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Antiviral activity and safety profile of silibinin in HCV patients with advanced fibrosis after liver transplantation: a randomized clinical trial

Authors :
M. Zappimbulso
N.M. Castellaneta
Nadia Brambilla
Giampaolo Giacovelli
Alfredo Di Leo
A. Castellaneta
Massimo D'Amato
Lucio C. Rovati
Salvatore Fabio Rizzi
Maria Rendina
R. Bringiotti
Source :
Transplant International. 27:696-704
Publication Year :
2014
Publisher :
Frontiers Media SA, 2014.

Abstract

Response to interferon-based therapies in HCV recurrence after liver transplantation (LT) is unsatisfactory, and major safety issues aroused in preliminary experience with boceprevir and telaprevir. As transplant community identified HCV viral clearance as a critical matter, efficacious and safe anti-HCV therapies are awaited. The aim of this study was to assess efficacy and safety of intravenous silibinin monotherapy in patients with established HCV recurrence after LT, nonresponders to pegylated interferon and ribavirin. This is a single center, prospective, randomized, parallel-group, double-blind, placebo-controlled, phase 2 trial including 20 patients randomly assigned (3:1) to receive daily 20 mg/kg of intravenous silibinin or saline as placebo, for 14 consecutive days. On day 14 of treatment, viral load decreased by 2.30 ± 1.32 in silibinin group versus no change in the placebo group (P = 0.0002). Sixteen days after the end of the treatment, viral load mean values were similar to baseline. Treatment resulted well tolerated apart from a transient and reversible increase in bilirubin. Neither changes in immunosuppressant through levels nor dosage adjustments were necessary. Silibinin monotherapy has a significant antiviral activity in patients with established HCV recurrence on the graft not responding to standard therapy and confirms safety and tolerability without interaction with immunosuppressive drugs (ClinicalTrials.gov number: NCT01518933).

Details

ISSN :
09340874 and 01518933
Volume :
27
Database :
OpenAIRE
Journal :
Transplant International
Accession number :
edsair.doi.dedup.....c82d980a570a28da4f42a761b624c7ad
Full Text :
https://doi.org/10.1111/tri.12324