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news.Schering-Plough has reported encouraging results from a planned interim analysis of an ongoing Phase II study of boceprevir, the company's investigational oral hepatitis C protease inhibitor, in 595 treatment-naive patients with chronic hepatitis C virus genotype 1.
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In a 28-week treatment regimen in which patients received four weeks of Pegintron and Rebetol prior to the addition of boceprevir (800mg TID), the rate of sustained virological response (SVR) at 12 weeks after the end of treatment (SVR 12) was 57% (ITT). Importantly, this treatment regimen provided an indication of early predictability of response, with patients who had undetectable virus (HCV-RNA) in plasma after four weeks of boceprevir treatment achieving an SVR 12 rate of 86%.
Paul Kwo, principal investigator of the study, said: “These interim results are very encouraging, especially given the response seen with a shorter course of therapy in a difficult-to-treat patient population. Boceprevir has been well tolerated by patients in this study, including in the longer duration treatment arms, and we look forward to further results from this ongoing study.”