News from Hepatitis Week of Jan. 25, 2004/ Vol. 4 No. 01
FDA Approves Oral Rebetol for Use With Intron A for Pediatric Chronic Hepatitis C

The U.S. Food and Drug Administration (FDA) has approved Schering-Plough's oral solution of Rebetol (ribavirin) for use in combination with injections of Intron A (interferon alfa-2b) for pediatric chronic hepatitis C.

The approval makes a treatment for children with hepatitis C available for the first time. About 160,000 of children in the United States are infected with hepatitis C. Schering markets Intron A in addition to Rebetol.

Dr. Maureen Jonas, associate professor of pediatrics at Harvard Medical School, said children with hepatitis C now have a proven effective treatment that can be given in tailored doses to their individual weight and size. She added that the ability to take the medicine orally also makes treatment easier.

The key study in the FDA approval process found that 46 percent of previously untreated pediatric patients achieved a sustained virologic response after treatment with Intron A and Rebetol.

The recommended length of therapy is 24 weeks for pediatric patients with the genotype 2 or 3 hepatitis C and 48 weeks for those with genotype 1 hepatitis C.

According to Schering, oral Rebetol is a new formulation of ribavirin developed specifically to meet the needs of pediatric patients. It also has a bubble gum flavor.

Other sources: Schering Plough