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news.Schering-Plough has reported that a planned interim analysis of a Phase II study showed that boceprevir, its investigational oral hepatitis C protease inhibitor, in combination with peginterferon and ribavirin markedly increased sustained virologic response rates with 28 weeks of therapy and nearly doubled SVR with 48 weeks of therapy compared to current standard of care, peginterferon and ribavirin for 48 weeks.
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In a 48-week boceprevir regimen, the sustained virologic response (SVR) rate was 74% at 12 weeks after the end of treatment (SVR 12) in patients who received four weeks of Pegintron and Rebetol prior to the addition of boceprevir (800mg TID) (P/R lead-in).
In a 28-week boceprevir regimen, the SVR rate was 56% at 24 weeks after the end of treatment (SVR 24) in patients who received the P/R lead-in. These results compared to a 38% SVR rate (SVR 12) for patients in the control group receiving 48-weeks of Pegintron and Rebetol alone.
Importantly, predictability of attaining SVR 12 or 24 based on rapid virologic response (RVR) was greater for boceprevir patients in the lead-in arms compared to the no lead-in arms. In addition, fewer patients in the lead-in arms discontinued treatment due to viral breakthrough. RVR is defined as undetectable virus in plasma on or before week four of boceprevir treatment.
Paul Kwo, lead investigator of the study, said: “The high response rates seen with boceprevir in this study are very exciting, especially given that genotype 1 is the most common and hardest to treat form of hepatitis C.
“Boceprevir was well tolerated by patients in this study, and the use of the four-week lead-in prior to the addition of boceprevir appears to reduce the incidence of viral breakthrough regardless of treatment duration and may improve SVR over a 48-week treatment period.”