FDA
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Food and Drug Administration
U.S. Department of Health and Human Services
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FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

T98-86                               Print Media:         301-827-6242
December 9, 1998                     
                                     Consumer Inquiries:  888-INFO-FDA

FDA APPROVES HEPATITIS C COMBINATION PRODUCT FOR USE IN PREVIOUSLY UNTREATED PATIENTS

FDA today expanded the indication of a drug/biologic product to include chronic hepatitis C patients who have not been treated with alpha interferon therapy. This product, Rebetron Combination Therapy, consists of Intron A (interferon alfa-2B recombinant for injection) and Rebetol (ribavirin) capsules, and was previously approved only for patients who had relapsed following treatment with interferon alone. 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 Rebetol/Intron A is not a cure for chronic hepatitis C, and it is unknown if this treatment will delay liver disease progression. Rebetol alone is not effective for the treatment of chronic Hepatitis C. It also is unknown how the two agents work together against the hepatitis C virus, but the combination appears to suppress blood levels of the hepatitis C virus better than treatment with interferon alone.

Clinical studies of treatment with Rebetol/Intron A over a course of 24 or 48 weeks resulted in higher virologic responses compared to Intron A treatment alone. However, the same studies found that patients who had not responded to Rebetol/Intron A therapy by week 24 were unlikely to benefit from further treatment. Due to the adverse reactions that can accompany the use of this combined therapy, it is important that the duration of its use be individually tailored to patient's baseline characteristics, virologic response at week 24, and tolerablility of the regimen.

Signs of serious side effects should be closely monitored by 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. Female patients and female partners of male patients must not become pregnant while receiving this therapy and for six months after completing therapy.

All women of childbearing potential who take this product, and their partners, should practice effective means of birth control. Any female patient or female partner of a male patient who becomes pregnant while on this therapy should immediately notify her health care provider, who in turn should contact the manufacturer's pregnancy registry.

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 Rebetol/Intron A. 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., markets the product as Rebetron Combination Therapy and includes detailed patient information with each dispensed package. FDA's approval of the Rebetron Combination Therapy package in no way restricts or precludes a request by the manufacturer to sell Rebetol or Intron A separately -- the decision to market them in a strictly combined form rests with the company.

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