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Schering-Plough Reports Potent Antiviral Activity With Narlaprevir (SCH 900518), an Investigational, Once-Daily Protease Inhibitor for Hepatitis C
Date:11/2/2009

BOSTON, Nov. 2 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today reported that interim results from an ongoing Phase IIa study of narlaprevir (SCH 900518), its investigational, once-daily protease inhibitor, demonstrated potent antiviral activity in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1. In the lead-in arms of the study, in which patients received a 4-week lead-in of PEGINTRON(R) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) followed by the addition of narlaprevir, 85-87 percent of patients achieved rapid virologic response (RVR), compared to 58-75 percent of patients in the no lead-in narlaprevir arms and no patients in the PEGINTRON and REBETOL control arm. RVR, defined in this study as undetectable virus (HCV RNA) at week 4 of narlaprevir treatment, is recognized as an important predictor for achieving sustained virologic response. These interim results from the NEXT-1 study were reported in an oral presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston, Oct. 30-Nov. 3.[1]

"These interim results, while preliminary, are very encouraging, and showed that narlaprevir has potent antiviral activity in hepatitis C," said John Vierling, M.D., professor of medicine and surgery, chief of hepatology, Baylor College of Medicine, Houston, and the lead investigator of the study. "In this study, once-daily narlaprevir greatly improved viral clearance at week 4 of treatment in genotype 1 hepatitis C infection compared to the control group. We look forward to further results from this ongoing study."

Importantly, patients in the lead-in narlaprevir arms also achieved improved rates of early virologic response (EVR), defined as undetectable virus at week 12 of treatment, with 85-87 percent of patients having undetectable
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