期刊
JOURNAL OF HEPATOLOGY
卷 58, 期 3, 页码 415-420出版社
ELSEVIER
DOI: 10.1016/j.jhep.2012.09.034
关键词
Silibini; Antiviral therapy; Hepatitis C recurrence; Viral kinetics; Liver transplantation
资金
- Instituto de Salud Carlos III
- Ministerio de Economia y Competitividad, Spain
- Hospital Clinic (Ajut a la Recerca Josep Font)
- Fundacion BBVA
- Instituto de Salud Carlos III, Ministerio de Economia y Competitividad [PI 10/01551, PI 11/01907]
- European Regional Development Fund (ERDF), Union Europea, Una manera de hacer Europa
- Rottapharm\Madaus
- Roche
- MSD
Background & Aims: Hepatitis C recurrence after liver transplantation (LT) is the main problem of most transplant programs. We aimed at assessing the antiviral activity and safety of intravenous silibinin (SIL) administered daily during the pen-transplant period. Methods: This was a single-centre, prospective, randomized, double-blind, placebo-controlled study including 14 HCV-infected patients awaiting LT. Eleven patients received SIL and 3 placebo, for a maximum of 21 days before LT and 7 days after LT. Results: Among the patients who received more than 14 days of pre-LT treatment, the median decrease in viral load (VL) was 2.31 log(10) (range 0.6-4.2) in the SIL-treated group (n = 9) versus 0.30 log(10) (0.1-0.6) in the placebo group (n = 3) (p = 0.016). During the post-LT treatment, HCV-RNA levels were consistently and significantly (p = 0.002) lower in the SIL group compared to placebo and decreased below the limit of quantification in 2 patients and below the limit of detection in 2 additional patients (all in the SIL-treated group). Pen-transplant treatment with SIL was well tolerated. Conclusions: This proof-of-concept study in patients in the waiting list for LT indicates that daily intravenous silibinin has evident antiviral properties and is well tolerated in the peri-LT period. A longer treatment regimen with silibinin (alone or in combination with other agents) should be assessed in clinical trials for the prevention of hepatitis C recurrence. (C) 2012 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
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