Interferon therapy for chronic hepatitis B - Tips from Other Journals

Date: Dec, 1990

Several small clinical trials have suggested that interferon may be helpful in the management of chronic hepatitis B. Benefit has also been noted from a short course of corticosteroids prior to interferon therapy. Perrillo and colleagues conducted a multicenter, randomized, placebo-controlled study of 169 patients with chronic hepatitis B to evaluate the efficacy of a 16-week course of recombinant interferon alfa-2b and to determine whether pretreatment with prednisone enhances the antiviral activity of interferon.

Patients were assigned to one of three treatment regimens. Forty-four patients received a six-week course of prednisone (two weeks of 60 mg daily, then 40 mg daily and then 20 mg daily for two weeks), followed by a two-week rest period and then 16 weeks of recombinant interferon alfa-2b, 5 million units per day. Forty-one patients received a six-week course of placebo, followed by a two-week rest period and 16 weeks of interferon, 5 million units per day. Forty-one patients received the placebo course, followed by a two-week rest and 16 weeks of a lower dose of interferon, 1 million units per day. The remaining 43 patients served as control subjects.

Disease remission occurred in 36 percent of the patients treated with prednisone plus 5 million units of interferon, in 37 percent of those treated with placebo plus 5 million units of interferon and in 17 percent of those treated with placebo plus 1 million units of interferon. Hepatitis subsided in 7 percent of the control subjects. A substantial percentage of patients, particularly those with high levels of viral replication, did not respond to interferon, either alone or combined with a short course of corticosteroids.

In an accompanying editorial, Hoofnagle cautions that proper patient selection for interferon therapy is critical. Interferon alfa must be given parenterally, has significant side effects and is ineffective in many cases. Serum aminotransferase levels and serologic markers of viral replication are more useful than liver biopsy in the selection of patients for treatment. Candidates for interferon therapy are patients with serum aminotransferase levels more than twice the upper limit of normal, low to moderate serum hepatitis B virus DNA levels and serologic tests positive for hepatitis B e antigen. (New England Journal of Medicine, August 2, 1990, vol. 323, pp. 295, 337.)

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