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Schering-Plough has announced that FDA has approved a 1,400-mg dose of ribavirin and recommended that it be dosed based on patient weight.
Treating chronic hepatitis C virus (HCV) patients with heavy weights used to be a problem for clinicians. Now a new solution is available from Schering-Plough Corp-a 1,400-mg dose of REBETOL (ribavirin, USP). The Food & Drug Administration has approved label revisions for PEGINTRON (peginterferon alfa-2b, Schering-Plough) and ribavirin combination therapy, recommending dosing of ribavirin (800-1400 mg daily) based on patient body weight. The revised label also suggests a shorter, 24-week course of the combination therapy for HCV patients with genotype 2 or 3. The Kenilworth, N.J., firm claims that the labeling changes are based on the results of the largest U.S. hepatitis C study, WIN-R trial, which covered more than 4,900 patients.