N Engl J Med 1990 Aug 2;323(5):295-301

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.
Perrillo RP, Schiff ER, Davis GL, Bodenheimer HC Jr, Lindsay K, Payne J,
Dienstag JL, O'Brien C, Tamburro C, Jacobson IM, et al.

St. Louis Veterans Affairs Medical Center, MO 63106
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