A cohort of patients with chronic type B hepatitis is being evaluated and followed to determine the long-term natural history of this common form of chronic liver disease. Selected patients have been entered into therapeutic trials of antiviral and/or immunomodulatory agents. Several agents have been evaluated for antiviral effect, including alpha interferon, dideoxyinosine (DDI) and ribavirin. A randomized, controlled trial to reevaluate the effects of alpha interferon alone (given at a dose of 10 million units three times weekly) has been completed in 47 patients with chronic hepatitis B. Loss of hepatitis B e antigen (HBeAg) and HBV DNA occurred by 6 mos in 11 of 26 (42%) treated but in only 1 of 21 (5%) control patients (p=.003). These findings together with results of previous studies confirm that interferon is effective in inducing a remission in selected patients with chronic hepatitis B. A pilot study of DDI has been completed in 7 patients with chronic hepatitis B. Although DDI was well tolerated, it did not appear to have significant antiviral action against hepatitis B. A pilot study of ribavirin therapy is currently underway in patients with chronic hepatitis B. Thirteen patients have been entered into this study and 2 have completed 6 mos of therapy so far. It appears that ribavirin inhibits hepatitis B replication, as most patients have shown a fall in serum levels of HBV DNA polymerase, by approximately 50%. However, no patients have yet cleared HBeAg or HBV DNA from serum. This study will be continued until 18 patients have been treated.
