Merck- Boceprevir, Vertex-Telaprevir Prep for Hep C Drug Panels

Today over at the street.com an investment site, the columnist Adam Feuerstein has a write up on the two drugs this HCV community has waited over five years for. (We have needed these drugs since 1999) Soon the wait will be over, seems the investors are pretty  pumped up also. Go take a look folks;.

A new era of hepatitis C treatment and the potential for billions of dollars in sales are on the line next week as an independent panel of experts meets to scrutinize new drugs from Merck and Vertex Pharmaceuticals.

Why is the FDA holding an advisory panel for boceprevir and telaprevir? Are there any serious doubts that these two drugs work?
No, not really. Both boceprevir and telaprevir are effective against the Hep C virus. Data from multiple phase III studies conducted by Merck and Vertex, presented and published widely, prove that point beyond doubt. With that said, both drugs represent entirely new ways of treating Hep C and each has unique side effect or safety issues. For these reasons, FDA decided wisely to convene advisory panels.

Investors absolutely expect both panels to recommend the approval of both boceprevir and telaprevir. A negative vote for either drug will be a shocking surprise. But even though the overall outcome of next week's panels are not in serious doubt, the discussions about safety and potential labeling claims are important and could throw some curveballs into the way the Street views the commercial potential of both drugs....continue reading...

Two new abstracts at GastroHep
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Improvements in mortality after diagnosis of hepatitis B or C infection

Chronic hepatitis B or C virus infection has been associated with increased risk of death, particularly from liver- and drug-related causes. Dr Scott Walter and colleagues examined specific causes of death among a population-based cohort of people infected with HBV or HCV to identify areas of excess risk and examine trends in mortality. HBV and hepatitis C cases notified to the New South Wales Health Department between 1992 and 2006 were linked to cause of death data and HIV/AIDS notifications. Mortality rates and standardized mortality ratios were calculated using person time methodology, with New South Wales population rates used as a comparison. Drug-related deaths among the Hep C group represented an elevated excess risk Journal of Hepatology The research team evaluated 42,480 individuals with HBV mono-infection and 82,034 with HCV mono-infection. HIV co-infection increased the overall mortality rate three to 10-fold compared to mono-infected groups. The research team found that liver-related deaths were associated with high excess risk of mortality in both hepatitis B or C virus groups. Drug-related deaths among the hepatitis C group also represented an elevated excess risk. Rates of hepatocellular carcinoma-related death remained steady in both groups. The researchers found that a decrease in non-hepatocellular carcinoma liver-related deaths was seen in the hepatitis B group between 1997 and 2006, but not in the hepatitis C group. After a sharp decrease between 1999 and 2002, drug-related mortality rates in the hepatitis C group have been stable. Dr Walter's team concluded, "Improvements in hepatitis B virus treatment and uptake have most likely reduced non-hepatocellular carcinoma liver-related mortality." "Encouragingly, hepatitis C drug-related mortality remained low compared to pre-2002 levels, likely due to changes in opiate supply, and maintenance or improvement in harm reduction strategies." J Hepatol 2011: 54(5): 879-886 21 April 2011 Anti-viral therapy prevents recurrence after curative treatment of Hep B-related hepatocellular carcinoma Anti-viral therapy has potential beneficial effects after the curative treatment of hepatitis B virus-related hepatocellular carcinoma in terms of tumor recurrence, liver-related mortality and overall survival, reports May's issue of the Alimentary Pharmacology & Therapeutics. The role of anti-viral therapy in prevention of hepatocellular carcinoma recurrence is to be defined. Dr Wong and colleagues from Hong Kong investigated the role of anti-viral therapy in prevention of tumor recurrence after curative treatment of hepatitis B virus-related hepatocellular carcinoma. The research team performed a systematic electronic search on keywords including HCC and different anti-viral therapies was performed through eight electronic databases, including Medline, EMBASE and Cochrane Databases. The primary outcome was hepatocellular carcinoma recurrence after curative treatment of hepatitis B virus-related hepatocellular carcinoma. The risk of hepatocellular carcinoma was reduced by 41% with antiviral therapy Alimentary Pharmacology & Therapeutics The team's secondary outcomes were mortality related to hepatocellular carcinoma, mortality related to liver failure and the overall mortality. The research team included 9 cohort studies with a total number of 551 patients. The team identified 204 patients with anti-viral treatment group and 347 patients without anti-viral treatment. The researchers observed a significant difference in the incidence of hepatocellular carcinoma recurrence in favor of the anti-viral treatment group. The risk of hepatocellular carcinoma was reduced by 41% in the anti-viral treatment group. There were also significant differences in favor of anti-viral treatment group in terms of liver-related mortality and overall mortality. Dr Wong's team commented, "Anti-viral therapy has potential beneficial effects after the curative treatment of hepatitis B virus-related hepatocellular carcinoma in terms of tumor recurrence, liver-related mortality and overall survival." "Anti-viral therapy should be considered after curative treatment of hepatocellular carcinoma." Aliment Pharmacol Ther 2011; 33: 1104–1112  21 April 2011 In Case You Missed It ICVH  Boceprevir, Telaprevir to Usher in New Era of HCV Therapy Clinical management of hepatitis C virus (HCV) is set to take a "major step" forward, with the anticipated approval of 2 new hepatitis C protease inhibitors in 2011, experts say. Medscape Medical News, April 15, 2011 EASL  High Viral Response Rates Seen With Boceprevir for HCV Boceprevir added to standard therapy produced a greater than 60% sustained viral response rate in patients with hepatitis C virus (HCV) whose previous therapy failed. New On The Blog Merck- Boceprevir, Vertex-Telaprevir Prep for Hep ... 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