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?Two new abstracts at GastroHep
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...
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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.
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
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