Pegintron(TM) Plus Weight-Based Rebetol(R) Resulted in Higher SVR Than Flat Dosing; Low Relapse Rates in Patients With Chronic H...( FDA Approves Label Revisions Recomme...),Health

FDA Approves Label Revisions Recommending New Weight-Based Dosing Regimen

KENILWORTH, N.J., March 27 /PRNewswire/ -- Schering-Plough Corporation (NYSE: SGP) today reported that the U.S. Food and Drug Administration (FDA) has approved label revisions for PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination therapy for chronic hepatitis C, recommending weight-based dosing of REBETOL (800-1400 mg daily) based on patient body weight. The revised label also recommends a shorter, 24-week course of the combination therapy for patients with chronic hepatitis C virus (HCV) genotype 2 or 3.

The revisions represent the first FDA approval of a 1400 mg ribavirin dose and the widest ribavirin dosing range approved for use in combination with peginterferon for treating chronic hepatitis C in patients with compensated liver disease.

The label changes are based on the results of the WIN-R trial,(1) the largest U.S. hepatitis C study, conducted in more than 4,900 patients. The study showed that PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient body weight) resulted in a significantly higher sustained virologic response (SVR)(2) compared to PEGINTRON in combination with a flat 800 mg daily dose of REBETOL, the previously labeled dose. Importantly, the study reported low relapse rates consistent with other PEGINTRON studies.(3,4)

"PEGINTRON and weight-based ribavirin was significantly more effective than flat-dosed ribavirin, especially in genotype 1 patients, and provided consistent efficacy across all weight groups," said WIN-R principal investigator Ira M. Jacobson, M.D., Vincent Astor Professor of Clinical Medicine at Weill Medical College of Cornell University and chie
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