Vitamin e for the treatment of e-antigen positive chronic hepatitis b in pediatric patients: results of a randomized phase 2 controlled study.
Liver Int. 2016 Jun 22. Epub 2016 Jun 22. PMID: 27333382
BACKGROUND & AIMS: The treatment of chronic hepatitis B infection (CHB) in children is still an area of great uncertainty. Vitamin E is an immunostimulating/antioxidant compound proven to be safe and effective for the treatment of adult CHB. The aim of this phase 2 controlled study was to evaluate the safety and efficacy of vitamin E for the treatment of pediatric HBeAg-positive CHB.
METHODS: Forty-six children were randomized in a 1:1 ratio to receive vitamin E at a dose of 15 mg/kg/day (in galenic preparation) or no treatment for 12 months and were monitored for the subsequent 12 months. Clinical, biochemical, hematological and sero-virological evaluations were carried out every 3 months.
RESULTS: No significant side effects were associated with the vitamin E treatment. At the end of the study, anti-HBe seroconversion were obtained in 7/23 (30.4%) of vitamin E-treated versus 1/23 (4.3%) of the control patients (p=0.05), while a virological response (≥2 log decrease in HBV-DNA from baseline) was observed in 9/23 (39.1%) versus 2/23 (8.7%), respectively (p=0.035).
CONCLUSIONS: Vitamin E administration for the treatment of pediatric CHB at the tested dosage has no significant side effects and may induce anti-HBe seroconversion. Vitamin E could represent a tool for the treatment of pediatric CHB. This article is protected by copyright. All rights reserved.