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BROWSE SLIDES

Design

* Fibroscan® < 12.5 kPa or FibroTes® ≤ 0.48 + APRI < 1

• GLE/PIB : 100/40 mg 3 tablets QD

Objective

• SVR₁₂ (HCV RNA < 15 IU/mL), by ITT

Baseline characteristics and SVR₁₂

Adverse events and laboratory abnormalities

* 1 patient with baseline risk factors discontinued treatment on D12 due to a transient ischemic attack (TIA); a second TIA occurred 24 days following discontinuation. This patient has not yet returned for SVR₁₂ visit
** 3 patients presented with anxiety, heartburn, and transient ischemic attack, respectively. Two of the 3 patients achieved SVR₁₂

Summary

• 99% of patients with genotype 4, 5 or 6 (120/121) without cirrhosis achieved SVR₁₂ in ITT population following treatment with 12 weeks of GLE/PIB, with no virologic failures
  • 100% SVR₁₂ in mITT population
• GLE/PIB was well tolerated
  • serious adverse events occurred in < 1% of patients
  • there were no grade 3 or higher laboratory abnormalities
  • discontinuation due to adverse events were rare
• 12-week treatment with the IFN- and RBV-free, once-daily GLE/PIB oral regimen can successfully treat patients with HCV genotype 4, 5, or 6, regardless of prior treatment experience or F0–F3 fibrosis status