DAA regimen achieves 91% HCV-1b clearance rate in LT recipients

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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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%).

Limitations

  • Small size.
  • Regimen is not currently approved.