A randomized, controlled trial of interferon alfa-2b alone and after prednisone withdrawal for the treatment of chronic hepatitis B. The Hepatitis Interventional Therapy Group.

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.

• 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.)

Chemical References

• DNA, Viral
• Hepatitis B Surface Antigens
• Hepatitis B e Antigens
• Interferon Type I
• Interferon alpha-2
• Interferon-alpha
• Recombinant Proteins
• Transaminases
• Prednisone

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)