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 less than 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 less than 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.
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Authors | R P Perrillo, E R Schiff, G L Davis, H C Bodenheimer Jr, K Lindsay, J Payne, J L Dienstag, C O'Brien, C Tamburro, I M Jacobson, R Sampliner, D Feit, J Lefkowitch, M Kuhns, C Meschievitz, B Sanghvi, J Albrecht, A Gibas, Hepatitis Interventional Therapy Group |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 323
Issue 5
Pg. 295-301
(08 02 1990)
ISSN: 0028-4793 [Print] United States |
PMID | 2195346
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- DNA, Viral
- Hepatitis B Surface Antigens
- Hepatitis B e Antigens
- Interferon Type I
- Interferon alpha-2
- Interferon-alpha
- Recombinant Proteins
- Transaminases
- Prednisone
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Topics |
- Adult
- Chronic Disease
- DNA, Viral
(analysis)
- Female
- Hepatitis B
(drug therapy, therapy)
- Hepatitis B Surface Antigens
(analysis)
- Hepatitis B e Antigens
(analysis)
- Hepatitis B virus
(genetics)
- Humans
- Interferon Type I
(therapeutic use)
- Interferon alpha-2
- Interferon-alpha
(administration & dosage, therapeutic use)
- Male
- Multicenter Studies as Topic
- Prednisone
(administration & dosage, therapeutic use)
- Randomized Controlled Trials as Topic
- Recombinant Proteins
- Transaminases
(blood)
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