Study shows weight-based REBETOL dosing in combination with PEG-INTRON significantly im...( ng approximately 4900 patients from ab...),Health

ng approximately 4,900 patients from about 250 centers throughout the United States. The community-based study is evaluating the safety and efficacy of weight-based PEG-INTRON in combination with fixed or weight-based REBETOL in a diverse patient population, including the largest number of African-American patients in any study to date.

PEG-INTRON is indicated for use alone or in combination with REBETOL for the treatment of chronic hepatitis C in patients not previously treated with interferon alpha who have compensated liver disease and are at least 18 years of age. The recommended dose in the United States of this combination therapy is PEG-INTRON 1.5 mcg/kg/week by subcutaneous injection and REBETOL 800 mg/day taken orally for 48 weeks. Overall, approximately 50 to 60 percent of patients receiving this combination therapy regimen achieve a sustained virologic response (SVR). SVR is defined as the absence of detectable levels of the hepatitis C virus (HCV) six months following treatment and is considered the standard measure of efficacy. Numerous studies have shown that SVR rates among African-Americans are lower (19 to 26 percent) in response to current treatments.

"We know that HCV genotype and the dose and duration of therapy are critical factors for treatment success, but these factors alone do not seem to account for the lower responses seen in

African-American patients," Dr. Jacobson said. "The large amount of data in African-American patients generated by the WIN-R study add to our body of knowledge of how to best treat the disease, but it's important to do additional research to improve outcomes for these patients."

In the WIN-R study, patients were randomized to receive PEG-INTRON (1.5 mcg/kg/week) combined with REBETOL given as a flat dose (800 mg daily) or a weight-based dose (WBD) (800 mg, 1,000 mg, 1,200 mg or 1,400 mg daily for body weights of less than 65 kg, 65 to 85 kg, 86 to 105 kg, and 106 to 125 kg, r
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29-Oct-2004

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