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T98-32                        Ivy Fleischer Kupec:  301-827-6242
June 3, 1998                  
                              Consumer Inquiries:   800-532-4440

FDA CLEARS NEW HEPATITIS C TREATMENT FOR MARKETING

The Food and Drug Administration today approved a drug/biologic combination to treat chronic hepatitis C in patients who have relapsed following previous treatment with interferon alone. The two therapies that comprise this combination are Intron A (interferon alfa-2B recombinant for injection) and Rebetol (ribavirin) capsules. The following can be used to answer questions:

Hepatitis C is a blood-borne liver disease. 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 cancer and liver failure. Chronic hepatitis C is the most common reason for liver transplantation in the United States today.

The combination of Intron A/Rebetol is not a cure for chronic hepatitis C, and it is unknown if this treatment will delay liver disease progression. It also is unknown how the two agents work together against the hepatitis C virus.

The combination appears to suppress blood levels of the 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 receiving 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 completed suicides). Depression, suicidal ideation and suicides occurred in patients treated with the combination of Intron A/Rebetol. Lastly, most patients who receive Intron A therapy complain of "flu-like" symptoms, fevers, chills and body aches. These symptoms are often relieved with nonprescription medicines such as acetaminophen or ibuprofen.

Schering Corporation of Kenilworth, N.J., will market the combination as Rebetron and include detailed patient information with each dispensed package.

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