LYMPHOBLASTOID INTERFERON-ALFA WITH OR WITHOUT STEROID PRETREATMENT IN CHILDREN WITH CHRONIC HEPATITIS-B - A MULTICENTER CONTROLLED TRIAL

The comparative efficacy of prednisolone followed by interferon alfa ( IFN-alpha) versus IFN-alpha alone in enhancing the rate of antibody to hepatitis B e antigen (anti-HBe) seroconversion has not been evaluate d in a large cohort of white children, To determine this, a multicente r-controlled trial was conducted in 95 hepatitis B virus (HBV)-DNA/hep atitis B e antigen (HBeAg)-positive children (median age, 9 years [ran ge, 2-16 years]; 56 boys; 84 [89%] white), all having inflammatory cha nges on liver biopsy, Patients were randomized to receive either predn isolone followed by IFN-alpha (n = 34); placebo followed by IFN-alpha (n = 30); or no treatment (n = 31). The prednisolone/placebo was given on a double-blind basis. Lymphoblastoid IFN-alpha was given at 5 MU/m (2) three times a week for 12 weeks, Baseline clinical, biochemical, a nd histological features were similar for the three groups. The majori ty (85%) had a baseline aspartate aminotransferase (AST) level less th an or equal to 100 IU/L. On follow-up between 12 and 18 months (median , 15 months) after treatment, the loss of HBeAg with anti-HBe seroconv ersion was more common in patients pretreated with steroids (12 of 34 [35%]) or placebo [12 of 30 (40%)] as against controls (4 of 31 [13%], P < .05). Factors predictive of anti-HBe seroconversion were baseline HBV-DNA concentration of less than or equal to 1,000 pg/mL and a grea ter degree of portal tract inflammation on pretrial biopsy. Our result s show that in white children treatment with IFN-alpha, at the dose an d duration used in this study, improves the rate of anti-HBe seroconve rsion. Steroid priming does not potentiate the effect of IFN-alpha.