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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 GLE/PIB regimen vs 12-week SOF + DCV , by ITT, with lower margin of the 95% CI for the difference : - 6 %, 90% power
• Non-inferiority of the 8-week vs 12-week GLE/PIB regimen, by ITT, with lower margin of the 97.5% CI for the difference : - 6% or lower margi n of the CI > 92% (> - 6% to historical 98% rate with SOF + DCV), 80% power
• Secondary endpoints
  • Virologic failure and relapse
  • Resistance analysis (15% detection threshold)
  • Safety

Baseline characteristics

Primary Endpoint (SVR₁₂)

NS3 and NS5A polymorphisms/substitutions at baseline and failure

SVR₁₂ by baseline polymorphisms in NS3 or NS5A

Adverse events and laboratory abnormalities, N (%)

Summary

• Once-daily treatment with GLE/PIB for either 8 weeks or 12 weeks achieved high rates of sustained virologic response among patients with HCV genotype 3 infection who did not have cirrhosis
• 95% of patients achieved SVR 12 with 8 weeks of GLE/PIB
• GLE/PIB was well tolerated
  • No patient discontinued for adverse event in GLE/PIB 8 weeks group
  • Only 3 patients (1%) discontinued study drugs for adverse event in GLE/PIB 12 weeks group
  • No significant laboratory abnormalities