INTERFERON-ALPHA THERAPY FOR CHRONIC HEPATITIS-B IN CHILDREN - A MULTINATIONAL RANDOMIZED CONTROLLED TRIAL

Background & Aims: Treatment of chronic hepatitis B with interferon al fa is not approved in children. The aim of this study was to evaluate the safety and efficacy of interferon alfa (IFN-alpha) in children wit h chronic hepatitis B and increased transaminase levels. Methods: Chil dren were given either IFN-alpha 2b (6 megaunits/m(2) thrice weekly fo r 24 weeks) or no treatment. Clearance of markers of viral replication was evaluated 24 weeks after therapy and after 48 weeks of observatio n in controls. Results: Of 149 children enrolled, 144 were evaluable ( 70 treated and 74 controls). Serum hepatitis B e antigen and viral DNA became negative in 26% of treated children and 11% of controls (P < 0 .05), Serum aminotransferase levels normalized and liver histology imp roved among responders, Hepatitis B surface antigen became undetectabl e in 10% of treated patients and 1% of controls, Female gender and int erferon treatment were the only significant predictors of response. Et hnic origin, baseline aminotransferase level, initial DNA levels, and histology did not correlate with response, Most adverse reactions were mild or moderate, and dose was reduced in 24% of children. Conclusion s: In children with chronic hepatitis B, INF-alpha promotes loss of vi ral replication markers and surface antigen and improves aminotransfer ases and histology.