Beta- and gamma-interferon in chronic active hepatitis B. A pilot trial of short-term combination therapy.

A controlled, randomized trial of a short-term, medium-dose combination therapy of beta- and gamma-interferon was performed in 20 patients with chronic active hepatitis B. According to clinical, biochemical, and histologic findings that were followed up for 16-24 mo, the combined treatment was successful in 5 of 10 patients. Two of the patients eliminated the virus completely, as confirmed by Southern blotting of hepatocellular deoxyribonucleic acid (DNA) against hepatitis B virus DNA. In the other 3 responders hepatitis B surface antigen persisted in the absence of hepatitis B e antigen, replicating hepatitis B virus DNA in the liver and inflammatory disease activity. Two of these responders with persistent hepatitis B surface antigen had hepatitis B virus DNA integrated into the hepatocyte genome and 1 responder had nonreplicating, episomal virus DNA. In the control group of 10 patients one spontaneous remission occurred. Antiviral treatment was significantly (p less than 0.05) more successful within the first 4 yr after infection (5 responders of 6 treated patients) than after longer disease duration (no responder of 4 treated patients). The results of this pilot study suggest that a combination of beta- and gamma-interferon may be an effective therapy for chronic active hepatitis B when started early after infection.

RCT Entities:   Population Interventions Outcomes