FDA Clears Rebetron, New Therapy For Hepatitis C

The US Food and Drug Administration has approved Rebetron, a newcombination drug for the treatment of chronic hepatitis C in patients with compensated liver disease who have relapsed following treatment with interferon alone. Rebetron, which comprises Schering-Plough's Intron A (recombinant interferon alfa-2b for injection) and ICN Pharma's Rebetol (ribavirin capsules), promises to be almost 10 times more effective than standard therapy. Prior to this approval, alpha interferons were the only drugs to be licensed for hepatitis C in the USA.

Data from clinical trials has demonstrated that 45.7% of patients who received six months Rebetron therapy plus six months follow-up had undetectable HCV-RNA compared to only 4.7% of patients who were treated with Intron A alone. Furthermore, over 50% of the Rebetron group saw improvement in inflammation in a liver biopsy at study-end, versus 34% of the control group.

Although the FDA approved Rebetron, it stressed in a statement that the drug combination is not a cure for chronic hepatitis C, and added that it has not been determined whether the therapy will delay liver disease progression.