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Initial Results of Phase II Study with HCV Protease Inhibitor Boceprevir in Treatment-Naive Hepatitis C Patients Show a High Rate of Early Virologic Response
Date:10/18/2007

Top Line Results of Phase II Study in Previous Nonresponders also Reported

KENILWORTH, N.J., Oct. 18 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today provided an update on the clinical development program for boceprevir, its investigational oral hepatitis C protease inhibitor. Initial results from an ongoing Phase II study in treatment-naive (previously untreated) hepatitis C patients showed boceprevir (800 mg TID) in combination with PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) achieved a high rate of early virologic response, with up to 79 percent of patients having undetectable virus (HCV-RNA) at week 12 of boceprevir treatment compared to 34 percent of patients receiving PEGINTRON and REBETOL alone.

"These initial results, while preliminary, are very encouraging, and showed that boceprevir is a potent antiviral agent for hepatitis C," said Paul Kwo, M.D., associate professor of medicine and medical director, liver transplantation, Department of Medicine, Division of Gastroenterology/Hepatology, Indiana University School of Medicine, Indianapolis, and the lead investigator of the study. "In this study, boceprevir improved viral clearance rates at week 12 in genotype 1 hepatitis C infection compared to the control group. We look forward to further results from this ongoing study."

Boceprevir is being evaluated in combination with PEGINTRON and REBETOL for the treatment of patients chronically infected with hepatitis C virus (HCV) genotype 1 in two large Phase II clinical studies, in which more than 800 patients have received boceprevir. One study involves treatment-naive patients and the other involves patients who were nonresponders to previous peginter
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SOURCE Schering-Plough Corporation
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