Wednesday, September 14, 2011

Hepatitis News Ticker;Coffee consumption reduces side-effects in people on hepatitis C treatment

Hepatitis B and C Coinfection among HIV Positive People in the U.S.
Liver disease and coinfection with hepatitis B or C are common among people with HIV, according to a recent analysis, leading researchers to recommend that viral hepatitis screening, vaccination, and treatment should be considered a priority for HIV positive individuals.

Coffee consumption reduces side-effects in people on hepatitis C treatment
Drinking three or more cups of coffee a day reduced the incidence of self-reported side effects by more than 80% compared to non-coffee drinkers in people co-infected with hepatitis C and HIV who were taking hepatitis C treatment, a French study has found.
The study adds to evidence that coffee could be a useful and cheap 'supplement' for people taking hepatitis C treatment and could considerably increase the rate of treatment success. A study published in June (Freedman) found that in patients with hepatitis C and not HIV, drinking three or more cups of coffee a day increased the likelihood of treatment success by 80%...

From Alimentary Pharmacology & Therapeutics
Systematic Review

The Epidemiology and Natural History of Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis in Adults

G. Vernon; A. Baranova; Z. M. Younossi
Authors and Disclosures
Posted: 09/14/2011; Alimentary Pharmacology & Therapeutics. 2011;34(3):274-285. © 2011 Blackwell Publishing

View Full Text Here
The spectrum of NAFLD and its subtype of NASH seem to be a final common pathway, in histological terms, of many causes of hepatic metabolic stress.
Given the strong association of NAFLD with metabolic syndrome as well as the worldwide epidemic of obesity, the prevalence of NAFLD and NASH are increasing. In the US alone, an estimated one-third of the population has NAFLD and approximately 2–5% have NASH. Within the NAFLD spectrum, only patients with histologically proven NASH develop progressive liver disease. Progression seems more likely in the setting of diabetes, insulin resistance and other pre-existing conditions.

The majority of the epidemiological studies summarised in this manuscript are based on a relatively small number of patients assessed with different pathological protocols, radiological modalities, or serum biomarkers and are followed for relatively short periods. This circumstance presents several important challenges for assessing the epidemiology of NAFLD. We lack well designed prospective studies profiling large, preferably ethnic-specific cohorts of patients with well characterised NAFLD who are followed for long periods. It is also important to develop consensus on the histological definition of NASH and other subtypes of NAFLD, because they are important for determining study inclusion at baseline. The cost and invasiveness of liver biopsy make it a less attractive modality for assessing long-term outcomes. Although many non-invasive biomarkers for NAFLD assessment have been developed, only some provide strong evidence of external validation.[117] Finally, the most important outcomes of mortality, morbidity and resource utilisation are studied only in limited cohorts of NAFLD patients. Therefore, because we expect the future prevalence and impact of NASH to increase with the obesity epidemic, we need to perform larger, longitudinal studies that assess the long-term natural history of NAFLD with validated, non-invasive biomarkers and by integrating morbidity and mortality data. Studies of this kind will provide the type of evidence needed to encourage clinicians, researchers and health policy experts to focus on NAFLD as one of the most common chronic human diseases worldwide

Incivek Pegasys and Rebotol dose may be reduced and still effective
The newly approved therapy for hepatitis C teams telaprevir (Incivek) with peginterferon alfa (Pegasys) and ribavirin (Copegus and Rebetol) and is just as effective if taken for 24 weeks compared to a 48 week regimen.
Michael W. Fried, MD, professor of medicine at the University of North Carolina at Chapel Hill, director of the UNC Liver Center and a co-author of the ILLUMINATE study, reports this is great news for four million people in the US suffering from this chronic liver disease. These medications do have side effects, so reducing a patient’s exposure to these medications will be beneficial for their health.

Lead author Kenneth E. Sherman, M.D., Ph.D., of the University of Cincinnati College of Medicine reports this study included 540 patients with chronic genotype 1 hepatitis C who either had never been treated with the current protocol or whose treatment was previously unsuccessful.
All the patients began taking all three drugs for a period of 12 weeks. Then, Incivek was discontinued.

At this point, patients who tested negative for the hepatitis C virus continued therapy for either 12 or 36 weeks with the other two drugs, Pegasys and Rebetol. The first group received a total of 24 weeks of drug therapy while the other group was treated for 48 weeks.In the group that took drugs for 24 weeks, 92 percent ultimately had the virus undetectable in their blood after treatment was discontinued. In the group on drug therapy for 48 weeks, 88 percent also achieved a cure to hepatitis C.

Dr. Fried reported mild to moderate side effects were associated with Incivek that included rashes and anemia. All were manageable.
This study was funded by Vertex Pharmaceuticals and Tibotec. Vertex markets Invicek in the US while Tiboetec will market the drug in Europe.
This study is published in the Sept. 15, 2011 issue of The New England Journal of Medicine.

Early Data on BMS-790052 HCV NS5A Inhibitor Published
This pilot study included 30 previously untreated patients with hard-to-treat genotype 1 chronic hepatitis C. About 80% were men and most were white. Individuals with cirrhosis and HIV or hepatitis B coinfection were excluded.

Genotyping hepatitis C patients improves prediction of treatment response
Press release from PLoS Medicine
In this week's PLoS Medicine, David Booth of the University of Sydney, Australia and colleagues show that genotyping hepatitis C patients for the IL28B, HLA-C and KIR genes substantially improves doctors' ability to predict whether or not patients will respond to antiviral treatment.
The results of the study suggest that an interaction between IL28B, HLA-C and KIRs provides a mechanism for hepatitis C viral control and highlight new insights into how the drug combination of pegylated interferon alpha and ribavirin clears hepatitis C virus infections, findings that may lead to improved therapies in the future. The findings have yet to be confirmed in patients of non-European descent.
Funding: VS, DB, GS, and JG were supported by Australian Research Council Roche Linkage Project grant LPO0990067 and the Robert W. Storr Bequest to the Sydney Clinical School, University of Sydney. GD is supported by an Australian National Health and Medical Research Council Practitioner Fellowship. TB is supported by the German Competence Network for Viral Hepatitis (Hep-Net), funded by the German Ministry of Education and Research (BMBF, Grant No. 01 KI0437, Genetic host factors in viral hepatitis and Genetic Epidemiology Group in viral hepatitis) and by the EU-Vigilance network of excellence combating viral resistance (VIRGIL, Projekt No. LSHM-CT-2004-503359) as well as by the BMBF Project: Host and viral determinants for susceptibility and resistance to hepatitis C virus infection (Grant No. 01KI0787, Project B). DS and MB (Newcastle University, UK) are funded by a Medical Research Council UK project grant G0502028. JN was supported by BMBF (German Ministry for Science and Education) [grant no. 01KI0791] and H.W. and J. Hector Foundation [grant no. M42]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing Interests: The authors have declared that no competing interests exist.
Citation: Suppiah V, Gaudieri S, Armstrong NJ, O'Connor KS, Berg T, et al. (2011) IL28B, HLA-C, and KIR Variants Additively Predict Response to Therapy in Chronic Hepatitis C Virus Infection in a European Cohort: A Cross-Sectional Study. PLoS Med 8(9): e1001092. doi:10.1371/journal.pmed.1001092

Study Finds Genotyping HCV Patients for HLA-C as well as IL28B ...
Genetic Engineering News - 4 hours ago
The International Hepatitis C Genetics Consortium (IHCGC) genotyped over 1000 chronic hepatitis C (CHC) patients of European descent, to evaluate whether ...

Healthy You

Feds, States Close In on Listeriosis Outbreak
By Cole Petrochko, Associate Staff Writer, MedPage Today
Published: September 14, 2011

Federal and state health agencies have begun to identify the source of a multistate listeriosis outbreak that has resulted in at least two deaths.
The agencies, including the FDA, the CDC, and state health departments, have found that the 15 patients affected by the outbreak strain had eaten whole cantaloupes that appeared to have all come from the Rocky Ford region of Colorado, an FDA statement said.
Patients affected with listeriosis became ill on or after Aug. 15, and had an median age of 84 years, ranging from 38 to 96 years.

The agencies are currently testing product and environmental samples. The outbreak has been reported in Colorado, Nebraska, Oklahoma, and Texas.

The outbreak was caused by Listeria, bacteria that can be found in water, soil, some farm animals, and raw milk, as well as in ready-to-eat deli meat, hot dogs, meat spreads, products made from unpasteurized milk, refrigerated smoked seafood, and raw sprouts. The bacteria can survive and grow in the cold of a refrigerator.

The FDA noted that the disease can be fatal in certain high-risk populations, including adults ages 60 and older, those with compromised immune systems, and patients with chronic medical conditions. Pregnant women with listeriosis may experience miscarriage, stillbirth, and other potentially serious or fatal effects in their newborns.

"While the investigation into the source of the Listeria outbreak is continuing, it is prudent for people who are at high risk for Listeria infection to avoid consumption of cantaloupe," Chris Urbina, MD, chief medical officer and executive director of the Colorado Department of Public Health and Environment, said in a release.

Additionally, the CDC advised consumers on its website to dispose of cantaloupes marketed as coming from the Rocky Ford region, to set refrigerators to 40 degrees F or below and freezers to 0 degrees F or below, and to rinse raw produce under running tap water before eating it.

Raise a fork: Pure maple syrup may be good for liver: Study
Raise a fork: Pure maple syrup may be good for liver: Study By Thandi Fletcher, Postmedia News Pancake and waffle lovers, prepare to raise your forks. New research suggests a diet that includes pure maple syrup may help to promote liver health. Researchers from the University of Tokyo, led by Dr. Keiko Abe, fed laboratory rats a diet consisting of 20 per cent pure maple syrup, and compared their liver health to that of rats fed with a 20 per cent syrup mixture, with a similar sugar content.

The study, to be published in the November issue of the science journal Bioscience, Biotechnology and Biochemistry, found after 11 days on the maple sugar diet, the rats had "significantly decreased" amounts of specific liver enzymes, the levels of which are used to test liver damage. Using nutrigenomics, the study of the effects of foods on gene expression, the researchers also found the maple syrup diet caused genes involved in the production of harmful ammonia in the liver to be less active. However, as the study so far, has been carried out using only rats, the benefits of consuming maple syrup for humans is not yet understood, said Dr. Melissa Palmer, clinical professor of medicine and director of hepatology at New York University Plainview. "Further studies need to be done in order to prove these results on humans before we can make any recommendations," said Palmer, a liver health specialist who was not involved in the study.

Palmer said the study confirms the role of lifestyle choices, such as poor diet, stress and lack of exercise, have on liver function. "If maple syrup did turn out to be beneficial to the human liver, it would be beneficial for patients to choose a sweetener, such as maple syrup, as opposed to pure sugar, an artificial syrup or another type of sweetener," said Palmer. Palmer said the health benefits of maple syrup for rats are likely a result of its antioxidant and anti-inflammatory properties, which are similar to benefits of phenols found in red wine and blueberries, and in the flavonoids found in grapefruits. "We've seen this in other types of foods, but the amount you have to take and how beneficial it would be, we don't know yet," said Palmer.

The findings come after a recent study from scientists at the University of Rhode Island suggested maple syrup contains cancer-fighting antioxidant compounds that may also help in the management of Type 2 diabetes. While the liver study does offer an interesting hypothesis, Dr. Eric Yoshida, chair of the medical advisory committee for the Canadian Liver Foundation, said the high sucrose content of maple syrup poses a greater health risk that could outweigh any potential benefits. "Sucrose is table sugar . . . and sugar is bad for the liver, simply bad for the liver," said Yoshida, who is also a professor and the head of gastroenterology at the University of British Columbia. "It can cause an accumulation of fat within the liver cell, and later oxidation, which is bad." The maple syrup used in the study is made up of 66 per cent sucrose, said Yoshida, and other research, including a 2010 study from Princeton University, has linked high fructose corn syrup, a type of sugar, with an increased risk of obesity. As the study looked only at rats, Yoshida recommended further studies on humans be carried out before touting the health benefits of maple syrup.

"Maple syrup is commercially available, so the researchers could simply look at people who consume a lot of maple syrup and see what the prevalence of liver diseases in that group is compared to the rest of the population," he said. "I think there's a ways to go before they can say maple syrup (promotes liver health)." As with anything diet-related, Yoshida said moderation is key. A healthy and functioning liver is important for storing glycogen, regulating blood glucose, producing amino acids, and filtering harmful substances from the blood. Although often believed to affect alcoholics, there are more than one hundred different forms of liver disease not related to excessive drinking.

According to the Canadian Liver Foundation, the most common form of liver disease in Canada is fatty liver disease. The study was funded by the Conseil pour le developpement de l'agriculture du Quebec and Agriculture and Agri-Food, on behalf of the Canadian Maple Syrup Industry and the Federation of Quebec Maple Syrup Producers.


Vertex CEO Chides Analyst In Front Of Investors
Of course, Emmens can crow a bit since Vertex stock is up more than 40 percent this year, thanks to early signs that Incivek is gaining the upper hand on an equally new, rival med from Merck, which is also working with Roche on developing and promoting hepatitis C treatments

Four Biotech Picks to Fight Hepatitis C
Credit Suisse likes Pharmasset, Inhibitex, Medivir and Achillon.
We continue to view the hepatitis C virus (HCV) market as one of the most exciting opportunities in biotech. In this note, we review what we know so far about the launch of Vertex's Incivek, what we have learned from recent interviews conducted with recent high-prescribing HCV physicians, and recent highlights and upcoming catalysts for the rest of our HCV coverage.

Vertex's (ticker: VRTX) Incivek has been strong out of the gates but there are already questions about when patient flow will slow down.
Second-quarter sales and [market researcher] IMS Health prescription data show that Incivek has been selling briskly (and capturing dominant market share versus Merck's (MRK) Victrelis). The recent deceleration in prescription growth may well be an issue of seasonality that leads to another boost in the fall.

However, our physician interviewees suggested that they are not seeing the rush of patients that they expected, and some physicians are already expecting their patient flow to plateau sometime next year.

In addition, high-prescribing physicians are hearing that their colleagues who focus less on HCV are often referring patients to specialists because of the perceived complexity associated with HCV protease inhibitor treatment.
We remain cautious on Vertex despite the fact that Incivek is off to a great start. We are reiterating our Underperform rating on Vertex. We believe that Incivek will continue to grow in the short run, and we view the cystic-fibrosis pipeline as very promising.

However, we think the HCV market is more complex than it appears at first glance, and that HCV competition coming in 2014 and beyond will have a material impact on Incivek. Our Incivek sales estimates have been increased for 2011 and 2012 and decreased in 2013-2016. Combined with lower gross margins and higher operating expenses, our discounted-cash-flow-based price target changes from $45 to $42.

We continue to highlight Outperform-rated Pharmasset (VRUS), Inhibitex (INHX), Medivir [of Sweden], and Achillon Pharmaceuticals (ACHN), and remain on the sidelines with Idenix Pharmaceuticals (IDIX). In our interviews, physicians seemed most enthusiastic about Pharmasset's PSI-7977 and Medivir/ Johnson & Johnson's (JNJ) TMC-435 as next generation agents to watch.

The impressive recent Phase IIb data for Pharmasset's PSI-7977 (91% SVR12 in genotype 1) validates our view that the company will be a long-term winner in HCV based on the attributes of "nucs" and their expected importance in future oral combinations.
Other than continued monitoring of prescriptions and sales of Incivek and Victrelis, the next big catalyst for the HCV sector will be the annual American Association for the Study of Liver Diseases (AASLD) conference. We expect that investors will focus on updates from Pharmasset, Medivir/Johnson & Johnson, Biophausia Integration (BI), and others, with a particular eye to direct-acting antiviral (DAA) combination regimens and development timelines.
-- Adam Cutler -- Ravi Mehrotra -- Lee Kalowski

Most Protocols Are Amended During Clinical Trials
Nearly 60 percent of all protocols used in clinical trials for new drugs are amended during the trial, but one-third of those changes could have been avoided and saved countless dollars, according to an analysis by the Tufts Center for the Study of Drug Development.

Stem Cells

Opinion: Reforming Stem Cell Tourism
Heightened guidelines and education are not enough to thwart the use of unproven and potentially harmful stem cell therapies. Scientists must get involved.
As with many new areas of technological advancements, stem cell research has received its fair share of hype. Though much of the excitement is warranted, and the potential of stem cells promising, many have used that hype for their own monetary gain. Some market beauty products containing the rejuvenation powers of stem cells and vitamins that claim to boost adult stem cell function while others have established stem cell clinics offering treatments for major diseases and injuries. Although creams and vitamins may (hopefully) be relatively benign, the same is not true for stem cell treatments. Young and elderly patients have died from receiving illegitimate stem cell treatments; others have developed tumors following stem cell transplantations....

FBI seems poised for flood of arrests for stem cell tourism
We have reached a watershed moment. The FBI has gotten very interested in stem cells. In my opinion we are on the cusp of a flood of arrests by the FBI of folks selling illegal stem cell treatments.
Selling non-approved FDA stem cell treatments, particular those involving transport of the stem cells across state lines?...

Off The Cuff

Scientists catch natural killer T-cell attacking disease cell on video
Molecular immunologists from Imperial College London filmed a natural killer T-cell attack a diseased using a specialized microscopy technique. In this video, provided by the research university, watch a single natural killer T-cell attack a diseased cell, starting at 1:20.

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