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DewDiligence

07/31/10 12:15 PM

#100326 RE: Shengli #100323

The quiz was a trick question insofar as a patient who reaches undetectable viral load during treatment and relapses before EoT+12w will presumably never have undetectable VL at EoT+24w. However, in the Boceprevir SPRINT-1 study, Schering-Plough actually reported an SVR rate in the 48-week “lead-in” arm that was higher than the SV12 rate in the same arm.

In this trial arm, SGP reported an SVR12 rate of 76/103=74% on 11/1/08 in a presentation at AASLD (#msg-33283156). Three weeks later, during a webcast for investors, SGP reported an SVR rate in this arm of 75% (presumably 75/100): http://www.merck.com/newsroom/news-release-archive/schering-plough-news-archive/all/releaseid=1229652.html . In other words, SGP excluded three patients from the SVR patient pool who were included in the SVR12 dataset.