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.
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