ENDURANCE-4

ENDURANCE-4 Study: glecaprevir/pibrentasvir in genotype 4, 5 or 6

Asselah T. AASLD 2016, Abs. 114

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
4
5
6
Treatment history
Naive
IFN-Experienced
Cirrhosis
No

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Design


* Fibroscan® < 12.5 kPa or FibroTes® = 0.48 + APRI < 1

  • GLE/PIB : 100/40 mg 3 tablets QD

Objective

  • SVR12 (HCV RNA < 15 IU/mL)

Baseline characteristics and SVR12

Adverse events and laboratory abnormalities


* 1 patient with baseline risk factors discontinued treatment on D12 due to a transient ischemic attack (TIA); a second TIA occurred 24 days following discontinuation. This patient has not yet returned for SVR12 visit
** 3 patients presented with anxiety, heartburn, and transient ischemic attack, respectively. Two of the 3 patients achieved SVR12

Summary

  • 99% of patients with genotype 4, 5 or 6 (120/121) without cirrhosis achieved SVR12 in ITT population following treatment with 12 weeks of GLE/PIB, with no virologic failures
  • 100% SVR12 in mITT population
  • GLE/PIB was well tolerated
    • serious adverse events occurred in < 1% of patients
    • there were no grade 3 or higher laboratory abnormalities
    • discontinuation due to adverse events were rare
  • 12-week treatment with the IFN- and RBV-free, once-daily GLE/PIB oral regimen can successfully treat patients with HCV genotype 4, 5, or 6, regardless of prior treatment experience or F0–F3 fibrosis status