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Design

• GLE/PIB: 100/40 mg 3 tablets QD

Objective

• SVR₁₂ (HCV RNA< 15 IU /ml)

Baseline characteristics and SVR₁₂

One patient with Genotype 3a infection and cirrhosis had on-treatment virologic failure

• At treatment W8
• NS3 RASs
  • no polymorphisms at baseline
  • Y56H at failure
• NS5A RASs
  • A30V at baseline
  • S24F + M28K at failure

HIV RNA suppression

• No virologic breakthrough

Adverse events and laboratory abnormalities, %

* Cerebrovascular accident and hemorrhage, unrelated to treatment ; treatment discontinuation on D23

Summary

• GLE/PIB (300 mg/120 mg QD) achieved a SVR of 98% in HCV infected patients with HIV infection,
  • After 8 weeks of therapy if no cirrhosis (SVR₁₂ of 99.3%)
  • After 12 weeks of therapy if cirrhosis
• SVR₁₂ was not impacted by baseline HCV viral load or other baseline factors
• GLE/PIB was well tolerated with a favorable safety profile in patients with or without cirrhosis
  • No drug-related serious adverse event
  • No grade = 3 laboratory abnormalities in ALT or AST