ENDURANCE-3

ENDURANCE-3 Study: glecaprevir/pibrentasvir versus sofosbuvir + daclatasvir in genotype 3

Foster G. EASL 2017, Abs. GS-007

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
3
Treatment history
Naive
Cirrhosis
No

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Design

  • Glecaprevir / pibrentasvir : 100/40 mg 3 tablets QD
  • Sofosbuvir: 400 mg 1 tablet QD + daclatasvir 60 mg 1 tablet QD

Primary efficacy endpoint

  • Non-inferiority of SVR12 of GLE/PIB compared to SOF + DCV (lower bound of 95% CI of the difference: - 6%)

Baseline characteristics

SVR12 by intention-to-treat analysis, %

  • Both GLE/PIB treatments met non-inferiority criteria (lower bound of the 95% confidence interval above -6%)
    • GLE/PIB 12W vs SOF + DCV : -1.2% (95% CI: -5.6 to 3.1)
    • GLE/PIB 8W vs GLE/PIB 12W : -0.4% (95% CI : -5.4 to 4.6)

SVR12 by baseline polymorphisms *


* Detected by next-generation sequencing using 15% detection threshold

3% of patients (N = 10) had virologic failure

  • Common baseline RASs
    • NS3A: A166S, N = 3
    • NS5A: A30K, N = 5
  • RASs at failure
    • A30K + Y93H in 5/10

Adverse events and laboratory abnormalities, N (%)


* No serious adverse event was assessed as related to study drugs

Summary

  • Glecaprevir / pibrentasvir achieved high efficacy in non-cirrhotic, treatment-naïve patients with genotype 3
  • 12 weeks of GLE/PIB was not inferior to 12 weeks of SOF+DCV
  • 8 weeks of GLE/PIB was not inferior to 12 weeks of GLE/PIB
  • Treatment was well-tolerated
  • Of note, resistance analysis observed that the combination of NS3 + NS5A RAs reduced SVR12 to 86% (GLE/PIB 12 weeks) and 71% (GLE/PIB 8 weeks)