Alpha- and gamma-interferon versus alpha-interferon alone in chronic hepatitis B. A randomized controlled study.

Thirty-two patients with chronic hepatitis B were randomly assigned to two groups. Sixteen patients received 10 million units of alpha-interferon per square meter of body surface (MU/m2), three times weekly for 4 months. Sixteen patients were treated simultaneously with gamma-interferon at a dose of 2 MU/m2, and 10 MU/m2 of alpha-interferon. At the end of the study (13th month), hepatitis B virus DNA was negative in 50% of the patients treated with alpha-interferon and in only 25% of those treated with alpha- and gamma-interferon. A similar trend was observed with respect to the hepatitis B e antigen negativization (31% and 19% of HBeAg negativization in patients treated with alpha- and gamma-interferon, respectively). In summary, these data demonstrate that, at the doses used in this study, the combination of alpha- and gamma-interferon does not give better results than the administration of alpha-interferon alone. The tolerance to simultaneous alpha- and gamma-interferons is poor and may decompensate the liver disease.

RCT Entities:   Population Interventions Outcomes