INTERFERON-ALFA TREATMENT OF CHRONIC HEPATITIS-B - RANDOMIZED TRIAL IN A PREDOMINANTLY HOMOSEXUAL MALE-POPULATION

Background/Aims: It has been suggested that human immunodeficiency virus (HIV) coinfection and male homosexuality predict poor response to interferon alfa therapy of chronic hepatitis B. The aim of this study was to examine the effect of HIV coinfection on the response of chronic hepatitis B virus (HBV) infection to interferon alfa therapy in a predominantly homosexual male population, Methods: Fifty patients (82% male homosexuals, 50% HIV positive) with evidence of chronic HBV infection were randomized, stratified by HIV status, to undergo either treatment with interferon alfa (10 MU/m(2) three times weekly for 12 weeks) or no treatment. Response was predefined as loss of serum HBV DNA, loss of hepatitis B e antigen, and the appearance of antibody to hepatitis B e antigen. HIV status and the interferon alfa-associated enzyme, 2',5'-oligoadenylate synthetase, were evaluated as potential predictors of response to therapy. Results: Six treated patients responded with development of antibodies to hepatitis B e antigen (P < 0.05). HIV-positive patients were about one-fifth as likely to respond to interferon alfa therapy (relative risk, 0.22; 95% confidence interval, 0.03-1.78). Pretreatment alanine aminotransferase levels were significantly higher in responders than in nonresponders (P = 0.0005). Pretreatment 2',5'-oligoadenylate synthetase levels did not predict response. Conclusions: Interferon alfa, 10 MU/m(2) three times weekly for 12 weeks, is effective in eradicating HBV replication in a predominantly homosexual male population not coinfected with HIV.