Sofosbuvir plus simeprevir: highly effective for HCV-1 after liver transplant

Takeaway

• A 12-wk regimen of sofosbuvir (SOF) plus simeprevir (SIM) without ribavirin (RBV) is highly effective for clearing recurrent hepatitis C virus-1 (HCV-1) in liver transplant (LT) recipients.

Study design

• A 2-center study of 67 patients receiving a 12-wk regimen of SOF + SIM for post-LT HCV-1. Treatment was extended to 24 wk for those with fibrosing cholestatic hepatitis.
• The primary endpoints were safety, end-of-treatment response (ETR), and sustained virologic response at 12 wk after therapy (SVR12).

Key results

• 58% of patients had previously not responded to or were intolerant of interferon-based therapy.
• All had estimated glomerular filtration rate 30 mL/min; 69% were male, 39% had HCV RNA 6,000,000 IU/mL, 22% had advanced fibrosis, and 6% had cholestatic recurrence.
• Mean time from LT to HCV-1 treatment was 6.1±5.2 y.
• Tacrolimus was the most commonly used immunosuppressive agent (84%); minimal dose adjust..