ENDURANCE-2

ENDURANCE-2 Study: glecaprevir/pibrentasvir in genotype 2 without cirrhosis

Kowdley KV. AASLD 2016, Abs. 73

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
2
Treatment history
Naive
IFN-Experienced
Cirrhosis
No

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Design


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

Objective

  • SVR12 (HCV RNA < 15 IU/mL): non-inferiority, by ITT (exclusion of prior SOF failures), compared with historical rate of 95% (SOF + RBV), with lower margin of the 2-sided 95% CI > 89% ; superiority compared to the historical rate of 95%

Baseline characteristics and SVR12


* All 6 SOF-experienced patients achieved SVR12

Adverse events and laboratory abnormalities, N (%)


* One patient each experienced a broken ankle, hemorrhoids, and a bile duct stone; all were unrelated to treatment
** Rheumatoid arthritis, unrelated to treatment

Summary

  • 99% of patients with genotype 2 infection treated with GLE/PIB for 12 weeks achieved SVR12, with no virologic failures
    • The primary and secondary endpoints were achieved: SVR12 rate achieved with GLE/PIB treatment was superior to the 95% historical SVR12 rate of SOF + RBV
  • GLE/PIB was well tolerated:
    • There were no discontinuations due to adverse event
    • There were no serious adverse event related to GLE/PIB
    • GLE/PIB demonstrated a safety profile similar to that observed in patients receiving placebo
  • Achievement of SVR12 was not impacted by treatment experience or any other baseline factor