Abstract Title:

Vitamin e for the treatment of e-antigen positive chronic hepatitis b in pediatric patients: results of a randomized phase 2 controlled study.

Abstract Source:

Liver Int. 2016 Jun 22. Epub 2016 Jun 22. PMID: 27333382

Abstract Author(s):

Sirio Fiorino, Elisabetta Loggi, Gabriella Verucchi, Donatella Comparcola, Ranka Vukotic, Michele Pavoni, Elena Grandini, Carmela Cursaro, Silvia Maselli, Maria Letizia Bacchi Reggiani, Cristina Puggioli, Lorenzo Badia, Silvia Galli, Pierluigi Viale, Mauro Bernardi, Pietro Andreone

Article Affiliation:

Sirio Fiorino


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.

Study Type : Human Study
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