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‐α) versus IFN‐α alone in enhancing the rate of antibody to hepatitis B e antigen (anti‐HBe) seroconversion has not been evaluated in a large cohort of white children. To determine this, a multicenter‐controlled trial was conducted in 95 hepatitis B virus (HBV)‐DNA/hepatitis B e antigen (HBeAg)‐positive children (median age, 9 years [range, 2‐16 years]; 56 boys; 84 [89 %] white), all having inflammatory changes on liver biopsy. Patients were randomized to receive either prednisolone followed by IFN‐α (n = 34); placebo followed by IFN‐α (n = 30); or no treatment (n = 31). The prednisolone/placebo was given on a double‐blind basis. Lymphoblastoid IFN‐α was given at 5 MU/m(2) three times a week for 12 weeks. Baseline clinical, biochemical, and histological features were similar for the three groups. The majority (85 %) had a baseline aspartate aminotransferase (AST) level ≤ 100 IU/L. On follow‐up between 12 and 18 months (median, 15 months) after treatment, the loss of HBeAg with anti‐HBe seroconversion 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 ≤ 1,000 pg/mL and a greater degree of portal tract inflammation on pretrial biopsy. Our results show that in white children treatment with IFN‐α, at the dose and duration used in this study, improves the rate of anti‐HBe seroconversion. Steroid priming does not potentiate the effect of IFN‐α.