Sofosbuvir and simeprevir without ribavirin effectively treat hepatitis C virus genotype 1 infection after liver transplantation in a two-center experience

• Published in: Clinical transplantation Vol. 30; no. 6; pp. 709 - 713
• Main Authors: Jackson, Whitney E., Hanouneh, Mohamad, Apfel, Tehilla, Alkhouri, Naim, John, Binu V., Zervos, Xaralambos, Zein, Nizar N., Hanouneh, Ibrahim A.
• Format: Journal Article
• Language: English
• Published: Denmark Blackwell Publishing Ltd 01-06-2016
• Subjects: Adolescent; Adult; Antiviral Agents - therapeutic use; Drug Therapy, Combination; Female; Genotype; Hepacivirus - genetics; Hepacivirus - isolation & purification; Hepatitis C - drug therapy; Hepatitis C - etiology; Hepatitis C - pathology; Hepatitis C virus; Humans; Immunosuppression; liver transplantation; Liver Transplantation - adverse effects; Male; Middle Aged; Prospective Studies; Recurrence; Retrospective Studies; Ribavirin - therapeutic use; simeprevir; Simeprevir - therapeutic use; sofosbuvir; Sofosbuvir - therapeutic use; Treatment Outcome; Young Adult; sofosbuvir; hepatitis C virus; simeprevir; liver transplantation
• ISSN: 0902-0063; 1399-0012
• DOI: 10.1111/ctr.12738

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 multicenter cohort study.
Results
Eighty‐one patients with HCV GT1 met criteria to be considered for treatment. Sixty‐seven patients received SOF + SIM following LT to date: 69% male, 39% with HCV RNA >6 000 000 IU/mL, 22% advanced hepatic fibrosis (stage 3–4), 6% cholestatic recurrence. Fifty‐eight percent previously failed or did not tolerate interferon‐based treatments. Mean time from LT to treatment was 6.1 ± 5.2 yr. 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 SVR.
Conclusions
Sofosbuvir + SIM combination therapy without ribavirin is well tolerated and results in high virologic response rates in recurrent HCV GT1 infection after liver transplantation.