News from Hepatitis Week of August 3, 2003 / Vol. 3 No. 31

FDA Approves Rebetol for Treating Pediatric Hepatitis C

The U.S. Food and Drug Administration (FDA) has approved Rebetol® as the first and thus far only therapy for treating hepatitis C in children, according to the drug's manufacturer Schering-Plough.

Fewer than 200,000 children in the United States are infected with the hepatitis C virus, according to government estimates.

Oral doses of Rebetol® (ribavirin) can now be used in combination with injections of Intron A® (recombinant interferon alfa-2b) in patients 3 years of age or older with compensated liver disease previously untreated with alpha interferon.

The recommended duration of therapy is 24 weeks for pediatric patients with genotype 2/3 virus and 48 weeks for pediatric patients with genotype 1 virus.

Schering-Plough submitted its new drug application to the FDA for Rebetol for pediatric use in January 2003 and received priority review because the drug addresses unmet medical needs and is a significant advance over existing treatments.

Other sources: Schering-Plough Corporation