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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

Objectives (SVR₁₂)

• Non-inferiority of the 12-week regimen, by ITT-PS (exclusion of HIV and prior SOF), with lower margin of the 2-sided CI > 91% (historical rate)
• Non-inferiority of the 12-week regimen, by ITT-PS-PP (ITT-PS + exclusion of premature discontinuation or virologic failure prior to W8 and missing data in the SVR₁₂ window), with lower margin of the 95% CI for the difference = 5%
• Non-inferiority of the 8-week regimen, by ITT-PS, with a lower margin of the 95% CI for the difference = 5%
• Secondary endpoints
  • Efficacy in HIV-co-infection and in patients with prior SOF treatment, by ITT
  • Virologic failure and relapse
  • Resistance analysis (15% detection threshold)
  • Safety

PS = Primary Subset

Baseline characteristics

Primary Endpoints (SVR₁₂)

ITT-PS: ITT population, excluding HIV co-infected and SOF-experienced patients
ITT-PS-PP: ITT-PS population excluding patients with premature discontinuation or virologic failure prior to W8, and missing data in the SVR₁₂ window

Secondary efficacy endpoints (SVR₁₂): ITT population

* 1 patient experienced on-treatment virologic failure, 1 patient discontinued on D2 due to non-compliance, 1 patient missing SVR₁₂ data
** 1 patient missing SVR₁₂ data

Adverse events and laboratory abnormalities, N (%)

* On treatment: pneumonia aspiration, atrial fibrillation, angina unstable, radius fracture, transient ischemic attack, irritable bowel syndrome. Post-treatment: bronchitis, uterine myoma, suicide attempt.
** dandruff, anxiety and amnesia, all deemed not related to therapy.
1 death occurred during post-treatment period due to an unknown cause considered unrelated to study drug

Summary

• 99-100% of genotype 1-infected patients without cirrhosis achieved SVR₁₂ with 8 or 12 weeks of glecaprevir / pibrentasvir (GLE/PIB)
• 8-week treatment was non-inferior to 12-week treatment (all 3 primary endpoints were met)
• SVR₁₂ rates were high regardless of
  • HIV-1 co-infection (limitation: 5% of the study population)
  • prior treatment experience
  • baseline HCV RNA
  • presence of baseline polymorphisms
  • or other factors
• GLE/PIB was well tolerated
  • Only 1 patient (0.1%) discontinued study drugs for adverse event
  • No significant laboratory abnormalities