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Vitamin e for the treatment of e-antigen positive chronic hepatitis b in pediatric patients: results of a randomized phase 2 controlled study
Sirio Fiorino1,2, Elisabetta Loggi1, Gabriella Verucchi1, Donatella Comparcola3, Ranka Vukotic1, Michele Pavoni1, Elena Grandini1, Carmela Cursaro1, Silvia Maselli4, Maria Letizia Bacchi Reggiani5, Cristina Puggioli4, Lorenzo Badia1, Silvia Galli6, Pierluigi Viale1, Mauro Bernardi1 andPietro Andreone1,*
DOI: 10.1111/liv.13192
This article is protected by copyright. All rights reserved.
Issue
Cover image for Vol. 36 Issue 7
Liver International
1 Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy
2 Unità Operativa di Medicina Interna, Ospedale Maggiore, AUSL Bologna, Bologna, Italy
3 Unità Operativa Malattie Epatometaboliche, Ospedale Pediatrico del Bambin Gesù, Rome, Italy
4 Unità Operativa di Farmacia Clinica, Azienda Ospedaliero Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy
5 Unità Operativa Malattie Cardiovascolari, Università di Bologna, Bologna, Italy
6 Unità Operativa di Microbiologia e Virologia, Azienda Ospedaliero Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy
* Contact name:
Pietro Andreone MD
Dipartimento di Scienze Mediche e Chirurgiche, Università degli Studi di Bologna
Via Massarenti 9, 40138 Bologna, Italy
Tel: 00390512143618; Fax: 0039051345806
Email: [email protected]
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/liv.13192
Keywords:
Chronic Hepatitis Bediatric Infection;Vitamin E;Treatment
Abstract
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.
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