Vitamin E for the treatment of E-antigen-positive chronic hepatitis B in paediatric patients: results of a randomized phase 2 controlled study
Articolo
Data di Pubblicazione:
2017
Citazione:
Vitamin E for the treatment of E-antigen-positive chronic hepatitis B in paediatric patients: results of a randomized phase 2 controlled study / 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.. - In: LIVER INTERNATIONAL. - ISSN 1478-3223. - 37:1(2017), pp. 54-61. [10.1111/liv.13192]
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.
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.
Tipologia CRIS:
Articolo su rivista
Keywords:
chronic hepatitis B; paediatric infection; treatment; vitamin E
Elenco autori:
Fiorino, S; Loggi, Elisabetta; Verucchi, Gabriella; Comparcola, D; Vukotic, Ranka; Pavoni, Michele; Grandini, Elena; Cursaro, C; Maselli, Serena; Bacchi Reggiani, Maria Letizia; Puggioli, C; Badia, L; Galli, S; Viale, Pierluigi; Bernardi, Mauro; Andreone, Pietro
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