Simeprevir and sofosbuvir with or without ribavirin to treat recurrent genotype 1 hepatitis C virus infection after orthotopic liver transplantation

Neil E. Crittenden, Laura A. Buchanan, Christina M. Pinkston, Barbra Cave, Ashutosh Barve, Luis Marsano, Craig James McClain, Christopher M. Jones, Michael R. Marvin, Eric G. Davis, Candice B. Kuns-Adkins, Roberto Gedaly, Guy Brock, Malay B. Shah, Jens Rosenau, Matthew C. Cave

Research output: Contribution to journalArticlepeer-review

19 Scopus citations


Although combination simeprevir (SIM) plus sofosbuvir (SOF) is an approved regimen for genotype 1 chronic hepatitis C virus (HCV), data regarding its safety and efficacy in liver transplant recipients remain limited. A multicenter retrospective study was performed to determine the efficacy and tolerability of a 12-week regimen of SIM/SOF with or without ribavirin (RBV) in 56 consecutive liver transplant recipients in 2014; 79% of patients had genotype 1a, 14% had cirrhosis, and 73% were treatment experienced. Sustained virological response at 12 weeks (SVR12) was 88% by intention to treat analysis (95% confidence interval, 84%-90%). Four patients relapsed, but no on-treatment virological failures occurred. The Q80K polymorphism did not impact SVR12, but there was a trend toward decreased sustained virological response with advanced fibrosis (P = 0.18). HCV RNA was detectable at treatment week 4 in 21% of patients, and those who had detectable levels were less likely to achieve SVR12 (58% versus 95%; P = 0.003). Five patients had baseline Child-Pugh class B cirrhosis, and 2 of them died (1 following early discontinuation of therapy). An additional discontinuation resulted from a severe photosensitivity reaction in a patient on concomitant cyclosporine. Seven patients receiving RBV developed progressive anemia requiring intervention. Immunosuppression dose modifications were minimal. SIM/SOF for 12 weeks was effective and well tolerated by compensated liver transplant recipients especially when administered without concomitant RBV or cyclosporine. SIM/SOF appears to have a niche as the only 12-week RBV-free treatment regimen currently recommended by guidelines for compensated transplant recipients. However, 12 weeks may not be the optimal duration of therapy for those with detectable virus at week 4 or possibly for those with cirrhosis. These data require confirmation by prospective randomized clinical trials.

Original languageEnglish
Pages (from-to)635-643
Number of pages9
JournalLiver Transplantation
Issue number5
StatePublished - May 1 2016

Bibliographical note

Publisher Copyright:
© 2016 American Association for the Study of Liver Diseases.

ASJC Scopus subject areas

  • Surgery
  • Hepatology
  • Transplantation


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