FDA Approves New Chronic Hepatitis C Treatment

It is estimated that 4 million people in the United States have chronic hepatitis C infection. In its chronic state, hepatitis C can lead to cirrhosis, liver failure or hepatocellular carcinoma. Chronic hepatitis C is currently the most common reason for liver transplantation in the US.

The combination of Rebetol/Intron A is not a cure for chronic hepatitis C . It is not known if this treatment will delay the progression of liver disease. It also is not known how these two agents work together against the hepatitis C virus. It does appear that this combination suppresses blood levels of hepatitis C virus better than retreating patients with interferon alone. The clinical trials showed that after six months of therapy followed by six months of follow-up without therapy, approximately 45 percent of patients treated with the combination were able to sustain reduced hepatitis C virus levels compared to 5 percent who were retreated with interferon alone. Although 34 percent of patients treated with interferon alone had improvement in inflammation on an end-of-study liver biopsy, more patients (50 percent) treated with the combination improved.

Serious side effects have occurred with treatment and patients should be closely monitored by their physicians. Both Rebetol and Intron A have been found to cause significant adverse reproductive effects, including fetal death or structural malformations, in the developing fetus in several animal species. Therefore, women must not become pregnant while on this therapy and for six months after completing therapy. All women of childbearing potential and their partners should practice effective means of birth control, and any pregnancies should be reported to the manufacturer's pregnancy registry immediately.

Rebetol causes anemia, which can be serious especially in patients with underlying cardiovascular disease. Intron A has been associated with psychiatric disorders, including depression and suicidal behavior (suicidal thoughts, suicide attempts, and suicides). Depression, suicidal ideation and suicides occurred in patients treated with the combination of Rebetol/Intron A. The most common adverse experiences occurring with combination Rebetol/Intron A therapy are "flu-like" symptoms, such as headache, fatigue myalgia,and fever. Antipyretics should be considered to prevent or partially alleviate the fever and headache.

Schering Corp. of Kenilworth, NJ, will market the combination as Rebetron and include patient information with each dispensed package. [June 3, 1998 (Talk Paper) -FDA]. The labeling text can be found on the Internet at http://www.fda.gov/cder/approval/index.htm.