- An interferon-free regimen of simeprevir (SMV; Olysio), daclatasvir (DCV; Daklinza), and ribavirin (RBV) achieved a 91% HCV-1b clearance rate in liver transplant (LT) recipients.
- Coadministration of cyclosporine (CsA) is not recommended.
Why this matters
- HCV clearance is associated with better graft survival.
- Open-label, multicenter, phase 2 SATURN study of 35 patients with post-LT HCV-1b recurrence, receiving a 24-wk regimen of SMV+DCV+RBV.
- 25 patients received tacrolimus (TAC) and 10 received CsA.
- Primary endpoint was sustained virologic response at 12/24 wk posttherapy (SVR12/24).
- Funding: Janssen.
- Median time from LT was 4.2 y; 63% were treatment-naïve and 77% had F1/F2 fibrosis.
- SVR12 was 91% (all subsequently achieved SVR24).
- 3 CsA-treated patients experienced virologic breakthrough, with emerging NS3/5A mutations.
- Patients with high baseline Fibroscan values demonstrated significant improvement at end of treatment and 24-wk follow-up.
- Most patients (71%) reported grade 1/2 adverse events (AEs).
- 14% had serious AEs potentially related to SMV (anemia, elevated bilirubin, and hyperbilirubinemia).
- Coadministration of CsA, but not TAC, significantly boosted SMV exposure.
- 30% of CsA-treated patients developed renal failure, impairment, or acute injury.
- Grade 3/4 hyperbilirubinemia was more commonly with CsA vs TAC (40% vs 32%).
- Small size.
- Regimen is not currently approved.