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| |  DDW: Schering-Plough Reports Results Of Clinical Studies Of Peg-Intron And Rebetol Combination Therapy For Hepatitis C At Digestive Disease Week Meeting Studies Show Activity in diverse Patient Populations 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. "The low response rate among African Americans has puzzled researchers for years," said Andrew Muir, assistant professor in medicine, division of gastroenterology, Duke University Medical Center. "Even though the response rate in the African American group was lower than in the non-Hispanic white group, treatment with Peg-Intron and Rebetol combination therapy achieved a higher response than had been seen previously. These results bring us one step closer to understanding how the virus behaves in African Americans and how to effectively treat this patient population." Dr. Muir is the lead investigator for this trial. Additional Peg-Intron Studies Presented at DDW "Data from this large patient population reinforces that Peg-Intron and Rebetol combination therapy is manageable in hepatitis C patients," said Ira Jacobson, M.D., chief, division of gastroenterology and hepatology, Weill Medical College of Cornell University, New York. "I am encouraged by these results and believe that studies like the WIN-R trial are critical in helping us better define treatment regimens for the many patients with hepatitis C." The results of the COPILOT (Colchicine versus Peg-Intron Long-Term) study, which investigated maintenance therapy with Peg-Intron in patients with advanced cirrhosis, were also presented. In this study, 250 patients with advanced cirrhosis who had previously failed interferon-based therapy were randomized to two groups: 130 patients received once-weekly Peg-Intron (0.5 mcg/kg) and 120 patients received colchicine (0.6 mg twice-daily). At the end of one year of treatment, the Peg-Intron group had a reduction in detectable1 virus (HCV RNA), while the virus levels in the colchicine group remained the same. These findings may be important for patients who have not responded to previous therapy. "Schering-Plough is committed to offering patients with hepatitis C the best possible treatment option with Peg-Intron and Rebetol combination therapy. The results of studies presented at this year's DDW conference support that commitment," said Robert J. Spiegel, M.D., senior vice president of medical affairs and chief medical officer, Schering-Plough Research Institute. "Through this research, we are achieving a better understanding of the disease and the factors that affect patient response to treatment." Schering-Plough HCV Products INTRON A is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects. Schering-Plough markets INTRON A for 16 major antiviral and anticancer indications worldwide. Rebetol is an oral formulation of ribavirin, a synthetic nucleoside analog. Schering-Plough has exclusive worldwide rights to market oral ribavirin for hepatitis C through a licensing agreement with ICN Pharmaceuticals, Inc. of Costa Mesa, Calif. When administered in combination with Peg-Intron, the recommended dose of Rebetol is 800mg/day.
SOURCE: Schering-Plough Corporation
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