Use of simeprevir following pre-emptive pegylated interferon/ribavirin treatment for recurrent hepatitis C in living donor liver transplant recipients: a 12-week pilot study.

BACKGROUND: The management of recurrent hepatitis C following liver transplantation remains a challenge.

METHODS: We prospectively investigated the efficacy and safety of simeprevir in combination with pegylated interferon and ribavirin in five patients undergoing living donor liver transplantation (LDLT) with recurrent hepatitis due to hepatitis C virus (HCV) genotype 1b.

RESULTS: As the immunosuppressive regimen, four received cyclosporine A (CsA) and one received tacrolimus (FK); no dose adjustment was made prior to the introduction of simeprevir, but the dose was accordingly modified afterwards. All five patients completed the intended 12-week treatment course without significant adverse events greater than grade 2, and no episodes of rejection were detected during the study period. The trough levels of CsA and FK were stably maintained. At week 12, HCV-RNA was not detectable in three of the five patients, whereas the HCV titer of the other two patients, including one with Q80L and V170I mutations at the HCV NS3 position, was at the lower level of quantification (1.2 log10 IU/ml).

CONCLUSIONS: Based on this pilot study, simeprevir-based triple therapy is safe and somewhat effective within the first 12 weeks in LDLT recipients with HCV recurrence. Further studies are warranted to obtain robust conclusions.