HCV-1: GLE/PIB highly effective if sofosbuvir + NS5A inhibitor fails

  • Lok AS & al.
  • Gastroenterology
  • 8 Aug 2019

  • International Clinical Digest
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • A 16-week course of glecaprevir/pibrentasvir (GLE/PIB; Mavyret) achieves HCV-1 clearance rates >90% in patients who have failed previous treatment with sofosbuvir (Sovaldi) plus an NS5A inhibitor.

Why this matters

  • High efficacy was demonstrated in patients with compensated cirrhosis.

Study design

  • Phase 3b randomised study of 177 patients (median age, 62 years; 81% male, 44% black) with HCV-1 (1a, 79%) refractory to treatment with sofosbuvir+NS5A inhibitor.
  • 76% had baseline NS5A resistance-associated substitutions (RAS), and 28.2% had cirrhosis.
  • Primary endpoint was sustained virologic response at 12 weeks after therapy (SVR12).
  • Funding: AbbVie.

Key results

  • Overall SVR12 rate was 91.5% (162/177).
  • SVR12 rates in patients with cirrhosis:
    • 90% with 12 weeks of GLE/PIB (n=78); failure rate, 7.7%.
    • 94% with 16 weeks of GLE/PIB (n=49); failure rate, 6.1%.
  • SVR12 rates in noncirrhotic patients:
    • 86% with 12 weeks of GLE/PIB+ribavirin (n=21); failure rate, 14.3%.
    • 97% with 16 weeks of GLE/PIB (n=29); failure rate, 3.4%.
  • Overall non-SVR12 rate was 7.3% (13/177).
    • All failures occurred in patients with HCV-1a (13/140, 9.3%), most with baseline RAS.
    • 1 case of reinfection and 1 death also reported.
  • Of 13 non-SVR12 patients, 10 developed NS5A treatment-emergent RAS and 9 developed NS3 RAS (some developed multiple RAS).

Limitations

  • Open-label design.

Please confirm your acceptance

To gain full access to GPnotebook please confirm:

By submitting here you confirm that you have accepted Terms of Use and Privacy Policy of GPnotebook.

Submit