Entecavir Treatment in Children and Adolescents with Chronic Hepatitis B Virus Infection

Background: The aim of this study was to investigate the treatment response of entecavir (ETV) in children and adolescents with chronic hepatitis B (CHB) who acquired infection perinatally or during early childhood. Methods: A total of nine treatment-naive patients [median aged 12.2 years (range: 2.6-18.0); five girls and four boys], with hepatitis B e antigen (HBeAg) seropositive > 6 months, alanine aminotransferase (ALT) > 2 times of upper limit of normal value (30 IU/L), were enrolled for ETV therapy. They received ETV therapy with a dose of 0.015 mg/kg/d, with a maximal dose of 0.5 mg daily for at least 52 weeks. Another 27 untreated CHB patients matched for age, sex, ALT levels, and HBeAg status were recruited as the control group. A complete response at 48 52 weeks was defined as follows: (1) normalization of ALT; (2) undetectable hepatitis B virus DNA; and (3) HBeAg/anti-HBe seroconversion. All 36 patients were retrospectively reviewed for their biochemical, serological, and virologic responses. Results: ETV-treated patients achieved rapid ALT normalization (all before 8 months of treatment) compared with the control group (p < 0.001) and they had a greater chance of achieving undetectable HBV DNA levels at Week 52 after treatment (55.6% vs. 11.1%, p = 0.013). The cumulative incidence rates of HBeAg seroconversion were similarly high in both groups (ETV group 44% at 1 year 78% at 2 years; control group 37% at 1 year 63% at 2 years, respectively). The ETV group also had a trend of better complete response than the control group (22.2% vs. 0%, p = 0.057). None of the ETV-treated patients reported significant adverse effects. Conclusion: Entecavir for pediatric CHB treatment is safe and shows clinical benefits in short-term biochemical and virologic responses. Further studies to determine long-term remission and drug resistance are required. (C) Copyright 2015, Taiwan Pediatric Association. Published by Elsevier Taiwan LLC.