EXPEDITION-8 Study

EXPEDITION-8 Study: glecaprevir/pibrentasvir 8 weeks in patients with cirrhosis

Brown RS. AASLD 2018, Abs. LB-7

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
1a
1b
Treatment history
Naive
Cirrhosis
Yes

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Design


* Fibroscan® ≥ 14.6 kPa or FibroTest® ≥ 0.75 + APRI > 2

  • GLE/PIB: 100/40 mg 3 tablets QD

Objective

  • SVR12 (HCV RNA < 15 IU/ml), non-inferiority, margin of - 6%
    • By per-protocol analysis vs historical SVR12 of 100%
    • By ITT analysis vs historical SVR12 of 99%

Baseline characteristics and SVR12

Adverse events and laboratory abnormalities, %

Summary

  • GLE/PIB (300 mg/120 mg QD) for 8 weeks achieved high efficacy in patients with genotype 1, 2, 4, 6 and 6 HCV infection and compensated cirrhosis
    • Non inferior to SVR12 in patients without cirrhosis
    • High efficacy regardless of baseline characteristics
    • No virologic failure
  • GLE/PIB was well tolerated with a favorable safety profile
  • Enrollment of patients with genotype 3 infection is ongoing