United States of America - The Food and Drug Administration has approved ribavirin (Rebetol®) capsules, an antiviral used with interferon alfa-2b for the treatment of patients with chronic hepatitis C infection. Also marketed in combination with interferon alfa 2b, this new stand-alone package of ribavirin provides patients and health care providers with flexibility in adopting individualized therapies.

The most important side effect of ribavirin is anaemia which occurs within one or two weeks after therapy begins. Tests to check red blood cell counts should be obtained before treatment and two to four weeks after initiation, or more frequently if clinically indicated. Fatal and non-fatal heart attacks have occurred in patients with anaemia caused by ribavirin. Therefore, patients with a history of significant or unstable heart disease should not be treated with ribavirin capsules.

Ribavirin may cause birth defects and may lead to death of the exposed fetus. Extreme care must be taken to prevent pregnancy in female patients and female partners of male patients. They must not be pregnant, or become pregnant while being treated with ribavirin and for six months after treatment has stopped. At least two forms of birth control must be used during this time.

Hepatitis C infection is a chronic condition caused by a virus that damages the liver. Ribavirin capsules are not effective for the treatment of chronic hepatitis C infection when used alone, and should only be used with interferon alfa 2b, which will suppress the level of hepatitis C in the blood. This treatment does not cure the infection.

Reference: FDA Talk Paper, T01 - 31 (2001).