DUAL-CENTER, DOUBLE-BLIND, RANDOMIZED TRIAL OF LYMPHOBLASTOID INTERFERON-ALPHA WITH OR WITHOUT STEROID PRETREATMENT IN CHILDREN WITH CHRONIC HEPATITIS-B

Thirty-five children with chronic HBV infection, HBV-DNA and eAg serum positivity, and HBcAg in liver tissue were treated with lymphoblastoi d human interferon alpha with (16 cases) or without (19 cases) prednis olone pretreatment. The patients were double-blind randomized to recei ve steroid or placebo for 4 weeks, followed after 2 weeks by 5 or 10 M U/m(2) interferon for 12 weeks. The e anti-e seroconversion rate reach ed 48%, which is much higher than the spontaneous seroconversion rate. The influence of ''prednisolone priming'' was not statistically signi ficant. HBeAg clearance was similar in both groups (44% after predniso lone/interferon and 53% after interferon alone). The response to eithe r treatment did not correlate with the pretreatment serum transaminase , HBV-DNA or degree of histological activity. Interferon was well tole rated, the side effects being less severe than in adults, and never le d to suspension of the treatment.