HCV-1/4: EBR/GZR highly effective in stage 4/5 CKD

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Takeaway

  • Elbasvir/grazoprevir (EBR/GZR) demonstrates high efficacy for clearing HCV-1 and HCV-4 infection in patients with advanced chronic kidney disease (CKD).

Why this matters

  • EBR/GZR dose adjustments are not required because of low renal excretion (

Study design

  • French multicenter study of 93 patients with CKD receiving 12 (76.3%), 16 (16.1%), or 24 weeks (n=1) of EBR/GZR; polypharmacy was common (mean, 7.7 medications).
  • Most had HCV-1b (54.8%), HCV-1a (21.5%), or HCV-4 (18.3%); 39.8% were treatment-experienced, and 15.1% had compensated cirrhosis.
  • Most had stage 5 CKD (75.3%; stage 4, 24.7%); 74.2% required hemodialysis.
  • Fibrosis was generally mild (53 patients; 57.0%).
  • Primary endpoint was sustained virologic response at 12 weeks posttherapy (SVR12).
  • Funding: Merck Sharp and Dohme.

Key results

  • Regimen duration was often 12 weeks (76.3%); some patients were treated for 16 (16.1%) or 24 (1.1%) weeks.
  • SVR12 rate was 96.7% (87/90); 2 patients had stopped EBR/GZR at 5 and 8 weeks, respectively.
  • Two of 3 treatment failures were virologic breakthroughs; 1 was a case of postdiscontinuation relapse.
  • SVR12 was high with/without cirrhosis (98.1%, 93.5%), HCV-1 vs HCV-4 (98.6% vs 87.5%), HCV-1b vs HCV-1a (98% vs 100%), viral load >800,000 IU/mL vs

Limitations

  • Observational design.