EXPEDITION-IV

EXPEDITION-IV Study: glecaprevir/pibrentasvir in patients with renal impairment

Gane E. AASLD 2016, Abs. LB-11

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
1
2
3
4
Treatment history
Naive
IFN-Experienced
Cirrhosis
No
Special population
Chronic Kidney disease

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Design

  • 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) diarrhea, 2) pruritus , 3) pulmonary edema, hypertensive cardiomyopathy with congestive failure, and 4) hypertensive crisis
** Serious adverse event of cerebral hemorrhage, not related to study drug, at post-treatment W2

Summary

  • GLE/PIB (300 mg/120 mg QD) achieved high efficacy in patients with stage 4 or 5 chronic kidney disease and HCV infection
    • 98% ITT SVR12 rate across all major HCV genotypes
    • No virologic failures
  • GLE/PIB was well tolerated with a favorable safety profile in this difficult-to-treat population:
    • No drug-related serious adverse event
    • No grade = 2 laboratory abnormalities in ALT or AST