A Randomized, Controlled Trial of Interferon Alfa-2b Alone and after Prednisone Withdrawal for the Treatment of Chronic Hepatitis B

Robert P. Perrillo, Eugene R. Schiff, Gary L. Davis, Henry C. Bodenheimer, Karen Lindsay, John Payne, Jules L. Dienstag, Christopher O'brien, Carlo Tamburro, Ira M. Jacobson, Richard Sampliner, David Feit, Jay Lefkowitch, Mary Kuhns, Carlton Meschievitz, Bharati Sanghvi, Janice Albrecht, Alexandra Gibas

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745 Scopus citations

Abstract

Background and Methods. Chronic hepatitis B is a common and often progressive liver disorder for which there is no accepted therapy. To assess the efficacy of treatment with interferon, we randomly assigned patients with chronic hepatitis B to one of the following regimens: prednisone for 6 weeks followed by 5 million units of recombinant interferon alfa-2b daily for 16 weeks; placebo followed by 5 million units of interferon daily for 16 weeks; placebo followed by 1 million units of interferon daily for 16 weeks; or observation with no treatment. Results. Hepatitis B e antigen and hepatitis B viral DNA disappeared from serum significantly more often in the patients given prednisone plus interferon (16 of 44 patients, or 36 percent) or 5 million units of interferon alone (15 of 41; 37 percent) than in the untreated controls (3 of 43; 7 percent; P<0.001); the difference between those given 1 million units of interferon (7 of 41; 17 percent) and the controls was not significant. The strongest independent predictor of a response to treatment was the amount of hepatitis B viral DNA in serum at entry (P<0.0001). Of the 38 patients who responded to interferon, 33 (87 percent) had normal serum aminotransferase levels after therapy; 11 patients who responded (29 percent), but no controls, lost the hepatitis B surface antigen. Blinded histologic assessment revealed a significant improvement in periportal necrosis in the treated patients (P = 0.03). Conclusions. In chronic hepatitis B, treatment with interferon alfa-2b (5 million units per day for 16 weeks) was effective in inducing a sustained loss of viral replication and achieving remission, assessed biochemically and histologically, in over a third of patients. Moreover, in about 10 percent of the patients treated with interferon, hepatitis B surface antigen disappeared from serum.

Original languageEnglish (US)
Pages (from-to)295-301
Number of pages7
JournalNew England Journal of Medicine
Volume323
Issue number5
DOIs
StatePublished - Aug 2 1990

ASJC Scopus subject areas

  • Medicine(all)

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    Perrillo, R. P., Schiff, E. R., Davis, G. L., Bodenheimer, H. C., Lindsay, K., Payne, J., Dienstag, J. L., O'brien, C., Tamburro, C., Jacobson, I. M., Sampliner, R., Feit, D., Lefkowitch, J., Kuhns, M., Meschievitz, C., Sanghvi, B., Albrecht, J., & Gibas, A. (1990). A Randomized, Controlled Trial of Interferon Alfa-2b Alone and after Prednisone Withdrawal for the Treatment of Chronic Hepatitis B. New England Journal of Medicine, 323(5), 295-301. https://doi.org/10.1056/NEJM199008023230503