Revised dosing for Pegintron/Rebetol
The FDA has approved label revisions for Schering-Plough's Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin) combination therapy for chronic hepatitis C. The revised label recommends weight-based dosing of Rebetol and a shorter, 24-week course of the combination therapy for patients with chronic hepatitis C virus (HCV) genotype 2 or 3.
The revisions are based on results from a clinical trial of over 4900 patients which showed that Pegintron and weight-based Rebetol dosing resulted in a significantly higher sustained virologic response (SVR) compared to Pegintron combined with a flat dosing regimen of Rebetol. The study also reported low relapse rates consistent with other Pegintron studies.
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