Pegylated interferon-based sequential therapy for treatment of HBeAg reactive pediatric chronic hepatitis B-First study in children.

backgroundOur aim was to evaluate the efficacy and safety of sequential therapy using pegylated interferon (Peg-IFN) and nucleos(t)ide analogue (NA) for treatment of children in immunoactive (IA) and immunotolerant (IT) phases of chronic hepatitis B.

methodsIt was a prospective observational study where those willing for sequential therapy were allocated to group 1 (sequential therapy) and others to group 2 (standard therapy). Sequential therapy included 8 weeks of NA followed by 44 weeks of combination of NA and Peg-IFN. In group 2, IA children received NA monotherapy, and IT children received no therapy. HBe seroconversion, HBs seroconversion, and loss of HBV DNA were the major outcome measures.

resultsA total of 61 children (36 IA and 25 IT) were included in the analysis. Among the IA children, 17 received sequential therapy and 19 received standard therapy; whereas, among the IT children, 12 received sequential therapy and 13 did not receive any therapy. In IA phase, sequential therapy led to higher HBe seroconversion (64.7% vs. 21.05%, p = 0.017) and higher virological clearance (94.12% vs. 52.63%, p = 0.008). In IT children, there was no benefit of treatment with sequential therapy over observation alone. Baseline ALT > 100 IU/L predicted response to therapy with 100% sensitivity, 89.5% specificity, and LR

conclusionSequential therapy leads to higher HBe seroconversion and virological response in children in IA phase. Children with baseline ALT > 100 IU/mL are more likely to respond to sequential therapy. There appears to be no role of sequential therapy in children in IT phase.