Vitamin E for the treatment of E-antigen-positive chronic hepatitis B in paediatric patients: Results of a randomized phase 2 controlled study

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

Research output: Contribution to journalArticle

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 paediatric 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, haematological and serovirological 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 was obtained in 7 of 23 (30.4%) of vitamin E-treated versus 1 of 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 of 23 (39.1%) vs. 2 of 23 (8.7%) respectively (P = 0.035). Conclusions: Vitamin E administration for the treatment of paediatric 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 paediatric CHB.

Original languageEnglish
JournalLiver International
DOIs
Publication statusAccepted/In press - 2016

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Keywords

  • Chronic hepatitis B
  • Paediatric infection
  • Treatment
  • Vitamin E

ASJC Scopus subject areas

  • Hepatology

Cite this

Fiorino, S., Loggi, E., Verucchi, G., Comparcola, D., Vukotic, R., Pavoni, M., Grandini, E., Cursaro, C., Maselli, S., Bacchi Reggiani, M. L., Puggioli, C., Badia, L., Galli, S., Viale, P., Bernardi, M., & Andreone, P. (Accepted/In press). Vitamin E for the treatment of E-antigen-positive chronic hepatitis B in paediatric patients: Results of a randomized phase 2 controlled study. Liver International. https://doi.org/10.1111/liv.13192