In 20 patients with HBsAg-and HBeAg-positive chronic active hepatitis, we determined the long-term effect of human leukocyte interferon as well as placebo treatment. During the 2-year follow-up period, HBsAg remained present in all patients, but the Dane particle markers HBeAg and DNA polymerase disappeared in two of 10 patients who had received interferon, and in 4 of 10 patients from the placebo group.
Patients with loss of HBeAg initially had HBs antigenemia for a longer period as well as a lower serum concentration of both HBsAg and DNA polymerase, fewer HBcAg-containing hepatocyte nuclei, and higher serum transaminase levels than did the patients in whom HBeAg persisted. Disappearance of Dane particle markers was associated with a decrease in HBsAg titer, appearance of anti-HBe, normalization of the serum transaminases, and morphological transition to inactive chronic hepatitis.
We conclude that, in HBsAg- and HBeAg-positive chronic active hepatitis, disappearance of Dane particle markers occurs in approximately 30% of the patients within a 2-year period and that arrest of active viral replication is associated with loss of activity of chronic hepatitis. Treatment with human leukocyte interferon in the doses used in this study did not change the natural course of the disease.