Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis ...( 48-week investigational regimen yield...),Health

48-week investigational regimen yielded nearly double SVR rate compared to standard of care

Update on next-generation HCV protease inhibitor SCH 900518 presented at EASL annual meeting

COPENHAGEN, Denmark, April 23 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today reported that final results of the HCV SPRINT-1 study showed boceprevir, its investigational oral hepatitis C protease inhibitor, in combination with peginterferon alfa-2b and ribavirin, significantly increased sustained virologic response (SVR)(1) rates with 28 and 48 weeks of therapy compared to current standard of care, peginterferon and ribavirin for 48 weeks (control group). The results from this Phase II study in 595 treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1 were presented at the 44th European Association for the Study of the Liver (EASL) 2009 Annual Meeting.(2) Genotype 1 is the most common and hardest to treat form of hepatitis C.

In Part I of the study, a 48-week boceprevir regimen achieved a 75 percent SVR rate (n=77/103) in patients who received 4 weeks of PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) (P/R) followed by the addition of boceprevir (800 mg TID) for 44 weeks (boceprevir P/R lead-in regimen). This represents a near doubling of the 38 percent SVR rate (n=39/104) for patients in the control group (p<0.0001). In a 28-week boceprevir P/R lead-in regimen 56 percent of patients (n=58/103) achieved SVR (p=0.005).(3)

Importantly, the likelihood (predictability) of attaining SVR was greater for patients who received the boceprevir P/R lead-in regimens compared to the no lead-in arms. Of patients in the boceprevir P/R lead-in arms who achieved a rapid virologic response (RVR), 94 percent in the 48-week regimen and 82 percent in the 28-week r
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