Intravenous silibinin monotherapy shows significant antiviral activity in HCV-infected patients in the peri-transplantation period.
OBJECTIVE
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 peri-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). Peri-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.
Liver Unit, Hospital Clinic, CIBERehd, IDIBAPS, Barcelona, Spain.
Zoe
Z
Mariño
Gonzalo
G
Crespo
Massimo
M
D'Amato
Nadia
N
Brambilla
Giampaolo
G
Giacovelli
Lucio
L
Rovati
Josep
J
Costa
Miquel
M
Navasa
Xavier
X
Forns
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D007275:Injections, Intravenous; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012367:RNA, Viral / Q000032:analysis; D000077385:Silybin; D012838:Silymarin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019562:Viral Load
D000998:Antiviral Agents; D012367:RNA, Viral; D012838:Silymarin; D000077385:Silybin