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Schering-Plough Reports Results Of Clinical Studies Of Peg-Intron And Rebetol Combination Therapy For Hepatitis C


SAN FRANCISCO, CA — May 23, 2002 —

Schering-Plough Corporation reported results of several clinical studies presented here at the 2002 Digestive Disease Week (DDW) conference involving Peg-Intron (peginterferon alfa-2b) Powder for Injection in combination with Rebetol* (ribavirin, USP) Capsules for the treatment of chronic hepatitis C.

 In all, 33 studies with Peg-Intron were presented by clinical investigators. Peg-Intron and Rebetol combination therapy received U.S. Food and Drug Administration (FDA) approval in August 2001 for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age. In an oral presentation, investigators reported clinical data from one of the largest clinical trials studying African Americans with hepatitis C.

The study indicated that the commonly lower response rate to treatment among African Americans is not related to genotype, as previously believed. Researchers have attributed lower treatment response rates in African Americans to the fact that this patient population predominantly contracts genotype 1 virus, which is the most difficult to treat. In this study, which compared the treatment response rate of African Americans to response rates of non-Hispanic whites, 98 percent of all patients studied had genotype 1.

 In the African American patient group, 28% had a virologic response after 12 weeks of therapy compared to a 58% response rate in the non-Hispanic white patient group. At week 24 of treatment, 25% of African Americans tested negative for the virus vs. 62% of non-Hispanic whites, indicating that factors other than genotype were affecting response to therapy. Researchers enrolled 100 African Americans and 100 non-Hispanic whites who had not been previously treated with alpha interferon therapy into each group. All patients received Peg-Intron (1.5 mcg/kg/week) for 48 weeks plus Rebetol (1,000 mg/day) for 12 weeks followed by 800 mg/day for 36 weeks. Patients with decompensated liver disease were excluded from the study.

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