HCV: GLE/PIB achieves >97% clearance rate in ENDURANCE-5,6

  • Asselah T & al.
  • Lancet Gastroenterol Hepatol
  • 8 Nov 2018

  • curated by Yael Waknine
  • Clinical Essentials
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Takeaway

  • Glecaprevir/pibrentasvir (GLE/PIB) achieves >97% clearance rates in patients with HCV genotypes (GTs) 5 and 6, according to data from the ENDURANCE-5,6 trial.

Why this matters

  • Findings add to the body of evidence for less prevalent genotypes typically underrepresented in registration trials.

Study design

  • Phase 3b trial of 84 patients with GT5 (27%) or GT6 (73%) treated at 24 centers in Europe, Oceania, North America, South Africa, and southeast Asia.
  • 12- and 8-week GLE/PIB regimens were used for patients with and without compensated cirrhosis, respectively (GT5, 13%; GT6, 10%).
  • Most patients were treatment-naive (GT5, 83%; GT6, 93%) with viral load ≥1000 IU/mL (87% for both).
  • Primary endpoint: sustained virologic response at 12 weeks posttreatment (SVR12).
  • Funding: AbbVie.

Key results

  • Of 15 included GT6 subtypes, GT6a (43%), GT6e (20%) were most common.
  • Overall SVR12, 97.6% (82/84; 95% CI, 94.4%-100.0%).
    • GT5: SVR12, 95.7% (22/23; 95% CI, 87.3%-100.0%).
    • GT6: SVR12, 98.4% (60/61; 95% CI, 95.2%-100.0%).
    • Cirrhosis: 89% (8/9).
  • Non-SVR12:
    • 1 failure at treatment week 12 (GT6f, cirrhosis).
    • 1 relapse at posttreatment week 12 (GT5a, no cirrhosis).
  • Events reported with >10% prevalence were fatigue and headache (13% each).
  • No grade ≥3 aminotransferase elevations reported.

Limitations

  • Open-label, noncontrolled design; small sample size.
  • High Asian participation (68%).

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