Peg-Intron/Rebetol combination therapy gains expanded indication

The FDA has approved new labeling for Schering-Plough’s Peg-Intron (peginterferon alfa-2b) and Rebetol (Ribavirin) combination therapy for treating chronic hepatitis C with compensated liver disease in patients ≥3 years of age. The new indication expands the use of Peg-Intron/Rebetol combination therapy to include treatment-experienced patients.

This approval was based on the results of a noncomparative clinical study involving 2,293 adult patients with moderate-to-severe fibrosis or cirrhosis who failed previous treatment with combination alpha interferon/ribavirin. Patients were retreated with combination Peg-Intron/Rebetol therapy. Results showed an overall study response rate of 22%. Data from the study helped define patients most likely to respond to retreatment.

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