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