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BROWSE SLIDES

Design

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

• GLE/PIB : 100/40 mg 3 tablets QD

Objective

• SVR₁₂ (HCV RNA< 15 IU/mL), by ITT
• Non-inferiority of SVR₁₂ for genotype 2 if lower margin of the 2-sided 95% CI > 89% (comparison to historical control of 95% SVR 12 rate)

Baseline characteristics and SVR₁₂

* Non- inferior to historical SVR 12 of 95%

Adverse events and laboratory abnormalities, %

* Cholecystitis (Day 30 of treatment) in 1 patient, urosepsis (post-treatment Day 15) in 1 patient, both assessed as not related to study drug

Summary

• 97% of genotype 2, 4, 5, or 6-infected patients without cirrhosis achieved SVR₁₂ following 8 weeks of GLE/PIB
  • In DAA-naïve patients with genotype 2, 8-weeks of GLE/PIB yielded a SVR₁₂ rate of 99%, that was non-inferior to the historical 95% SVR₁₂ rate achieved with 12 weeks of SOF + RBV
  • There were no virologic failures in patients with genotype 4, 5 or 6 infection
  • SVR₁₂ was not impacted by baseline HCV RNA, genotype/subtype, F0-F3 fibrosis stage, baseline polymorphisms, and prior treatment experience with IFN/PEG-IFN- or SOF-based regime ns SVR rates were similar to those following 12-weeks with GLE/PIB
• In patients with genotype 2 infection, 42% (53/126) had NS5A RAS 31M at baseline ; 96% (51/53) of these patients achieved SVR 12
  • The 2 relapses occurred in treatment-experienced patients with genotype 2a and baseline NS5A RAS L31M, with no treatment-emergent RAS at failure
• GLE/PIB for 8 weeks was well-tolerated, with no discontinuations due to adverse event, no drug-related serious adverse event, and rare grade 3 or higher laboratory abnormalities