Combo treatment shows improvement for Hepatitis C

FDA Consumer, Sept-Oct, 1998

A new drug and biologic combination can be used to treat chronic hepatitis C in patients who have relapsed after treatment with interferon, a commonly used therapy.

Rebetron, approved June 3, combines Intron A (interferon alfa-2B recombinant for injection) with Rebetol (ribavirin) capsules.

Chronic hepatitis C, a blood-borne liver disease, affects about 4 million Americans. It can lead to cirrhosis, liver cancer, or liver failure.

While Rebetron does not cure hepatitis C, and it is unknown if the treatment will delay liver disease progression, the product appears to suppress blood levels of the virus better than re-treatment with interferon alone. In clinical trials, 50 percent of patients treated with the combination showed improvement in liver inflammation, versus 34 percent treated with interferon alone.

Serious side effects can occur with Rebetron, and physicians should monitor patients closely. For example, because animal studies have linked both Rebetol and Intron A to adverse reproductive effects such as fetal death and malformations, women must not become pregnant during therapy and for six months after. Rebetol also causes anemia, which can be especially serious in patients with underlying cardiovascular disease. Intron A is associated with psychiatric disorders such as depression and suicidal behavior, as is the Rebetol/Intron A combination. Intron A also prompts flu-like symptoms which often can be relieved with over-the-counter medications.

Rebetron is marketed by Schering Corp., Kenilworth, N.J.