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Top-Line Results of Boceprevir Phase II Study Showed High Rate of Sustained Response (SVR) in Genotype 1 Treatment-Naive Hepatitis C Patients
Date:8/4/2008

74 percent of patients achieved SVR 12 with 48-week boceprevir-based

combination therapy

High SVR 24 rate also reported for 28-week boceprevir arm

KENILWORTH, N.J., Aug. 4 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today reported top-line results from a planned interim analysis of a Phase II study of boceprevir, its investigational oral hepatitis C protease inhibitor. The analysis showed a high rate of sustained virologic response (SVR) in patients receiving boceprevir-based combination therapy in this study of 595 treatment-nave patients with chronic hepatitis C virus (HCV) genotype 1.

In a 48-week treatment regimen, the SVR rate at 12 weeks after the end of treatment (SVR 12) was 74 percent (ITT) in patients who received 4 weeks of PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) prior to the addition of boceprevir (800 mg TID) (P/R lead-in), compared to 38 percent for patients in the control group receiving 48-weeks of PEGINTRON and REBETOL alone.(1-3)

Patients in the study who received 48-weeks of boceprevir in combination with PEGINTRON and REBETOL from the beginning of treatment (no P/R lead-in) achieved 66 percent SVR 12.

In the two 28-week boceprevir arms of the study, SVR at 24 weeks after the end of treatment (SVR 24) was 56 percent and 55 percent for patients in the lead-in and no lead-in arms, respectively.

Importantly, for patients who received the PEGINTRON and REBETOL lead in and had rapid virologic response (RVR), defined as undetectable virus (HCV-RNA) in plasma after 4 weeks of boceprevir treatment, SVR (ITT) was 82 percent in the 28-week regimen and 92 percent in the 48 week regimen.

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SOURCE Schering-Plough Corporation
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