EXPEDITION-I

EXPEDITION-I Study: glecaprevir/pibrentasvir in genotype 1, 2, 4, 5 or 6 with compensated cirrhosis

Forns X. EASL 2017, Abs. GS-006

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
1
2
4
Treatment history
Naive
IFN-Experienced
SOF-experienced
Cirrhosis
Yes

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Design

  • GLE/PIB: 100/40 mg 3 tablets QD
  • Patients enrolled in Belgium, Canada, Germany, South Africa, Spain and the United States

Objective

  • Primary endpoint: SVR12 (HCV < 15 IU/mL)

Baseline characteristics

SVR12 by ITT, %

  • One patient with genotype 1a relapsed at post-treatment week 8
    • NS5A RASs: Y93N at baseline, Y93N, Q30R and H58D present at failure
    • NS3 RASs: none

Adverse events and laboratory abnormalities, N (%)

  • No serious adverse event related to study drugs
  • Occurrence of hepatocellular carcinoma in 2 patients
  • One patient with a history of hemophilia died (post-treatment cerebral hemorrhage, not related to study drugs)

Summary

  • Glecaprevir / pibrentasvir for 12 weeks achieved a 99% SVR12 rate in patients with compensated cirrhosis and genotype 1, 2, 4, 5 or 6
  • Treatment was well-tolerated