Author information
1Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH.
2Department of Internal Medicine, Cleveland Clinic, Cleveland, OH.
3Department of Gastroenterology and Hepatology, Cleveland Clinic Florida, Weston, FL.
Abstract
BACKGROUND:
The interferon-free antiviral regimen, Sofosbuvir (SOF) and Simeprevir (SIM) without ribavirin has been reported to achieve high sustained virologic response (SVR) rates with few adverse effects when treating patients with hepatitis C genotype 1 (HCV GT1) infection. However, there is scarcity of safety and efficacy data in this regimen after liver transplantation (LT).
AIM AND METHODS:
We aim to report the safety, tolerability and efficacy of SOF+SIM to treat LT recipients with recurrent HCV GT1 in a multi-center cohort study.
RESULTS:
81 patients with HCV GT1 met criteria to be considered for treatment. 67 patients received SOF+SIM following aLT to date: 69% male, 39% with HCV RNA >6,000,000 IU/mL, 22% advanced hepatic fibrosis (stage 3-4), 6% cholestatic recurrence. 58% previously failed or did not tolerate interferon-based treatments. Mean time from LT to treatment was 6.1 years ± 5.2. All patients had estimated GFR >30 mL/min. Tacrolimus was primary immunosuppression in 84% of patients and minimal immunosuppression dose adjustments were required during treatment. In intention to treat analysis, 90% achieved end of treatment virologic response and 88% achieved sustained virologic response.
CONCLUSIONS:
SOF+SIM combination therapy without ribavirin is well tolerated and results in high virological response rates in recurrent HCV GT1 infection after liver transplantation.