DAA-refractory HCV: novel combination effective in GT3 with cirrhosis

  • Papaluca T & al.
  • Liver Int
  • 29 Jul 2019

  • International Clinical Digest
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Takeaway

  • A combination of sofosbuvir (SOF; Sovaldi) and elbasvir/grazoprevir (EBR/GZR; Zepatier) with/without ribavirin (RBV) is an effective salvage regimen for patients for whom first-line HCV direct-acting antivirals (DAAs) fail.

Why this matters

  • The triple-DAA combination had previously shown benefit in DAA-experienced patients with cirrhosis and genotype (GT) 1/4 infection.
  • This study shows that high efficacy extends to patients with cirrhosis and GT3 infection; a 16-week course with RBV may be optimal.

Study design

  • Study of 40 DAA-experienced patients (mean age, 53 years; 80% male) receiving SOF+EBR/GZR for 12 (58%) or 16 weeks (42%); 90% received RBV.
  • Primary endpoint: sustained virologic response at 12 weeks posttherapy (SVR12).
  • Funding: None disclosed.

Key results

  • Most patients were infected with GT3 (53%), followed by GT1 (33%; 1a, 28%), GT4 (7%), and GT6 (7%).
  • 25 patients (63%) had cirrhosis, many with portal hypertension (9/25, 36%).
  • Overall SVR12 rate was 98% (39/40).
  • The one case of non-SVR12 occurred in a patient with GT3 infection and cirrhosis receiving a 12- vs 16-week regimen.
    • Testing indicated Y93H resistance-associated substitution.
  • A second patient with cirrhosis and GT3 was switched to SOF+velpatasvir (Epclusa) because of increased bilirubin and international normalized ratio at week 6, subsequently achieving SVR12.

Limitations

  • Small sample size.

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