Hep C Pipeline update from AASLD

[iana5252]

Hep EIC Tim Horn is in San Francisco at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). His first post is about the much anticipated interferon-free PSI-7977 regimen. The latest data shows a 100% cure rate in Hep C genotype 2/3. Wow!

http://www.hepmag.com/articles/psi7977_svr_hcv_2501_21405.shtml

[farmgirl]

100% cure rate sounds to good to be true has that ever happened before for any medicine?

[worriedsilly]

it was only 10 people!!! get back to me when it is hundreds

[curiousinsanjose]

anotehr study was only 47 people? what gives. is that normally for drg trials to use so few people and consider the results 'good'

[Tim Horn]

Keep in mind, A LOT of the data coming out of the AASLD gathering in San Francisco are from Phase II studies, which tend to be smaller than Phase III studies (the clinical trials the U.S. Food and Drug Administration are generally most interested in when deciding whether or not to approve a new drug). What's really important about Phase II studies is that they provide pharmaceutical companies and researchers a broad sense of how well a new drug works and help everyone decide what to focus on in Phase III studies, which need to be very, very expensive and need to be extremely strict in their design.

You guys are right -- the 100% SVR (cure) rate in the interferon-free patients in the PSI-7977 study only reflects ten of 40 people in the trial. Obviously, no drug or unique combination of drugs should even consider being approved based on such small numbers. But the findings are clearly significant enough to pave the way for larger Phase III studies exploring the potential of interferon-free treatment, which is exactly what Pharmasset is doing now. It's a gamble on the company's part, to be sure, but Pharmasset -- and clearly many who saw the data presented in San Francisco -- will be quick to point out that the Phase II data are compelling enough to place their bets.

Tim Horn