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Design

• GLE/PIB : 100/40 mg 3 tablets QD

Objective

• SVR₁₂ (HCV RNA < 15 IU/ml), with 2-sided 95% CI, by ITT

Baseline characteristics and SVR₁₂

Adverse events and laboratory abnormalities, %

* Diarrhea ; pruritus ; pulmonary edema, hypertensive cardiomyopathy with congestive failure ; 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