Peg-Intron/Rebetol combination therapy approved for pediatric hepatitis C

The FDA has approved Schering-Plough’s Peg-Intron (peginterferon alfa-2b) and Rebetol (ribavirin) combination therapy for the treatment of previously untreated chronic hepatitis C in children ≥3 years old. This approval was based on a clinical trial of 107 treatment-naïve children ages 3 to 17 years of age with chronic hepatitis C and compensated liver disease. The study showed a safe and efficacious result from the pediatric patient population.

Peg-Intron and Rebetol combination therapy is already indicated for chronic hepatitis C in adults with compensated liver disease.

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