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FDA Prioritizes Hepatitis C

December 28, 2010

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In order for our society to overcome the burden of Hepatitis C, we must prioritize efforts to increase its awareness, detection and treatment. Moving along those lines, the FDA makes an important step in that direction.

by Nicole Cutler, L.Ac.

The pharmaceutical industry has identified the tremendous gap between effective Hepatitis C treatment and adequacy of the currently approved Hepatitis C antiviral drugs. Improvements in training, research and drug development are getting closer to narrowing the gap in eliminating the Hepatitis C virus, but an equally intensive effort for approving medications is warranted. Progress in Hepatitis C awareness has not yet sufficiently infiltrated the public health sector. However, the U.S. Food and Drug Administration (FDA) has recently taken a monumental step in acknowledging that specialized education and greater funding is required to aid the plight of advancements in Hepatitis C therapy.

More on Hepatitis C
Hepatitis C infects an estimated four to five million American adults, statistics that dwarf the number of Americans living with HIV - the virus that causes AIDS. Because symptoms of this infection go relatively unnoticed until it has progressed to advanced liver disease, many people don't know that Hepatitis C resides in their liver. An undiagnosed Hepatitis C infection can lead to cirrhosis, liver failure or liver cancer, a fact that renders such an oversight to be dangerous.

Even for those who know they are infected with Hepatitis C, treatment is not guaranteed to help. Sadly, even knowing that you have Hepatitis C and diligently receiving treatment may not rid you of this virus. Since the currently approved treatment for Hepatitis C is only about 50 percent effective in individuals with the most common strain of the virus, the need for better treatment options is blatant.

Government Involvement
As a testament to the government support needed, the National Viral Hepatitis Roundtable (NVHR) took an official stand on Hepatitis C education last year. The NVHR urged Congress to move quickly on bipartisan legislation advocating new Hepatitis C state-based detection, research and surveillance efforts. Their urging followed the publication of a study in the December 2009 edition of Hepatology where University of Michigan investigators found:

· Fewer than 20 percent of Americans with chronic Hepatitis C received antiviral therapy between 2002 and 2007.

· Treatment rates are sub-par, because only about 50 percent of those with Hepatitis C know they are infected.

· Barriers to Hepatitis C screening include the absence of health insurance coverage, limited access to standard medical care and lower priority of Hepatitis C testing by primary care physicians.

Without a doubt, increased public health efforts are needed to improve awareness, testing and access to Hepatitis C antiviral therapy. The Michigan researchers also recommended further research of health services delivery and quality of care for Hepatitis C patients.

Hooray FDA
Government support to improve Hepatitis C detection, research and surveillance is important, but it is not the only type of aid needed. Addressing another portion of government support, the U.S. Food and Drug Administration recently announced its search looking for new members of its Antiviral Drugs Advisory Committee.

As a group of individuals who consider evidence from clinical trials and make recommendations about whether new drugs should be approved or denied, the FDA is now looking for qualified medical and/or scientific consultants who have medical expertise and experience in Hepatitis C. More specifically, the FDA wants new members who:

1. are hepatologists or another type of medical doctor who treat a substantial number of Hepatitis C patients

2. can interpret and analyze detailed scientific data

3. comprehend the magnitude new Hepatitis C drugs pose to public health

In order to keep the motivations of the new committee members honest, the FDA is considering any ties to a pharmaceutical company to be a conflict of interest. Since the first of the next generation of Hepatitis C drugs are expected to be up for approval in 2011, strengthening the Hepatitis C-knowledgeable contingent in the FDA's Antiviral Drugs Advisory Committee is a great step forward in fighting this illness.

Just about everyone personally affected by chronic Hepatitis C infection recognizes the need to improve mass education and medical advances for this disease. When it comes to comprehending the prevalence and health implications of Hepatitis C, public health campaigns have a great deal more progress to make. On the other hand, drug companies are well aware that Hepatitis C represents a major health crisis capable of crippling our current healthcare system. Now, the branch of the government that approves medications is finally joining the pharmaceutical industry in realizing that our community needs and deserves a commitment towards improving the future of Hepatitis C treatment.


References:

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm222191.htm, What is an FDA Advisory Committee?, Retrieved December 12, 2010, US Food and Drug Administration, 2010.

http://www.fda.gov/AdvisoryCommittees/default.htm, Advisory Committees, Retrieved December 12, 2010, US Food and Drug Administration, 2010.

http://www.prnewswire.com/news-releases/nvhr-new-data-finding-fewer-than-1-in-5-hepatitis-c-patients-receiving-antiviral-therapy-is-wake-up-call-for-washington-72130697.html, NVHR: New Data Finding Fewer than 1 in 5 Hepatitis C Patients Receiving Antiviral Therapy is 'Wake-Up Call' for Washington, Retrieved December 12, 2010, PR Newswire Association LLC, 2010.

http://www.hivandhepatitis.com/hep_c/news/2010/1210_2010_a.html, Hepatitis C Experts Sought for FDA Advisory Committee, Retrieved December 12, 2010, hivandhepatitis.com, 2010.

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Developmental Hep C Drug Gets Good Initial Marks

December 23, 2010

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Designed to stimulate the immune system so the body can produce its own natural interferon, Idera's IMO-2125 posted great results from its Hepatitis C Phase 1 trial.

Idera Pharmaceuticals reports positive antiviral results from phase 1 study for Hep C drug

Monday, December 20, 2010

Idera Pharmaceuticals (Nasdaq: IDRA) announced Monday positive preliminary results from a phase 1 study for IMO-2125, the company's investigational drug treatment for chronic hepatitis C infection.

Hep C is an infectious disease affecting the liver. It is often asymptomatic, but once established, chronic infection can progress to scarring of the liver. In some cases, people will go on to develop liver failure or other complications, including liver cancer.

During the 4-week dose-ranging trial, the IMO-2125 drug was tested in combination with ribavirin, in 60 patients with the virus. The results indicated a "substantial decline" in virus levels at two days after the first dose of IMO-2125, and after four weeks of treatment, the company said.

Continue reading this entire article:
http://www.proactiveinvestors.com/companies/news/10985/idera-pharmaceuticals-reports-positive-antiviral-results-from-phase-1-study-for-hep-c-drug-10985.html

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Could Probiotics Help Those With Hepatitis C?

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Talk of probiotics facilitating good health is heard everywhere these days - but is Hepatitis C one of the conditions that could benefit from these "good bacteria"?

by Nicole Cutler, L.Ac.

As the undisputed center of the immune system, the intestinal tract has long been regarded as a location capable of revealing a person's overall health. The tiny, beneficial bacteria that colonize the intestines are essential to the proper functioning of our immune system - but many of us are severely deficient in these microorganisms. Probiotics contain different strains of healthy gut flora and are believed to help restock the intestinal tract with these desirable living bacteria. A growing list of reasons supports the notion that those with Hepatitis C will benefit from probiotic supplementation.

About Probiotics
Although relatively new to mainstream medicine, knowledge of probiotics' value to human health has been around for a long time. In 1908, Ellie Metchnikoff was awarded the Nobel Prize for discovering the important role that probiotics play in the immune response. Probiotics are dietary supplements of live bacteria or yeasts intended to restore a healthful balance of the body's naturally occurring gut flora.

More than 50 percent of the body's immune cells reside in the intestinal lining. Beneficial bacteria in the intestines play several important roles, as they:

· improve the function of the entire intestinal tract

· protect the body against pathogenic bacteria by blocking their entrance

· help produce necessary vitamins and hormones

· maintain the chemical balance of the intestinal tract

· stimulate the immunologic function of the spleen

· compete with harmful bacteria for nutrients, which curtails the growth of harmful bacteria

Decline of Good Bacteria
Despite a normal ratio of healthy bacteria being 85 percent good to 15 percent bad, experts believe that ratio is reversed in many individuals. Several reasons that bad intestinal bacteria outnumber the good intestinal bacteria are:

· Antibiotics prescribed for fighting infections also kill healthy intestinal bacteria.

· Chlorine used to sterilize drinking water kills healthy bacteria.

· Non-steroidal anti-inflammatory drugs kill healthy intestinal bacteria.

· Fluoride used in water for preventing cavities is toxic to healthy intestinal bacteria.

Relevant Studies
According to a myriad of health experts, including those at the University of Maryland Medical Center, probiotics promote gastrointestinal and immune health for those with severe viral infections, such as viral hepatitis. These two studies affirm this notion:

· As published in the May 2009 edition of the Journal of Nutrition, Italian researchers found that administrating probiotics could limit oxidative and inflammatory liver damage in non-alcoholic fatty liver disease. Those with Hepatitis C may or may not have a concurrent diagnosis of fatty liver disease; however, these results demonstrate that probiotics exert a liver protective effect. Such an effect would definitely benefit those with chronic Hepatitis C.

· As published in the July 2005 edition of the Journal of Clinical Gastroenterology, researchers evaluated the effect probiotics therapy had on the liver for those with various types of chronic liver disease. Results of the study suggest that manipulation of intestinal flora should be taken into consideration as a possible adjunctive therapy in some types of chronic liver diseases - particularly individuals with cirrhosis.

Cirrhosis and Probiotics
For those with Hepatitis C who have liver cirrhosis, probiotics appear to offer some help. Those with cirrhosis of the liver are often found to have an imbalance of intestinal bacteria flora. In addition, probiotics reduce bacterial endotoxins that further challenge the liver. For these reasons, experts believe that those who have cirrhosis - where the liver is permanently scarred and hardened - can especially benefit from probiotics.

The scientific evidence suggests that probiotics may be beneficial in protecting and supporting the liver, but this conclusion is not airtight. There has not been a double-blind, large-scale clinical trial evaluating the effect of probiotics specifically for chronic Hepatitis C. The healthcare community is waiting for in-depth research on how the gut flora balance obstructs or assists those with chronic Hepatitis C. In the meantime, there are plenty of reasons for those with Hepatitis C to consider supplementing with beneficial intestinal bacteria.


References:

http://www.drhoffman.com/page.cfm/622, Hepatitis, Leyla Muedin, MS, RD, CDN, Retrieved October 10, 2010, Dr. Ronald Hoffman, 2010.

http://www.healthyhepper.com/probiotics.htm, Probiotics for Hepatitis C, Retrieved October 10, 2010, Healthyhepper.com, 2010.

http://www.livestrong.com/article/79842-antiviral-foods/, Antiviral Foods, Retrieved October 10, 2010, Demand Media Inc., 2010.

http://www.newswithviews.com/Howenstine/james28.htm, Superb Probiotic Substitute from Russia, James Howestine, MD, Retrieved October 10, 2010, newswithviews.com, 2010.

http://www.ncbi.nlm.nih.gov/pubmed, Beneficial effects of a probiotic VSL#3 on parameters of liver dysfunction in chronic liver diseases, Loguercio C, et al, Retrieved October 10, 2010,
Journal of Clinical Gastroenterology, July 2005.

http://www.ncbi.nlm.nih.gov/pubmed, Probiotics reduce the inflammatory response induced by a high-fat diet in the liver of young rats, Esposito E, et al, Retrieved October 10, 2010, Journal of Nutrition, May 2009.

http://www.ncbi.nlm.nih.gov/pubmed, Probiotics restore bowel flora and improve liver enzymes in human alcohol-induced liver injury: a pilot study, Kirpich IA, et al, Retrieved October 10, 2010, Alcohol, December 2008.

http://www.wellness.com/reference/allergies/hepatitis-b/prevention-and-treatment, Hepatitis B, Retrieved October 10, 2010, Wellness.com, 2010.

http://www.wjgnet.com/1007-9327/16/403.pdf, Probiotics and gut health: A special focus on liver diseases, Silvia Wilson Gratz, et al, Retrieved October 10, 2010, World Journal of Gastroenterology, January 2010.

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Exhaustion During Hepatitis C Treatment

December 22, 2010

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An extreme degree of fatigue, exhaustion is common during HCV treatment - and it may also hinder the treatment outcome.

by Nicole Cutler, L.Ac.

Fatigue is the number one complaint of those living with the Hepatitis C virus. The likelihood of being fatigued with Hepatitis C appears to be even higher during antiviral treatment. When tiredness becomes severe enough to where it interferes with the ability to function normally, exhaustion sets in. Unrelenting exhaustion is a major problem during Hepatitis C treatment and, if a solution is not found promptly, therapy could be stopped prematurely.

When treating the most common strain of Hepatitis C in the U.S. with antiviral therapy, there is an estimated 50 percent chance of success. Unfortunately, those whose exhaustion has prevented them from completing antiviral treatment (at the suggested dosage for the entire duration) have a much slimmer possibility of eliminating the Hepatitis C virus.

Hepatitis C is often referred to as the "silent killer." This moniker was earned, because those infected rarely have symptoms until the virus damages a significant portion of their liver. However, fatigue is a frequent exception to Hepatitis C being asymptomatic. In fact, fatigue is:

· The most frequent extra-hepatic (outside of the liver) manifestation of those with Hepatitis C.

· Reported in up to 67 percent of those with Hepatitis C.

· Present in 70-100 percent of patients treated with interferon-based therapy (the current, standard, Hepatitis C antiviral treatment).

Clinicians have found that if fatigue is present prior to starting therapy, interferon treatment can exacerbate it to the point of exhaustion. As the severity of fatigue grows, so too does the chance of Hepatitis C treatment being discontinued.

When exhaustion is evaluated during interferon therapy, a wide range of conditions must be ruled out. A handful of those, include:

· Insomnia
· Anemia
· Excess iron
· Dehydration
· Depression
· A thyroid imbalance
· Hormone imbalance
· Diabetes
· Severe pain
· Allergies

Upon working with a clinician to determine the best way to regain energy levels, it is important for the patient to deliver an accurate description of exactly how tired he or she is. This is because there is no objective test to measure tiredness, so clinicians must rely on their patients' subjective reports to determine the severity of their fatigue. Especially important when exhaustion has been reached, such communication is essential to expedite finding its resolution. After ruling out fatigue-causing factors that lie outside of the domain of the Hepatitis C virus and the medication used to treat it, there is a wide range of approaches to help reduce fatigue. Some of the top non-pharmacological strategies to ease exhaustion, include:

· Bedtime administration of interferon
· Reduction of interferon dose (although this also may reduce the medication's effectiveness)
· Improving nutritional intake
· Replacing fluids and electrolytes
· Alternating periods of rest and activity
· Treating with Traditional Chinese Medicine (primarily acupuncture and herbal therapy)
· Engaging in regular aerobic exercise
· Scheduling strenuous activities during peak times of energy

Most individuals can find some degree of exhaustion relief by combining these strategies. In addition, some doctors may prescribe exhaustion-alleviating drugs. While this could enable certain individuals to complete a course of Hepatitis C interferon therapy, all medications have side effects. Several examples of drugs considered for this purpose are:

· Anti-depressants - Research indicates that anti-depressants may be useful in reducing fatigue, especially when it manifests with depression.

· Methylphenidate - Known widely by its brand name Ritalin, methylphenidate is a central nervous system stimulant that may ease interferon-related fatigue. However, methylphenidate will exacerbate many underlying substance use disorders.

· Modafinil - Also a central nervous system stimulant, Modafinil is another pharmacological option for easing interferon-related fatigue.

As anyone who has experienced exhaustion before will attest, this extreme degree of fatigue is debilitating. Luckily, there are many ways to ease fatigue. Especially for those fighting Hepatitis C with antiviral therapy, reducing fatigue severity is paramount to completing treatment. Therefore, alleviating fatigue before and during interferon therapy serves to increase the odds at beating Hepatitis C.


References:

http://www.hcvadvocate.org/hcsp/articles/hauser-1.html, Hepatitis C and Fatigue, Peter Hauser, MD, Retrieved June 9, 2010, Hepatitis C Support Project, 2010.

http://www.hcvadvocate.org/news/newsLetter/2010/advocate0610.html#3, Healthwise: Making Friends with Fatigue, Lucinda K. Porter, RN, Retrieved June 9, 2010, The Hepatitis C Support Project, 2010.

http://www.mentalhealth.com/drug/p30-r03.html, Methylphenidate, Retrieved June 11, 2010, Phillip W. Long, MD, 2010.

http://www.springerlink.com/content/3502632747149t5p/, Modafinil's Use in Combating Interferon-Induced Fatigue, Kari A. Martin, et al, Digestive Diseases and Sciences, February 2007.

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SeraCare Aiming to Improve Early Diagnosis of Hepatitis C

December 15, 2010

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Designed to accurately detect the virus early in the immune response process, SeraCare is introducing two new blood panels to improve Hepatitis C diagnostics.

SeraCare Introduces New HCV Seroconversion Panels

SeraCare Life Sciences, a leading expert in human biologicals and the manufacturer of ACCURUN® controls, introduces two new, highly characterized HCV seroconversion panels designed to help diagnostic manufacturers and clinical laboratories effectively evaluate their HCV test systems.

Milford, MA (PRWEB) December 11, 2010

The safety of the blood supply and the accurate diagnosis of Hepatitis C infection depend on the sensitivity and overall quality of tests for markers of HCV. Test developers, regulators and clinical laboratories require highly characterized panels and control materials to challenge sensitivity accuracy and reproducibility of their assays.

SeraCare Life Sciences, a leading expert in human biologicals and the manufacturer of ACCURUN® controls, introduces two new, highly characterized HCV seroconversion panels designed to help diagnostic manufacturers and clinical laboratories effectively evaluate their HCV test systems. The specimens in each panel are collected from a single individual during the evolution of the immune response to HCV. Accurate detection of early HCV infection is especially important for tests used to screen the blood supply, as HCV is not initially symptomatic upon infection.

Continue reading this entire article:
http://www.prweb.com/releases/2010/12/prweb4882614.htm

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Symptoms and Severity of Chronic Hepatitis C

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Some medical tests are more accurate than others in ascertaining how severe Hepatitis C infection is - and that severity may or may not be associated with how much an infected person suffers with Hepatitis C's symptoms.

by Nicole Cutler, L.Ac.

Hepatitis C is a notoriously nasty liver virus that affects four times more people in the U.S. than HIV, the virus that causes AIDS. Like HIV, the symptoms of chronic Hepatitis C can vary greatly. While a large proportion of those with Hepatitis C have no symptoms at all, others can have nearly disabling symptoms of liver disease. Sometimes there seems to be no rhyme or reason to differentiate between who feels great and who feels awful with this virus. However, there are a handful of circumstances practically guaranteed to worsen the symptoms of someone battling chronic Hepatitis C.

Liver Health Measurements
Chronic Hepatitis C infection can be tricky to track because the only true indicator of how far the illness has advanced is a liver biopsy or equivalent method.

· Biopsy - A liver biopsy is a procedure where a small piece of liver tissue is removed for examination under a microscope. Under high magnification, the sample is evaluated for signs of liver scarring (liver damage).

· Biopsy Alternative - While a liver biopsy remains the medical gold standard for determining the extent of liver disease, newer alternatives have emerged. The two most lauded involve the use of magnetic resonance and specialized blood tests to detect the degree of liver scarring.

Since liver biopsies are somewhat invasive and carry some risk, they are typically used sparingly. Unfortunately, the biopsy alternatives require more studies to prove their accuracy so that they can become part of Hepatitis C medical protocol. Instead, most physicians rely on liver function tests and viral load counts to evaluate the apparent severity of Hepatitis C. Although seemingly indicative of liver health, liver function tests and viral load counts do not always correlate with the degree of liver damage. Regrettably, the degree of liver damage is the only way to know the extent of someone's liver disease.

Hepatitis C Symptoms
It would seem logical that the more chronic Hepatitis C has damaged a liver, the more pronounced someone's symptoms are. While this seems logical, it is not always a reliable association. This is mostly because the symptoms associated with Hepatitis C are also symptoms caused by so many other health issues. Complicating an understanding of Hepatitis C's symptoms is that an estimated 80 percent of those infected are asymptomatic. For those who do have symptoms, they may not appear for a decade or two after initial infection with this liver virus.

Even when Hepatitis C has steadily assaulted a liver for many years, symptoms can be intermittent, mild and vague. Unless derived from a different cause, those who experience pronounced Hepatitis C symptoms usually already have significant damage to their liver. Typical Hepatitis C symptoms, include:

· fatigue
· sporadic abdominal pain
· reduced appetite
· weight loss
· nausea/vomiting
· depression
· jaundice
· dark urine/pale stool
· fluid retention
· skin itchiness
· coughing/vomiting blood
· confusion

What Worsens Hepatitis C Infection (and, thus, its symptoms)
Even with a relatively low viral load and liver function tests that are not alarming, severe symptoms are still possible. The following are three repeatedly proven ways to worsen liver damage from Hepatitis C and exacerbate symptoms:

1. Drinking Alcohol - any amount of alcohol dramatically magnifies the Hepatitis C virus' ability to cause liver damage. Alcoholics with chronic Hepatitis C are especially vulnerable to having advanced liver disease.

2. Co-Infection With HIV - The risk of developing liver damage is much higher in those co-infected with Hepatitis C and HIV than those only infected with Hepatitis C. People with both viral infections do best with aggressive treatment, close supervision and guidance by their physician.

3. Certain Medications - Many drugs are very harsh on the liver and should not be taken by those with Hepatitis C. Anyone with liver disease must carefully evaluate every medication he or she takes - including over-the-counter drugs - with his or her doctor.

Although those with chronic Hepatitis C are usually required to evaluate their health with periodic liver function and viral load tests, these results often don't translate into symptoms or disease severity. Until there is a simpler way to determine the extent of liver scarring in those with chronic Hepatitis C, those infected should be aware of how drinking alcohol, co-infection with HIV and certain medications can impact their health - both by worsening their symptoms and by causing more liver damage.


References:

http://forums.webmd.com/3/hepatitis-exchange/forum/586?ecd=wnl_hep_091610, I'm Always Sick, Retrieved September 16, 2010, WebMD, LLC, 2010.

http://gut.bmj.com/content/53/3/451.abstract, Progression of hepatic fibrosis in patients with hepatitis C: a prospective repeat liver biopsy study, S D Ryder, Retrieved September 16, 2010, Gut, 2004.

http://www.aac.org/site/PageServer?pagename=info_hepC#11, Hepatitis C Frequently Asked Questions, Retrieved September 16, 2010, AIDS Action Committee of Massachusetts, 2010.

http://www.emedicinehealth.com/hepatitis_c/page3_em.htm, Hepatitis C, Retrieved September 16, 2010, WebMD, Inc., 2010.

http://www.pegasys.com/about-pegasys/hcv-hiv-coinfection.aspx, Hepatitis C and HIV Treatment--PEGASYS® (Peginterferon alfa-2a), Retrieved September 16, 2010, Genentech USA, Inc., 2010.

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Liver Restoration: New Hope for Advanced Hep C

December 14, 2010

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New research presents evidence that reversing cirrhosis is possible - a development that could eliminate the need for a liver transplant and benefit those with advanced Hepatitis C.

by Nicole Cutler, L.Ac.

End-stage liver disease due to chronic Hepatitis C viral infection has become the leading indication for liver transplantation in the United States. Since there are many more in need of a liver transplant than organs available, scientists are investigating other options by pushing medical technology towards new breakthroughs. Along those lines, researchers from Weill Cornell Medical College in New York have discovered that endothelial cells play a key role in regeneration of the liver - an understanding that could facilitate restoration of an ailing liver.

The liver is a remarkable organ, capable of regenerating when parts of it sustain damage. However, the repeated assault by chronic Hepatitis C infection can outpace the liver's regenerative capabilities, resulting in scarring that is too dense to be repaired. Studies have shown that 20 to 25 percent of people with Hepatitis C will develop cirrhosis, severe scarring of the liver believed to be irreversible.

Infecting between four and five million Americans, chronic Hepatitis C is an illness of growing concern. About half of those infected with the most common genotype of Hepatitis C are able to eliminate the virus from their blood with aggressive treatment, but the rest are vulnerable to this disease progressing to advanced liver disease. If liver disease escalates to the point where the liver can no longer perform its functions (such as is the case with advanced cirrhosis), a liver transplant is needed. Aside from a liver transplant, there is currently no other approved, therapeutic approach for cirrhosis.

Despite our vast understanding of the human body, the mechanism driving the liver's ability to repair itself has mostly been a mystery. According to Dr. Bi-Sen Ding, an author of the Weill Cornell Medical College research, "Until our study, the molecular and cellular pathways that would initiate and maintain liver regeneration were not known. Attempts to transplant hepatocytes [liver cells] directly into the liver led to very limited success. But now we have identified liver sinusoidal endothelial cells - that, when activated, are critical to liver regeneration and may enable proper engraftment when hepatocytes are implanted into the injured liver."

More information about the Weill Cornell Medical college study is as follows:

· The cells that form the lining of blood vessels, endothelial cells appear to play an instructive role in initiation, regeneration and restoration of circulation in the liver.

· These highly specialized blood vessel cells in the liver (sinusoidal endothelial cells), initiate and sustain liver regeneration by producing growth factors that have been identified.

· Mice deficient in sinusoidal endothelial cell growth factors manifest defects throughout the liver regeneration process.

According to Dr. Shahin Rafii and Dr. David Lyden, two additional authors of this research, these findings are likely to open the door for designing new therapies to treat damaged livers.

Because Hepatitis C infection is the leading reason for liver transplants in America - and the livers available for this procedure are limited - those with this condition have a lot to gain from effective liver transplant alternatives. As a result of the recent Weill Cornell Medical College findings, more research into how sinusoidal endothelial cells can grow new liver tissue will soon follow. If all goes well, implanting these specialized cells will help regenerate the liver, ultimately reversing cirrhosis in those with advanced Hepatitis C.


References:

http://weill.cornell.edu/news/releases/wcmc/wcmc_2010/11_11_10.shtml, Specialized Blood Vessels Jumpstart and Sustain Liver Regeneration, Retrieved November 15, 2010, Weil Cornell Medical College, 2010.

http://www.hcvadvocate.org/hcsp/articles/Herrera.html, Cirrhosis in Chronic Hepatitis C Infection, Jorge L. Herrera, MD, Retrieved November 16, 2010, Hepatitis C Support Project, 2010.

http://www.hcvadvocate.org/hcsp/articles/Shaw-Stiffel-1.html, Hepatitis C and Liver Transplantation, Thomas Shaw-Stiffel, MD, Retrieved November 16, 2010, Hepatitis C Support Project, 2010.

http://www.medicaldaily.com/news/20101113/3674/key-blood-cell-helps-liver-regeneration.htm, Key blood cell helps liver regeneration, Retrieved November 15, 2010, MedicalDaily, 2010.

http://www.ncbi.nlm.nih.gov/pubmed/21068842, Inductive angiocrine signals from sinusoidal endothelium are required for liver regeneration, Ding, BS, et al, Retrieved November 17, 2010, Nature, November 2010.

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Differentiating Between Hepatitis C Genotypes and the IL-28B Genotype

December 13, 2010

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Hepatitis C research represents how far the medical application of genetics has come in the past decade. Although they analyze different genetic material, tests that determine Hepatitis C genotype and IL-28B genotype will help guide the future of Hepatitis C treatment.

by Nicole Cutler, L.Ac.

As we learn more about Hepatitis C, it becomes increasingly clear that treatment regimens need to be customized for each infected individual. Besides different strains of the virus requiring different treatment approaches, differences on the human genome add another variable to how easy or difficult it can be to defeat the Hepatitis C virus.

There are many things a physician and his or her patient must take into account when trying to decide if that person is a candidate for treatment, which combination of drugs to begin with and what length of time is ideal. Among the long list of considerations to arrive at the answers to these questions, two important issues are:

· What Hepatitis C genotype does the person have?

· What is the person's IL-28B genotype?

Although there is some terminology shared between these two characteristics, their origins and implications for Hepatitis C treatment are distinct.

Hepatitis C Genotype
As of late 2007, there are seven known variations of the Hepatitis C virus. Known as Hepatitis C genotypes, these genetic differences are routinely tested for with every new Hepatitis C diagnosis. Although not associated with someone's race, Hepatitis C genotypes are more common in differing locations.

· Genotypes 1, 2 and 3 - These Hepatitis C genotypes are most common in North America and Western Europe.

· Genotype 4 - Hepatitis C genotype 4 is most common in Africa, Egypt and the Middle East, but is increasingly seen in some parts of Europe.

· Genotype 5 - Hepatitis C genotype 5 is mostly seen in Africa and the Middle East.

· Genotype 6 - Hepatitis C genotype 6 is most common in Southeast Asia.

· Genotype 7 - Hepatitis C genotype 7 has primarily been encountered in Central Africa.

Of particular importance, each genotype has a different response to conventional treatment.
In order to prescribe a treatment plan with the highest chances of success, a person must have his or her particular Hepatitis C genotype identified.

IL-28B Genotype
Just like the Hepatitis C virus has its own genetic make-up, so do we. An international research effort to sequence and map all of humans' genes - together known as the genome - was completed in April 2003. This discovery gave us the ability to read nature's complete genetic blueprint for building a human being.

The human genome comprises a sequence of approximately three billion parts, called nucleotides, which are organized into DNA molecules. The nucleotides, which serve as the alphabet for the language of life, are represented by just four letters: A, C, G and T - corresponding to adenine, cytosine, guanine and thymine.

Research presented in 2010 revealed that the coding at a single site on the human genome made a big difference in people's response to Hepatitis C treatment. Known as IL-28B, this site may have either a T or a C on the genome. Since a person inherits two copies of the genome (one from each parent) to make up each allele, individuals may have one of the following alleles at IL-28B:

· TT - These individuals were found to have the poorest response to Hepatitis C treatment.

· CC - These individuals have the best response to Hepatitis C treatment.

· TC - These individuals appear to have a response to Hepatitis C treatment in between those with the TT and CC alleles.

Since the C nucleotides are more common in Europeans than in Africans, it makes sense that those of European descent have a better rate of beating the virus than those of African descent.

Testing for IL-28B
A person's genetic code at a specific spot in the genome could foretell his or her response to Hepatitis C treatment. As such, the test evaluating the IL-28B allele is gaining popularity. David King, CEO of LapCorp, singled out their IL-28B assay as partially responsible for his company's modest growth.

At this point, many people are interested in receiving the IL-28B assay to help determine their chances for successful Hepatitis C treatment. Unfortunately, most insurance companies do not currently cover this pricey test. While several individuals have reported that some Hepatitis C clinical trials may include this test in their screening protocol, the majority of those with this virus may not be able to obtain it yet. The time needed for such a policy change within health insurance companies can be a positive or a negative.

· On the plus side, knowing your IL-28B allele combo can better guide a doctor and patient toward a custom-tailored Hepatitis C treatment regimen.

· On the other hand, revelation of a TT allele combo could be cause for an insurance company to deny treatment coverage.

Regardless of what tests are currently covered by health insurance companies, there is little doubt that Hepatitis C treatment is becoming increasingly specialized. Besides knowing the Hepatitis C genotype you are infected with, each person will eventually need to know which nucleotides are on the IL-28B segment of his or her genome. Being armed with specific genetic information about the virus and specific genetic information about the infected person will help practitioners construct the best possible Hepatitis C treatment plan for their patients.


References:

http://www.cbse.ucsc.edu/research/human_genome, What is the Human Genome?, Retrieved November 28, 2010, Center for Biomolecular Science & Engineering, 2010.

http://www.genome.gov/10001772, All About the Human Genome Project, (HGP), Retrieved November 28, 2010, National Human Genome Research Institute, 2010.

http://www.genomeweb.com/newsletter/sample?page=1, LabCorp's Esoteric Testing Grew 7 Percent in Q3 as Total Revenues Rose 7.7 Percent, Kirell Lakhman, Retrieved November 28, 2010, GenomeWeb LLC, 2010.

http://www.hepatitis-central.com/mt/archives/2008/01/an_updated_repo.html, An Updated Report on Hepatitis C Genotypes, Nicole Cutler, L.Ac., Retrieved November 28, 2010, Natural Wellness, 2010.

http://www.hivandhepatitis.com/2010_conference/croi/docs/0312_2010_c.html, IL28B Gene Variation Linked to Spontaneous Clearance and Treatment Response in HIV/HCV Coinfected People, Liz Highleyman, Retrieved November 27, 2010, hivandhepatitis.com, 2010.

http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/57185, Unit Code 57185: Interleukin 28B (IL28B) Polymorphism (rs12979860), Retrieved November 27, 2010, Mayo Foundation for Medical Education and Research, 2010.

http://www.natap.org/2010/HCV/062810_01.htm, Reaping the Early Harvest of the Genomics Revolution - IL28B gene predicts response to Peg/Rbv SVR in Caucasians & African-Americans-Editorial, Raymond T. Chung, Retrieved November 28, 2010, Gastroenterology, May 2010.

Posted by Editors at 10:32 AM --- Printer-friendly version

Unfavorable IL-28 Genotype Benefits from the GI-5005 Hep C Vaccine

December 7, 2010

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When added to conventional antiviral therapy, GlobeImmune's investigational, therapeutic Hepatitis C vaccine appears to correct a fundamental deficit in cellular immunity in those with the disadvantaged T/T allele of the IL-28 gene.

Hepatitis C Vaccine Elicits Immune Response in Some Patients

By: Diana Mahoney, Internal Medicine News Digital Network

BOSTON - A therapeutic vaccine against the hepatitis C virus was associated with a significantly higher sustained virologic response rate when added to standard-of-care treatment, and the findings justify further development of the vaccine, Dr. Paul Pockros reported at the annual meeting of the American Association for the Study of Liver Diseases.

In the proof-of-concept trial, 133 patients infected with hepatitis C virus (HCV) genotype 1 were randomized to either triple therapy comprising the experimental GI-5005 vaccine, which is designed to elicit a T-cell response specific to HCV, along with pegylated interferon alfa-2b plus ribavirin (P/R), or the standard P/R therapy alone.

Continue reading this entire article:
http://www.internalmedicinenews.com/news/infectious-diseases/single-article/hepatitis-c-vaccine-elicits-immune-response-in-some-patients/4f49d68bff.html

Posted by Editors at 9:57 AM --- Printer-friendly version

A Vaccine Plus Antiviral Meds Could Conquer Hepatitis C

December 2, 2010

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Clinical trials in Oxford are gathering evidence that a therapeutic Hepatitis C vaccine can help defeat the virus when combined with antiviral therapy.

Advances made in developing hepatitis C vaccine

By Aaron Derfel, Postmedia News

November 22, 2010

MONTREAL -- Scientists are zeroing in on a promising vaccine to treat hepatitis C, an international symposium was told Friday in Montreal.

Three preliminary clinical trials in England are showing that a so-called therapeutic vaccine can boost the immune response in those infected with the hepatitis C virus.

Still, a viable vaccine is a decade away, said Paul Klenerman, a University of Oxford physician researcher who is conducting the trials.

"Other vaccine trials have been done already, but ours is the first where we're treating people (with drugs) and giving them the vaccine at the same time," he said.

Continue reading this entire article:
http://www.montrealgazette.com/health/Advances+made+developing+hepatitis+vaccine/3865544/story.html

Posted by Editors at 12:33 PM --- Printer-friendly version

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