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BROWSE SLIDES

Design

* Fibroscan > 12.5 kPa , or FibroTest > 0.75 + APRI > 2
** On stable ART with TDF or ABC, 3TC/FTC + RAL or DTG or RPV for ≥ 8 weeks, and CD4 > 200/mm³, and undetectable HIV RNA

Objective

• SVR₁₂ (HCV RNA < 15 IU /ml), by ITT analysis, 99% power to demonstrate superiority to a reference rate of 40% at an overall 1-sided 2.5% alpha level

Baseline characteristics

Primary endpoint : SRV₁₂ (HCV RNA < 15 IU /ml), % [95% CI], ITT

* ITT, mFAS : exclusion of 1 patient (genotype 1b) who discontinued due to non compliance

Impact of baseline RASs on

Impact of baseline RASs in patients with genotype 1a (population sequencing with threshold of 20%)

• NS5A RAVs at baseline in 4/47 (8.5%): SVR 12 = 1/4
• NS3 RAVS at baseline in 26/47 (55%)
  • 22 with NS3 only: SVR₁₂ = 100%
  • 4 with NS3 + NS5A RAVs: SVR₁₂ = 1/4

Relapses

• All patients were HCV treatment-naïve and had no cirrhosis

Adverse events and laboratory abnormalities, %

Summary

• 12 weeks of EBR/GZR was highly efficacious in patients with inherited blood disorders and HCV genotype1 and 4 infection, and evidenced in various patient subgroups
  • Cirrhosis
  • HIV co-infection
  • All IBLDs
• Lower response in patients with genotype 1a infection with baseline NS5A RASs
• Tolerance was generally good
  • No impact on measures of hematology and clotting or on the treatment of the underlying blood disorder