FDA Consumer

Ribavirin and Chronic Hepatitis C Infection – health

Ribavirin and Chronic Hepatitis C Infection – health – Brief Article

People with hepatitis C now have more flexible treatment options. In July, the FDA approved a stand-alone package of Rebetol (ribavirin) Capsules, an anti-viral drug for use with Intron A (interferon alfa-2b) for the treatment of chronic hepatitis C infection.

In 1998, the FDA approved Rebetol in a combination package with Intron A. This package, Rebetron Combination Therapy, was approved for treatment of people with chronic hepatitis C infection who have not had previous interferon therapy or who have relapsed following successful interferon therapy. Both ribavirin products are marketed by Schering Corp., Kenilworth, N.J.

This separate packaging of Rebetol Capsules gives health-care providers flexibility in adopting individualized ribavirin and interferon-based therapies for people with hepatitis C. These therapies do not cure the infection, but work together to suppress the level of hepatitis C virus in the blood. Rebetol Capsules are not effective when used alone.

People who buy Rebetol Capsules will receive a medication guide that explains side effects associated with Rebetol Capsules and Rebetron Combination Therapy.

The most important side effect of Rebetol Capsules is anemia. People taking the drug should have their red blood cell counts checked regularly. Fatal and non-fatal heart attacks have occurred in people with anemia caused by Rebetol Capsules. People with a history of significant or unstable heart disease should not be treated with Rebetol Capsules.

Rebetol Capsules may cause birth defects and may lead to death of a fetus. To avoid birth defects, extreme care must be taken to prevent pregnancy in women being treated with Rebetol Capsules and in women whose male sexual partner is being treated.

Other common adverse events associated with Rebetol Capsules include fatigue, nausea, rash and itching.

Hepatitis C infection is a chronic condition caused by a virus, spread mainly by contact with an infected person’s blood, that damages the liver. (See “Hepatitis C: An Update” in the July-August 2001 FDA Consumer.)

COPYRIGHT 2001 U.S. Government Printing Office

COPYRIGHT 2004 Gale Group