex, many experience reduced libido, erectile dysfunction and diminished sexual satisfaction. Learn how Hepatitis C impacts the sex lives of both men and women and how opening up about these issues can help improve patients' quality of life.

by Nicole Cutler, L.Ac.

Hepatitis C is commonly accompanied by fatigue and depression, followed by a decreased interest in sex. Additionally, antiviral medications typically used to battle Hepatitis C may cause sexual dysfunction and decreased libido. Sexual dysfunction is the most frequently encountered side effect of many antidepressant medications used to treat the depression and anxiety associated with Hepatitis C combination treatment. When discontinued, the medication-induced sexual dysfunction typically vanishes. Due to its prevalence in chronic Hepatitis C patients, openly discussing sexual problems with a physician can help identify if the source is the disease, prescribed medications or some other condition.

Studies
Although no large-scale clinical trials have been conducted proving that the Hepatitis C virus (HCV) directly causes sexual dysfunction, many patients report an association between the two. The following two studies demonstrate a relationship between sexual dysfunction and Hepatitis C:

1. A study published in the June 2006 issue of American Journal of Gastroenterology investigated the prevalence of sexual dysfunction among men with chronic HCV infection and evaluated its impact on health-related quality of life. After evaluating 350 participants, researchers concluded “…Our study demonstrates a strong association between chronic HCV infection and sexual dysfunction among men in the United States. Men with chronic HCV infection had markedly reduced sexual function in all the five domains evaluated (sex drive, erectile function, ejaculation, sexual problem assessment and overall sexual satisfaction) compared to HCV-uninfected controls…”

2. A study published in the February 2005 edition of Journal of Endocrinology evaluated sexual dysfunction in men with chronic HCV on antiviral therapy. Researchers found that testosterone levels decreased significantly during antiviral therapy, closely correlating with decreased libido and sexual function. Additionally, depression increased during interferon therapy, a condition also associated with sexual dysfunction.

Hormone Changes
Hepatitis C infection also contributes to advanced liver disease which can alter levels of hormones. Approximately two percent of middle-aged men experience decreased sexual interest and erectile dysfunction. This percentage remains consistent both in men without liver disease and those in the early stages of liver disease. However, men with advanced liver disease are more likely to experience the following conditions related to changes in hormone levels:

· Testicular dysfunction
· Loss of body hair
· Gynecomastia (enlarged breasts)
· Redistribution of body fat
· A female configuration of pubic hair
· Decreased muscle mass
· Decreased sexual desire
· Erectile dysfunction

The male sex hormone (testosterone) is typically lowered with advanced liver disease, while the female sex hormone (estrogen) typically increases. Because alcohol abuse further lowers testosterone levels, alcoholic men with Hepatitis C who have progressed to advanced liver disease are particularly vulnerable to sexual dysfunction issues.

Women
Women with chronic Hepatitis C commonly complain of vaginal dryness, which typically results in decreased sexual interest. The majority of women with Hepatitis C who experience pain during intercourse, vaginal irritation, vaginal burning and itching are on interferon and ribavirin therapy. Discomfort may be severe when combined with atrophic vaginitis, a condition common when estrogen levels decline, such as in postmenopausal women. While a topical estrogen and progesterone cream can improve or alleviate the dryness, oral estrogen supplements should only be taken under a physician’s close supervision. Whether in the form of natural soy estrogen or oral estrogen supplements, estrogen supplementation carries the following risks to women with liver disease:

· Worsening jaundice
· Cholestasis
· Hepatitis

Regardless of your gender or whether or not you are undergoing combination therapy, living with Hepatitis C can spawn sexual dysfunction. Even though it is a subject that most of us prefer to avoid, speaking up on impaired sexual function or interest can prompt your physician to re-evaluate your liver management plan. Since a healthy sex life is one expression of physical, spiritual and emotional health, supporting this component can dramatically increase someone’s quality of life. By discussing this sensitive topic, people with Hepatitis C can get the help needed to reclaim this most basic part of being human.

References:

Jensen SB, Gluud C, Sexual dysfunction in men with alcoholic liver cirrhosis, Liver, April 1985.

M R Krauss, et al., Sexual dysfunction in males with chronic hepatitis C and antiviral
therapy: interferon-induced functional androgen deficiency or depression?, Journal of Endocrinology, February 2005.

www.liverdisease.com, Sex and Liver Disease, Melissa Palmer, MD, 2007.

www.natap.org, Sexual Dysfunction is Highly Prevalent Among Men with Chronic Hepatitis C Virus Infection and Negatively Impacts Health-Related Quality of Life, The American Journal of Gastroenterology, Ann Danoff, MD, et al, June 2006.

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Hepatitis C's Other Symptoms

Although most people with chronic Hepatitis C do not exhibit symptoms of the "silent" epidemic, a significant number will experience its impact in organs other than their liver. Learn how to recognize these lesser-known conditions to help in the early detection and treatment of Hepatitis C.

by Nicole Cutler, L.Ac.

Many people infected with the Hepatitis C virus have no symptoms. Even if the person has been infected with Hepatitis C for a long time, no symptoms of the disease may present themselves until cirrhosis has developed. When symptoms are present, they can range from mild to severe. The most common symptom of chronic Hepatitis C is fatigue. Additional common symptoms of Hepatitis C include:

· Intermittent abdominal pain
· Reduced appetite and weight loss
· Nausea or vomiting
· Depression
· Jaundice – yellowing of the skin or whites of the eyes
· Low-grade fever
· Muscle aches
· Pale or grey colored stool
· Dark urine
· Generalized itching
· Ascites
· Bleeding varices – dilated veins in the esophagus

Extrahepatic Manifestations
People with Hepatitis C may exhibit symptoms and signs of infection that manifest in organs other than the liver. Known as extrahepatic manifestations, or immune-complex mediated diseases, these symptoms arise from the immune system’s effort to fight off the infection. Chronic Hepatitis C infection leaves people vulnerable to the development of diseases involving the kidneys, the skin, eyes, joints, immune system and the nervous system. The occurrence of an extrahepatic manifestation does not correlate with the severity of the underlying liver disease. The following associated conditions are the most commonly seen as a result of liver disease:

1. Cryoglobulinemia – This condition is due to the presence of abnormal antibodies (called cryoglobulins) that come from Hepatitis C virus stimulation of lymphocytes (white blood cells). These antibodies can deposit in small blood vessels, thereby causing inflammation of the vessels (vasculitis) in tissues throughout the body. The skin, joints and kidneys (glomerulonephritis) are often targets of the vasculitis.

People with cryoglobulinemia can present a variety of symptoms, including weakness, joint pain or swelling (arthralgia or arthritis), and a raised, purple skin rash (palpable purpura) usually in the lower portion of the legs. As well, people may experience swelling of the legs and feet due to loss of protein in the urine from the kidney involvement and nerve pain (neuropathy). What is more, this vascular condition can spawn Raynaud’s phenomenon, in which the fingers and toes turn color (white, then purple, then red) and become painful in cold temperatures.

2. B-cell non-Hodgkin's lymphoma – This cancer of the lymph tissue is associated with the chronic Hepatitis C virus. Its cause is believed to be excessive stimulation by the Hepatitis C virus of B-lymphocytes, resulting in the abnormal reproduction of the lymphocytes. Most individuals with Hepatitis C virus-associated non-Hodgkin’s lymphoma will require standard anti-cancer therapies.

3. Porphyria cutanea tarda (PCT) – PCT is a skin condition characterized by the overproduction of enzymes involved in the manufacturing of blood. People with PCT often have blisters and vesicles form on the back of the hands, forearms and neck, as well as the face. Lesions develop in areas exposed to the sun or have sustained minor trauma. Increased facial hair and pigmentation changes are also common. Major risk factors for the development of PCT include excessive iron exposure, heavy alcohol use, and the use of estrogens.

4. Lichen planus – A skin condition, Lichen planus appears as shiny, flat-topped bumps that often have an angular shape. This rash can occur anywhere on the skin, but often favors the inside of the wrists and ankles, the lower legs, back and neck. The mouth, genital region, hair and nails are affected in some individuals. Thick patches may occur, especially on the shins. About 20 percent of those affected with lichen planus of the skin experience minimal symptoms and need no treatment. However, in many cases the itching can be constant and intense.

5. Diabetes mellitus – An increasingly common metabolic disorder, diabetes mellitus is characterized by resistance to insulin, the hormone that regulates the amount of sugar in your blood. The accompaniment of Hepatitis C with diabetes is strongly associated with advanced liver fibrosis or cirrhosis. People with cirrhosis are believed to have decreased hepatic uptake of glucose, along with reduced hepatic clearance of insulin, leading to high levels of insulin and, therefore, insulin resistance syndrome.

Other conditions noted to be associated with Hepatitis C infection, include:

· Thyroid disease
· Kidney disease, especially Membranoproliferative Glomerulonephritis (MPGN)
· Vitiligo
· Arthritis
· Sjogren’s syndrome
· Mooren’s ulcer
· Neuropathy

While Hepatitis C is perceived as a virus attacking only the liver, clinical practice proves that its ramifications extend beyond solitary hepatic involvement. Perhaps due to the liver’s involvement in nearly every aspect of health, Hepatitis C is a systemic problem. The wide range of possible manifestations of this virus should signal increased public education for earlier diagnosis and treatment of Hepatitis C. Additionally, understanding the commonality between conditions associated with Hepatitis C can help a person suffering with multiple ailments recognize the likely origin of their extrahepatic manifestations.

References:

www.aocd.org, Lichen Planus, American Osteopathic College of Dermatology, 2006.

www.ccjm.org, Hepatitis C Infection: A Systemic Disease with extrahepatic manifestations, Aman Ali, MD, Nizar N Zein MD, Cleveland Clinic Journal of Medicine, November 2005.

www.hcvadvocate.org, Extrahepatic Manifestations of Chronic Hepatitis C, Roderick Remoroza, MD, Herbert Bonkovsky, MD, Hepatitis C Support Project, 2003.

www.idph.state.il.us, Health Beat: Hepatitis C, Illinois Department of Public Health, 2006.

www.medicinenet.com, What Conditions Outside the Liver are Associated with Hepatitis C?, Tse-Ling Fong, MD, MedicineNet, Inc, 2006.

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New Drug Being Tested to Prevent HCV Recurrence

The percentage of liver transplant patients who experience Hepatitis C recurrence is extremely high. The Mayo Clinic Transplant Center is currently conducting research on Civacir, a potential drug therapy that could inhibit the return of HCV.

www.allamericanpatriots.com

Mayo Clinic Tests New Drug to Prevent Hepatitis C Recurrence after Liver Transplant

March 08, 2007 -- ROCHESTER, Minn. -- The Mayo Clinic Transplant Center is studying whether Hepatitis C Immune Globulin (Human), an investigational drug candidate known as Civacir, prevents the recurrence of hepatitis C-related liver disease in liver transplant patients.

Mayo Clinic sites in Arizona, Florida and Minnesota are looking for adults to participate in this study. Eligible participants must have hepatitis C and need a liver transplant. Individuals who have liver cancer may participate.

Hepatitis C is a liver infection caused by the hepatitis C virus (HCV). Each year approximately 6,000 liver transplants are performed in the United States, and more than 2,000 of those are due to HCV. There are no approved or effective treatments for HCV-positive liver transplant patients or patients who receive HCV-positive livers.

"The clinical need for hepatitis C prevention in liver transplant patients is great," says Michael Charlton, M.D., medical director of the liver transplant program at Mayo Clinic's campus in Rochester, Minn. "HCV recurrence for liver transplant patients is nearly 100 percent. Five years after transplantation, one-third of re-infected patients either pass away, get re-transplanted or experience cirrhosis from HCV."

Civacir is a human-pooled antibody product created from blood and serum donated by individuals who have HCV antibodies. The idea for this potential therapy for hepatitis C came from an unexpected result of a similar human antibody drug for hepatitis B, known as HBIG.

"Prior to the discovery of hepatitis C in 1988, HBIG unknowingly included hepatitis C antibodies," says Dr. Charlton. "A retrospective study of approximately 200 patients who received HBIG found that in addition to preventing hepatitis B, it also prevented hepatitis C in about half of the cases."

The Mayo Clinic study will test whether Civacir can prevent HCV recurrence after liver transplant.

More than 400 patients receive liver transplants at Mayo Clinic's three sites each year. Mayo Clinic is the most experienced liver transplant center in the nation, with some of the highest survival rates in the world.

For more information on eligibility requirements and the screening process for this study, contact Kristin Eggebraaten, Mayo Clinic liver transplant referral coordinator at 1-507-538-5908.

Civacir is a product of NABI Biopharmaceuticals and Kedrion S.p.A.

Source: Mayo Clinic

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March 08, 2007

Can Saliva Transmit Hepatitis C?

With over 5 million Americans infected, the Hepatitis C virus is the most common cause of liver disease today. Although it is believed to be primarily transmitted through blood to blood contact, there are indications that other means of contracting Hepatitis C are possible. Of primary interest to those concerned with the number one cause of liver disease is the possibility of transmitting Hepatitis C via saliva.

by Nicole Cutler, L.Ac.

As the most common chronic blood borne infection in the United States, the concentration of Hepatitis C virus in a drop of infected blood is exponentially higher than the concentration of HIV in a drop of infected blood. This explains why it is important to avoid anything that could possibly be tainted with any amount of blood. While not normally found in urine, semen, vaginal/cervical fluids, feces or saliva, injury or illness may cause some of these substances to be contaminated with blood.

In nearly half the cases of Hepatitis C, the infected individuals cannot identify the source for their infection. While it is believed most cases are due to risk factors involving contaminated blood, there remain unidentified modes of Hepatitis C transmission. Salivary transmission is one potential explanation for many unexplained viral causes.

Tiny and Infectious
Measuring only about 50 nanometers in diameter, Hepatitis C is an extremely small virus. A nanometer is one billionth of a meter; 200,000 Hepatitis C viruses placed end to end would only measure a single centimeter. Smaller than the wavelength of visible light, viral particles have no color. In those who are infected, Hepatitis C may produce approximately one trillion new viral particles every day.

Unlike many other viruses (like HIV), any potential source of blood to blood contact seems capable of carrying the Hepatitis C virus. This is true, even if the source is indirect, such as a used razor, making HCV far more transmissible than most other blood borne viruses. As documented by occupational exposure statistics, Hepatitis C is approximately seven times more infectious than HIV.

Saliva
People with chronic Hepatitis C are advised not to share toothbrushes, razors, nail clippers or other personal articles that may have potentially been in contact with their blood. While there is very little emphasis on saliva as a vehicle of Hepatitis C transmission, under the right circumstances there is some evidence to the contrary:

1. As published in the September 2006 issue of Journal of Viral Hepatitis, German researchers investigated the transmission of Hepatitis C via a toothbrush. A team from the University of Regensburg examined 30 patients with Hepatitis C to see whether they had contaminated their toothbrushes with the virus. They collected saliva samples from infected patients both before and after tooth brushing. Figures showed that 30 percent of infected patients tested positive for traces of the virus in their saliva before brushing their teeth, while 38 percent tested positive in their saliva after brushing. Additionally, about 40 percent of the water used to rinse the infected toothbrushes tested positive for the virus. This information confirms the caution against toothbrush sharing, and also sounds a possible Hepatitis C transitory alarm.

2. In September of 2003, evidence that saliva contains the Hepatitis C virus was disclosed at the Interscience Conference on Antimicrobial Agents and Chemotherapy. Scientists from the University of Washington in Seattle concluded that while saliva may be infectious, the strongest predictor of viral presence in the saliva is serum viral load. Researchers found that Hepatitis C was not found in saliva if the person’s viral load was under one million. Additionally, any risk of acquiring infection through salivary contact existed only in the presence of gum disease. Investigators attribute this risk to microscopic amounts of blood in the saliva and visually undetectable open mouth wounds present in gum disease.

All possibilities must be considered in trying to determine how unknown sources of Hepatitis C infection took place. Although Hepatitis C has been detected in saliva, the necessary conditions render it unlikey—but not impossible—to be transmitted by kissing or through the sharing of a toothbrush. Before anybody panics about these potential risks, remember that there are conditions accompanying these possible modes of transmission:

· The person with the virus must have a viral load over one million.
· Both parties involved have gum disease.

While experts view the risk of transmitting this disease through saliva as extremely low, it is recommended to maintain good oral hygiene, and toothbrushes be used solely by their owners.

References:

Jancin, Bruce, Hepatitis C virus may be spread through saliva: avoid toothbrush sharing, OB/GYN News, November 2003.

Hepatitis C – contamination of toothbrushes: myth or reality?, Journal of Viral Hepatitis, September 2006.

www.cdc.gov, Hepatitis C FAQ, US Department of Health and Human Services, 2006.

www.epidemic.org, The Hepatitis C Virus, Trustees of Dartmouth College, 2006.

www.hcvadvocate.org, HCV: Important Study on Dried Blood Stability, Hepatitis C Support Project, January 2004.

www.hcvets.com, Saliva may have infectious amounts of HCV in presence of high HCV viral load and gum disease, Michael Carter, HCVets.com, September 2003.

www.hepnet.com, Stopping the Spread of the Virus, Molly Colin, Schering Canada Inc., 2006.

www.medicalnewstoday, Kissing Could Spread Hepatitis C, MediLexicon International, Ltd., September 2003.

www.pafp.com, Hepatitis C Virus can Live in Dried Blood, Pennsylvania Academy of Family Physicians, 2003.

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February 26, 2007

How You Can Stop HCV from Leading to Gallstones

Recent research has shown how Hepatitis C patients have a greater tendency to develop gallstones. Learn how to prevent your diagnosis from leading to one of the 1 million new cases of gallstones reported each year.

by Nicole Culter, L.Ac.

Gallstone disease is the most common disorder affecting the body's biliary system, the network of organs and ducts responsible for creating, transporting, storing and releasing bile. Responsible for the digestion of fat, bile is a fluid produced by the liver and stored in the gallbladder. Bile primarily consists of water, cholesterol, fats, bile salts, proteins and bilirubin. If the chemical balance of bile contains too much of any of these components, particularly cholesterol, crystals form and harden into gallstones.

Gallstones can be as small as a grain of sand or as large as a golf ball. The gallbladder can develop just one large stone, hundreds of tiny stones, or anywhere in between. When gallstones lodge in bile ducts, they can prevent the flow of bile or digestive enzymes or lead to severe abdominal pain, vomiting, inflammation and possible infection.

Symptoms
Symptoms of gallstones are often called a gallstone "attack" because they occur suddenly. A typical attack can cause:

· Steady pain in the upper abdomen that increases rapidly and lasts from 30 minutes to several hours
· Pain in the back between the shoulder blades
· Pain under the right shoulder
· Nausea or vomiting

Gallstone attacks often follow fatty meals, and they may occur during the night. Other gallstone symptoms include:

1. Abdominal bloating
2. Recurring intolerance of fatty foods
3. Belching
4. Gas
5. Indigestion

The Link Between Hepatitis C and Gallstones
Over the years, the medical community has suspected a connection between liver disease and gallbladder disease. Researchers looking to prove this suspicion have shown how people with Hepatitis C have a greater tendency to develop gallstones.

· An Italian study published in the Archives of Internal Medicine in 1999 suggested that cirrhosis represents a major risk factor for gallstones.

· A New York study published in the May 2005 issue of Hepatology concluded that chronic Hepatitis C infection demonstrated a strong association with gallbladder disease and that gallbladder disease was more common in adults with severe liver disease.

· Published in the September 2005 issue of Journal of Gastroenterology and Hepatology, a Taiwanese study involving nearly 30,000 people confirmed that infection with Hepatitis C contributes to gallstone formation.

How This Impacts People with Hepatitis C
Considering the clinical proof that people with chronic Hepatitis C are at a greater risk for developing gallbladder disease, those harboring this virus are strongly encouraged to practice gallstone prevention.

Diet modification is the primary method to prevent gallstones from developing. Increasing consumption of both soluble and insoluble fiber may prevent gallstones. Fiber reduces the absorption of deoxycholic acid by producing a favorable shift in the triad of factors controlling cholesterol's solubility in bile. Soluble fibers that are effective include guar gum and pectin, as well as oat bran, wheat bran, and soy fiber, all of which are found in many fruits and vegetables.

Additionally, regular, vigorous, exercise may decrease gallstone risk. One study, reported by WebMD, found that men who performed endurance activities for 30 minutes, five times a week, experienced a 34 percent reduction in gallbladder disease risk. The benefits derived from exercise were more dependent on intensity than type of exercise. Researchers theorize that exercise helps to normalize blood sugar and insulin levels which may contribute to gallstones when abnormal.

Evidence gathered on gallstone formation clearly points to an increased risk for individuals with the Hepatitis C virus. While people with chronic Hepatitis C likely have plenty of other health concerns, practicing gallstone prevention is easy due to its similarity to liver supportive lifestyle changes. Now there is one more reason for those with liver disease to incorporate healthful habits by increasing the fiber in their diet and getting started on a regular exercise routine.

References:

Bini EJ, McGready J, Prevalence of gallbladder disease among persons with hepatitis C virus infection in the United States, Hepatology, May 2005.

Conte D, et al., Close relation between cirrhosis and gallstones: cross-sectional and longitudinal study, Archives of Internal Medicine, July 1999.

T S Chang, et al., Hepatitis C virus infection facilitates gallstone formation, Journal of Gastroenterology and Hepatology, September 20, 2005.

www.digestive.niddk.nih.gov, Gallstones, National Digestive Diseases Information Clearinghouse, November 2004.

www.womenshealth.about.com, Preventing Gallstones, Tracee Cornforth, About, Inc., 2006.

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Genetics May Determine Hepatitis C Treatment Success

New research looks at gene expression as a possible explanation for the significant number of HCV interferon/ribavirin non-responders. In light of the difference in gene expression between responders and non-responders, genetics may play a role in predicting antiviral medication success.

Changes in Gene Expression during Hepatitis C Treatment Distinguish Responders from Non-Responders
www.hivandhepatitis.com
By Liz Highleyman

While treatment of chronic hepatitis C using pegylated interferon plus ribavirin leads to sustained HCV clearance and clinical improvement in approximately half of all patients, response rates are lower in certain "difficult to treat" groups, including patients with genotype 1 HCV and African-Americans.

It is unclear why treatment response rates vary by race/ethnicity, but genetic factors may play a role.

As reported in the January 31, 2007 electronic edition of the Journal of Virology, researchers used DNA micro-arrays to assess gene expression in a group of 33 African-American and 36 Caucasian-American patients with genotype 1 chronic HCV infection during the first 28 days of treatment with pegylated interferon/ribavirin.

Results

• Patients showed a response to treatment at the gene expression level in RNA isolated from peripheral blood mononuclear cells (PBMCs) regardless of degree of decrease in HCV RNA levels.

• Gene expression responses were relatively blunted in patients with poor virological response (< 1.5 log10 IU/mL decrease in HCV RNA at 28 days) compared to those with a marked (> 3.5 log10 decrease) or intermediate (1.5-3.5 log10 decrease) response.

• The number of genes that were up-regulated or down-regulated by pegylated interferon/ribavirin was fewer in patients with a poor virological response compared to those with a marked or intermediate response.

• Induced levels of known interferon-stimulated genes such as OAS, MX1, IRF-7, and the toll-like receptor TLR-7 were lower in poor responders compared to patients with marked or intermediate responses.

• However, African-Americans had stronger interferon responses than Caucasian patients overall.

Conclusion

The authors concluded that, "the relative lack of viral response to interferon therapy of hepatitis C is associated with blunted interferon cell signaling. No specific regulatory gene could be identified as responsible for this global blunting or racial differences."
It remains unclear why African-Americans tend to respond more poorly to interferon-based therapy, given their overall stronger gene expression response to interferon.

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February 19, 2007

Why Antioxidants are Important for Hepatitis C Patients

The goal of those currently undergoing treatment for chronic Hepatitis C is to prevent further liver damage from the Hepatitis C virus. Read this exclusive article to learn how to incorporate antioxidants into your lifestyle. Here is a simple, reputable and reasonably priced way to support your liver.

by Nicole Cutler, L.Ac.

Cellular oxidation occurs when oxygen or disease excessively breaks down a substance, producing free radicals. As negatively charged electrons no longer attached to their atoms, free radicals create chemical instability. This instability invites another atom or molecule to easily bond with the free radical, resulting in a cellular-altering chemical reaction capable of damaging cell walls, cellular structures and the genetic material inside cells. This process is readily seen in Hepatitis C’s deterioration of liver tissue. Antioxidants reduce, neutralize, and prevent the damage inflicted by free radicals.

Research illustrating the role of oxidation in advancing liver disease has consistently been produced over the years:

· 2006 – The Journal of Translational Medicine published a Turkish study whose aim was to determine oxidant/antioxidant status of patients with chronic Hepatitis C and the effect of combination therapy (pegylated interferon alfa-2b plus ribavirin) on oxidative stress. Researchers reported that patients with chronic HCV infection are under the influence of oxidative stress associated with lower levels of antioxidant enzymes. These impairments return to healthy levels following combination therapy. Although interferon and ribavirin are not antioxidants, their antiviral capacity might reduce viral load and inflammation, allowing for a reduction in virus-induced oxidative stress. Therefore, antioxidants can reduce the oxidative stress of Hepatitis C and make combination therapy more successful.

· 2005 - An Israeli study published in the Journal of Clinical Gastroenterology observed that oxidative stress in the liver is associated with chronic Hepatitis C infection. Researchers concluded that treatment with multiple antioxidants for people with chronic HCV was well tolerated and has a therapeutic benefit for hepatic inflammation and liver cell death. Therefore, antioxidant therapy can reduce liver inflammation and cell death.

· 2002 – A study published in the Journal of Hepatology measured levels of fibrosis and corresponding levels of oxidative stress in Hepatitis C patients. The authors found oxidative stress to be a significant feature of HCV infection. Although more severe in those with cirrhosis, there was clear evidence of oxidative stress in non-cirrhotic patients with the virus. The authors concluded that antioxidant therapy may have a role in slowing disease progression to cirrhosis.

· 1999 – A University of New Mexico study combined three potent antioxidants (alpha-lipoic acid, silymarin, and selenium) for administration to patients with cirrhosis, portal hypertension and esophageal varices secondary to chronic Hepatitis C infection. Those on the triple antioxidant program recovered quickly from HCV and their laboratory values remarkably improved. Furthermore, liver transplantation was avoided and the patients returned to work, carried out their normal activities, and reported feeling healthy. Therefore, antioxidants can help people improve their quality of life and recover more rapidly from Hepatitis C.

The overwhelming evidence suggests that antioxidants may hinder the Hepatitis C virus in the following ways:

· Impairs HCV replication
· Improves liver enzyme levels
· Protects against liver cell damage
· Renders interferon anti-viral therapy more effective

Dietary Sources of Antioxidants
A simple way to add antioxidants to your life is to seek them in food sources. Found in fruits and vegetables rich in Vitamins C and E, selenium, carotenoids and anthocyanins, antioxidants are optimally absorbed from whole food sources. Since antioxidants are the substances responsible for color, brightly colored produce represent the sources highest in free radical fighting power. Some examples of foods high in antioxidants are:

· Cabbage, broccoli, spinach and kale (Note to Hepatitis C patients: both spinach and kale are high in iron; check with your doctor before including in your regular diet.)
· Citrus fruits, strawberries, melons, apricots and mangos
· Sweet potatoes, tomatoes, corn, eggplant
· Romaine lettuce, avocadoes, carrots
· Blueberries, cranberries, red grapes

Additionally, antioxidants are widely available in supplement form. A refined milk thistle extract is a highly trusted antioxidant supplement that demonstrates tremendous benefits to the liver.

Whether you intend to improve the outcome of combination therapy, or simply wish to halt the progression of cirrhosis, remember the research demonstrating the benefits of antioxidants. Including antioxidant-rich foods and supplements into a daily routine can provide enormous protective benefit to those with chronic Hepatitis C.

References:
Jain SK, Pemberton PW, Smith A, et al, Oxidative stress in chronic hepatitis C: not just a feature of late stage disease, Journal of Hepatology, 2002.

Levent G, Ali A, Ahmet A, et al., Oxidative stress and antioxidant defense in patients with chronic hepatitis C before and after pegylated interferon alfa-2b plus ribavirin therapy, Journal of Translational Medicine, June 2006.

Melhem A, Stern M, Shibolet O, et al, Treatment of chronic hepatitis C virus infection via antioxidants: results of a phase I clinical trial, Journal of Clinical Gastroenterology, September 2005.

www.deliciousorganics.com, Antioxidants, Delicious Organics, Inc., 2004.

www.healthyhepper.com, Antioxidants, Free Radicals and Your Liver, healthyhepper.com, 2004.

www.integrative-healthcare.com/mt, Anti-Inflammatory Foods, Natural Wellness, 9/22/05.

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January 17, 2007

Diabetes Risk for HCV Patients Receiving Liver Transplant

Although the connection remains tentative, Hepatitis C patients who have received a liver transplant and are taking the post-transplant drug, Prograf, may be at higher risk for developing type 2 diabetes.

www.medpagetoday.com
Hepatitis C Infection Raises Diabetes Risk After Liver Transplants

VILLEJUIF, France, Jan. 8 -- Liver transplant recipients who are hepatitis C-virus (HCV) positive and receive Prograf (tacrolimus) as part of their immunosuppressant regimen are at a significantly higher risk for new-onset type 2 diabetes than HCV-negative patients, researchers here reported.

Among 211 primary liver-graft recipients, 22.7% developed new-onset diabetes, and the occurrence was higher among those treated with Prograf compared with Neoral (cyclosporine), particularly when the patients were HCV positive, found Faouzi Saliba, M.D., from the Hôpital Paul Brousse, and colleagues.

The evidence suggests that HCV status is a strong predictor of post-transplant diabetes, and that "the immunosuppressive treatment should therefore be tailored to the patient's risk, especially in case of HCV infection," the investigators wrote in the January issue of Liver Transplantation.

But the new diabetes cases may be transient, as seen by the fact that nearly all of the incident cases were taking steroids and developed diabetes within three months of their transplants, noted Paul J. Thuluvath, M.D., of Johns Hopkins in Baltimore, in an accompanying editorial.

"In a previous study, 24 of 88 patients (27%) were found to have diabetes mellitus at the end of the first postoperative year and were considered as having new-onset diabetes mellitus," Dr. Thuluvath wrote, "but at the second year after liver transplantation, only eight patients (9%) had evidence of diabetes mellitus, which implies the transient nature of diabetes mellitus in many transplant recipients."

"This may suggest that many patients in the cohort studied by Saliba et al may not have diabetes with longer follow-up, especially when corticosteroid therapy is discontinued."

Dr. Saliba and colleagues conducted a cross-sectional, multicenter retrospective study of the incidence of new-onset diabetes and potential risk factors in the 211patients who had undergone a primary liver transplant from six to 24 months earlier.

For each patient, data on demographics, immunosuppressive regimens, familial and personal histories, hepatitis status, and cardiovascular risks were collected at a single routine post-transplant visit, and the data on patients who developed new-onset diabetes were compared with those of patients in the same cohort who did not develop the disease.

They used American Diabetes Association/World Health Organization criteria to define diabetes: fasting blood glucose of more than 1.26 g/L confirmed on at least two occasions, or current treatment with an oral antidiabetic drug or insulin. They defined impaired fasting glucose as two fasting blood glucose measurements > 1.10 to < 1.26 g/L (> 6.1 and < 7.0 mmol/L) without antidiabetic therapy.

The authors found that the overall rate of new-onset diabetes was 22.7%, occurring in 24% of the 175 Prograf-treated patients, and in 16.7% of the 36 Neoral-treated patients. About four in five cases (81%) were diagnosed within three months of the transplant.

The occurrence was also significantly higher among HCV-positive patients compared with HCV-negative patients, at 41.7% vs. 18.9% respectively (P=0.008).

When they broke the data down by calicineurin inhibitor type, they found that in Prograf-treated patients, the rate of diabetes was 46.7% among those patients who were HCV positive, compared with 19.3% for those were HCV negative (P=0.0014).

Among Neoral-treated patients, 16.7% (one in six) of HCV-positive patients developed diabetes, as did 17.2% (five of 29) of HCV-negative patients. There was no significant difference between the groups.

In addition to HCV status, independent pretransplantation risk factors for new diabetes included impaired fasting glucose and a maximum lifetime body-mass index more than 25 kg/m2.

"Emergence of new onset diabetes mellitus after liver transplantation is related to risk factors that can be detected prior to the graft, like maximum lifetime BMI, impaired fasting glucose, and HCV status," the authors wrote. "Tacrolimus induced a significantly higher incidence of new onset diabetes mellitus in the HCV-positive compared to the HCV-negative patients."

In his editorial, Dr. Thulavath noted that the authors failed to clarify the role of corticosteroids in the development of post-transplant diabetes.

"It is unclear whether the actual dose or dose adjusted for body weight is more relevant for the development of corticosteroid-induced DM in transplant recipients," he wrote. "The authors do not provide data on median or mean corticosteroid dose when new-onset diabetes mellitus was diagnosed. Another concern with this study was that the diagnosis of new-onset diabetes mellitus was made on the basis of fasting blood glucose on two separate occasions. In a retrospective study from 10 centers, it may not be safe to assume that the blood glucose was drawn in a fasting state even in the most compliant patients."

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January 05, 2007

Race a Factor in Fatty Liver Disease in Hepatitis C Patients

Recent research has uncovered a racial disparity in regard to fat accumulation in the livers of Hepatitis C patients. The same research also indicates that levels of insulin resistance vary among races. This discovery may prove beneficial to HCV patients if modifications to insulin resistance factors lead to controlling the progression of a fatty liver.

Posted 1/2/07
www.Eurekalert.com

Racial differences seen in steatosis in patients with hepatitis C

Caucasian patients with chronic hepatitis C virus (HCV) are more likely to have hepatic steatosis, or fat in the liver, compared to African-American patients. However, steatosis is not associated with HCV treatment response. These findings are published in the January 2007 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). Published by John Wiley & Sons, Inc., the journal is available online via Wiley InterScience (http://www.interscience.wiley.com/journal/hepatology).

Hepatic steatosis is common among patients with HCV and often indicates more advanced disease. Researchers, led by Hari Conjeevaram, M.D., M.S. Division of Gastroenterology at the University of Michigan at Ann Arbor, sought to investigate racial differences in the prevalence and severity of hepatic steatosis in patients with HCV, genotype 1. Additionally, they investigated the relationship between steatosis and body characteristics and other measures of insulin resistance. "We also wanted to assess whether the presence and severity of hepatic steatosis and/or insulin resistance were important factors to predict virological response in this population," the authors write.

The researchers studied 194 African-American and 205 Caucasian patients with HCV, genotype 1. All patients were participating in a multi-center prospective study of peginterferon and ribavirin therapy. The researchers compared the prevalence and severity of steatosis and steatohepatitis to demographic, lifestyle and clinical characteristics. They also investigated relationships between sustained virological response and both steatosis and insulin resistance.

The researchers found hepatic steatosis in 61 percent of the African-American patients and 65 percent of Caucasian patients. In a univariable analysis, the steatosis was associated with HOMA-IR (a measure of insulin resistance), body mass index, waist circumference, serum triglycerides, aminotransferase levels, and histological scores for inflammation and fibrosis. After adjusting for those features, they found that African-Americans had a dramatically lower risk of steatosis. For a given degree of overweight and obesity or insulin resistance, African-Americans were approximately half as likely to have hepatic steatosis. After examining patient characteristics and their responsiveness to treatment, the authors report, "insulin resistance and fibrosis are important and obesity and steatosis may be less or not as important."

The results may have been confounded by patients taking oral anti-diabetic agents, and by the possibility that HOMA underestimated the degree of insulin resistance in overtly diabetic patients.

Still, "the importance of these findings is that insulin resistance is a potentially modifiable factor, so that responses to antiviral therapy in hepatitis C may be improved by modulation of insulin signaling and improvements in insulin resistance and glucose control. These possibilities deserve prospective evaluation," they conclude.

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December 21, 2006

Hepatitis C and HIV Coinfection May Change Treatment Guidelines

A recent study has shown how HIV diminishes the immune system's ability to respond to Hepatitis C. Researchers from Massachusetts General Hospital indicate that co-infected individuals should begin anti-retroviral treatment earlier than those only infected with Hepatitis C.

Science Daily
December 18, 2006

Coinfection With Both HIV And Hepatitis C Virus A Growing Problem

Although many individuals infected with the hepatitis C virus (HCV) are naturally able to control levels of the virus with their immune systems, those who also become infected with HIV, the virus that causes AIDS, may lose that ability. In a report in the December issue of PLOS Medicine, a group of researchers from the Partners AIDS Research Center at Massachusetts General Hospital (PARC-MGH) report one of the first studies of how HIV infection impacts immune system functions involved with HCV control. Their findings suggest that beginning antiretroviral therapy earlier than is generally recommended may help preserve HCV control in patients infected with both viruses.

"The global burden on health of chronic viral infections is immense, and HCV and HIV are chief among culprit viruses," says Arthur Kim, MD, of PARC-MGH, co-first author of the PLOS Medicine report. "Due to shared routes of transmission, infection with both viruses is common. Unfortunately, HCV behaves as an opportunistic infection in the presence of HIV and is becoming a leading cause of illness and death in persons with HIV."

In order to examine immune system factors associated with spontaneous control of HCV and how that control is altered by HIV infection, the researchers enrolled four groups of participants: 60 were infected with both viruses, and half of those had low HCV levels upon entering the study. The other two groups of 17 participants were infected with HCV only, with one group successfully controlling viral levels. Spontaneous HCV control is known to rely on the activity of CD4 helper T cells specifically targeted against the virus, and destruction of CD4 cells by HIV underlies the immune deficiency that characterizes AIDS. Therefore the researchers measured participants' T cell response to HCV at the outset of the study and at two- to six-month intervals during the study period.

The results showed that those individuals able to maintain low HCV levels in spite of HIV coinfection had stronger virus-specific responses for both CD4 T cells and the CD8 "killer" T cells than did those with elevated HCV counts. Not surprisingly, participants infected only with HCV had even more powerful antiviral T cell responses. About a quarter of those infected with both viruses who originally controlled HCV levels lost control during the two-and-a half-year study period, and their increased virus levels corresponded with an overall drop in CD4 T cells. None of the viral controllers who were infected with HCV alone had any increase in viral levels during the study period. Loss of protective responses and susceptibility to recurrent HCV infection may help to explain the higher rates of persistent HCV observed in subjects who are HIV/HCV coinfected, compared to those with HCV alone.

In analyzing factors that might be associated with the loss of HCV control in those infected with both viruses, the researchers made a surprising discovery. The factor most powerfully associated with maintaining HCV control was not the CD4 T cell count upon entering the study but the lowest previously recorded or 'nadir' CD4 count. That finding suggests that, for individuals infected with both viruses, beginning antiretroviral treatment before CD4 levels drop too low to maintain HCV responses may be desirable.

The researchers also found that, among those whose HCV levels rose, individuals who maintained some T cell responses had lower viral levels than did those with little or no T cell response. This suggests that the immune system retains a level of secondary immunity against HCV -- the kind of 'memory' response against a previously encountered pathogen seen in many infections.

"Currently a nationwide trial is recruiting people for a study examining whether earlier treatment of HIV will improve hepatitis C treatment outcomes," Kim says. "Part of this study will investigate how earlier treatment may affect immune responses. It also will be important to follow the impact of loss of HCV control on liver disease, since this will probably have important consequences for patients with HIV." Kim is an instructor in Medicine at Harvard Medical School.

Note: This story has been adapted from a news release issued by Massachusetts General Hospital.

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November 22, 2006

Hepatitis C Toothbrush Contamination

Separating personal items used by a person with Hepatitis C from other household members to prevent transmission may seem overly cautious. However, a recently published study confirms the risk of spreading Hepatitis C by sharing a toothbrush.

Hepatitis C – contamination of toothbrushes: myth or reality?

Chronic hepatitis C patients are advised not to share toothbrushes, razors, nail-scissors or other personal articles that potentially may have been in contact with blood, with others. This study examines the contamination of toothbrushes in patients with chronic hepatitis C as a model for a possible unconventional way of transmission. In 30 patients with chronic hepatitis C, 2 mL of saliva (before and after toothbrushing) and the toothbrush rinsing water after toothbrushing were tested for HCV-RNA. Saliva before and after toothbrushing was positive for HCV-RNA in nine (30%) and 11 patients (36.7%), respectively. Twelve of the toothbrush rinsing water specimens (40%) tested HCV-RNA-positive. In six of these 12 patients, the 'native' saliva had been negative for HCV-RNA. Patients with HCV-RNA-positive toothbrush rinsing water showed no significant differences from those with negative rinsing water with respect to certain clinical, biochemical and virological parameters. In conclusion, our study demonstrates a contamination with HCV-RNA of a considerable portion of toothbrushes used by hepatitis C patients, suggesting at least a theoretical risk of infection by sharing these objects and strengthening the recommendations to take care of a clear separation of these personal care objects between patients and their household members.

Source:
Journal of Viral Hepatitis
Volume 13 Page 571 - September 2006
doi:10.1111/j.1365-2893.2006.00735.x
Volume 13 Issue 9

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November 10, 2006

Study Announcement for Advanced Cancer and Liver Dysfunction

Western medicine has typically had little to offer those with end stage liver disease, which can be marked by advanced cancer and irregular liver function. In the following press release, you will learn more about a recently announced Phase 1 study examining the effects an experimental drug has on this serious combination of conditions.

Summary: PHI-50 NCI#6432: A Phase I Pharmacokinetic Study of PS-341 in Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction for the CTEP-Sponsored Organ Dysfunction Working Group

You have been asked to participate in this research study because you have advanced cancer that is no longer responding to standard treatment and your liver function is normal or is no longer normal. The purpose of this research study is to find out the highest dose of an experimental drug PS-341 that can be given to subjects with advanced cancer and abnormal liver function without causing unmanageable side effects. Additionally, researchers will be looking to find out how the study drug moves through the body. Y

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

Contact:

City of Hope National Medical Center
1500 East Duarte Road
Duarte, CA 91010-3000
Telephone: 866-896-HOPE (4673)

Source: www.centerwatch.com

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November 08, 2006

Hepatitis C Cleared in Some Drug Users

Although sharing contaminated needles for illicit drug use is the most common way of transmitting the Hepatitis C virus, many physicians are hesitant to administer treatment to active drug users. New research demonstrates how drug users are just as likely to clear the virus as non-drug users, which will likely change this prescribing trend and help reduce the spread of the disease.

Patients who recover from hepatitis C have lower risk of reinfection

A new study found that individuals who had tested positive for hepatitis C (HCV) but later tested negative for the virus were significantly less likely to become infected again compared to those who had never been infected, even though they had the same exposure risks.

The results of this study appear in the November 2006 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD).

HCV, a major public health threat affecting over 170 million people worldwide, is primarily acquired through injection drug use (IDU). IDU accounts for over 75 percent of HCV cases and HCV is seen in up to 90 percent of IDUs, with most of these individuals going on to develop chronic infection. Recent advances in effectively treating HCV have led to a "cure," (meaning no virus is detectable) in many cases, however there is a concern that treatment is not as beneficial to IDUs because they are continually exposed to the virus.

Through a collaborative effort between Jason Grebely and Brian Conway of the University of British Columbia, Mark Tyndall of the BC Centre for Excellence in HIV/AIDS, the BC Centre for Disease Control, and Vancouver Coastal Health in Vancouver, a large community-based study was conducted comparing 926 individuals who tested negative for HCV during the recruitment period of the study between January 2003 and June 2004 with 506 individuals who had HCV, 152 of whom had spontaneous clearance of the virus. Clearance was considered to be the presence of HCV antibodies followed by at least one negative test for HCV. Using medical records, they then looked at the incidence of HCV infection between 1992 and 2005 in those who had antibodies but no detectable virus and those who tested negative in order to evaluate the effect of previous infection on reinfection rates. Although the two groups were similar in terms of the proportion of individuals engaging in illicit drug use, those previously infected were more likely to be engaged in frequent illicit drug use and IDU. Individuals who had tested positive for HCV, but subsequently tested negative were followed for an average of five years, compared to almost three years for those without previous HCV infection.

The results showed that those with previous HCV infection and viral clearance were four times less likely to develop infection again than those infected for the first time, despite the fact that they had higher rates of HIV coinfection, illicit drug use and injection drug use. In fact, 90 percent of those reinfected continued to engage in illicit drug use, including 50 percent who reported IDU.

"Our data lend support to the hypothesis that previous exposure to HCV may be protective, possibly on an immunologic basis, despite repeated exposure to HCV," the authors state. They propose two potential explanations for their results: those with HCV clearance are genetically predisposed to resist HCV infection and reinfection, or those previously exposed to HCV may be more experienced and have safer injection routines, which would have some protective value. The authors acknowledge some limitations in their study, such as the fact that HCV antibody tests have become more sensitive in recent years compared to the period from which the study looked at results and the fact that the study was retrospective, with testing being performed only by physician request, not systematically. However, they note that these limitations could easily be addressed in future prospective studies with systematic testing for HCV.

The authors point out that treatment for HCV infection is often withheld from IDUs because of the supposed high risk of reinfection. "However, our data suggest that spontaneous clearance may confer some protection against re-infection," they write. "If protection against HCV infection extends to those who have cleared their viremia following antiviral therapy, it could provide a stronger rationale for expanding treatment programs for IDUs, including those who continue to be at risk for HCV exposure." Although further research is required, the present study indicates that since IDUs play such an important role in HCV transmission, strategies that address this group could have a significant impact on the HCV epidemic.
###

Source: "Hepatitis C Virus Reinfection in Injection Drug Users," Jason Grebely, Brian Conway, Jesse D. Raffa, Calvin Lai, Mel Krajden, Mark W. Tyndall, Hepatology; November 2006 (DOI: 10.1002/hep.21376).

Excerpt taken from public press release,Nov. 1
John Wiley & Sons, Inc.

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October 25, 2006

Dangerous Lack of HCV Awareness in College Students

American college students are not sufficiently educated about Hepatitis C, according to a recent study. A startling percentage of surveyed students are at risk for contracting the virus due to some fairly common college activities. If you have a loved one who is an undergraduate student, you will want to send them this link to discover the risk factors for their own protection.

75 Percent of College Students Report Risk Factors for Hepatitis C

College undergraduates in the United States do not recognize the magnitude of their risk behaviors for contracting Hepatitis C, according to a survey conducted at a large Midwestern university. Researchers found that 75 percent of undergraduates in this study had a potential hepatitis C risk factor, from tattoos to sharing body jewelry. Results of this study were presented at the 71st annual Scientific Meeting of the AmericanCollege of Gastroenterology in Las Vegas.

Researchers surveyed 610 college undergraduates on their knowledge of hepatitis C and their personal experience with traditional (intravenous drug use, blood transfusions) and novel risk factors (sharing of body jewelry, tattoos). Twenty-seven percent didn’t know hepatitis C virus (HCV) could be spread through intravenous drug use, while 77 percent of students were unaware HCV could be transmitted by intranasal cocaine use. Furthermore, 53 percent of students reported sharing pierced jewelry.

“We were surprised by the proportion of undergraduates who were inadvertently putting themselves at risk for hepatitis C,” says Thomas Shehab, MD, of St. Joseph Mercy Health System and Huron Gastro. “In addition to well documented traditional risk factors, we are concerned about students who may be putting themselves at risk for this serious disease with even something as simple as sharing pierced body jewelry.“

One of the other concerning findings was the low frequency that the undergraduates were asked about viral hepatitis/HIV risk factors when seen by their primary-care providers. “The majority of the group had been to the physician for a healthcare maintenance examination in the last three years, but during that visit most had never been asked about behaviors that put them at risk for serious infection,” says Shehab. Given the prevalence of these behaviors, researchers say further study should focus on this high-risk age group.

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV). The infection is spread by blood-to-blood contact with an infected person. HCV can be spread through contaminated needles, unsterilized tattoo or body piercing equipment, and shared toothbrushes, razors, nail clippers or other hygiene items that have HCV-infected blood on them. There is no vaccine against HCV. Serious complications include chronic liver disease, cirrhosis, and liver cancer.

Source: American College of Gastroenterology

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October 24, 2006

Promising Partnership in Treating Hepatitis C

Two leading companies are merging in an effort to accelerate Hepatitis C treatments. The goal of this collaboration is to further the development of Hepatitis C protease inhibitors.

Roche and InterMune to develop hepatitis C products

Pharmaceutical Business Review Online
By Victoria Harrison

Roche and InterMune have signed an agreement to develop and commercialize candidates from InterMune's hepatitis C protease inhibitor program

The agreement includes InterMune's lead compound ITMN-191, which is expected to enter clinical trials before the end of the year. The companies will also collaborate on a research program of novel second-generation hepatitis C protease inhibitors.

"We believe this partnership will help accelerate the development of ITMN-191 and future second-generation protease inhibitors," said Dan Welch, CEO of InterMune.

Roche will exclusively license ITMN-191 and will have the right to exclusively license further hepatitis C protease inhibitor development candidates resulting from the research collaboration.

InterMune will conduct phase I studies of ITMN-191, and thereafter Roche will lead clinical development and commercialization. Upon closing, InterMune will receive from Roche an upfront payment of $60 million. InterMune could potentially receive up to $470 million in milestones as a result of the deal. The companies will co-commercialize the product in the US.

The economic terms for ITMN-191 could also apply to additional compounds that InterMune and Roche develop.

The transaction will close following the expiration or early termination of an antitrust regulatory waiting period.

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October 05, 2006

Latest Test May Predict Hepatitis C Treatment Results

When undergoing interferon/ribavirin treatment for Hepatitis C, being able to judge the treatment's chance of success is critical in deciding whether to continue. By increasing an RNA test's sensitivity, American researchers have found a more reliable method for physicians to judge treatment outcome.

Abstract from Hepatology August 2006
Volume 44, Issue 2, Pages 360-367

HCV RNA detection by TMA during the hepatitis C antiviral long-term treatment against cirrhosis (Halt-C) trial

For making treatment decisions related to chronic hepatitis C, the utility of HCV RNA tests with increased sensitivity has not been defined. Prior interferon nonresponders with advanced fibrosis (n = 1,145) were retreated with peginterferon alpha-2a and ribavirin.

Patients who were HCV RNA-negative by a polymerase chain reaction (PCR)-based assay (Roche COBAS AmplicorTM HCV Test, v. 2.0; lower limit of detection [LOD] 100 IU/mL) at week 20 (W20) received treatment for 48 weeks.

Stored specimens were tested using the Bayer VERSANT HCV RNA Qualitative (TMA) Assay (LOD 9.6 IU/mL) and compared to PCR results for the ability to predict sustained virological response (SVR; defined as undetectable HCV RNA by PCR at W72).

Nearly all PCR-positive samples (1006/1007, 99.9%) were positive as assessed by TMA. Among 1,294 PCR-negative samples, 22% were TMA-positive.

Negative TMA results were more predictive of SVR than were negative PCR results at W12 (82% vs. 64%, P < .001) and at W20 (66% vs. 52%, P = 0.001).

SVR was more likely the earlier TMA had become negative during treatment (82% at W12, 44% at W20, 20% at W24).

Among 45 patients who were TMA-positive but were PCR-negative at W20 and W24, none achieved SVR (95% CI: 0%-8%).

Approximately 10% of patients with a single positive TMA result at the end of treatment still achieved SVR.

In conclusion, negative TMA results at or after W12 were superior to negative PCR results for predicting SVR. In patients with negative PCR results during treatment, a single positive TMA test did not exclude SVR, although persistently positive tests did.

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July 31, 2006

Understanding Hepatitis C Interferon Therapy

Whether you are a candidate for interferon therapy or simply want to learn more about the most common medical treatment for viral hepatitis, this article can be your introduction to how it works, and more importantly, how effective it is.

Understanding Hepatitis C Interferon Therapy
July 31, 2006
LiverSupport.com
Nicole Cutler, L.Ac.

Interferon is a cytokine, a specific protein that is no stranger to the human body. In fact, the human body is constantly making interferon, and makes even greater amounts when trying to fight off an intruder, such as a virus. People experience this when suffering with the flu. When sick with the flu, the body makes extra interferon to defeat the virus causing the illness. The extra interferon causes symptoms such as fever, nausea, achy and sore muscles, joint pain and fatigue. This is called an antiviral effect. Interferon therapy is currently the gold standard in treatment for certain types of hepatitis B and C.

How Does it Work?

While the interferon used for hepatitis treatment is slightly different from the kind made in the body, it helps defeat the virus in three ways:

1. By attaching to healthy cells to help defend against invading viruses.

2. By helping the immune system to stop the virus from multiplying.

3. By assisting the body in ridding itself of infected cells while preventing healthy cells from being infected.

Interferon helps the body distinguish between cells infected by the virus and non-infected cells, targeting infected cells for destruction. For unknown reasons, a virus in the liver often becomes invisible to the immune system. If your body can't see the virus, it can't destroy it. This invisibility permits the virus to multiply within the liver, fostering a more chronic and severe infection. Scientists have learned that if they gave synthetic (created through genetic engineering) interferon to a person with chronic viral hepatitis, they could increase the immune system's ability to detect, or see, the infection. Imagine liver cells blending in with invaders, both a clear transparent color. The addition of interferon is like staining the infection deep red, highlighting them so they can be targeted for the immune system’s fighter cells. Interferon also helps patients with viral hepatitis by directly suppressing the formation of new virus particles within the liver.

What kinds are there?

Scientists have determined that the body makes three distinct types of interferon; alpha, beta and gamma interferon, each containing several members. Alpha interferon has been approved for therapeutic use against a specific type of leukemia, hepatitis B and C, genital warts, AIDS- related Kaposi’s sarcoma and some rare cancers of blood and bone marrow. Nasal sprays containing alpha interferon provide some protection against colds caused by rhinoviruses.

There are two primary types of interferon currently available. To date, interferon-alpha 2a or 2b is the compound that has been extensively used and tested. Though the dose varies, patients with chronic hepatitis C usually receive 3 million units, three times per week. Individuals with chronic hepatitis B receive a higher dose of 10 million units, three times per week. Although it can widely vary, the typical duration of therapy is 48 weeks for hepatitis C, and 16 weeks for hepatitis B.

A newer formulation on the market is called pegylated interferon. This drug was developed in response to the fall in blood levels, rapid breakdown and subsequent loss of antiviral effect of interferon given 3 times per week. By attaching a molecule called polyethylene glycol to interferon-alpha 2a or 2b, researchers were able to slow its breakdown by the body. More consistent drug levels were achieved with the need to only give the drug once per week. Above and beyond the convenience of once a week injection, the pegylated formulations also result in higher viral clearance rates.

Side Effects

Interferon used for hepatitis treatment — alpha and pegylated forms — have been known to cause severe side effects, including:

* worsening of psoriasis
* irritability and insomnia
* trouble breathing
* chest pain
* high fever and chills
* fatigue
* headaches
* decreased appetite, nausea and vomiting
* weight loss
* muscle aches
* bone marrow suppression
* weight and hair loss
* depression and mood changes
* decreased white blood cells and platelets
* elevated liver enzymes
* difficulty concentrating and impaired memory

Interferon’s effectiveness

For hepatitis C, the cure rate is defined as the inability to detect virus in the blood 6 months after stopping therapy. This rate varies significantly depending on a number of patient, viral and drug regimen characteristics. The most important factor is the viral genotype. Unfortunately, genotypes 1a and 1b, the most common types in North America, have the worst response rate, with only 19 percent in interferon and 25-40 percent in pegylated interferon responses, respectively. Adding a second anti-viral drug, ribavirin, increases the response rate to between 35 and 60 percent. Genotypes 2 and 3 carry a much higher eradication rate (60 percent or more).

Hepatitis B is associated with a 35 percent response rate as defined by normalization of liver enzymes and loss of markers of active viral infection. Such a response signifies conversion to a healthy carrier state. This is further characterized by a decrease in the ability to spread the virus to others and a decrease in the liver damage associated with viral infection. Complete elimination of the Hepatitis B virus is rare.

As you can see, not everyone responds to interferon therapy, causing some people to turn to natural alternatives. According to many physicians in Japan, the prescription-strength remedy Sho-saiko-to may be helpful for nonresponders to interferon therapy. If you want more information about Sho-saiko-to, you may wish to visit http://www.shosaikoto.com.

Perhaps having a better understanding of interferon, including what it is, how it works, what its side effects are and how effective it is will help people make the best treatment decisions. Clinical trials are being conducted around the world to increase interferon’s effectiveness, reduce its side effects and create even better alternatives for the eradication of viral hepatitis.

References:

www.aids.about.com, Interferon – alpha, Mark Cichocki, About Inc., 2006.

www.en.wikipedia.org, Interferon, Wikipedia Foundation, Inc., 2006.

www.gihealth.com, Interferon Therapy, Three Rivers Endoscopy Center, 2005.

www.hepatitis-c.de, What is Interferon?, Deutsches Hepatitis C Forum, 2006.

www.immunityfacts.com, Interferon and Its Role in Immune Health, Center for Immune Research, 2006.

www.introna.com, What are Interferons?, Schering Corporation, 2002.

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July 28, 2006

Hepatitis C and the Immune System

Australian researchers have uncovered a link between hepatitis C infection and an individual's immune system. By examining this virus on a genetic level, new understanding about hepatitis C's ability to mutate and persevere in certain people brings us closer to the development of a successful vaccine.

WA leads bid for hep-C cure
by Louise Pemble
July 22, 2006 11:27am

PERTH researchers are closer to explaining why some people can fight off the Hepatitis C virus while others succumb to the potentially deadly infection.

Their findings could pave the way for a vaccine against hepatitis C infection, which affects more than 210,000 Australians and 200 million people worldwide.

The team, based at the Centre for Clinical Immunology and Biomedical Statistics at Royal Perth Hospital, already has made headway in understanding the interplay between the individual and the virus at the genetic level, and how this influences the body's immune response to the virus.

This followed groundbreaking work headed by the centre's director, Simon Mallal, whose study of Perth HIV sufferers was the first in the world to show that patients had different forms of the virus as it tailored itself to individual immune responses and different populations.

Prof Mallal was awarded a $US9.8 million grant by the Bill and Melinda Gates Foundation to create state-of-the-art databases recording the genetics of the virus and people in key populations around the world.

Prof Mallal said it was on the back of those findings that he shifted attention to hepatitis C because the jlbehaviour of the virus was poorly understood, even though it affected so many Australians.

His team worked on a hunch that hepatitis C would behave in the same way as the HIV virus, which constantly mutated to evade a knockout blow by the body's natural defence, the immune system.

Researcher Silvana Gaudieri said the HIV research had been crucial in laying the groundwork for the hepatitis C study, though there were key differences.

"Unlike HIV, of those individuals exposed to hepatitis C, about 30 per cent resolve their infection without the need for therapy," she said.

"For those who become chronically infected, many suffer liver disease, including cirrhosis, and require liver transplants.

"In essence, the hepatitis C epidemic is a time bomb within the community, with a likely high burden on the health system in the years to come."

The research team has just recruited new subjects who are ideal candidates for answering many of the puzzles surrounding hepatitis C.

With funding from the Haemophilia Foundation of Australia, a study now involves West Australians with haemophilia, who will provide a unique nts cohort nte opportunity for discoveries in this area. Many people with haemophilia were exposed to the virus through blood donation before widespread screening was introduced.

Throughout the '70s and '80s, they were given multiple infusions of blood, including plasma infected with hepatitis C, but not all succumbed to the virus.

This made them ideal candidates for study because they had been exposed to many different strains of the virus over time, according to trial investigator Michaela Lucas.

Dr Lucas, working in collaboration with colleagues from the Haemophilia Centre of WA headed by Associate Professor Ross Baker and from CCIBS including Dr Katja Pfafferott, said they offered a rare opportunity to find out why some resolved infection while others did not.

"Work published on HIV showed that an individual's ability to fight the virus leaves an imprint on the virus," she said.

"That's why the virus is always changing to try to evade the body's immune response.

"We were looking for information about how the hepatitis C virus interacts with an individual to resolve why the progress of the disease can differ markedly in each person."

The team is faced with many unsolved questions about hepatitis C. For instance, some people can be infected with hepatitis C for 10 to 20 years with few or no clinical symptoms, while others get liver disease quite rapidly.

Some of the factors that influence the disease's progress are sex, age, alcohol consumption and the presence of another infection, such as HIV.

Researchers turned their attention to which parts of the virus could change to escape or "hide" from the body's immune response.

Two factors were crucial - the way the body fought the virus and the type of virus.

The study focuses on the immune system's specialised white blood cells, or T-cells, that are the key to fighting the virus.

As with HIV, a better understanding of how the virus changes as it moves through a population will help develop designs for vaccines, though Dr Lucas stressed that this was early stage research, rather than a vaccine trial.

Hepatitis C is potentially curable, but many patients do not respond to treatment.

Dr Lucas, who has previously worked with leading hepatitis C researcher Dr Paul Klenerman at Oxford University, said the Perth findings would help explain the role mutation of the virus played in escaping an individual's immune response.

The study, which is now in its second year, has also been supported by the National Health and Medical Research Council and from this month, funding will be added by the Haemophilia Foundation to specifically investigate a person's immune response to multiple strains of HCV.

copyright 2006 The Sunday Times, News Limited

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June 27, 2006

Coffee's Liver Benefits

New research points to coffee's ability to minimize the progression of liver disease, including cutting the risk of alcohol-related cirrhosis. This study concludes coffee has no such effect on cirrhosis caused by other means, such as Hepatitis C (although other studies have found some positive effect in the past). Find out more about how coffee can further your own efforts to support and protect your liver.

by Nicole Cutler, L.Ac.

The healthcare community has done its fair share of investigating the effects of drinking coffee, and a subsequent array of health warnings and encouragements have been issued regarding its regular consumption.

Since the liver processes all that we ingest, people living with liver disease, including hepatitis, must be extra vigilant in watching what enters their digestive system. Coffee is turning heads as a liver cancer and cirrhosis preventative. It has also been noted as a factor in reducing insulin resistance, a prominent liver disease risk factor. The keys to accentuating coffee’s benefits while avoiding any harm, are to stay within moderation, be aware of conditions contraindicating its consumption, and be careful of what you add to your brew.

While a recent study states coffee reduces the risk of alcohol-related cirrhosis but has no effect on cirrhosis caused by Hepatitis C, there is research indicating that moderate coffee consumption provides several liver-related health benefits.

To learn more about how coffee consumption can aid the liver, read the entire article at www.liversupport.com

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November 25, 2005

A Good AASLD Meeting Summary

This is a terrific overview article regarding the AASLD meeting. Liz Highleyman did a fantastic job of condensing the key aspects and announcements.

One of the most interesting updates/corrections of known information is the upward measurement of the number of infected persons in the USA. It could be one million more than most commonly estimated.

Hepatitis research reported at liver disease meeting

Liz Highleyman

Treatments for hepatitis B and C continue to improve, with refinements to approved regimens and new experimental agents in the development pipeline, researchers reported at the 56th annual meeting of the American Association for the Study of Liver Diseases, held November 11-15 in San Francisco.

Hepatitis B and C are viral diseases that can cause long-term liver damage including cirrhosis and cancer. The Centers for Disease Control and Prevention estimates that some 75,000 people in the U.S. are newly infected with hepatitis B each year – a number that has declined dramatically since the advent of routine childhood vaccination.

Unlike hepatitis A and B, there is not yet a vaccine for hepatitis C. The National Health and Nutrition Examination Survey found that about 3.9 million people in the U.S. had contracted hepatitis C, but Dr. Brian Edlin from Cornell University presented evidence suggesting this is an underestimate. As a household survey, Edlin said, NHANES does not count several groups that have higher rates of hepatitis C than the general population. These include prisoners (nearly 2 million, with an estimated hepatitis C rate of 32 percent), the homeless (more than 800,000, with an estimated rate of 35 percent), patients in hospitals and nursing homes, and members of the military. Taking these groups together, Edlin estimated that about 1 million more people have hepatitis C than usually reported, for a total of 5 million. Basing public health projections on the lower figure, he warned, "may underestimate the burden of liver disease we will see in coming decades."

Hepatitis C
The hepatitis C virus is spread primarily through contact with blood, and rates are highest among injection drug users. Several studies have shown that sexual transmission between monogamous heterosexual partners is rare, but it appears more common among men who have sex with men and people coinfected with HIV. While outbreaks of sexually transmitted hepatitis C have not been reported in North America, a cluster of more than 200 such cases among gay HIV-positive men in the United Kingdom raises concern.

According to a presentation by Dr. Mark Danta from the Royal Free and University College Medical School in London, a variety of factors related to sexual activity and drug use have contributed to the recent English epidemic. In a case-control study comparing 60 HIV-positive gay men with acute (recently acquired) hepatitis C and 130 matched HIV-positive men without HCV, Danta's team found that the HCV-infected men were significantly more likely to have engaged in unprotected receptive or insertive anal intercourse, fisting, analingus (rimming), use of sex toys, SM, and group sex. Further, the men with hepatitis C were more likely to meet partners in sex clubs, bathhouses, or on the Internet; had more sex partners overall; were more likely to have ever had a sexually transmitted disease; and more often used club drugs including crystal methamphetamine.

While all these factors are linked to higher rates of hepatitis C, Danta said it is "difficult to tease out" how each specifically contributes. He recommended that education about safe sex and drug-sharing practices should be the focus of public health interventions for this population.

At a satellite symposium, HIV specialist Dr. Paul Volberding from the University of California, San Francisco joined several hepatitis experts to discuss similarities and differences between the HIV and HCV viruses and their treatment. Research on hepatitis C is some five to 10 years behind HIV research, Volberding estimated. Hepatitis C researchers are at a disadvantage because HCV cannot be grown in the laboratory, which is important for understanding the virus life cycle and early drug testing (instead, various model systems are used). But patients with hepatitis C enjoy a big advantage: HCV can essentially be eradicated, while HIV persists indefinitely in long-lived memory T-cells.

Current standard treatment for hepatitis C is based on interferon, an injected cytokine (cell messenger chemical) that stimulates the immune response, but future therapies under study directly target HCV. Like current HIV drugs, these new agents will likely be used in combination, since HCV – like HIV – can mutate rapidly and develop drug resistance. But because hepatitis C can be cured in a matter of months or years, there is less concern about long-term side effects such as lipodystrophy.

"This field is getting very lively and will become even more competitive," predicted hepatology researcher Dr. John McHutchinson of Duke University Medical Center in North Carolina.

Indeed, researchers at AASLD presented data on several new candidate hepatitis C drugs. Those furthest along in the pipeline include Idenix Pharmaceuticals' nucleoside analog valopicitabine (NM283) and two HCV protease inhibitors, Shering Plough's SCH503034 and Vertex Pharmaceuticals' VX-950.

Presenting the first data from a phase II trial of valopicitabine, Dr. Christopher O'Brien from the University of Miami reported that 50 percent to 70 percent (depending on dose) of patients with genotype 1 HCV – the hardest type to treat – who did not respond to previous interferon therapy saw an early reduction in HCV viral load after 12 weeks of treatment with the new drug plus pegylated interferon.

"These are promising results, particularly for the many treatment-refractory patients in urgent need of new therapeutic options," O'Brien said.

Dr. Stefan Zeuzem from Germany reported that in a small 14-day study of patients who did not respond to standard treatment with interferon, 60 percent of those receiving the highest dose of SCH503034 three times daily experienced a substantial (at least two logs) reduction in HCV viral load. SCH503034 also showed promising activity when combined with pegylated interferon.

As reported by Dr. Henk Reesink from Amsterdam, in a small early study, all participants with genotype 1 HCV who received VX-950 saw at least a two-log drop in HCV viral load. "As far as I know, this is the most rapid and dramatic response that has been seen with a single agent," he stated.

All three pipeline drugs appear safe, with no serious side effects seen in clinical trials so far. This is reassuring since research on an earlier HCV protease inhibitor, BILN-2061, had to be stopped when it was linked to heart problems in animals. It is too soon to say whether these agents will ultimately produce a cure for hepatitis C (sustained virological response, or continued undetectable HCV viral load six months after the end of treatment). Most experts agree, however, that combinations of antiviral drugs are the wave of the future for hepatitis C therapy.

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November 23, 2005

Shorter Therapy Effective for Genotypes 2 and 3

Genotypes 2 and 3 are much more responsive to current interferon combination therapies. This report details studies that show a shorter course of treatment might be just as effective as longer courses.

Researchers continue to refine treatment protocols for HCV patients.

Short Therapy Regimens Effective for Hepatitis C Virus Genotype 2 and 3: Presented at AASLD

By Crystal Phend

SAN FRANCISCO, CA -- November 21, 2005 -- Hepatitis C infected patients with genotype 2 or 3 may be able to shorten their course of therapy without losing effectiveness, according to a study presented here at the American Association for the Study of Liver Diseases annual meeting (AASLD).

According to presenter Olav Dalgard, MD, PhD, Infectious Diseases Specialist, Aker University Hospital, Oslo, Norway, the viral response at week 4 may be a guide to considering shorter treatment.

Two recently published studies found shorter therapy to be effective, but left unanswered which subgroups are less likely to respond, that is, dosing and baseline predictive factors, Dr. Dalgard said during a presentation on November 14th.

To answer those questions, his group used pooled data from two studies involving a total 403 adults with hepatitis C genotype 2 or 3 who were treatment naïve.

The Norwegian study dosed pegylated interferon alpha-2b at 1.5 mcg/kg once weekly with 800 to 1,200 mg of ribavirin for 14 weeks or for 24 weeks if patients had not achieved a response by week 14.

The Italian study followed the same schedule as the Norwegian study, with a slightly lower 1.0 mcg/kg pegylated interferon alpha-2b dose for 12 weeks or 24 weeks for non-responders at week 12.

Patients were tested for virus RNA levels at weeks 4, 12 or 14 and 24.

The 313 patients who achieved a sustained viral response (SVR) were analyzed by subgroup.

Results show a significant difference in the percentage of patients who achieved SVR according to fibrosis score ( 83% with a score of 0 to 2 vs. 67% with a score 3 to 4).

Patients with genotype 2 were significantly more likely to respond than those with genotype 3 (81% vs. 73%).

"In non-rapid viral response patients, 24 weeks of therapy for HCV 2 patients may be satisfactory whereas longer courses should be considered for genotype 3," Dr. Dalgard said.

Patients who had a rapid viral response by week 4 were significantly more likely to have a sustained viral response than those who did not (85% vs. 62%).

Those who had a rapid viral response at week 4 were significantly more likely to have a low fibrosis score (70% 0 to 2 vs. 56% 3 to 4) and to be at the higher 1.5 dose of peginterferon (78% vs. 64%).

Multivariate analysis found that the response at 4 weeks was a significant predictor of sustained response, although genotype, baseline viral load and treatment regimen were not.

Relapse could not be predicted by any baseline characteristic.

"In HCV 2 or 3, viral response at week 4 may reliably guide treatment duration as the majority of rapid responders may safely receive shorter courses of therapy without compromising SVR," the researchers concluded.

[Presentation title: Short-Term Treatment Duration for HCV-2 and HCV-3 Infected Patients with Chronic Hepatitis. Abstract 849]

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November 16, 2005

Pegasys Shown More Effective In Study

Schering and Roche are taking part in dueling press releases.

Each claiming their solution is better. Either way, they seem to be splitting hairs regarding effectiveness.

There is no clear winner when they keep firing PR salvos back and forth. Who is a patient to believe? How do doctors determine what is best for their patients?

Be sure to stay informed and make as educated a choice as you can.

HEPATITIS C PATIENTS FARE BETTER WITH PEGASYS(R) - STUDY FROM POLAND SHOWS SIGNIFICANT DIFFERENCE IN EFFICACY BETWEEN LEADING TREATMENTS
15-11-2005 06:30

WARSAW, Poland, November 15 /PRNewswire/ -- Early results from a new study comparing the efficacy of the two leading hepatitis C treatments suggests that patients may increase their chance of a cure by more than 10% if they are treated with PEGASYS(R) and COPEGUS(R) combination therapy. The study, presented today at the 56th Annual Meeting of the American Association for the Study of Liver Diseases, is one of the first scientifically rigorous research efforts comparing leading treatments to determine which provides the best solution for patients battling hepatitis C [1].

"Patients and the medical community are understandably anxious to have reliable information regarding what treatment is most likely to provide a cure for hepatitis C," said Dr Andrzej Horban, from Infection Disease Hospital in Warsaw who headed the study. "My colleagues and I wished to undertake a study that would clearly answer this question and use a methodology that would inspire confidence in the results."

To date, there have been a number of comparative studies undertaken, but few if any, have generated results which reflect best practices in clinical research. In fact, a number of studies promoted to the public have been retrospective analyses of small research efforts that were designed to address different research questions altogether.

More PEGASYS Patients Respond After Only 12 Weeks of Treatment
The study was undertaken in Poland and involved more than 200 people infected with hepatitis C. All patients were assigned to be treated with either PEGASYS combination therapy or Peg Intron(R) combination therapy. After 12 weeks of treatment, 85% of the PEGASYS patients were responding to therapy as compared to only 74% of the Peg Intron patients. Response to therapy at 12 weeks (defined as either a significant drop in viral load or eliminating the virus completely) is typically an excellent indicator that a patient will be cured of the disease upon completing the full course of therapy.

Local Patient Groups Respond with Enthusiasm
Mr Jaroslaw Chojnacki - The chairman of the Prometeusze Community - said: "although we are still awaiting the final results of this study, the patient community is very pleased that this study has been undertaken in Poland. The results of this study can help infected people a lot. If we are convinced that someone's odds of beating this disease are increased by 10% because they took this drug, it would be important information for us", he said.

Like many countries in Europe, Poland is actively addressing the potential time bomb that is hepatitis C. Official figures state 1.5% of the population may have the virus. However patient groups and treating doctors believe that the figure is much higher.

Reference:
[1] Berak, H et al. "Randomized, Open Label Trial Comparing efficacy and safety of pegylated interferon alfa 2a vs 2b treatment of patients with chronic hepatitis infected with non 2/3 genetypes - 12 week virological response" Presented at AASLD, 2005.

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November 15, 2005

Weight-based Treatment of HCV

Weight-based dosing has always made sense to us. We don't really understand why Roche has not changed their dosing to weight-based.

Although the difference is subtle, it is certainly significant according to this study.

You must also note, though, that Schering is funding this study. Does bias matter in science? What do you think?

Largest Hepatitis C Trial in U.S. Patients Shows Weight-Based REBETOL in Combination With PEG-INTRON Increases Sustained Response, Lowers Relapse

Final Results of Community-Based WIN-R Study Also Demonstrate Efficacy of Shorter, More Tolerable 24-Week Regimen in Patients With Genotype 2 or 3 Virus

SAN FRANCISCO, CA -- (MARKET WIRE) -- 11/14/2005 -- Final results of the WIN-R trial,(1) the largest hepatitis C study conducted in U.S. patients, showed that weight-based REBETOL® (ribavirin, USP) in combination therapy with PEG-INTRON® (peginterferon alfa-2b) achieved significantly higher rates of sustained virologic response (SVR)(2) and lower rates of relapse compared to the combination therapy using a flat dose of ribavirin. The study also showed that, for patients infected with hepatitis C virus (HCV) genotype 2 or 3, a shorter, 24-week course of therapy was as effective as the standard 48-week course, with better tolerability.

These results from WIN-R (Weight-Based Dosing of PEG-INTRON and REBETOL), a community-based access trial involving more than 4,900 patients at 225 centers across the United States, were reported in an oral presentation today at the 56th annual meeting of the American Association for the Study of Liver Diseases (AASLD).

"These findings help further define optimal therapy for U.S. hepatitis C patients treated in real-world community settings," said principal investigator Ira M. Jacobson, M.D., Vincent Astor Professor of Clinical Medicine at Weill Medical College of Cornell University and chief of the division of gastroenterology and hepatology at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York City.

Treating U.S. hepatitis C patients can be especially challenging as they tend to have disease characteristics that are associated with poor response to treatment, including high prevalence of HCV genotype 1, the most difficult type of the virus to treat; high viral load; and advanced liver fibrosis. Other factors such as age, high body weight and African-American ethnicity also have been shown to be associated with poor response.

"Our findings showed that the weight-based dosed combination therapy significantly increased efficacy compared to the flat-dosed ribavirin regimen, especially in more difficult-to-treat patient groups, such as patients with genotype 1 and African-American patients. This confirms what many treating physicians have come to know in their everyday practice and experience," Jacobson said. "Importantly, sustained virologic response rates in this community-based U.S. study were consistent with those seen in the U.S. cohorts of the earlier pivotal studies for the two approved peginterferon combination therapies."(3,4)

Study Design

In the WIN-R study, 4,913 patients were randomized to receive weight-based PEG-INTRON (1.5 mcg/kg weekly) in combination with REBETOL given either as a flat dose (800 mg daily) or a weight-based dose (800 mg, 1,000 mg, 1,200 mg or 1,400 mg daily for body weights of less than 65 kg, 65 to 85 kg, 86 to 105 kg, or 106 to 125 kg, respectively). Patients were treated for 48 weeks (genotype 1) or 24 weeks (genotype 2 or 3). Patients in the treatment arms were evenly matched for gender, age, body weight, genotype, viral load and stage of liver fibrosis.

Key Results

A challenge with conducting large community-based HCV studies such as WIN-R, as opposed to registration trials with their more intensive monitoring capabilities, is the tendency for a high rate of patients to miss their follow-up viral testing (PCR) visit 24 weeks after treatment ends due to the limited ability of many sites to conduct rigorous monitoring of patients once they have received their final treatment dose. In the WIN-R study, 13.1 percent (164/1,256) of patients in the weight-based dose group and 13.7 percent (163/1,193) of patients in the fixed-dose group who were responders at the end of treatment were lost to follow up and subsequently counted as treatment failures under a strict intent-to-treat (ITT) analysis.

Nonetheless, the WIN-R study showed significantly better outcomes for the weight-based combination regimen as compared to the flat-dosed ribavirin regimen, including:

-- Significantly higher SVR overall (44.3 percent vs. 40.6 percent, p=0.01, ITT) and for patients with genotype 1 (34 percent vs. 29 percent, p=0.004, ITT). These SVR rates are consistent with those seen in the U.S. cohorts of the earlier pivotal studies for the two approved peginterferon combination therapies.(3,4)

-- Using an estimated SVR analysis, based on results for patients who had undetectable virus at the end of treatment and were subsequently lost to follow up, SVR was 53 percent vs. 48 percent (p=0.008), respectively, for the weight-based vs. flat-dosed ribavirin groups.

-- Consistent SVR rates were seen across all weight groups for patients in the weight-based dosed regimen compared to the flat-dosed ribavirin regimen where SVR rates declined in the higher weight groups, ranging from 52 percent to 34 percent. Consistent with other U.S. studies, patient weight tended to be high in the WIN-R study, with 45 percent of patients weighing 86 kg (189 lbs) or more.

-- For patients with HCV genotype 2 or 3 virus, a 24-week course of the combination therapy was as effective as 48 weeks, with better tolerability. In the weight-based dose arms, SVR was 68 percent for the 24-week course compared to 60 percent for the 48-week course, with the lower percentage attributable to more missing follow-up data.

-- Lower rates of relapse were seen for patients receiving the weight- based combination therapy compared to the flat-dosed ribavirin regimen, 15 percent vs. 19 percent overall, and 23 percent vs. 29 percent for patients with HCV genotype 1. Relapse is defined as patients with undetectable virus levels at the end of treatment who subsequently had detectable virus at 24 weeks post-treatment.

-- Although there was a higher rate of anemia (hemoglobin < 10 gm/dl) in the weight-based dosing group and more dose reductions (29 percent vs. 23 percent), no difference was seen in the rate of occurrence of serious adverse events between the two groups (12 percent vs. 11 percent) and there were similar rates of discontinuations for adverse events (15 percent vs. 14 percent).

WIN-R Study

Serving with Dr. Jacobson as co-principal investigator of the WIN-R study is Dr. Robert S. Brown Jr., associate professor of clinical medicine at Columbia University College of Physicians and Surgeons; and chief of clinical hepatology and medical director of the Center of Liver Disease and Transplantation at NewYork-Presbyterian Hospital/Columbia University Medical Center. Drs. Jacobson and Brown are also co-directors of NewYork-Presbyterian Healthcare System's Liver Clinical Trials Network (LCTN).

Dr. Jacobson also is medical director of the Center for the Study of Hepatitis C, a unique interdisciplinary center established jointly by The Rockefeller University, NewYork-Presbyterian Hospital and Weill Cornell Medical College in New York City.

WIN-R is an investigator-initiated clinical study supported by Schering-Plough Corporation and monitored by Schering-Plough Research Institute as part of a post-marketing commitment to the U.S. Food and Drug Administration (FDA). PEG-INTRON and REBETOL are registered trademarks of Schering-Plough.

About Hepatitis C

Hepatitis C is the most common blood-borne infection in America, affecting approximately 4 million people or about one in every 50 adults. Chronic hepatitis C can cause cirrhosis, liver failure and liver cancer. It has been estimated that at least 20 percent of patients with chronic hepatitis C develop cirrhosis, and a smaller percentage of patients with chronic disease develop liver cancer. Patients with chronic hepatitis C and related cirrhosis are 100 times more likely to develop liver cancer than uninfected persons.(5) About half of all cases of primary liver cancer in the developed world are caused by hepatitis C, and hepatitis C related liver disease is now the leading cause for liver transplants.(6)

About New York-Presbyterian Hospital/Weill Cornell Medical Center

The New York-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian Hospital and its academic partner Weill Cornell Medical College. NewYork-Presbyterian/Weill Cornell provides state-of-the-art in-patient, ambulatory, and preventive care in all areas of medicine, and is committed to excellence in patient care, research, education, and community service.

References

1. Jacobson I, Brown Jr. R, Freilich B, Afdahl N, Kwo P, Santoro J, Becker S, Wakil A, Pound D, Godofsky E, Strauss R, Bernstein D, Flamm S, Bala N, Araya V, Davis M, Monsour H, Vierling J, Regenstein F, Balan V, Dragutsky M, Epstein M,. Herring RW, Rubin R, Galler G, Pauly MP, Griffel LH, Brass CA, the WIN-R Study Group. Weight based ribavirin dosing (WBD) increases sustained viral response (SVR) in patients with chronic hepatitis C (CHC): final results of the WIN-R study, a U.S. community-based trial. Oral presentation at: 56th Annual Meeting of the American Association for the Study of Liver Diseases, San Francisco, CA, Nov 11-15, 2005.

2. Sustained virologic response (SVR) is defined as undetectable virus (HCV-RNA) levels in the blood at 6 months after the end of therapy.

3. Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001 Sep 22;358(9286):958-65.

4. Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL Jr, Haussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002 Sep 26;347(13):975-82.

5. Ince N, Wands JR. The increasing incidence of hepatocellular carcinoma. N Engl J Med 1999 March 11;340:10.

6. Centers for Disease Control and Prevention. Recommendations for prevention and treatment of hepatitis C virus (HCV) and HCV-related chronic disease. MMWR Weekly Report 1998 Oct. 16;1.

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November 09, 2005

Your Results May Vary For HCV Treatment

According to this study, actual treatment results may be only half as good as touted. Doctors tend to trust the numbers presented by the pharaceutical companies. The pharmaceutical companies have a vested interest in presenting the best numbers they can find.

Patients may be unpleasantly surprised with the actual results.

Hepatitis C Often Untreated and Outcomes Lag behind Trials in Clinical Practice: Presented at ACG

By Paula Moyer

HONOLULU, HI -- November 9, 2005 -- When patients with hepatitis C go on antiviral therapy, the likelihood of a response may be half of that seen in clinical trials, according to investigators who presented their findings here at the 70th annual meeting of the American College of Gastroenterology (ACG).

The research was presented on November 2nd by Ramsey C. Cheung, MD, Chief of Hepatology, Veterans Affairs Palo Alto Health Care System, and Associate Professor of Medicine, Stanford University Medical School, Stanford, California, United States.

"A lot of people with a diagnosis of hepatitis C are not being treated for multiple reasons," Dr. Cheung, MD, said in an email. "When we decide to treat a patient and when the patient decides to go on treatment, the probability of achieving a cure is important to both parties."

However, he added, his study showed that the response rate is much lower in clinical practice than has been seen in the registration trial. "It is important for the treating physician and the patient to know what the response rate is likely to be, not what has been reported in registration trial."

He noted that studies of patients with hepatitis C within the Veterans Affairs system showed that the sustained viral response rate was low. The investigative team conducted the current study to see if the same results would be seen in a community cohort.

The team reviewed several databases of selected sites within the Kaiser Permanente Northern California Health System, and identified 1470 patients with chronic hepatitis C who were seen within the system from 1999-2004. They obtained demographic information from administrative files on age, gender, and ethnicity and patients' laboratory records.

The system's pharmacy records held data on patients' treatment with interferon combined with ribavirin or pegylated interferon combined with ribavirin, along with information regarding the patients' use of erythropoetin (Procrit), filgrastim (Neupogen), antidepressants, and transfusions.

Results show that 246 (16.5%) underwent treatment; 65.3% of these patients were men. Data were completely evaluable for 242 patients; 119 of these were treated with interferon plus ribavirin, and 123 were treated with pegylated interferon plus ribavirin. Patients were an average of 47.1 years old (range 33.3-60.91).

The vast majority of treated patients (72.4%) had HCV genotype I, while 24% had HCV genotypes II and III, and 3.6% had HCCV genotypes IV-VI.

Patients were treated for an average of 29.2 weeks. A sustained virologic response occurred in 19.8% of treated patients, including 11.8% of those who received interferon plus ribavirin, and 27.6% of those treated with pegylated interferon plus ribavirin.

In clinical trials, sustained viral response rates have reached more than 70%, Dr. Cheung said.

Although the reasons for the gap are unclear, these findings may help physicians and patients have more realistic expectations of treatment, Dr. Cheung said.

[Presentation title: Practice Patterns and Treatment of Outcomes in the Management of Chronic Hepatitis C (CHC) Infection in a Large Managed Care Cohort. Abstract 785]

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October 26, 2005

More HCV Treatment News Coverage

The Los Angeles Times is one of the largest daily newspapers in the U.S. Their interest in HCV is indicative of a growing awareness of the extent of the disease in this country.

The article clearly focuses on the hope of safer, more effective treatments than what is now available.

Science & Medicine | Los Angeles Times Examines Study Results of Three Experimental Hepatitis C Treatments

[Oct 25, 2005]

More than 24 hepatitis C treatments currently are in development, and at least three drugs are demonstrating the potential to prevent the virus from replicating, the Los Angeles Times reports. "These drugs are more potent and have much less side effects" than treatments that currently are available, Eugene Schiff, director of the Center for Liver Diseases at the University of Miami, said.

One drug, called valopicitabine -- which is manufactured by Cambridge, Mass.-based Idenix Pharmaceuticals and is currently in more advanced clinical trials than other experimental hepatitis C therapies -- works by blocking the action of RNA polymerase, an enzyme the virus needs to replicate. In a study of 79 patients conducted last year, the once-a-day pill reduced hepatitis C viral levels by up to 90% after two weeks of treatment, even though 87% of the trial's participants had received previous treatments that failed to reduce their viral loads. The interim results of another valopicitabine trial -- which involved 190 hepatitis C patients not helped by conventional treatment regimens -- are scheduled to be released in November. Preliminary results of that trial show a decrease in viral reproduction, according to the Times. Nathaniel Brown, chief medical officer at Idenix, said that valopicitabine likely will be part of a combination therapy, "but we're in a race against time because the number of people with advanced disease is steadily increasing."

Two other experimental hepatitis C drugs recently have completed early stage clinical trials: SCH-503034, made by Schering-Plough, and VX-950, made by Cambridge, Mass.-based Vertex. Both treatments target the protease enzyme, which the virus uses to reproduce. Results from a Shering study on SCH-503034 are expected to be released in November, and Shering liver expert Janice Albrecht said that the decrease in viral levels was "significant." A study conducted this year of VX-950 involving 34 volunteers showed that after two weeks of treatment, the medication proved 250 times as powerful as conventional medication in reducing hepatitis C levels. Researchers are planning additional studies for both drugs (Marsa, Los Angeles Times, 10/24).

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September 29, 2005

A Good HCV Newspaper Article

This is one of the best general audience articles we've come across on HCV in quite a while. There is lots of good info on treatment. Notice that even the doctor says the "cure" rate has only risen to about 50% (and that includes the over 80% for genotype 2) This indicates that, in real numbers, it is even lower than 50% for Genotype 1 patients.

Dr. Godofsky says he was encouraged about Tarvacin because it has low toxicity.

Clearly, this is the sort of treatment we are waiting for. We're just protecting and supporting our liver as best we can (through natural means) in the meantime.

For more info on how to protect and support your liver (if you aren't already aware) you can go to http://www.liversupport.com/interview.htm

Bradenton doctor chips away at hepatitis C virus
Medical office runs 10 to 20 drug trials a year

By KATHLEEN MCLAUGHLIN

kathleen.mclaughlin@heraldtribune.com

BRADENTON — When Eliot Godofsky started treating viral hepatitis in 1996, about 10 percent to 15 percent of patients could be cured.

After the introduction of some new drugs, that rate is up to 50 percent.

Godofsky likes those numbers, but he knows they could be even better. “HIV is controllable. Hep-C is potentially curable.”

That’s why his Bradenton-based medical office — the nation’s largest infectious disease practice specializing in viral hepatitis — runs 10 to 20 drug trials a year.

Private practice physicians get involved in clinical research for many reasons: money, experience with cutting-edge treatment, access to drugs for patients.

Godofsky says his prime motivator is fundamental: “The benefit to me is to cure people who thought they were incurable.”

The 46-year-old came to Bradenton to join Michael Bach, a pioneer in HIV/AIDS treatment who died of melanoma in 1998.

Bach & Godofsky, M.D. PA, which now employs six other doctors, still staffs the HIV/AIDS clinic that Bach opened in Manatee County. But Godofsky has expanded the scope of the practice and become an expert on viral hepatitis. Part of that includes doing early-stage drug trials, such as the one for Peregrine Pharmaceuticals that began Aug. 29.

He hopes to help find something that will work for the roughly 50 percent of people who don’t respond to treatment, which involves a yearlong course with debilitating side effects.

The virus

The hepatitis C virus is more widespread than HIV, but it gets relatively little attention.

About 4 million people in the United States are infected with hepatitis C, while about 1 million have HIV.

No national fund like the one established by the Ryan White CARE Act for HIV pays for hepatitis drugs. Treatment, not including lab work, costs about $20,000 per year, Godofsky said.

There are a lot of drugs under research for hepatitis C, but there is not a high-profile, independent center testing them head-to-head, said Lisa Ball, executive director of the Hepatitis Resource Network, a doctors education group.

Sharing needles is the most common cause forof the illness, representing 60 percent of new infections. Although commonly associated with illegal drug use, hepatitis crops up unexpectedly in many middle-aged people because the disease can stay in the body for 10 to 20 years without causing anything more than flu-like symptoms, said Michelle May, the nurse practitioner who runs clinical trials for Godofsky.

Some patients trace their risk back to recreational cocaine use, in which they shared straws, May said.

One woman’s only identifiable risk factor was the fact that she was a seamstress. She might have pricked her finger on a needle used by someone else.

A lot of people don’t realize they can be cured. Some go through the treatment, only to find themselves among the “non-responders.”

“The worst part of my job is helping them through 12 months of therapy, then six months later having to call and say, ‘Your virus is back,’” May said.

There are 12 to 15 companies trying to develop new drugs, and many of them contact Godofsky’s office for trials.

Godofsky thought Peregrine’s drug, Tarvacin, looked promising. The small California company realized the antibody treatment it was developing for cancer tumors might work against hepatitis and other viruses.

The Bradenton doctor agreed to the trial because the drug seems to have low toxicity, and it’s a novel approach: Patients will get one intravenous injection of the antibody, which might block the virus from invading liver cells and remove the virus from the body.

Supporting treatment

Godofsky was drawn to research as an intellectual pursuit, but he has become an expert on the ins and outs of using it to support the practice. He gave a presentation on it last year at the annual meeting of the Infectious Diseases Society of America.

Listed among the reasons for doctors to get involved in trials was “cost-effective income production.”

The medical office gets “good” reimbursement for patient visits and lab reviews with limited billing and collections overhead. Doctors spend no time with managed care, Godofsky notes.

One of his tips on setting up a budget for a clinical trial was “do not be afraid to negotiate.”

“Physicians are not usually terrific businessmen,” but can be, Godofsky says.

Research is not a profit center, Godofsky acknowledges, but by using it he can support the staff required to care for the disease.

Treating viral hepatitis requires a lot of patient monitoring and education.

It can also be very complicated. About 10 percent of viral hepatitis sufferers also have HIV. Doctors know little about how the drugs used to treat the two viruses separately might interact.

Making a living at that kind of medicine is difficult, said Ball, the executive director of the Puyallup, Wash.-based Hepatitis Resource Network.

“There’s no procedure, so it’s not particularly well-reimbursed,” she said. “But patients have lots of questions.”

Many doctors don’t want to be involved.

Godofsky is on the board of directors of the organization, which was started in 1997 to raise awareness of hepatitis C among physicians.

Infectious disease doctors proved to be more interested in the disease than liver or intestinal doctors, Ball said. They are used to dealing with trying to get paid for the time they spend consulting, and many, like Godofsky, do it for the intellectual challenge.

Bach is what brought Godofsky to Bradenton: “He had that zest or lust for research.”

After his partner died, Godofsky said, he worked seven days a week, 20 hours each day for the subsequent year and a half. “I kept the research going. I kept the HIV care going. I gradually added more and more doctors.”

Now the seven doctors, including Godofsky, cover the three hospitals in Manatee County and the Michael Bach Treatment Center. They also work with Infectious Disease Associates of Sarasota.

Bach and Godofsky also runs a wound care center and a large outpatient IV clinic. The IV clinic, which is open every day, sees 80 to 100 people each day.

Godofsky estimates that he has a patient base of about 1,000 and that he accepts about 300 new patients a year.

Patients

May, the nurse practitioner who runs trials for Godofsky, does not have to recruit patients, even for early phase trials where the focus is on establishing safe doses, not treatment.

“They clamor to do these phase-one trials,” she said. “They want to make something good out of something bad.”

Fort Lauderdale resident Philip Younger is the kind of patient who would benefit from a breakthrough drug. He’s among the 50 percent who didn’t respond to treatment, even after three courses.

The 56-year-old was diagnosed with the disease in 2000 and soon started treatment: three shots a week of one drug, interferon, and six pills a day of another, ribavirin.

Younger, hurt on his job moving furniture, took work as as telemarketer to accommodate the side effects: headaches, fever, muscle aches and loss of appetite. He went on three medications to counteract the insomnia and depression.

During that time, Schering-Plough came out with an improved drug,he tried that, too. Younger went through 15 months of treatment, but the virus came back six months after the treatment ended.

Younger tried another company’s drug. That didn’t work, either.

“It’s a freaky virus,” he said.

Younger, who now works for a patient advocacy group called Hep-C Alert, said the treatment at least bought time for his liver, which showed no cirrhosis in his latest biopsy.

“I live right, eat right, hope for the best and counsel people on hepatitis,” he said.

Younger said that if he could take the time off work, he would join a trial now.

“I’ve always said I would shoot toothpaste if it would get rid of this virus,” he said.

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September 02, 2005

Report Claims MOST HCV Patients Will Develop Cirrhosis

This is one of the most broad announcements regarding Hepatitis C I've seen in a long time. It appears to apply to all Hepatitis C patients.

And, while it seems to predict eventual doom and gloom for most HCV patients, it does so on a very shaky foundation.

And, oh boy,I've got a bit to say about the study this article refers to. Here is the actual conclusion of the study authors:

The prevalence of cirrhosis in patients with chronic HCV increases with increasing duration of infection. In Asian patients infected at birth, infection for over 60 years causes cirrhosis in 71% of infected individuals. Because relationship between the severity of fibrosis and age in Asian patients is similar to that seen in Caucasian patients it is likely that similar rates of cirrhosis will be seen in other patients who are infected for more than 60 years.

First of all, there is no mention of what genotype the "Asian" patients were infected with. According to data I have seen each genotype seems to progress at different rates and with differing levels of severity. 70% of North Americans have genotype 1. And Genotype 1b seems to progress differently than even 1a. And, in Asia, genotype 6 is fairly common. So, does the finding of this study really apply to genotype 1 (or 70% of Americans)?

The study also does not mention mode of infection, and other studies show there is a big difference in progression between those who were infected through transfusion and those infected through other means.

The broad conclusion of this study is that most HCV patients (up to 80%)will progress to cirrhosis after 60 to 80 years of chronic infection. Of course, this conclusion is drawn without taking into account certain variables (as mentioned above).

The actual report from Clinical Gastroenterology and Hepatology goes on to say this about one aspect of the study:

The authors also assumed that the Asian patients were infected at a very young age, largely on the basis of extrapolation of regression lines down to an age in which patients would presumably not have had fibrosis. This conclusion is speculative and goes well beyond the data presented in the study.

The study authors concluded that the majority of patients will progress to cirrhosis after 60 years. The Journal goes on to say this:

Such conclusions are currently premature. Specifically, additional studies are needed in other patient populations that overcome the design limitations of the current study and to address the alternative interpretation of the data that, although during a lifetime there might indeed be progression to cirrhosis, this might only seldom result in end-stage liver disease or the development of HCC.

So, while this looks pretty bad at first glance, closer scrutiny helps put it in clearer perspective.

Oh, one more thing. Most Americans were infected in their early 20's. 60 to 80 years puts them into their 80s to over 100. Hmmm, with an average life expectancy in this country of 72, it seems like HCV patients may do even better than average (wink).

Just shows you've got to take these preliminary study conclusions with a grain of salt. (By the way, be sure you note who helped sponsor this study. The info is near the bottom.)

----------------------------------------------------------------------

Public release date: 1-Sep-2005

American Gastroenterological Association

Most chronic hepatitis C sufferers will develop cirrhosis in later life

Study suggests cirrhosis and liver disease nearly inevitable for people with hep C

Bethesda, Maryland (Sept. 1, 2005) – Nearly 80 percent of chronic hepatitis C sufferers who have the disease for several decades will develop cirrhosis or end-stage liver disease later in life, according to a study published today in the American Gastroenterological Association (AGA) journal Clinical Gastroenterology and Hepatology. Researchers found that it is highly likely that people who are infected with hepatitis C (HCV) for more than 60 years will develop cirrhosis--the highest rate of hepatitis C-associated cirrhosis reported to date.

Hepatitis C is a virus that affects the liver and is spread primarily by contact with blood and blood products in transfusions and among drug users who share needles. Other common routes of transmission are infants born to HCV-infected mothers, tattoos and body piercings and risky sexual behavior. Of those who are infected, more than 80 percent will be chronic carriers of the disease.

HCV can cause long-term scarring of the liver and usually presents with mild and non-specific symptoms, if any. They include fatigue, nausea, poor appetite and muscle and joint pain. It is estimated that more than 4 million Americans are now infected with HCV (more than 170 million people worldwide) and nearly 10,000 Americans die from the disease each year.

"Hepatitis C begins generally as a silent acute infection, with a fraction of the patients developing cirrhosis, end-stage liver disease or liver cancer," according to an editorial appearing in this month's journal. "Although this is a generally accepted scenario in persons infected with HCV, there remains uncertainty about the true frequency of evolution of liver disease and its rate of progression."

According to results of the study from researchers at the Queen Mary's School of Medicine and Dentistry in London, the prevalence of cirrhosis in patients with chronic HCV increases with the duration of the disease. Nearly 80 percent of Asian patients who were infected at birth and lived with the disease for 60 years or more developed cirrhosis--a finding that researchers say can be applied to the general population because of the similarity in the way the disease progresses in all ethnic groups.

"This study suggests that prolonged infection with hepatitis C leads to cirrhosis in the majority of those who are infected," said Graham R. Foster, PhD, FRCP, study author and professor of hepatology at Queen Mary's School of Medicine and Dentistry in London. "While previous studies have found differences in disease progression in various ethnic groups, our findings confirm that fibrosis progression is the same across these groups and leads to development of cirrhosis and liver disease at the same rate in everyone."

Researchers conducted retrospective analyses of 382 patients diagnosed with hepatitis C at three hospitals in northeast London between 1992 and 2003. Study participants were divided into two groups: Asian patients presumably infected in childhood and Caucasian patients. While the prevalence of cirrhosis in Caucasian patients was similar to the findings of previous studies, the statistics in Asians were markedly higher than previously found. The higher prevalence was partially attributed to the longer duration of HCV in the Asian patient population, those patients having suffered with the disease nearly 30 years more than the Caucasian subjects.

###
This study was funded by local investigators and an unrestricted research grant from Roche Pharmaceuticals.

About the AGA
The American Gastroenterological Association (AGA) is dedicated to the mission of advancing the science and practice of gastroenterology. Founded in 1897, the AGA is the oldest medical-specialty society in the United States. The AGA's 14,500 members include physicians and scientists who research, diagnose and treat disorders of the gastrointestinal tract and liver. On a monthly basis, the AGA publishes two highly respected journals, Gastroenterology and Clinical Gastroenterology and Hepatology. The AGA's annual meeting is Digestive Disease Week®, which is held each May and is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

About Clinical Gastroenterology and Hepatology
The mission of Clinical Gastroenterology and Hepatology is to provide readers with a broad spectrum of themes in clinical gastroenterology and hepatology. This monthly peer-reviewed journal includes original articles as well as scholarly reviews, with the goal that all articles published will be immediately relevant to the practice of gastroenterology and hepatology. For more information, visit www.cghjournal.org.

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August 26, 2005

Hepatitis A Vaccinations Highly Recommended

If you are a Hepatitis C patient and have not yet been vaccinated against Hepatitis A, you should be as soon as possible. The story below helps to underline this fact.

While Hepatitis A is not normally deadly for most people, when contracted in HCV patients it has a much higher chance of killing them.

Don't delay. There is really no downside risk to getting the vaccination, and you could be risking your life unnecessarily otherwise.

Hepatitis A vaccine not widely used for Hepatitis C patients

25 Aug 2005

A new study examining whether patients with chronic Hepatitis C virus (HCV) were routinely vaccinated against Hepatitis A virus (HAV) found that vaccination rates were low, even though HAV vaccination is recommended for patients with chronic liver disease.

The results of this study appear in the September 2005 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). Published by John Wiley & Sons, Inc., Hepatology is available online via Wiley InterScience at interscience.wiley.com/journal/hepatology.

The HAV vaccine has been available since 1995, yet HAV infection continues to be one of the most preventable illnesses in the United States. It can cause severe liver disease, liver failure, and even death in patients who already have chronic liver disease. HAV vaccination was recommended for these patients by the 1996 Advisory Committee on Immunization Practices and numerous other health agencies, but it is not known to what extent it is being carried out.

Researchers led by Edmund J. Bini, M.D., M.P.H of the New York University School of Medicine identified 1,193 patients from January to December 2000 at the Veterans Affairs New York Harbor Healthcare System in New York who had chronic HCV infection. Follow-up information was collected through June 30, 2002 to determine the number of patients who were tested for HAV and the number who actually received the HAV vaccine. Patients were considered to be vaccinated if they received at least one dose of the vaccine. The study also examined the number of vaccine doses received, the proportion of patients who were susceptible to HAV among those tested (indicated by a negative HAV antibody result), the incidence of HAV infection during follow-up and the number of visits patients made to their primary care provider.

The results showed that 53.6 percent of the 1,193 patients had antibody testing performed, and almost half of these were susceptible to HAV infection. Yet only 94 patients received the HAV vaccine and of these, 45 received only 1 dose. Among the 94 patients who received the vaccine, 88 had been tested for HAV antibody. A total of 3 patients with HCV infection developed acute HAV infection, one of whom died of liver failure. All of them were known to be susceptible to HAV, but none had received the vaccine.

"The low rates of HAV testing and vaccination are striking given the presence of recommendations to vaccinate these individuals against HAV since 1996, the long duration of follow-up, and the high number of visits with their primary care provider," the authors state. "These findings have substantial public health implications and represent missed opportunities for prevention."

The authors speculate that the reasons for the low vaccination rates could include patient refusal (such as a belief that patients weren't at risk for HAV infection, doubts about the vaccine's effectiveness, or misconceptions about side effects), a lack of knowledge on the part of health care providers, a lack of resources, or because of a greater need to address more pressing health issues during medical visits.

The authors conclude: "Public health efforts at raising awareness about HAV vaccination in patients with chronic liver disease should be strongly encouraged. In addition, further studies to evaluate patient and provider barriers to HAV vaccination are needed to prevent future missed opportunities for vaccination."

Article: "Susceptibility to Hepatitis A in Patients with Chronic Liver Disease Due to Hepatitis C Virus Infection: Missed Opportunities for Vaccination," Michael Shim, Inessa Khaykis, James Park, Edmund Bini, Hepatology; September 2005; (DOI: 10.1002/hep.20830).

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August 04, 2005

HCV Treatment and Obesity

This article contains quite a few tidbits of good information (in addition to the primary focus). The description of "signs" that a small number of patients have does a good job of covering possible symptoms and effects of the disease.

It also seems that the main difference in success between Pegasys and Peg-Intron in these patients may have more to do with the difference in dosing between standard levels of medication and weight based dosing.

PEG-Intron Shows Higher Sustained Responses in Obese Patients

by John C. Martin
Article Date: 08-03-05

A small observational study from the Cleveland Clinic is suggesting that the hepatitis C treatment PEG-Intron (peginterferon alfa-2b) helps obese patients with the viral infection achieve sustained therapy responses better than its competitor product, Pegasys (peginterferon alfa-2a).1

The results of the preliminary trial were released at Digestive Disease Week, an annual gastroenterology conference, held this year in Chicago.

Interferon/Ribavirin: The 'Gold Standard'
According to estimates, nearly 4 million Americans are infected with hepatitis C. Three-quarters of this population go on to become chronically infected, and most have accompanying chronic liver disease. HCV accounts for about 15% of acute viral hepatitis, up to 70% of chronic hepatitis cases, and half of all cases of cirrhosis, end-stage liver disease, and liver cancer. The disease is transmitted primarily through contact with blood or blood products, and the "gold standard" treatment at this point includes the combination of a pegylated, or longer-lasting, interferon combined with ribavirin.2

Symptoms of HCV may be absent, but in some cases may include the following:

• Fatigue
• Mild discomfort or tenderness on your upper right side
• Nausea
• Poor appetite
• Muscle and joint pains

A small number of people with the infection develop certain signs, such as skin rashes, kidney disease, neuropathy, cyroglobulins (abnormal blood proteins), rheumatoid factor (an abnormally produced autoantibody that reacts against immunoglobulins in the blood), and low levels of complement (proteins) in the blood.2

PEG-Intron (peginterferon alfa-2b), manufactured by Schering-Plough Pharmaceuticals, is a form of pegylated, or longer-lasting, interferon for hepatitis C. It is prescribed alone or in combination with an oral antiviral medication called ribavirin for adults with the disease. Another pegylated interferon, Pegasys (peginterferon alfa-2a), manufactured by Hoffman-LaRoche Pharmaceuticals, is also combined with ribavirin as a treatment for hepatitis C. Both PEG-Intron and Pegasys, manufactured by Hoffman-LaRoche Pharmaceuticals, are injectable medications used as therapy for hepatitis C.

Sustained Treatment Responses Compared
Doctors in the study compared sustained virologic responses (SVR) in people classified as obese with those considered non-obese using both medications. SVR is defined as continual non-detectable levels of the hepatitis virus for a minimum of six months after therapy ends.3 "Obese patients with hepatitis C virus (HCV) may have more rapid progression of liver disease and lower rates of response to antiviral therapy than nonobese patients," wrote the study's lead investigator, Nizar Zein, MD, in the department of Gastroenterology and Hepatology at the Cleveland Clinic, and his associates.

Thus, the investigators wanted to determine if either Pegasys or PEG-Intron, both combined with the oral antiviral drug, ribavirin, could help their obese patients achieve an SVR.

Study Participant Characteristics
Through a record search, Zein and his group identified nearly 100 patients who had arrived at the Cleveland Clinic between 2001 and 2004 for treatment of their hepatitis C. None of the patients had received treatment prior to their arrival. Each of the patients was infected with genotype 1 HCV, the most common and most difficult to treat strain of the virus.

Thirty-five patients were classified as obese, and the remaining 61 patients were designated non-obese. Each had undergone a biopsy before therapy to determine the health of their livers.

The researchers reported no significant differences in disease characteristics like liver enzyme levels or levels of HCV RNA, the virus' genetic material that doctors look for as an indicator of its presence. Forty percent of the obese patients had steatosis, or fatty liver, compared with just 16 percent of those classified as non-obese. "But frequency of advanced fibrosis or marked inflammation were not significantly different" between the two groups, Zein and his team wrote.

Which Medication Had Better Outcomes?
When analyzing which patients taking Pegasys in combination with ribavirin had achieved an SVR, the researchers found that two of eleven obese patients in this group (18 percent) did so, compared to eight of 29 non-obese patients (28 percent). By contrast, of those in the group taking PEG-Intron combined with ribavirin, nine of 17 obese patients (52 percent) and 14 of 29 non-obese patients (48 percent) similarly achieved a sustained response, the investigators found.

"Mild fibrosis, lower pretreatment HCV RNA, and weight-based dosing were independently associated with attainment of SVR," wrote the study team. In this research, weight-based doses of PEG-Intron were given to the patients compared with standard dosing using Pegasys. That means people taking PEG-Intron are assigned a specific dose based on their individual weight, as opposed to a standard dose that everyone taking Pegasys receives.

"Obese and non-obese patients have equal SVR when treated with weight-based doses of [peginterferon alfa-2b] in combination with ribavirin," wrote Zein and his group in conclusion. "However, when treated with standard-dosed [peginterferon alfa-2a] and ribavirin, obese patients are less likely to attain SVR."

So far, no formal clinical trials have been published comparing the efficacy of PEG-Intron versus Pegasys. However, Schering is sponsoring such a trial whose results will reportedly be released in 2007.

1. Cesario K, Khandwala F, Edwards K, Carey W, Barnes D, Zein N. Impact of obesity on degree of liver disease and response to therapy in patients with chronic hepatitis C genotype 1 infection. Digestive Disease Week 2005. 2005 May 14-19. Chicago, IL.
2. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). National Institutes of Health. Chronic Hepatitis C: Current Disease Management. Available at: http://digestive.niddk.nih.gov/
ddiseases/pubs/chronichepc/index.htm. Accessed July 28, 2005.
3. Fried MW, Shiffman ML, Reddy KR et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002 Sep 26;347(13):975-82.

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July 26, 2005

HCV Treatment Clincal Trial Announcement

Another new treatment being tested against Hepatitis c. The drug companies are scrambling to get a better treatment to market than what is currently available. God bless them!

lobeImmune Initiates Phase 1b Study of GI-5005 for Chronic Hepatitis C Infection

DENVER, July 26 /PRNewswire/ -- GlobeImmune, Inc., a biopharmaceutical company that discovers, develops and manufactures immunotherapeutic products known as Tarmogens(TM) to treat cancer and infectious disease, today announced that it has initiated a Phase 1b study of GI-5005, a Tarmogen for the treatment of chronic hepatitis C infection (HCV). This study is being conducted under an Investigational New Drug application (IND) that was filed with the U.S. Food and Drug Administration in March 2005.

The Phase 1b study is a double-blind, placebo controlled, dose-escalation, multi-center trial evaluating the safety, immunogenicity, and efficacy of GI- 5005, a Tarmogen expressing a NS3-Core fusion protein. NS3 and Core are HCV protein antigens that are expressed in infected cells and are essential for virus replication. GI-5005 has demonstrated robust activity in preclinical models of HCV. Because Tarmogens elicit a balanced immune response that is similar to the response occurring in the minority of individuals who successfully clear primary hepatitis C infection, the Company believes that the GI-5005 Tarmogen may represent a successful approach to treating this difficult disease.

"Hepatitis C is an area of major unmet medical need," said Timothy C. Rodell, M.D., CEO of GlobeImmune. "We are hopeful that GI-5005 will ultimately be able to treat the significant proportion of patients for whom there is currently no effective therapy. This is a significant event for GlobeImmune, as this milestone represents the second Tarmogen product to enter human clinical trials in 18 months and the first clinical trial of a Tarmogen for the treatment of an infectious disease."

Chronic hepatitis C infection, a viral liver disease, is a global health epidemic. Currently, there are approximately 170 million people worldwide who are infected with the hepatitis C virus. Of these, 4-5 million live in the United States with an additional 5 million living in Western Europe. Approximately 20-30% of all hepatitis C patients will face life threatening complications as a result of their disease. Hepatitis C accounts for 20% of cases of acute hepatitis, 70% of cases of chronic hepatitis, 40% of cases of end-stage cirrhosis, 60% of cases of hepatocellular carcinoma (liver cancer) and 30% of liver transplants in the United States.

The incidence of new symptomatic infections with hepatitis C has been estimated to be 13 cases/100,000 persons annually. For every one person that is infected with the AIDS virus, there are more than four infected with hepatitis C. The Centers for Disease Control Prevention (CDC) estimate that there are up to 230,000 new hepatitis C infections in the United States every year. Currently, 8,000 to 10,000 deaths each year are attributed to the disease.

ABOUT GLOBEIMMUNE

GlobeImmune, Inc., is an emerging biopharmaceutical company pioneering the discovery, development and manufacturing of potent, targeted molecular immunotherapies called Tarmogens for the treatment of cancer and infectious diseases. The Company's lead products are in Phase 1 testing for the treatment of hepatitis C infection and for the treatment of cancers of the lung and gastrointestinal tract. Tarmogens are whole, heat-killed recombinant Saccharomyces cerevisiae yeast genetically modified to express one or more protein antigens that stimulate the immune system against diseased cells.

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June 22, 2005

Shorter HCV Treatment? Yes, for some...

Because genotypes 2 and 3 respond so well to interferon therapy, researchers are studying how little they can give and still have a positive effect.

This is great for 30% of North Americans who have chronic Hepatitis c. But the rest of us are still looking at a year of treatment and maybe a 50% chance of success (at best).

Actually, I look at articles like this as much for secondary information as primary. For instance, I hadn't realized that only 5% of Americans have type 2. Wow! This means the best resonse to interferon can only be acheived by 5% of us.

Shorter Hepatitis C Treatment Works for Some
For Those With Hepatitis Type 2 or 3, 3-Month Treatment May Suffice
By Daniel DeNoon

WebMD Medical News

Reviewed By Michael Smith, MD
on Wednesday, June 22, 2005

June 22, 2005 -- Some people with hepatitis C may get by with only three months of treatment, an Italian study shows.

The findings apply only to people infected with type 2 or type 3 hepatitis C virus. They do not apply to people infected with the more common type 1 virus. In the U.S., about 70% of hepatitis C infections are type 1, about 5% are type 2, and about 20% are type 3.

Treatment for hepatitis C isn't easy. The drugs of choice are a once-a-week form of interferon alpha (peg-interferon) plus ribavirin, an antiviral drug. The side effects -- including flu-like symptoms, fatigue, and depression -- can be very hard to handle.

Current guidelines call for six months of treatment for hepatitis C type 2 and type 3 infections. A year of treatment is needed for type 1 infections.

But Alessandra Mangia, MD, of Casa Sollielo della Sofferenza Hospital, in San Giovanni Rotondo, Italy, and colleagues report that some patients with hepatitis C type 2 or type 3 infections may be able to cut their treatment time in half.

Fast Response, Shorter Treatment?

The goal of hepatitis C treatment is what doctors call a sustained virologic response. That's when the hepatitis C virus can no longer be detected in the blood. Many experts call this a cure; others are more cautious. Whatever it's called, patients with sustained virologic responses to treatment almost never see their hepatitis C infection come back to dangerous levels.

Side effects force some patients to quit treatment early. Usually, that means treatment failure; usually -- but not always.

"We saw that a few patients, who withdrew from therapy before the standard six-month period, had sustained virologic responses anyway despite their short course of treatment," Mangia tells WebMD. "And we saw that some patients show a very fast reduction of hepatitis C virus levels after their first interferon treatment."

Did early response to treatment predict who would do well with short-term therapy? The researchers designed an experiment. They enrolled 283 people with hepatitis type 2 or type 3 infection. Seventy of the patients got the full six months of peg-interferon plus ribavirin. The other 213 patients started with the same treatment. If, after four weeks, their blood levels of hepatitis C virus became undetectable, these "fast responders" got only three months of treatment -- called variable-length treatment.

Mangia and colleagues report their findings in the June 23 issue of The New England Journal of Medicine.

What happened?

The researchers had good news for patients with hepatitis C type 2 or 3 that had no evidence of the virus after four weeks of treatment. "Patients treated for 12 weeks were spared the expense and inconvenience of extended treatment and still had a high response rate."

Too Good to Be True?

The response rates were similar between those treated for three months and those treated for six months. Overall, 76% of patients getting standard treatment and 77% of patients getting the variable-length treatment had a sustained virologic response.

But there were some differences.

At first, early responders -- those who had undetectable levels of hepatitis C virus after four weeks of treatment -- looked the same in both the standard and variable treatment groups. Ninety-three percent of early responders treated for six months and 95% of those treated for three months still had no detectable virus at the end of treatment. Six months later, that percentage dropped from 93% to 91% in those treated for six months. But it dropped from 95% to 85% in those treated for three months.

Although it sounds like the variable-length group have more viral "rebound," Mangia notes that the results were very similar between the two groups. And of the 13 patients who rebounded after three months of treatment, 10 agreed to 24 more weeks of treatment. This second course of treatment was successful for nine of these 10 rebounders.

"Only this small number of persons rebounded, without any major side effects, and without any reduction in the response rate for [further] treatment," Mangia says.

But these numbers worry hepatitis C expert Robert Fontana, MD, associate professor of medicine and medical director for liver transplant at the University of Michigan in Ann Arbor.

"Is this really an efficient way to manage patients? If you are going to go through this therapy, you would rather get rid of the virus," Fontana tells WebMD. "Yes, you have less of the side effects with 12 vs. 24 weeks of treatment. But if someone is tolerating it well, why risk the relapse? Plus there is the whole psychological letdown from learning you've had a rebound. ... If you can get by with less treatment, great. But when you start to have a trend toward rebound, I don't think it's worth the risk."

Mangia says her hospital already is using the variable-treatment strategy for all patients with type 2 or type 3 hepatitis C infection.

Based on the study findings, Fontana doesn't think this is a good idea. He praises the Mangia study. Though he notes that it was carefully done and that it addresses crucial issues in hepatitis C treatment, he says doctors and patients would do better to focus on managing side effects than by trying to shorten treatment.

"During the first 12 weeks, the most severe side effects are flu-like symptoms," Fontana says. "Beyond 12 weeks, the depression, the weakness, and the sort of mental aspect becomes more prominent. That is where a lot of patients going out to 48 weeks just can't hack it. By reducing the dose, by seeing patients more often, by introducing antidepressants, and by helping with sleep, you can get a lot of those patients through."

SOURCES: Mangia, A. The New England Journal of Medicine, June 23, 2005; vol 352: pp 2609-2617. Alessandra Mangia, MD, Casa Sollielo della Sofferenza Hospital, San Giovanni Rotondo, Italy. Robert Fontana, MD, associate professor of medicine and medical director for liver transplant, University of Michigan, Ann Arbor. Zeuzem, S. Annals of Internal Medicine, March 2, 2004; vol 140: pp 370-381. AASLD Practice Guideline: "Diagnosis, Management, and Treatment of Hepatitis C," Strader, D. B. Hepatology, April 2004; vol 39: pp 1147-1171.

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May 06, 2005

Specific Genes Predict HCV Treatment Success

Wow! Now this is a great discovery. Imagine being able to know in advance if you can be helped by interferon combination therapy. You would not need to go through any discomfort to discover whether or not it would be effective for you.

Toronto, Ontario, May 2 /PR Direct/ -

Identification of specific genes predicts which patients will respond to Hepatitis C treatment

Simple blood test in the near future possible

(Toronto, May 2, 2005) - For the first time, physicians at University Health Network and University of Toronto have identified a small subset of genes that can predict whether a patient with chronic Hepatitis C will be able to respond to current treatments.

These genes could also become the basis of a simple new test in the future to predict which patients will respond to therapy.

The study, published in the May issue of the American Gastroenterological Association's Gastroenterology, found that the difference between those patients who responded to treatment and those who did not was the level of expression - whether the genes were turned on or turned off - of 18 genes.

"Our results demonstrate that a relatively small number of genes can predict response to therapy. These genes may be important to the ability of the patient to eliminate the virus, so studying these genes in more detail will hopefully lead to novel antiviral treatments," said Dr. Ian McGilvray, the senior author of the study. Dr. McGilvray is a transplant surgeon at Toronto General Hospital, University Health Network and an Assistant Professor of Surgery at the University of Toronto. "By manipulating the products of these genes we might be able to improve treatment responses to this chronic disease."

"This information is helpful for patients because it's one more piece of evidence that we hope will encourage 'responder' patients to start and continue treatment for Hepatitis C, despite it's many side effects," said Dr. Jenny Heathcote, a hepatologist at Toronto Western Hospital, University Health Network and Professor of Medicine at University of Toronto, who contributed to the study and treats many of the patients in the study. "We want to be able to give patients as much information as we can, so that they can make the best decisions about their treatment options."

Tony Angelini, 42, was one of the patients in the study who responded to treatment. He is now clear of the virus. "Knowing that you are a responder gives you the courage and the fight to go on. It was devastating, but having the support of my friends and hospital staff really helped me through the treatment. And I wanted to participate in this study so that the research could help others in the future."

The study followed 31 patients with chronic Hepatitis C who were treated at Toronto Western Hospital from October 2001 until May 2004. Hepatitis C is a disease of the liver caused by the hepatitis C virus (HCV). About 230,000 Canadians are infected with it, and about 170 million people worldwide. Over time the viral infection leads to liver damage, cirrhosis and/or liver cancer. It is currently the leading indication for liver transplants.

Liver biopsies were performed on the 31 chronic HCV patients before treatment, and were compared to 20 biopsies from healthy, uninfected livers. 16 patients did not respond to subsequent treatment, while 15 did; both groups were well matched with respect to age, HCV viral load (number of viral particles circulating in the blood), and liver disease activity.

In order to define which genes discriminate between those patients who respond to therapy to those who do not, microarray technology, based in a Banting and Best Department of Medical Research laboratory at University of Toronto, was used to analyze the pattern of genes in all participants. This technology allows scientists to compare levels of expression for tens of thousands of genes on a glass slide - these "gene chips" are the size of a postage stamp. The technology is able to quickly scan the expression of those genes and differentiate between genes which are "turned on" or "turned off". Comparing "genetic fingerprints" allows researchers to rapidly and effectively identify sensitive genetic changes associated with various stages of disease, and hopefully identify the most suitable candidates for specific therapies.

"We went into this experiment without any hypothesis about what to look for," said Aled Edwards, a Professor in the Banting and Best Department of Medical Research at University of Toronto with cross appointments in the Departments of Medical Biophysics and Medical Genetics and Microbiology. He is also a senior scientist at the Clinical Genomics Centre at the University Health Network and Director and CEO of the Structural Genomics Consortium. "We cast a very wide net, looking at 19,000 genes of each of the patients."

The researchers found that the difference between those patients who did not respond to therapy to those who did was a subset of 18 genes. In the non-responders to treatment, 16 genes were turned on and two were turned off. Many of the 16 genes which were turned on are stimulated by interferon, one of the key antiviral agents that the body produces in response to viral infection and a medication that patients currently receive as part of their therapy. "Paradoxically, in the non-responders, the liver is revved up and the genes are responding like mad, but there is something about the response that just does not work," said Dr. McGilvray.

In the near future, determining the levels of a small subset of genes in patients' liver biopsies, with perhaps a simple blood test, may be helpful in deciding who will respond to treatment of chronic Hepatitis C with the current combination therapy using the synthetic antiviral agent ribavirin and interferon. This treatment can currently get rid of the virus in only roughly 50% of persons infected with genotype 1, the most common genotype in North America and world-wide.

The study was supported by grants from the PSI Foundation and the Canadian Institute of Health Research.

University Health Network consists of Toronto General, Toronto Western and Princess Margaret Hospitals. The scope of research and complexity of cases at University Health Network has made it a national and international source for discovery, education and patient care. It has one of the largest hospital-based research programs in Canada, with major research projects in transplantation, cardiology, neurosciences, oncology, surgical innovation, infectious diseases, and genomic medicine. University Health Network is a teaching hospital affiliated with the University of Toronto.

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April 20, 2005

Hepatitis C and Diabetes (Type 2)

This article was a real surprise with regard to diabetes and Hepatitis C.

In the conclusions I found this mention quite fascinating: "Approximately 40% of patients with HCV infection will display symptoms of some extrahepatic manifestation during the illness (1). Most extraliver manifestations of chronic HCV infection are immunological..."

This mention that most patients who have symptoms experience immunolgical manifestations was an eye opener. I have long heard that the aches, pains, brain fog, fatigue, etc. that many patients experience are due to the immune system going a bit haywire with the virus circulating in the system. This surely seems to acknowledge that theory.

However, the article does go on to say that the virus also directly affects other organs and tissues in the body besides the liver. This accounts for many of the more serious symptoms people experience that have nothing to do with the liver being infected.

The more I learn about this disease, the more I realized there is to learn.

Hepatitis C Virus Infection and Human Pancreatic [Beta]-Cell Dysfunction

Abbreviations: HCV, hepatitis C virus.

Many patients with chronic hepatitis C virus (HCV) develop type 2 diabetes (1). This prevalence is much higher than that observed in the general population and in patients with other chronic liver diseases such as hepatitis B virus, alcoholic liver disease, and primary biliary cirrhosis. Furthermore, it has been shown that post- transplantation type 2 diabetes appears to be higher among patients with HCV (2). However, the pathogenetic basis for the association between HCV infection and diabetes has not been understood. A direct involvement of the virus in the development of insulin resistance has been proposed, and β-cell dysfunction in HCV-positive patients has been observed in some cases (1). Because HCV can infect many tissues other than the liver (3), we hypothesized that the virus might directly damage insulin-secreting cells. This article suggests that HCV may be present in human pancreatic β-cells and demonstrates that islet cells from HCV-positive patients have morphological and functional defects.

RESEARCH DESIGN AND METHODS- The pancreases of 5 HCV-positive (age 68 9 years, 3 men and 2 women, BMI 25.8 1.6 kg/m^sup 2^) and 10 HCV-negative (age 67 9 years, 6 men and 4 women, BMI 26.8 2.0 kg/m^sup 2^) donors were harvested and studied with the approval of our local ethics committee. Histological studies were performed by immunohistochemistry (using the monoclonal mouse anti-HCV E2 protein, clone IGH222 [Innogenetics, Gent, Belgium]) and electron microscopy, as described elsewhere (4,5). Isolated islets were prepared by enzymatic digestion and density gradient purification, and islet functional and survival studies were accomplished as previously described (5,6).

RESULTS- Histology results are summarized in Fig. 1. No sign of islet cell staining was found in HCV-negative pancreases by immunohistochemistry (Fig. 1A); however, focal or diffuse HCV- positive islet cells were observed in HCV-positive pancreatic glands (Fig. 1B). Positive staining was found in 39 12% of 140 examined islets, and the percentage of stained cells was 54 13% per islet. The appearance of a control β-cell at electron microscopy is given in Fig. 1C, showing the characteristic insulin granules and normally preserved mitochondria. In β-cells from HCV-positive pancreases, the presence of virus-like particles was observed, mainly close to the membranes of Golgi apparatus, which, in turn, appeared hyperplastic and dilated (Fig. 1D). The mitochondria appeared round-shaped with dispersed matrix and fragmented cristae (Fig. 1D). Additional β-cell changes were observed at the level of rough endoplasmic reticulum, which showed long and dilated tubular membranes, with numerous electrondense ribosomes bound to the latter (not shown). These morphological changes were accompanied by reduced in vitro glucose-stimulated insulin release (Table 1); however, apoptosis was similar in control as in infected islet cells (Table 1).

CONCLUSIONS- Approximately 40% of patients with HCV infection will display symptoms of some extrahepatic manifestation during the illness (1). Most extraliver manifestations of chronic HCV infection are immunological; however, the virus may have a direct cytopathic action, because it can infect many tissues other than the liver (3). In the present article we have suggested the presence of HCV infection in pancreatic β-cells of human subjects, and we have provided evidence that this was associated with morphological cell changes and altered islet cell function. The immunohistochemical method we have used to show the presence of infection in islet cells has been previously validated (4), and the electron microscopy morphological alterations of the β-cell are similar to those reported in other cell types during HCV infection (7). The insulin secretion functional defects of islets from HCV-positive donors might contribute to the development of diabetes in predisposed subjects. On the other hand, the absence of increased apoptosis is in line with the observation that reducing viral load is associated with improvement of diabetes in HCV-positive patients (8). In conclusion, the present article proposes that HCV can infect human pancreatic β-cells and that this is accompanied by β-cell dysfunction. A direct cytopathic effect of HCV at the islet cell level is therefore suggested to explain, at least in part, the association between HCV infection and diabetes, especially in predisposed subjects (1).

Table 1-Insulin secretion and apoptosis data of HCV-negative and HCV-positive pancreatic islets

Figure 1-A and B show the results obtained by an immunoperoxidase technique for anti-HCV-E2 in pancreatic islets (original magnification 400). in A, the endocrine cells from a control pancreas are completely devoid of the viral antigen. In B, the endocrine cells from an HCV-positive pancreas show a brown, finely granular staining, indicating the presence of the HCV proteins. C and D show the results obtained by electron microscopy (original magnification 46,000). In C, a control β-cell is shown, with the characteristic insulin granules (G) and normal mitochondria (M). In D, a β-cell from an HCV-positive pancreas is represented, showing virus-like particles (VL) close to dilated, hyperplastic Golgi apparatus (GA) and round-shaped mitochondria with dispersed matrix and fragmented cristae.

A table elsewhere in this issue shows conventional and Systme International (SI) units and conversion factors for many substances.

2005 by the American Diabetes Association.

References

1. Lecube A, Hernandez C, Genesca J, Esteban JI, Jardi R, Simo R: High prevalence of glucose abnormalities in patients with hepatitis C virus infection: a multivariate analysis considering the liver injury. Diabetes Care 27:1171-1175, 2004

2. Bruchfeld A, Wilczek H, Elinder CG: Hepatitis C infection, time in renal-replacement therapy, and outcome after kidney transplantation. Transplantation 78:745-750, 2004

3. Mayo MJ: Extrahepatic manifestations of hepatitis C infection. Am J Med Sci 325: 135-148, 2003

4. Verslype C, Nevens F, Sinelli N, Clarysse C, Pirenne J, Depla E, Maertens G, van Pelt J, Desmet V, Fevery J, Roskams T: Hepatic immunohistochemical staining with a monoclonal antibody against HCV- E2 to evaluate antiviral therapy and reinfection of liver grafts in hepatitis C viral infection. J Hepatol 38:208-214, 2003

5. Marchetti P, Del Guerra S, Marselli L, Lupi R, Masini M, Pollera M, Bugliani M, Boggi U, Vistoli F, Mosca F, Del Prato S: Pancreatic islets from type 2 diabetic patients have functional defects and increased apoptosis that are ameliorated by metformin. J Clin Endocrinol Metab 89:5535-5541, 2004

6. Marchetti P, Lupi R, Federici M, Marselli L, Masini M, Boggi U, Del Guerra S, Patan G, Piro S, Anello M, Bergamini E, Purrello F, Lauro R, Mosca F, Sesti G, Del Prato S: Insulin secretory function is impaired in isolated human islets carrying the Gly(972)[arrow right]Arg IRS-1 polymorphism. Diabetes 51:1419-1424, 2002

7. Falcon V, Acost-Rivero N, Chinea G, Gavilondo J, de la Rosa MC, Menendez I, Duenas Carrera S, Vina A, Garcia W, Gra B, Noa M, Reytor E, Barcelo MT, Alvarez F, Morale-Grillo J: Ultrastructural evidences of HCV infection in hepatocytes of chronically HCV- infected patients. Biochem Biophys Res Commun 305:1085-1090, 2003

8. Bahtiyar G, Shin JJ, Aytaman A, Sowers JR, McFarlane SI: Association of diabetes and hepatitis C infection: epidemiologic evidence and pathophysiologic insights. Curr Diab Rep 4:194-198, 2004

MATILDE MASINI, MD1

DANIELA CAMPANI, MD2

UGO BOGGI, MD3

MICHELE MENICAGLI, MD2

NICOLA FUNEL, MD1

MARIA POLLERA, MD1

ROBERTO LUPI, PHD1

SILVIA DEL GUERRA, PHD1

MARCO BUGLIANI, PHD1

SCILLA TORRI, PHD1

STEFANO DEL PRATO, MD1

FRANCO MOSCA, MD3

FRANCO FILIPPONI, MD4

PIERO MARCHETTI, MD, PHD1

From the 1 Metabolic Unit, Department of Endocrinology and Metabolism, University of Pisa and Pisa University Hospital, Pisa, Italy; the 2 Section of Transplantation Pathology, Division of Surgical, Molecular and Ultrastructural Pathology, Department of Oncology, University of Pisa and Pisa University Hospital, Pisa, Italy; the 3 Referral Center for the Treatment of Pancreas Diseases, Department of Oncology, University of Pisa and Pisa University Hospital, Pisa, Italy; and the 4 Liver Transplant Unit, University of Pisa and Pisa University Hospital, Pisa, Italy.

Address correspondence and reprint requests to Piero Marchetti, MD, Department of Endocrinology and Metabolism, Metabolic Unit, Ospedale Cisanello, Via Paradisa 2, 56124 Pisa, Italy. E-mail: marchant@immr.med.unipi.it.

Received for publication 30 November 2004 and accepted in revised form 29 December 2004.

Copyright American Diabetes Association Apr 2005

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April 18, 2005

Early Treatment of HCV Questioned

You are not necessarily going to see information like this printed in the US press. It seems the party line is to not alienate the pharmaceutical industry.

Even when there are suspicions regarding certain drugs or studies there is generally nothing publicly noted until there is undeniable proof (see Bextra, Celebrex and Vioxx).

This article is also the first place I've seen the prognosis differential between infected women and men mentioned.

For doctors to recommend current therapy for anyone who shows up in their office with Hepatitis C seems short sighted, at best, and irresponsible, at least.

Bear this in mind when considering therapy for yourself or a loved one.

Report Questions Early Treatment of Hepatitis C
Monday April 18, 2005 (1525 PST)

ISLAMABAD: People with hepatitis C whose livers remain healthy may be better off not undergoing drug treatment, which can produce severe side effects such as nausea and depression and does not always work, researchers said.

The recommended 48-week course of treatment for the blood-borne virus -- injections of interferon and oral ingestion of ribavarin -- is effective in, at most, 60 percent of patients. It also has potentially severe side effects such as nausea, fatigue, depression and, in some cases, suicidal impulses.

The treatment, which costs in excess of $20,000, has been shown to lengthen the lives of hepatitis C sufferers with existing liver damage, a condition which can lead to deadly cirrhosis or cancer.

But a majority of hepatitis C patients do not develop liver damage before dying of other causes, so the drug treatment may not be cost-effective or helpful for them, the report from the Harvard School of Public Health's Center for Risk Analysis said.

In the United States, 2.7 million people have chronic cases of hepatitis C and there are about 25,000 new cases each year, most infected through needle sharing or from receiving blood from an infected donor. But four out of five have no signs or symptoms and many of them are unaware they have it.

The disease's progression varies considerably and milder cases, especially among women, may never progress to cirrhosis. The report's analysis of U.S. health data showed that the probability of infected men developing cirrhosis over a 30-year period was between 13 percent and 46 percent, and among women the probability was between 1 percent and 29 percent.

"There has been a huge effort over the last few years to identify people infected with (hepatitis C), but this wider group of patients will likely include those who are least likely to develop advanced liver disease," Sue Goldie, author of the report published in this week's issue of the Journal of the American Medical Association said in a statement.

"For patients at low risk of progressing, the overall health gain from treatment may be minimal given the potential for toxic side effects," she said.

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April 06, 2005

Retinal Toxicity and Combination Therapy

This article from HIVandHepatitis.com makes a strong statement regarding the possible negative effects of interferon combination therapy on the eyes of patients.

Although warned of in package and label warnings this report brings the very real possiblity of serious damage home in a powerful way.

Retinal Toxicity During Pegylated Alfa Interferon Therapy for Chronic Hepatitis C

By Ronald Baker, PhD

There have been documented and anecdotal reports of ocular side effects during therapy with pegylated interferon and ribavirin. The aim of the current study was to evaluate the effect of therapy with pegylated interferon and ribavirin on the eyes of patients with chronic hepatitis C.

In this small study, 10 patients receiving peginterferon alfa-2a (Pegasys) and ribavirin and 10 healthy volunteers underwent full ophthalmic investigations and multifocal electroretinogram testing at baseline, and at regular intervals during treatment and post-treatment. The multifocal electroretinogram maps retinal function. Responses were compared with sequential recordings from healthy volunteers.

Results

All patients had normal clinical ophthalmic investigations at baseline. During therapy a single patient experienced central visual disturbance lasting 24 h with no prolonged ill effect.

No other patient was aware of any change in vision.

Fundal abnormalities [relating to the retinal area] appeared in five patients during treatment.

The multifocal electroretinogram showed reductions in retinal function in five patients.

Nine of 10 patients exhibited abnormalities on at least one multifocal electroretinogram or fundoscopic investigation.

The authors conclude, "Subclinical retinal toxicity during anti-viral therapy with pegylated alpha-interferon and ribavirin was frequent in this study and it suggests that patients should be warned of this risk and monitored during therapy."

Department of Clinical Physics and Bioengineering, Gartnavel General Hospital, Glasgow, UK.

See also Is Screening for Peginterferon-related Retinopathy in Hepatitis C Justified? and

Treatment with Pegylated Interferon May Cause Eye Complications in Patients with Chronic Hepatitis C

Commentary

Serious ocular disorders do not appear to occur frequently among patients using standard interferon or the peginterferons plus ribavirin. However, such problems can occur. If vision problems develop, patients should immediately call their physician and set up an appointment to see an ophthalmologist for a complete eye examination.

The product information on the pegylated interferons contains a warning about potential ophthalmologic disorders. The following text is excerpted from the WARNINGS section of the Pegasys Product Information (9). There is a similar WARNING on potential ocular disorders associated with peginterferon alfa-2b in the Peg-Intron/Rebetol product information:

“Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, and papilledema are induced or aggregated by treatment with PEGASYS or other alpha interferons.

“All patients should receive an eye examination at baseline. Patients with preexisting opthalmologic disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic opthalmologic exams during interferon alpha treatment. Any patient who develops ocular symptoms should receive a prompt and complete eye examination.

“Pegasys treatment should be discontinued in patients who develop new or worsening ophthalmologic disorders.” [emphasis added]

Selected Excerpts from the Literature on Retinal Toxicity Related to Therapy with Standard Interferon and/or Pegylated Interferon:

“The incidence of serious ocular pathology associated with anti-HCV therapy may be very high and is probably associated with peg-IFN alpha-2b. Increased monitoring of patients treated with peg-IFN alpha-2b for retinal and visual changes is warranted.” C Farel et al (3).

“Although ocular toxicity is uncommon, it should be emphasized that it can occur any time after the start of interferon therapy, and physicians now treating chronic hepatitis C patients with pegylated interferon must be aware of this potentially serious adverse event.” RA Willson (8).

The multifocal electroretinogram can detect retinal dysfunction in chloroquine retinopathy even when the full-field electroretinogram is normal and retinal alterations are subtle. Kellner et al (5).

“This case report underlines the necessity of an EOG on patients with INF-alpha therapy. Until now, the pathogenesis of this retinal toxicity has been poorly understood. These results show that the retinal pigmented epithelium is probably implicated at an early stage in this retinal toxicity.” M Crochet et al (2)

“Subclinical retinal toxicity during anti-viral therapy with pegylated alpha-interferon and ribavirin was frequent in this study and it suggests that patients should be warned of this risk and monitored during therapy.” Chisolm et al (1)

‘Subclinical neurovisual impairment is a frequent, largely unrecognized complication of low-dose IFN therapy, and patients with chronic hepatitis B and older age appear to be most susceptible. This apparently innocuous complication is long lasting, possibly irreversible in some patients, with yet undetermined consequences on visual function.” Manesis et al (6)

“8/19 patients, while on treatment, developed an asymptomatic retinopathy. Among these 3/8 were relapsers and 5/9 were non-responders to interferon monotherapy. All retinal changes faded, often while the patients continued the therapy. There was no significant association in occurrence of retinopathy with haematological and/or biochemical changes.” Jain et al (4)

“Although ocular toxicity is uncommon, it should be emphasized that it can occur any time after the start of interferon therapy, and physicians now treating chronic hepatitis C patients with pegylated interferon must be aware of this potentially serious adverse event.” Willson (8)

04/06/05

Citations

(1) J A Chisholm and others. Retinal toxicity during pegylated alpha-interferon therapy for chronic hepatitis C: a multifocal electroretinogram investigation. Alimentary Pharmacology & Therapeutics. 21(6): 23-32. March 15, 2005.

(2) M Crochet and others. Retinopathy caused by interferon alpha associated with ribavirin therapy and the importance of the electro-oculogram: a case report. Journal of French Ophthalmolology 27(3):257-262. March 2004.

(3) C Farel and others. Serious ophthalmic pathology compromising vision in HCV/HIV co-infected patients treated with peginterferon alpha-2b and ribavirin. AIDS 18(13):1805-9. September 3, 2004.

(4). K Jain and others. Retinopathy in chronic hepatitis C patients during interferon treatment with ribavirin. British Journal of Ophthalmology 85(10):1171-3. October 2001.

(5). U Kellner, Kraus H, Foerster MH.. Multifocal ERG in chloroquine retinopathy: regional variance of retinal dysfunction. Graefe's Archive for Clinical and Experimental Ophthalmology 238(1): 94-97. January 2000.

(6). E K Manesis and others. Neurovisual impairment: a frequent complication of alpha-interferon treatment in chronic viral hepatitis. Hepatology 27(5):1421-7. May 1998.

(7). A Tsolakos and N Zalatimo. Hepatitis C: a review of diagnosis, management, and ocular complications from treatment. Optometry 74(8): 517-23. August 2003.

(8). R A Willson. Visual side effects of pegylated interferon during therapy for chronic hepatitis C infection. Journal of Clinical Gastroenterology 38(8): 717-722. September 2004.

(9). Hoffman-La Roche. WARNINGS: Ophthalmologic Disorders. Pegasys Product Information. Page 10. January 2004.

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April 05, 2005

Coffee Reduces Chances of Liver Cancer

I drink a lot more green tea than coffee. This report makes me want to drink at least one cup of coffe per day even if just for therapeutic reasons.

Very convincing results to this study make this report very credible.

Coffee Consumption Reduces the Risk of Liver Cancer

Coffee Beans

Over the past 20 years, a body of data has accumulated that suggests a clear benefit for liver function and liver disease from drinking coffee. Several studies have demonstrated that drinking coffee lowers gamma-glutamyltransferase (GGT) activity, especially among heavy alcohol drinkers. In a Japanese study of 2494 men, the mean GGT was about 30% lower among those who drank 4 or more cups of coffee daily compared to non drinkers.

Although GGT is a relevant indicator of the risk for cirrhosis, serum alanine aminotransferase (ALT) activity is a more specific marker of liver injury, and a few population-based surveys from Italy and Japan have found a similar inverse relation between coffee drinking and ALT levels.

Results of a study by Gelatti et al published in the current issue of the Journal of Hepatology (April 2005) provide more evidence of an inverse relation between drinking coffee and hepatocellular carcinoma (HCC) [liver cancer].

The aim of this study was to investigate the role of coffee in HCC, taking the main risk factors into account. Researchers conducted the study in northern Italy, where they enrolled 250 hepatocellular (HCC) patients and 500 controls who had been hospitalized for any reason other than neoplasms and liver and alcohol-related diseases.

A standardized questionnaire provided information to the investigators concerning the patients' lifetime history of coffee.

Results

Coffee consumption by the study group in the decade prior to the questionnaire/interview was associated with a decreasing risk of HCC with a clear dose-effect relation.

With respect to non coffee drinking participants, the odds ratios (ORs) were: 0.8, for 1-2 cups/day, 0.4 for 3-4 cups/day and 0.3 for 5 or more cups/day.

The ORs for HCC decreased for drinking >2, compared to 0-2 cups/day of coffee, for an alcohol intake >80g/day, for presence of hepatitis B virus infection or hepatitis C virus infection.

The authors conclude, "Coffee drinking was inversely associated with hepatocellular carcinoma regardless of its etiology."

Discussion

Compared with non coffee drinkers, the relative risks (RRs) were 0.8 for drinkers of 1-2 cups per day, 0.4 for those of 3-4 cups, and 0.3 for drinkers of five or more cups per day. The inverse relation between coffee and primary liver cancer is stronger than in previous studies, indicating that the relation is probably real, and not due to chance.

The combined, pooled RR from three published studies of coffee and hepatocellular carcinoma for drinkers of three or more cups of coffee per day as compared to non coffee drinkers is approximately 0.6.

More important, the study by Gelatti et al. provides original information on the independent effect of coffee from the major recognized risk factors for primary liver cancer. The inverse relation with coffee, in fact, was of similar magnitude in subjects negative or positive for HBV or HCV serum markers, as well as in non- or moderate drinkers and in heavy drinkers.

Coffee appears to have a real, but moderate effect in reducing the risk of hepatocellular carcinoma. Various components of coffee have been related to such a favorable effect, including caffeine, coffee oils kahweol or cafestol, and antioxidant substances from coffee beans, but no definite evidence is available for any of these components.

Despite these uncertainties, HCC should be added to other digestive tract cancers on which a favorable role of coffee drinking has been suggested, including oral and pharyngeal, oesophageal and colorectal cancers.

04/04/05

References
U Gelatti and others (for the Brescia HCC Study Group). Coffee consumption reduces the risk of hepatocellular carcinoma independently of its aetiology: a case-control study. Journal of Hepatology 42(4): 528-534. April 2005.

C La Vecchia. Coffee, liver enzymes, cirrhosis and liver cancer (Editorial). Journal of Hepatology 42(4): 444-446. April 2005.

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March 16, 2005

Mother to Child HCV Transmission Studied

The article mentions the incidence of mother to child transmission is very low. Of those infected, fully one third contracted the disease in utero. It seems these were mostly genotype 1. Clearly more study is recommended.

When Does Mother-to-Child Transmission of Hepatitis C Virus Occur?

The rate of HCV transmission from mother to child is generally though to be very rare. However, it does occur, however rarely. The aim of the present prospective cohort study was to investigate when hepatitis C virus (HCV) infection from mother to child occurs, and to evaluate possible associated factors.

Fifty-four HCV positive children and their mothers were tested within three days of birth. The main outcome measure of the study was HCV RNA polymerase chain reaction (PCR) results.

Results

Seventeen of the children (31%) were positive in the first 3 days of life and could be assumed to have acquired infection in utero.

Testing PCR positive was not associated with sex (53% v 49% boys; p=0.77) or mode of delivery (29% elective caesarean section in both groups; p=0.98).

Children with evidence of intrauterine infection were significantly more likely to be of lower birth weight and infected with genotype 1 (58% v 12%, p=0.01).

Although a higher proportion of infants born to HCV/HIV co-infected women were HCV PCR positive in the first 3 days of life, this difference did not reach statistical significance.

Excluding infants born to co-infected women did not affect the results.

Thirty seven of the children (68%) were negative in the first 3 days of life, 27 of whom were positive when tested again at 3 months, and nine were first PCR positive after 3 months (one child had no further tests).

Conclusions

The authors conclude, “These results suggest that at least one third and up to a half of infected children acquired infection in utero. Although postpartum transmission cannot be excluded, these data suggest that it is rare. The role of HCV genotypes in the timing and mechanism of infection should be explored further.”

Paediatric HIV Service, Royal Hospital for Sick Children, Edinburgh, Scotland, UK.

03/16/05

References
J Mok and others (for the European Paediatric Hepatitis C Virus Network). When does mother to child transmission of hepatitis C virus occur? Arch Dis Child Fetal Neonatal Ed 90(2): F156-160. March 2005.

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March 10, 2005

Treating Non-responders

I'm not a mathematician, but it seems to me that one with those skills could discern from this article what the SVR rate among genotype 1 patients is after initial treatment and what it is after retreatment.

The article states that about 45% of patients are unresponsive to treatment. We know that genotypes 2, 3, are more responsive (each one is different, but I've heard that two is up over 85%).

They mention the results for non 1 genotypes but not for 1.

If anyone reading this can do the math, please post it.

Thanks.

Gastroenterologie
Clinique et Biologique

Volume 29 No 2 de March 2005

Treatment of chronic hepatitis C in patients unresponsive to interferon

Aim

About 45% of patients with chronic hepatitis C are unresponsive to the present reference treatment combining pegelated interferon plus ribavirin; before pegylated interferon was available the non-response rate was around 60%. This open multicenter pilot study, initiated before pegylated interferon became available, was designed to evaluate, in patients unresponsive to interferon monotherapy, the rate of biological and virological response and side-effects of the ribivirin- alpha 2b interferon combination.

Methods

The combination protocol was ribavirin (1 to 1.2 g/d) plus alpha 2b interferon at induction doses (9 MU/d the first week; 4.5 MU/d the eleven following weeks; 3 MU/2 days the 36 following weeks).

Results

Among the 27 included patients, 17 (63%) were viremia-negative (PCR) after 12 weeks of treatment, 9 (33%) were complete responders (undetectable viremia and normal transaminases) at the end of treatment (48 weeks) and of follow-up (72 weeks). Patients with non-1, non-4 genotypes who derived full benefit from this therapeutic strategy (6/7 (86%) were complete responders: 4/5 with genotype 3 and 2/2 with genotype 5). Quality-of-life was impaired during treatment, especially during the first 12 weeks of high-dose interferon therapy.

Conclusion

While waiting for new therapeutic possibilities, these good results suggest interferon induction at the beginning of treatment remains a valid option.

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February 24, 2005

Increased Cancer Risk With HCV

The following report seems scary at first. A significantly higher incidence of two serious types of cancer in Hepatitis C patients is certainly important. But, the normal incidence of non-hodgkin's lymphoma is just 12 cases per 100,000 worldwide in 2001. So, with double the incidence that would be just 24 cases per 100,000 Hepatitis C patients. Not exactly a widespread or common situation.

It is very important to keep reports like these in perspective.

Normal multiple myeloma incidence is approximately 6 cases per 100,000 population in the US. So, 2.5 times that, is just 15 cases per 100,000 Hepatitis C patients.

Cancer in patients with hepatitis C
24 Feb 2005

People infected with the hepatitis C virus (HCV) have a higher risk of developing non-Hodgkin's lymphoma and multiple myeloma, according to a recent study of the Swedish population. These findings are published in the March 2005 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). Published by John Wiley & Sons, Inc, the journal is available online via Wiley InterScience: http://www.interscience.wiley.com/journal/hepatology.

Previous studies have shown that people with HCV have a higher risk of developing cirrhosis and liver cancer, however, studies of the association between HCV and other malignancies have yielded varied and conflicting results. In Sweden, a cluster of four cases of non-Hodgkin's lymphoma in 554 HCV patients raised the question of an association between those two diseases and other related cancers in the country's population.

To evaluate this possibility, researchers, led by Ann-Sofi Duberg of Örebro University Hospital in Sweden, gathered data from the Swedish Institute for Infectious Disease Control and the Swedish Cancer Registry to examine the incidence of non-Hodgkin's lymphoma, multiple myeloma, chronic lymphatic leukemia, acute lymphatic leukemia, Hodgkin's lymphoma and thyroid cancer in the country's entire cohort of HCV patients.

For 27,150 HCV patients, the researchers modelled the date of HCV infection based on age and mode of transmission. They then collected data on the relevant cancer diagnoses among these patients for the time period from 1990 to 2000, excluding those whose HCV diagnosis was within 3 months of their cancer diagnosis. Lastly, they performed statistical analyses to compare these patients' cancer rates to those of the entire Swedish population.

They found that the risk of both non-Hodgkin's lymphoma and multiple myeloma were significantly higher compared to the general population - 1.99 and 2.54 times higher, respectively. Their risk of chronic lymphatic leukemia and thyroid cancer were not significantly higher, and the incidence of both acute lymphatic leukemia and Hodgkin's lymphoma was too low to be included.

"The majority of the non-Hodgkin's lymphoma and multiple myeloma patients were estimated to have been infected more than 15 years, which is consistent with the theory that lymphomagenesis is a slow process and non-Hodgkin's lymphoma develops after a long influence," say the authors. They suggest that the risk for HCV-related malignancy increases with time of HCV infection.

As in many countries, Sweden has had an increase in the incidence of malignant non-Hodgkin's lymphoma in recent years. As most Swedish HCV patients were born after 1950, the cancer increase might be related to long-lasting HCV infection.

In conclusion, "this is the first study of the incidence of non-Hodgkin's lymphoma, multiple myeloma, chronic lymphatic leukemia, acute lymphatic leukemia, Hodgkin's lymphoma and thyroid cancer in a nationwide cohort of HCV-infected persons," the authors report. "Although the delayed diagnosis of hepatitis C most probably has made us underestimate the risk, this study showed that the risk of B-cell non-Hodgkin's lymphoma and multiple myeloma were significantly increased."

--------------------

Article: "Non-Hodgkin's Lymphoma and Other Nonhepatic Malignancies in Swedish Patients With Hepatitis C Virus Infection," Ann-Sofi Duberg, Marie Nordström, Anna Törner, Olle Reichard, Reinhild Strauss, Ragnhild Janzon, Erik Bäck, and Karl Ekdahl, Hepatology; 41:3; March 2005 (DOI: 10.1002/hep.20608).

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February 23, 2005

HCV Hides From Immune System

The conclusion of this study, that HCV disguises itself to appear to be part of the patient's own immune system, is very intruiging. Not just because it helps explain why HCV becomes chronic in 85% of people who contract it, but also because many of the extrahepatic symptoms of HCV appear to be similar to certain auto immune disorders.

Autoimmune disorders are when the immune system of the body actually begins to attack the body. Is the fact that the virus disguises itself as part of the immune system partially responsible for this? It seems more research is needed. So stay tuned...

Canadian scientists may have found why hepatitis C triggers chronic infection

Helen Branswell
Canadian Press
Wednesday, February 23, 2005

TORONTO (CP) - A team of Canadian researchers believes it has unravelled the mystery of how hepatitis C evades the human immune system to cause chronic disease in about three-quarters of the people who become infected.

Their discovery provides a bright ending to the personal tragedy of the hepatitis C patient whose blood they studied, a man who became infected through a medical error in a hospital clinic.

The researchers report that the virus escapes detection because its external coat mimics immunoglobulin, one of the immune system's warriors. Further, the virus may evolve to maintain or improve its camouflage as time goes on, they suggest.

Because the immune system is set up to attack only things it considers foreign, it does not attempt to destroy the virus.

"If you want to hide in a forest, it's often good to look like a tree," explained Dr. Earl Brown, a virologist at the University of Ottawa and senior author of the paper.

The team came to its conclusions by studying blood drawn from the first infected blood donor caught by heightened screening methods put in place after Canada's tainted blood scandal. The man was so newly infected with hepatitis C that his immune system hadn't yet responded to it. As a consequence, the scientists were able to chart that response over time.

"We watched it (the virus) walk into the forest," Brown said, continuing with his metaphor.

The blood donor had become infected in an Alberta hospital in the spring of 2000 while receiving intravenous antibiotics. Now living in southeastern British Columbia, he's pleased his misfortune may help science figure out how to foil the virus.

"It was such a bizarre sequence of events that I wanted to see some good come out of it," said Randy, 47, who asked that his surname not be made public.

"This might be something that could potentially lead to a cure or a better treatment for a lot of people. And that kind of drives you along on this," said Randy, who was cleared of infection in 2003 after two courses of treatment with expensive anti-viral drugs.

However, Brown said the findings - reported in this week's issue of the journal Virology - suggest a vaccine for hepatitis C may be an elusive, even dangerous target that could backfire by prompting the immune system to attack itself.

The team, which also involves scientists from Canadian Blood Services and the Alberta provincial laboratory of public health, compared the genetic codes for the virus's envelope with those of some components of the immune system, finding areas where the virus appeared to be mimicking the body's defenders.

The findings will influence future research into not just hepatitis C but other viruses that don't provoke an extended immune response, Brown said.

"It's going to change the way (scientists) think in hepatitis C (research) for sure, and probably a bunch of other diseases. It's impossible for it not to."

Others interpreted the findings more cautiously.

"It's an intriguing hypothesis but I think at this point it's really only a hypothesis," said Dr. Jake Liang, chief of the liver diseases branch of U.S. National Institute of Diabetes and Digestive and Kidney Diseases.

Liang, an expert in viral hepatitis, said the study was well done. But he and others believe the whole notion of viral "mimicry" is overhyped.

"A lot of these hypotheses are based on very weak evidence. It does have some appeal to it. Sounds good. But very few of them have ever been proved to be causal," Liang said.

Dr. Mel Krajden of the British Columbia Centre for Disease Control said he doubted the mechanism identified is the full answer to why some hepatitis C infections become chronic.

"I'm sure it's more complex than just this," said Krajden, who heads the centre's hepatitis service.

It is estimated that about 240,000 Canadians are infected with hepatitis C, which causes inflammation of the liver that can lead to cirrhosis or liver cancer.

It spreads from person to person via contact with infected blood. Shared drug paraphernalia - needles, pipes and straws - are currently the main vehicle of transmission, though prior to changes in blood screening methods, blood transfusions were also a key source of infection. The virus can also be transmitted during sex with an infected person, although the risk is low.

In about 20 or 25 per cent of cases, people will spontaneously clear the virus. The remainder are chronically infected, though treatment with anti-viral drugs appears to cure some - though not all - cases.

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February 07, 2005

HCV article from Amednews.com

The following article is from Amednews.com (American Medical News, The Newspaper For America's Physicians). This is a publication of the American Medical Association. I find it interesting to see what doctors are hearing about Hepatitis C from their own association.

Again, because genotype 1 infects approximately 70% of Americans it is important to note the success rates reported. According to this article somewhere between 30 and 40% success is being experienced with genotype 1, depending upon race (interferon combination therapy is significantly less effective for African Americans).

The article ends on an up note regarding emerging therapies---particularly protease inhibitor types (as we have previously pointed out here).

Larger gains sought in hepatitis C treatment

Despite some success, the viral disease is still the most common chronic bloodborne infection in the United States.

By Susan J. Landers, AMNews staff. Feb. 14, 2005.

Washington -- There are still gains to be made in the treatment of hepatitis C, and a recent congressional hearing on the disease as well as a National Institutes of Health workshop to discuss a vaccine to fight this liver-ravaging condition hold out hope for more progress.

"In the last 10 years, we've quadrupled the treatment response rate," said Michael Bernstein, MD, director of the Hepatitis Clinic at Coney Island Hospital in Brooklyn, N.Y.

There is now an overall success rate of about 55%, researchers say. Treatment with long-acting interferon or a combination of interferon and other antiviral drugs has made the difference.

"We are still, however, left with those unfortunate 45% who don't respond," said Adrian M. DiBisceglie, MD, chief of hepatology at Saint Louis University School of Medicine.

And that's a lot of people. Hepatitis C is the most common chronic bloodborne infection in the United States. About 4 million Americans are chronically infected, and most are not even aware of this threat to their health.

Primary care physicians have a major role to play in diagnosing the infection, so that those who can benefit from treatment will receive it in time to prevent extensive liver damage, Dr. Bernstein said. The AMA and the Centers for Disease Control and Prevention have collaborated on materials targeted to doctors and patients to help with early diagnosis.

"Hepatitis C was only identified 15 years ago, so we still have much to learn about this disease," said Rep. Tom Davis, (R, Va.), chair of the House Committee on Government Reform. Davis held a hearing on hepatitis C Dec. 14, 2004.

An NIH workshop on vaccine development was scheduled for Feb. 1 and 2.

Early warning system

Hepatitis C infection often presents no warning symptoms, and many people could have unknowingly become infected from intravenous drug use years earlier or from contaminated blood or blood products received before widespread screening for the virus began in the early 1990s.

The virus is sometimes only discovered after a patient exhibits signs of serious liver disease, such as cirrhosis or liver cancer, Davis said.

Still, the forward march of treatment has resulted in substantial gains for many of those infected. "We started out treating patients with hepatitis C in the mid-80s with interferon," Dr. DiBisceglie said. At that stage, no more than 5% to 10% of patients had a sustained virologic response, he added.

Treatment refinements made since then include the use of combination therapy with pegylated interferon and ribavirin that extends the life of interferon, thus allowing it to fight the virus longer.

Today's positive outcomes jump even higher for those infected with one of the less common viral genotypes. For those infected with genotype 2 the success rate is probably 90%, and for genotype 3, it's about 70% to 80%, Dr. Bernstein said.

However, treating genotype 1 infections, the most common of the viral types, has not met with as much success. African-Americans, for whom the cure rate is the lowest, are most frequently infected with this genotype.

But it isn't just infection with genotype 1 that is making the difference in this population, Dr. DiBisceglie said. "Even if you account for genotype, the response rate is less than in whites," he said. While about 40% of whites with the genotype respond to treatment, the level drops to 30% to 40% for African-Americans. Studies are under way to examine the possible reasons for the poorer response rate.

A lesson can be drawn from this conundrum, said Stanley M. Lemon, MD, professor of microbiology and immunology at the University of Texas Medical Branch in Galveston and director of the Hepatitis Research Center there.

 That lesson is to include all populations in clinical studies, he said. "If you have selected populations that don't really need to be treated by the drug, you are going to lose valuable information."

Work also has been ongoing to develop an effective vaccine, and some candidates are currently being tested. But the complex nature of the virus presents many obstacles.

"The problem is, like the AIDS virus, the envelope proteins you would likely target mutate very quickly," Dr. Bernstein said, which makes it much more difficult to design a vaccine. In contrast, proteins in hepatitis B, for which a successful vaccine has been developed, are much less variable.

Dr. Lemon finds promise in the development of small molecule antiviral inhibitors, which have been shown to cause a sharp drop in hepatitis C viral levels in a short time. Although studies of one such drug were halted because of high toxicity, others could meet with more success. "The importance of those studies, even if that drug never makes it to market, is that small molecule therapy, antivirals like we have for HIV and herpes, are nearing reality and have incredible potential," Dr. Lemon said.

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February 02, 2005

HCV On List of Cancer Causing Agents

This announcement is not news to most Hepatitis C patients. We have been told about the possible long term risks associated with Hepatitis C and liver cancer has always been included among them. However, and this needs to be stated, compared to the number of patients with chronic Hepatitis C, the number of patients who develop Hepatocellular Carcinoma (liver cancer) is very small.

The huge majority of patients are not at risk. But, it doesn't hurt to behave as if we all are. That is why I always recommend choosing a lifestyle, diet, and nutritional supplementation that will protect and support your liver (along with any therapy you might choose to do---pharmaceutical or otherwise).

New entries on list of cancer-causing agents

Monday, January 31, 2005 Posted: 2:26 PM EST (1926 GMT)

WASHINGTON (AP) -- The government on Monday added 17 substances to the official list of cancer-causing agents, including the first viruses: hepatitis B and C and some human papillomaviruses that cause common sexually transmitted diseases.

Lead and lead compounds, X-rays, compounds found in grilled meats and various substances used in textile dyes, paints and inks are among the other new listings, the Department of Health and Human Services said in releasing the 11th edition of the federal Report on Carcinogens.

The additions bring to 246 the total number of substances that either are "known to be human carcinogens" or "reasonably anticipated to be human carcinogens." The report now lists 58 "known" -- including the viruses -- and 188 "reasonably anticipated" substances.

Hepatitis B and C, which cause liver disease, were added because studies in humans show that chronic infections cause liver cancer. Some of the human papillomaviruses, which are sexually transmitted, were included because studies show they cause cervical cancer in women, the department said.

Federal law requires the HHS secretary to publish the report every two years.

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January 27, 2005

HCV Market Analysis Redux

Here is another press release regarding the state of the market for Hepatitis B and C treatment. The press release is about the industry report available from Research and Markets, an industry research organization. It is the same report referenced by DataMonitor in my January 12th update.

Incidentally, the price of this report is $15,200.

Please note, this report states that "the needs of non-responders, genotype 1 and intolerant patients will not be satisfied in the short term." It also suggests that the pharmaceutical companies look to "tap into a substantial amount of unidentified cases or meet the needs of non-responder or difficult to treat patients.

Press Release
Source: Research and Markets

Hepatitis B and C - Winning Battles But Not The War
Thursday January 27, 8:01 am ET

DUBLIN, Ireland--(BUSINESS WIRE)--Jan. 27, 2005--Research and Markets (http://www.researchandmarkets.com/reports/c12272) has announced the addition of Stakeholder Insight: Hepatitis B & C - Winning Battles But Not The War to their offering

According to the WHO, 350-400 million are chronically infected with HBV and 170-200 million with HCV. Although HBV vaccination and routine screening of donated blood has decreased incidence, the death toll resulting from chronic disease, cirrhosis and HCC is as high as one million per year (WHO, 2002). For HCV related conditions, this number will increase further over the next 10-20 years.

Despite substantial prevalence for both HBV and HCV, the incidence of new infections within the seven major markets has reduced over the last decade due to HBV vaccination, increased blood and pre-natal screening along with awareness campaigns regarding routes of transmission. Our recent physician survey indicates that while diagnosis rates of HBV have remained flat since 2002, HCV diagnosis rates have increased 2-4 fold, with highest growth in Japan

Increased uptake and aggressive life-cycle management of peginterferons (plus ribavirin) have driven the current standard of care to 73% of first-line choice for HCV. Our physician research (180 respondents) reveals higher use of branded peginterferon plus ribavirin packages, where consistency was cited as key selection criterium. Again, the treated patient pool will be increased by higher diagnosis, redefinition of 'normal' ALT and maintenance therapy. However, the needs of non-responders, genotype 1 and intolerant patients will not be satisfied in the short term.

Scope of Report

• Comprehensive overview of HBV and HCV epidemiology with comment on latest dynamics

• Analysis of drug treatment choice per line therapy per region for both HBV and HCV

• Discussion with key opinion leaders with regard to clinical and non-clinical attributes of therapy

• Future outlook for new HBV and HCV therapies along with unmet needs assessment

Highlights

• While diagnosis rates of HBV have remained flat since 2002, HCV diagnosis rates have increased 2-4 fold with highest growth in Japan.

• Based on current estimates of prevalence, diagnosis and treatment current patient pools of between 1.8-2.0 million per disease.

• To increase the treatment pool, manufacturers of hepatitis treatments can either tap into a substantial amount of unidentified cases or meet the needs of non-responder or difficult to treat patients.

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Caffeine, HCV and Liver Health

The following report is of interest because I've heard for many years that liver patients need to abstain from caffeine consumption. To be honest, I've consistently included about a cup a day in my diet (along with a pot of green tea and lots of water).

This article makes me feel better, still, about my choice. I never thought of it as being therapeutic, I just figured that one cup would not do much damage (if any).

Even though it is only one study, this is a fairly large study.

Incidentally, I do not drink any alcohol at all anymore. It is common knowledge that alcohol is a potent liver toxin. In fact, it is used in a medical procedure to kill small liver cancer tumors. They actually inject alcohol into the specific site of the tumor because alcohol is such and effective and efficient liver cell killer.

Coffee and Caffeine Consumption Reduce the Risk of Elevated Serum Alanine Aminotransferase Levels

Based on experimental and epidemiologic studies, researchers at the National Institute of Diabetes and Digestive and Kidney Diseases investigated whether coffee and caffeine consumption reduced the risk of elevated alanine aminotransferase (ALT) activity in persons at high risk for liver injury in a national, population-based study.

Participants were 5,944 adults in the Third US National Health and Nutrition Examination Survey, 1988–1994, with excessive alcohol consumption, viral hepatitis, iron overload, overweight, or impaired glucose metabolism.

Liver injury was indicated by abnormal serum ALT activity (>43 U/L).

Results

Elevated ALT activity was found in 8.7% of this high-risk population.

In unadjusted analysis, lower ALT activity was associated with increasing consumption of coffee (P = .001) and caffeine (P = .001). Multivariate logistic regression analyses showed that the risk of elevated ALT activity declined with increasing intake of coffee (P for trend = .034) and caffeine (P < .001).

Comparing persons who drank more than 2 cups per day with non coffee drinkers, the odds ratio was .56 (95% confidence interval, .31–1.0). Comparing persons in the highest caffeine quintile with the lowest, the odds ratio was .31 (95% confidence interval, .16–.61).

These relationships were consistent across subgroups at risk for liver injury and were relatively unchanged when analyses included the entire population or when limited to persons without impaired liver function or right upper quadrant pain.

Fasting insulin concentrations did not mediate the effects.

In conclusion, the authors write, “In this large, national, population-based study, among persons at high risk for liver injury, consumption of coffee and especially caffeine was associated with lower risk of elevated ALT activity.”

This study was supported by a contract from the National Institute of Diabetes and Digestive and Kidney Diseases.

01/21/05

Reference

C E Ruhl and J E Everhart. Coffee and caffeine consumption reduce the risk of elevated serum alanine aminotransferase activity in the United States. Gastroenterology 128(1): 24-32. January 2005.

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January 24, 2005

Hepatitis C Treatment Study Being Questioned

A lot of time, money and effort is being spent on this study when other (more effective and less toxic) treatments could be being developed, instead. It seems like comparing two brands of aspirin. In the long run, there is so little difference that it just comes down to what the marketing people choose to advertise and how.

Also, I am suspect of any study funded by an entity that has a vested interest in the final result. Call me suspicious, call me skeptical, but conflict of interest is a known problem wherever it exists. If the study shows the Roche product is better can we really expect Schering not to put some kind of spin on it to do major damage control? We are talking about a billion dollar annual business (Hepatitis C treatment). What do you think?

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Biopsy Unnecessary for Successful Hepatitis C Treatment

This article reports on a study that shows biopsy need not be required to treat chronic Hepatitis C. The statistically significant results show that other indicators (ultrasound, fibrosis blood tests, etc.) can suffice when measuring liver damage and treatment success. Because biopsy is an invasive medical procedure with known risks, proceeding successfully without biopsy would be a preferred approach.

Also of note in this report are the success rates. Sustained virologic response was seen in 41 to 43.6% of patients. I keep seeing results like this and can't help wondering how the common knowledge (and that preached by most doctors) is better than a 50% success rate.

Treatment of Patients with Chronic Hepatitis C with or without Liver Biopsy

Expert consensus recommends liver biopsy before therapy for chronic hepatitis C. A cost effectiveness analysis suggested that the best strategy in the management of patients was to treat without biopsy.

In this study, researchers compared therapy in patients who did, or did not undergo biopsy.

Hepatitis C virus (HCV)-positive patients (78) who did not agree to (n = 57) or with contraindications to liver biopsy (n = 21) (group A) were matched for age, sex and genotype with those who consented (group B).

Before therapy (interferon/ribavirin for 12 months), all patients must have received a clinical diagnosis of chronic hepatitis, on the basis of standard biochemical and ultrasonographic parameters. The two groups showed similar baseline characteristics.

A noninvasive, diagnosis of chronic hepatitis was made in 75.6% of group A, and in 83.3% of group B (P = 0.26). Concordance between clinical and histological diagnosis in group B amounted to 91%.

End-of-therapy virological response was 52.6% in group A, and 57.7% in group B (P = 0.63). Sustained virological response was 41.0% and 43.6% in the two groups (P = 0.87).

Predictors of sustained response were noninvasive diagnosis of chronic hepatitis (P = 0.006), lack of portal hypertension (P = 0.037), platelets >105/mm3 (P = 0.007), prothrombin >70% (P = 0.02), and genotype 2 or 3 (P < 0.0001). At multivariate analysis, genotype (P < 0.0001) and platelets (P = 0.004) maintained their predictive power.

The authors conclude, “In most patients with HCV infection, virological clearance after therapy can be achieved irrespective of whatever a liver biopsy might show.”

01/19/04

Reference

A Andriulli and others. Treatment of patients with HCV infection with or without liver biopsy. Journal of Viral Hepatitis 11(6): 536-541. November 2004.

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January 14, 2005

Hepatitis C Treatment Depression May Affect Outcome

This article surprised me. I'm not sure what to think of emotional depression as an indicator of treatment success. What is it about the virus or the treatment that causes non-responders to become more clinically depressed than responders during treatment?

Incidentally, this study was co-funded by Schering and the CDC. And, yet, it only claims a 40-50 percent rate of clearing the virus among patients. This is with a supposed 80 percent clearance for genotype 2. How low must the clearance rate actually be for genotype 1? Closer to 30 percent is my guess.

Depression caused by common treatment for hepatitis C may affect outcome

ATLANTA–An article appearing in the January 2005 issue of Brain, Behavior and Immunity suggests that developing depression while on interferon-alpha plus ribavirin may impact how well the medications work.

In a study conducted in the Department of Psychiatry and Behavioral Sciences at Emory University School of Medicine, Charles L. Raison, MD, Andrew Miller, MD, and colleagues, observed that patients who develop depressive symptoms during interferon-alpha plus ribavirin therapy were significantly less likely to have cleared the hepatitis C virus from their blood following six months of treatment.

"Hepatitis C infection affects three to five million Americans, and is the leading cause of liver transplantation," said Dr. Raison. "With advances in treatment, 40-50 percent of patients can be cleared of the virus. Unfortunately, however, the current treatment for hepatitis C – interferon-alpha plus ribavirin – produces a high rate of psychiatric side effects that have long been recognized as impediments to successful antiviral therapy. In the past we primarily worried that depression interfered with quality of life, or would cause patients to stop taking the medicine. These new data suggest that even if patients stay on treatment, they are less likely to have a good outcome if they develop depressiom."

The study examined 103 participants who received pegylated interferon-alpha-2b plus ribavirin (PEG IFN/ribavirin). All participants were psychiatrically evaluated prior to initiation of the medication and at 4, 8, 12 and 24 weeks of PEG IFN/ribavirin treatment.

Only 34% of the patients who had a significant increase in depression cleared the hepatitis C virus from their blood at 24 weeks, as compared to 59%-69% of patients with milder increases in depression. The effect of depression on viral clearance persisted even after adjusting for factors known to affect treatment outcome, such as viral genotype, or whether medications had to be reduced.

"The findings of this study provide preliminary evidence that baseline mood state should be assessed in patients prior to commencing treatment," said Dr. Raison. "Significant deviations from this state may increase the likelihood of treatment failure. Moreover, these findings provide further support that the development of depression can have a negative impact on health outcomes in medically ill subjects."

Researchers from the Rollins School of Public Health, Emory University and the Department of Medicine, Gasteroenterology and Hepatology, Weill Medical College of Cornell University were also involved in the study. The study was supported by grants from the National Institute of Mental Health, Schering–Plough, and the Centers for Disease Control and Prevention.

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January 12, 2005

Chronic Hepatitis B and C: Chronic Lack of Effective Treatment

The following article is from Pharmalive.com (The Pulse of the Pharmaceutical Industry).

The first interesting statistic I noticed is the statement that with the easier to treat genotypes they claim an 80% success rate and when factoring in the harder to treat (read genotype 1) the overall rate is around 50%.

While admitting I am no math whiz, it appears that the success rate for Genotype 1 must be well below 50% to end up with a 50% success rate when combined with the 80% claimed for other, more treatable, genotypes.

The authors of this article call current pharmaceutical therapies for chronic viral hepatitis b and c "inadequate", "sub-optimal" and "far from perfect". Remember, this is the "Pulse of the Pharmaceutical Industry" speaking.

 Certainly, in my opinion, if I were to choose between the Roche or Schering therapies, I would choose Roche. For a few reasons, it seems to be the superior choice.

 The authors are pointing out opportunity for pharmaceutical companies to come up with better solutions than currently exist. Especially for the harder to treat varieties like HCV genotype 1. This opportunity is what will drive these drug companies to continue to scramble to develop new treatments.

 As I've said all along, their shareholder-driven need for profits will, ultimately, work to the advantage of patients.

 

 Chronic Hepatitis B and C: Chronic Lack of Effective Treatment

 LONDON, Jan. 12, 2005--The World Health Organization (WHO) estimates that one-third of the entire world’s population has been exposed to hepatitis B (HBV) resulting in an estimated

 350-400million chronically infected patients globally. Most of these patients reside in Southeast Asia and Sub-Saharan Africa and in most cases are infected at birth. However the seven major pharmaceutical markets* (including the USA) are estimated to harbour up to seven million chronic carriers, with transmission occurring primarily through sexual contact during adulthood. Additionally, while Hepatitis C (HCV) infection is less common, the WHO estimates the numbers of chronically infected individuals at a further 200m. Perhaps most frightening of all however, is that less than one third of patients with either chronic hepatitis B or C (CHB or CHC) are actually receiving treatment.

 Viral hepatitis – a significant public health problem

 Globally, HCV infection is less common than HBV infection. However in the west, HCV (7.5m chronic carriers in the seven major markets) is more common than HBV. Historically this has been due to transmission through contaminated blood or blood products and is currently a result of shared utensils used for intravenous drug use.

 Recently completed research by independent market analyst Datamonitor** has revealed that despite increasing HBV and HCV disease awareness and diagnosis, treatment rates of patients with chronic viral hepatitis remain low, and despite the large pool of CHB and CHC patients, less than one-third of these are currently receiving medical treatment. One underlying reason is the low rate of disease diagnosis, on average 54% for HBV and 40% for HCV, says Datamonitor infectious diseases analyst Brigitte de Lima. “Chronic liver disease (CLD) is a long-term consequence of HBV and HCV and commonly leads to liver cirrhosis or hepatic decompensation within 10-40 years following primary infection.”

 “Furthermore, long-term CHB and CHC cause a type of liver cancer known as hepatocellular carcinoma (HCC). Both diseases combined account for over 80% of HCC cases and almost half a million lives annually. Once diagnosed, prognosis for HCC can be as low as six to eight months.”

 Diagnosis and treatment – still sub-optimal in the seven major markets

 Although HCV diagnosis rates are lower than those for HBV, they have increased considerably in the past two years, while those for HBV have remained flat. Key to the enhanced identification of new patients among both high-risk groups and the general population has been education and awareness campaigns organized by both the private and the public sector, de Lima says.

 “In addition to the low rates of diagnosis, inadequate therapies also account for the sub-optimal treatment levels. Although up to 80% of CHC patients with the easy-to-treat viral genotypes 2 and 3 can currently be cured, the larger prevalence of the less responsive genotype 1 translates into only half of the total patient pool achieving virus eradication.”

 “In the case of CHB the scenario is even worse, with viral eradication occurring in less than 5% of all patients. Current CHB therapy therefore focuses on long-term suppression of virus replication rather than virus clearance. Similar to CHC, the proportion of patients less responsive to treatment, namely those infected with the HBeAg-negative variant of HBV, is increasing globally.”

 Sub-optimal current first-line therapies for CHB and CHC are unable to benefit the already predominant and increasing pools of difficult-to-treat patients, leaving ample scope for opportunistic manufacturers willing to invest in potent, tolerable drugs in a market largely driven by therapy cost, de Lima says.

 Prescription choice – largely driven by cost-considerations

 The pharmaceutical HBV market is currently dominated by two antivirals, GlaxoSmithKline (GSK)’s Zeffix (lamivudine, LAM) and Gilead’s Hepsera (adefovir dipivoxil, ADV). Datamonitor’s research reveals that the preference of the former for first-line therapy is predominantly cost-driven, as the price of Zeffix is substantially lower than that of Hepsera, de Lima says. “ADV is commonly reserved for second-line therapy following the development of resistance to LAM, which can occur in up to 67% of patients after four years of therapy. For CHC, the standard of care is now pegylated interferon (pegIFN) and ribavirin (RBV) combination therapy.”

 “Similarly, the HCV market consists of two major players; Schering-Plough, who markets PegIntron and Rebetol, and Roche, with its drugs Pegasys and Copegus. The lack of clinical differentiation between the two rival pegIFNs and the absence of any alternative anti-HCV drugs has led to physician prescription choice being driven almost exclusively by cost and special deals provided by the manufacturers.”

 Current therapies – compromise is necessary

 Current therapies for either disease are far from being perfect solutions. None of the HBV drugs cure the disease and long-term therapy with LAM is associated with development of resistance, while ADV entails a high financial expenditure. Pegylated IFN combination therapy might be effective in some forms of CHC disease, but it is also a therapy dreaded by most patients due to the injectable mode of delivery and the high incidence of severe side effects elicited over the entire course of the treatment, de Lima says.

 “Given the clear limitations of the current HBV and HCV therapies, major players in both pharmaceutical markets have developed different strategies aimed at increasing treatment rates. In the case of CHC, these focus on treating patients with normal alanine aminotransferase (ALT) levels, prolonging treatment for slow responders and maintaining non-responders on pegIFN monotherapy. The main strategy for CHB patients is the extension of therapy, especially for HBeAg-negative patients, as most patients relapse following cessation of therapy.”

 The current stalemate in the CHB and CHC treatment markets is only susceptible to being broken with the launch of new developmental drugs, which will have to combine high potency and good tolerability at a reasonable cost. Crucially, new drugs are more likely to gain market share if, in addition to winning the battles against the more responsive variants of the diseases, they are also effective in the difficult-to-treat CHB and CHC patients. Drugs with high potency in the latter patients are the key to meeting the growing therapeutic needs and consequently boosting treatment rates, de Lima says.

 “The future viral hepatitis treatment landscape is predicted to follow the HIV precedent, in that drug monotherapy is likely to become obsolete and novel, potent drugs will be administered simultaneously as part of a combination. Furthermore, the focus needs to shift from patients with easily treatable variants of the disease to those that obtain little benefit from current therapies, as these are steadily accumulating in the total patient pools. New strategies are awaited to take the lead in this long-standing battle against the hepatitis viruses.”

 

 *The seven major pharmaceutical markets are the USA, the UK, France, Germany, Italy, Spain and Japan

 **Stakeholder Insight: Hepatitis B and C

 Datamonitor plc (DTM.L) is a premium business information company specialising in industry analysis. We help our clients, 5000 of the world's leading companies, to address complex strategic issues. Through our proprietary databases and wealth of expertise, we provide clients with unbiased expert analysis and in-depth forecasts for six industry sectors: Automotive, Consumer Markets, Energy, Financial Services, Healthcare, Technology. Datamonitor maintains its headquarters in London and has regional offices in New York, San Francisco, Sydney, Tokyo, Frankfurt, Shanghai and Hong Kong.

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January 05, 2005

Hepatitis C With Fatty Liver Increases Risk

The following article comments on a study published in the January issue of the medical journal, Hepatology.

It starts out saying that the usefulness of antiviral therapy in patients with mild Hepatitis C is debatable. This indicates that the degree of steatosis in Hepatitis C patients should be one of the metrics in deciding on proceeding with interferon combination therapy.

Again, doctors will tend to prescribe therapy to 100% of patients who present with chronic Hepatitis C (because it is the only medical treatment available to them). This study is one more that calls into question this approach. Assessment of risk/reward ratio before proceeding with therapy needs to take this criterion into consideration, as well as others.

What is not stated in the author's conclusion is that they would not necessarily recommend antiviral therapy in patients with mild chronic Hepatitis C who do not present steatosis. Impact of Steatosis on the Progression of Fibrosis in Patients with Mild Hepatitis   

In patients with mild hepatitis C, the usefulness of antiviral therapy is a subject of debate, as a low risk for progression of fibrosis is assumed. Several studies have shown that steatosis (fatty liver) is a strong and independent predictor of the severity as well as the progression of fibrosis in chronic hepatitis C.

The present study assessed the impact of steatosis on the progression of fibrosis between paired liver biopsies in untreated patients with mild hepatitis on index biopsy.

One hundred thirty-five untreated patients (mean age, 38 years; M/F sex ratio, 1.43) with one known risk factor of infection (68 transfusions, 67 injecting drug use) had 2 liver biopsies after a median interval of 61 months (18-158). All had METAVIR score of A1F1 or lower at first liver biopsy.

Unequivocal progression of fibrosis was considered if patients had a fibrosis score of 3 or 4 at the second liver biopsy. The probability of progression of fibrosis was estimated by using the Kaplan-Meier method.

During follow-up, progression of fibrosis occurred in 21 patients (16%) after a median delay of 65 months. Cumulative probabilities of the progression of fibrosis at 4 and 6 years were 5.2% and 19.8%, respectively.

In multivariate analysis, steatosis was the only independent factor predictive of progression of fibrosis. Probability of progression of fibrosis was significantly related to the percentage of hepatocytes with steatosis.

The authors conclude, “Steatosis is a major determinant of the progression of fibrosis in mild hepatitis C, regardless of the genotype. Our results argue for antiviral treatment in the subgroup of patients with mild hepatitis and steatosis.”

01/05/05

Reference
L Fartoux and others. Impact of steatosis on progression of fibrosis in patients with mild hepatitis. Hepatology 41(1): 82-87. January 2005.

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December 16, 2004

The "Other" Hepatitis and Hepatitis C

The following article is from the Conway Daily Sun. It is quite instructive for all hepatitis patients.

If high fat and alcohol can cause the sorts of liver problems mentioned in otherwise healthy people, then how much more important is it for chronic viral hepatitis people to keep these factors under control.

The bottom line is what I have been recommending for years. Regardless of what other approach you take to dealing with your condition, eat a whole foods balanced diet and do not drink alcohol.

Incidentally, milk thistle in general (and Maximum Milk Thistle in particular) has been shown to help maintain, protect and support a healthier liver, regardless of the condition. It has even been shown in laboratory testing to help regenerate healthy liver cells. Read more...

The Other Hepatitis
Dr. Brian Irwin

— Hepatitis literally means "inflammation of the liver." There are many causes of hepatitis. Quite often when they hear the term, most people immediately think of hepatitis caused by a series of viruses. Over time, an increasing number of viruses that cause liver inflammation have been identified and have been named accordingly. Hepatitis A. Hepatitis B. Hepatitis C, which, until fairly recently, was named "Hepatitis non-A, non-B." Delta hepatitis. The list goes on.

However as well known as these famous viruses are, they cause a proportionally small number of hepatitis cases in the Western Hemisphere. What is responsible for much more liver disease and subsequently death in the western world, and particularly in the United States, is fat.

By fat, I'm referring to accumulation of fat in the liver cells themselves. Triglycerides can, due to a number of causes, accumulate in the liver cells and ultimately cause inflammation, liver congestion and even liver failure. By far the most common cause of excess fat accumulation in liver cells is alcohol abuse. Excessive alcohol intake can damage the liver in a number of ways, but one of the known mechanisms is by excess fatty acid production that is a result of ethanol metabolism, and subsequent deposition of these acids in the liver.

Malnutrition alone can also cause this to occur, but unfortunately many heavy drinkers do not eat properly. Subsequently, these people suffer damage from their poor nutrition AND from their alcohol intake.

There are other causes for fat deposition in the liver. Other than alcohol, the most common cause in this country is a high-fat diet. The liver performs the function of "detoxifying" the bloodstream. The liver produces the enzymes and a material (called bilirubin) that is required to "dissolve" fat, help metabolize it and store or excrete it.

A tremendously high concentration of triglycerides can easily overwhelm the system, back up and regurgitate into the liver cells proper. The result is slow, but steady liver damage that can, eventually, become irreversible.

The recent documentary "Supersize ME" showed the effects of a fat- and sugar-rich diet on a previously healthy person. One of the major changes in this previously healthy subject's condition was his liver function. The subject of the film experienced an increase in his "Liver Function Tests," which are a series of tests that measure enzyme production by liver cells. These "LFT?s" are increased in almost all cases of inflammation; quite literally the subject of the film, by diet alone, gave himself hepatitis.

So what happens if you ignore hepatitis, fatty or alcoholic? Hepatitis can be with or without symptoms and, quite often, is a diagnosis that health-care providers "stumble" upon by finding incidentally elevated LFTs. Symptoms can range from painless jaundice (yellowing of the skin that occurs as bilirubin, one of the products of the liver, "spills over" into the bloodstream and deposits in the skin), to nausea, vomiting, atrophy of the testicles, hair loss or a whole host of other symptoms.

More concerning, perhaps, than the health ramifications of hepatitis are the health ramifications of chronic hepatitis....cirrhosis. Cirrhosis is the end-stage result of hepatitis. A liver with chronic inflammation will eventually scar, shrink up and eventually stop working. At this point severe fluid accumulation, severe mental status changes (confusion, seizures or coma), infection, bleeding tendencies and cancer can all present.

As ominous as all this sounds, there is good news. Not all cases of hepatitis progress to cirrhosis. Although not all kinds of hepatitis are reversible, most cases of fatty liver caused by increased fat intake or excess alcohol will revert to normal or near-normal liver function...IF the offending agent is removed! While health-care providers can't promise all cases will totally revert to normal, we can promise that if a patient has fatty liver disease and hepatitis, if lifestyle changes aren't instituted, that patient's liver will progress to failure.

Of course, there is a genetic component to liver disease. Some people can eat a very high fat diet and never develop fatty hepatitis. Some people drink eight drinks every day and never have a problem. However, others can develop fatty liver disease from a relatively small amount of dietary fat and triglycerides or only a modest alcohol intake history.

This doesn't mean everyone should be on a no-fat diet or that no one should ever have a glass of wine. What it does mean is that at this time there's no way to tell who will luck out and who won't. Some of us are more susceptible to liver disease than others, so to be safe, eat right, take everything, not just alcohol and fat, in moderation and if you ever have any questions ask your health-care provider for

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December 03, 2004

Blood Tests vs. Biopsy For Fibrosis Assessment

This reference is from an article in the latest issue of the medical journal, Gastroenterology.

What we found most interesting is the reference to the fact that biopsy can be painful and dangerous and that assessment of biopsies is subjective and prone to sampling error. So much for accuracy in the gold standard test for gauging liver condition.

More and more progress is being made with blood and serum tests to determine fibrosis progression and liver condition. This bodes very well for keeping an eye on liver disease progress without invasive and potentially dangerous or faulty biopsies.

Our only question is why the authors concluded this could or should be used in conjunction with biopsy. We feel "instead of" may be a better choice.

Serum Markers Detect the Presence of Liver Fibrosis

Histologic examination of a liver biopsy specimen is regarded as the reference standard for detecting liver fibrosis. Biopsy can be painful and hazardous, and assessment is subjective and prone to sampling error.

Researchers developed a panel of sensitive automated immunoassays to detect matrix constituents and mediators of matrix remodeling in serum to evaluate their performance in the detection of liver fibrosis.

In an international multicenter cohort study, serum levels of 9 surrogate markers of liver fibrosis were compared with fibrosis stage in liver biopsy specimens obtained from 1021 subjects with chronic liver disease.

Discriminant analysis of a test set of samples was used to identify an algorithm combining age, hyaluronic acid, amino-terminal propeptide of type III collagen, and tissue inhibitor of matrix metalloproteinase 1 that was subsequently evaluated using a validation set of biopsy specimens and serum samples.

Results

The algorithm detected fibrosis (sensitivity, 90%) and accurately detected the absence of fibrosis (negative predictive value for significant fibrosis, 92%);

Performance was excellent for alcoholic liver disease and nonalcoholic fatty liver disease.

The algorithm performed equally well in comparison with each of the pathologists.

In contrast, pathologists’ agreement over histologic scores ranged from very good to moderate.

Conclusions

The authors conclude, “Assessment of liver fibrosis with multiple serum markers used in combination is sensitive, specific, and reproducible, suggesting they may be used in conjunction with liver biopsy to assess a range of chronic liver diseases.”

12/03/04

Reference
W M C Rosenberg and others. Serum markers detect the presence of liver fibrosis: A cohort study. Gastroenterology 127(6): 1704-1713. December 2004.

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November 27, 2004

Another Biopsy Alternative For Hepatitis C Patients

It seems doctors all want to do biopsies for liver patients, especially with Hepatitis C. In order to undergo interferon therapy doctors insist on a biopsy first.

Until recently there was no other way to get an exact measurement of fibrosis progression. We have already reported on a few blood tests that are currently approved for measuring fibrosis instead of undergoing a biopsy. One is Fibrospect and another is FibroTest.

Now, there is a report of yet another way to assess fibrosis without sticking a needle through your abdomen and into your liver.

This is great news for hemopheliacs and those of us who prefer to avoid the possible negative side effects of a biopsy (bleeding into the abdomen, liver damage, etc.).

Non-invasive Assessment of Liver Fibrosis by Liver Stiffness Measurement (LSM) in HCV Patients

Despite limitations such as sampling error and risks of complications, liver biopsy remains the gold standard for assessment of liver fibrosis. Among alternative non invasive methods, LSM based on transient elastography appears promising.

The purpose of this study was to investigate in comparison with histological staging in patients with chronic hepatitis C (CHC) focusing on patients with the largest liver biopsy samples.

French researchers prospectively included 327 patients with CHC who underwent both liver biopsy and LSM in four centers. LSM was performed with the FibroScan (Echosens Co, Paris, France) a non invasive device measuring liver stiffness in a volume of parenchyma of about 1,5 cm3.

In order to minimize the bias of histological evaluation, fibrosis stage was assessed according to METAVIR classification by two experienced pathologists. Moreover, biopsies were selected to have at least ten portal tracts or obvious cirrhosis.

The studied population was then split into two groups according to the biopsy sample length: biopsy sample larger than the median size (18 mm for F01, F2 and F3 patients and 13 mm for F4 patients) were considered separately.

Taking into account the whole studied population, LSM was significantly correlated with fibrosis stage (Kendall tau beta coefficient of correlation: 0.55, p < 0.0001) and the area under the ROC curves was 0.79 for F ≥ 2, 0.91 for F ≥ 3 and 0.97 for F = 4. These values were even improved when only the largest biopsies were considered: 0.81 for F ≥ 2, 0.95 for F ≥ 3 and 0.99 for F = 4.

The authors conclude, “LSM is a reliable, non invasive method for the evaluation of liver fibrosis in patients with CHC. The volume of liver parenchyma explored obviates the risk of sampling error present in liver biopsy.”

11/24/04
Reference
M Ziol and others. NON INVASIVE ASSESSMENT OF LIVER FIBROSIS BY LIVER STIFFNESS MEASUREMENT (LSM) IN PATIENTS WITH CHRONIC HEPATITIS C (CHC): THE IMPORTANCE OF SAMPLING. Abstract 263 (poster). 55th AASLD. October 29-November 2, 2004. Boston, MA.

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November 23, 2004

Hepatitis C and Quality of Life

The following article is about quality of life issues with Hepatitis C patients.

It is our opinion that anyone who knows they have a chronic and potentially deadly disease is going to have a negatively affected quality of life. Fear, anxiety, concerns about debilitating illness and mortality all take a toll on a persons outlook on life.

People infected prior to age 25, as well as male gender, seem to be the only factors that predicted a lesser impact on quality of life for Hepatitis C patients.

To make the leap of logic in the conclusion of this report that even those with little or no liver damage should consider anti viral therapy left us a bit incredulous. What pharmaceutical company funded this study, anyway?

Did the authors not consider the impact of interferon therapy on QoL (at least during therapy)? And, what of the other important factors, like a 30% success rate for genotype 1? Shouldn't that figure into the equation?

Food for thought, no?

The Quality of Life Among Patients with Chronic Hepatitis C in Relation to Host and Viral Factors

There is increasing evidence for impaired Quality of life (QoL) in patients with hepatitis C virus (HCV) infection even in the absence of liver disease. The aim of the study was to discriminate the role of viral and host factors in regard to QoL.

A cohort of 630 patients initially recruited in 1996/1997 in eight European Hepatology Centers to analyse epidemiology and immunogenetics of HCV infection were followed in 2002/2003. All patients answered an SF-36 questionnaire for the assessment of their QoL.

Two summary scores were analysed: the Physical Component Score (PCS) and the Mental Component Score (MCS). These patients are representative of what is usually seen in clinical practice since no restriction was made at inclusion.

Results

Patients with sustained virological response showed significantly better QoL than patients with either relapse or non-response (p<0.001 and p=0.001, for MCS and PCS respectively), even when limited to patients with only minimal fibrosis (F<2), p=0.001 for PCS.

An association was also found with age at infection and sex. Patients younger than 25 years at infection and males showed better PCS (p<0.001 and p=0.008) and MCS (p=0.063 and p=0.002), respectively.

None of the HLA alleles tested showed any association with QoL. Likewise genotype 1a vs. 1b or genotype 1 vs. non-1 had no significant relevance.

Conclusion

The authors conclude, “The better quality of life in patients with sustained virological response indicates that antiviral therapy might even be indicated in the absence of any liver disease.”

11/22/04
Reference
H L Tillmann and others (for the HENCORE group). QUALITY OF LIFE IN HEPATITIS C PATIENTS IN RELATION TO HOST AND VIRAL FACTORS. Abstract 1207 (poster). 55th AASLD. October 29-November 2, 2004. Boston, MA.

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November 17, 2004

Hepatitis C and Fatigue

We have long noted the number one complaint of chronic Hepatitis C patients is fatigue. The following study, presented at the latest AASLD conference in Boston, verifies this observation.

Currently there is no real medical solution to the fatigue felt by Hepatitis c patients. The best natural fatigue intervention we have seen, to date, is Fatigue Relief Plus.

If you can relate to the information in this study, perhaps you should consider giving Fatigue Relief Plus a try. It has worked for others, it very well may work for you.

Sleep and Fatigue in Patients with Chronic Hepatitis C

Fatigue and disordered sleep have been shown to affect quality of life in patients with chronic illnesses. The purpose of this study was to evaluate fatigue and sleeping behavior reported by patients with Chronic Hepatitis C (CHC).

Subjects completed the Fatigue Severity Scale (FSS) resulting in a total average fatigue score derived from 9 Likert type scale items assessing disabling fatigue (range 1-7). Subjective sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI) in which a global score (ranging from 0-21) and 7 component scores were derived. In both cases a high score indicated more severe complaints.

Subjects were 59 CHC patients attending UCSD Adult Liver Clinics who completed both the FSS and PSQI questionnaires. CHC patients were 49% males, 57.6% Caucasian, 35.6% Latino, and 3.4% African-American. Mean age and education were 51.9 ± 9.18 and 12.4 ± 3.31 years respectively. 24 patients were non-cirrhotic, 31 were cirrhotic (Child-Turcotte-Pugh Score A=16, B=11, C=3, 1-unknown), and 4 were unknown. No patients were receiving antiviral therapy at the time of assessment.

Results

The mean FSS score was 4.69 ± 1.88 indicating greater fatigue than past reports of normal healthy adults (2.3) and patients with CHC (3.8). The mean PSQI global score was 8.97 ± 5.38.

64.4% of the patients were found to be ‘poor sleepers’ as defined by a global PSQI score of > 5. There was no significant difference between males and females on both measures.

Significant correlations were found between the FSS score and the global PSQI score (r=0.58, p < 0.01), and with 6 of the PSQI component scores: subjective sleep quality (r=0.46, p < 0.01), sleep latency (r=0.39, p < 0.01), sleep duration (r=0.26, p = 0.05), habitual sleep efficiency (r=0.44, p < 0.01), sleep disturbances (r=0.62, p < 0.01), and daytime dysfunction (r=0.65, p < 0.01).

There were no significant differences between cirrhotic and non-cirrhotic patients on the FSS and PSQI global score. Poor sleepers were 51.6% and 75% of the cirrhotic and non-cirrhotic patients respectively (p=0.10). Non-cirrhotic patients showed greater use of sleeping medications when compared to cirrhotic patients (p < 0.01).

Weekly use of sleeping medications was reported in 33% of non-cirrhotic versus 9.7% of cirrhotic patients.

In conclusion, the authors write:

(1) Patients with CHC suffer from poor quality of sleep regardless of their stage of liver disease.

(2) Fatigue is significantly correlated to poor sleep quality.

11/17/04

Reference
M 55th AASLD. October 29-November 2, 2004. Boston, MA.Carlson and others. SLEEP AND FATIGUE IN PATIENTS WITH CHRONIC HEPATITIS C. Abstract 19 (poster).

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October 22, 2004

Hepatitis C Virus Linked to Non-Hodgkins Lymphoma

The following release is interesting but, unfortunately, not very detailed. The researchers give no numbers to put their findings into perspective. I'll try to help.

In 1991, 15 people per 100,000 were likely to contract NHL. If HCV patients are 6 times more likely to contract NHL then that means 90 HCV patients out of 100,000 might contract NHL.

90 people out of 100,000 (or about one in a thousand) is certainly no cause for panic, but instead something HCV patients and their doctors should be aware of.

SEATTLE--Patients infected with the hepatitis C virus (HCV) are six times as likely to develop non-Hodgkin's lymphoma (NHL) than individuals that are virus free, according to research presented today at the Third Annual Frontiers in Cancer Prevention Research meeting.

HCV infected patients have a seventeen fold higher risk for developing diffuse large B-Cell lymphoma, researchers from British Columbia documented. Diffuse large B-cell lymphoma is the most common variety of NHL, comprising approximately 30 percent of all NHL patients.

Compared to Europe and Japan, incidence of hepatitis C viral infection is fairly low in North America, and previous studies from Canada and the United States have not shown an association between the virus and development of NHL, said Ms Agnes Lai, lead author for the research. The British Columbia study examined HCV status in 550 NHL cases and 205 population controls. The study had the strength of numbers of patients to ascertain an association between HCV and NHL, confirming the viral-cancer link suspected in studies from other areas of the world where the virus is more prevalent.

"People who have been exposed to the virus comprise a high risk group for developing non-Hodgkin's lymphoma, particularly diffuse b-cell lymphoma," said John Spinelli, a cancer researcher from the British Columbia Cancer Agency, Vancouver, BC, and principal investigator of the research study.

The spread of hepatitis C in the United States has dropped significantly since the 1980s. Currently, the number of new cases per year is around 25,000. Approximately 3.8 million Americans have been infected with the virus. The most common means of infection in the past was blood transfusion, and in recent years is among drug users who share needles.

Approximately 53,000 patients were diagnosed with NHL in the United States in 2003. There were 23,000 deaths from the disease that year.

Spinelli and Lai conducted their research with colleagues Randy Gascoyne, Joseph Connors, Pat Lee, Rozmin Janoo-Galani, and Richard Gallagher, BC Cancer Agency; Anton Andonov, Health Canada National Microbiology Laboratories, Winnipeg, Manitoba, and Darrel Cook, British Columbia Centre for Disease Control.

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October 19, 2004

Retreatment of Non-Responders

According to this article, retreatment is not a very viable strategy in most cases of a failed first attempt to eradicate the virus with interferon therapy. This repeat approach only seems somewhat successful with people who were not treated with combination therapy to begin with.

It seems only some of those who received monotherapy (before the combo was developed) really have any chance of success with this subsequent combo treatment. And, only if they are not genotype 1, have a low viral load, do not have cirrhosis.

Reading between the lines here also reinforces our belief that the success rates being tossed about by doctors are misleading. This article states that nearly half do not respond. If this includes all genotypes then the higher rate for genotype 2 (supposedly around 80%) is clearly being reduced by the lower rate for genotype 1 (supposedly around 50% but more likely less than 30% to arrive at the "nearly half" statement). With 70% of the US chronic Hepatitis C having genotype 1, this is significant.

Retreatment of Non-Responders

Despite improvements in the treatment of chronic hepatitis C virus (HCV) infection, nearly half of all patients do not respond to initial therapy.

Retreatment of these patients with pegylated interferon and ribavirin has been successful in only a limited percentage of cases.

Factors associated with sustained virologic response (SVR) following retreatment include prior treatment with interferon monotherapy, HCV genotype 2 or 3, a low serum HCV RNA level, and the absence of cirrhosis.

Fewer than 6% of nonresponders who were previously treated with interferon and ribavirin and who have cirrhosis, genotype 1, and a high viral load achieve SVR following retreatment with pegylated interferon and ribavirin.

No therapy has been shown to yield SVR in patients who do not respond to pegylated interferon and ribavirin.

Long-term maintenance therapy with pegylated interferon is currently being evaluated in nonresponders with advanced fibrosis and cirrhosis. Its use should be considered investigational at this time.

Hepatology Section, Virginia Commonwealth University Medical Center, Richmond, VA.

10/18/04

Reference
M L Shiffman. Retreatment of patients who do not respond to initial therapy for chronic hepatitis C. Cleveland Clinical Journal of Medicine 71 (Suppl 3): S13-16. May 2004.

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October 18, 2004

Hepatitis C and Sex

One of the most frequent questions I hear from newly diagnosed Hepatitis c patients is whether or not they could pass this disease on to their loved ones through sexual intercourse. I am also frequently contacted by people in relationship with Hepatitis c patients. They have heard the disease was sexually transmitted and are afraid of contracting it themselves.

There has been much confusion and misinformation about this subject out there. Even the Centers for Disease Control (CDC) website states that sexual transmission is possible (although unlikely).

This new study (cited below) basically proves once and for all that there is no real risk of sexual transmission as long as blood to blood contact is avoided. This is good news, and it also points to the wisdom of staying up to date with emerging knowledge about hepatitis C. More is being discovered and clarified about this disease on an ongoing basis. Even the smallest of these discoveries can directly impact our lives as hepatitis c patients.

Incidenally, this finding does not mean you should be cavalier or nonchalant about the fact you have this infectious and potentially deadly disease. Sharing toothbrushes or razor blades are still considered risky activities. And high risk sexual behavior that might cause any blood to blood contact is to be rigorously avoided. To be safe, be sensible.

No Evidence of Sexual Transmission of Hepatitis C among Monogamous Couples: Results of a 10-Year Prospective Study

The risk of sexual transmission of hepatitis C virus (HCV) infection was evaluated among 895 monogamous heterosexual partners of HCV chronically infected individuals in a long-term prospective study, which provided a follow-up period of 8,060 person-years. Seven hundred and seventy-six (86.7%) spouses were followed for 10 yr, corresponding to 7,760 person-years of observation.

One hundred and nineteen (13.3%) spouses (69 whose infected partners cleared the virus following treatment and 50 who ended their relationship or were lost at follow-up) contributed an additional 300 person-years.

All couples denied practicing anal intercourse or sex during menstruation, as well as condom use. The average weekly rate of sexual intercourse was 1.8.

Three HCV infections were observed during follow-up corresponding to an incidence rate of 0.37 per 1,000 person-years. However, the infecting HCV genotype in one spouse (2a) was different from that of the partner (1b), clearly excluding sexual transmission.

The remaining two couples had concordant genotypes, but sequence analysis of the NS5b region of the HCV genome, coupled with phylogenetic analysis showed that the corresponding partners carried different viral isolates, again excluding the possibility of intra-spousal transmission of HCV.

The authors conclude, “Our data indicate that the risk of sexual transmission of HCV within heterosexual monogamous couples is extremely low or even null. No general recommendations for condom use seem required for individuals in monogamous partnerships with HCV-infected partners.”

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October 01, 2004

Hepatitis C Treatment Options

What Is the Best Treatment for Chronic Hepatitis C?

The treatment of hepatitis C is expensive, difficult and arduous from the patient's perspective. It is similarly difficult for the clinician to decide who and when to treat.

What Is the Best Treatment for Chronic Hepatitis C?

By JF Dillon, MD

The treatment of hepatitis C is expensive, difficult and arduous from the patient's perspective. It is similarly difficult for the clinician to decide who and when to treat.

If hepatitis C is viewed from the liver's perspective, we need only treat those patients who will develop the complications of chronic liver disease within their lifetimes. If we take a more holistic approach, then we have to consider the implications of being a carrier of a potentially transmissible blood borne virus on the patient themselves, their relationships, their families and their sense of well-being.

There is now evidence of the large impact HCV has on quality of life and we have to consider extra hepatic manifestations of hepatitis C infection, possibly including the syndrome of brain fog recently described.

An additional factor that has to be considered in the decision to treat is whether patients perceive hepatitis C as a significant problem for themselves.

For some patients, who have chaotic live styles, it is extremely difficult to get them to access healthcare. To then undergo the rigors and tribulations of hepatitis C therapy that is posing no current problem is unlikely to succeed.

However, failure to engage these patients with therapy will lead to a significant proportion of them presenting with serious complications of chronic liver disease, with its attendant mortality, morbidity and cost.

Underlying all these considerations is the tension between the costs of therapy and the benefits of therapy.

The author concludes, Good arguments can be made in terms of cost-effectiveness for treating patients with a high likelihood of progressing to chronic liver disease and its complications. These arguments become much less persuasive when all patients are concerned.

Department of Digestive Diseases and Clinical Nutrition, Ninewells Hospital and Medical School, Dundee, UK.

09/20/04
Reference
J F Dillon. What is the best treatment for Chronic Hepatitis C? Journal of Viral Hepatitis 11 Suppl 1:23-27. September 2004.

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