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.
Among the patients who received more than 14 days of pre-LT treatment, the median decrease in viral load (VL) was 2.31 log10 (range 0.6-4.2) in the SIL-treated group (n = 9) versus 0.30 log10 (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.
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.