DOWNLOAD THIS SLIDE KIT

BROWSE SLIDES

Design

* Randomisation of treatment-experienced patients was stratified on prior relapse vs non relapse (partial, null, interferon-intolerant)
** Liver biopsy or Fibroscan® > 12.5 kPa

Objective

• Primary endpoint: SVR₁₂ (HCV RNA < 15 IU/mL) with 95% CI, full analysis set (patients who received = 1 dose of study drug)

Baseline characteristics

SVR₁₂ (FAS), %

* SVR₁₂ = 100% in mFAS analysis, excluding patients who discontinued treatment for reasons unrelated to study medication (* lost to follow-up, ** consent withdrawal, *** discontinuation at D7 for cellulitis)

Resistance data

• SVR₁₂ according to baseline NS5A RASs (15% sensitivity threshold): NS5A polymorphisms at positions 24, 28, 30, 31, 32, 38, 58, 62, 92, or 93)
  • 98% (49/50) if RASs
  • 98% (46/47) if no RASs
  • If Y93H present (N = 4): SVR₁₂ = 0/1 (relapse) if 8 weeks treatment ; 3/3 (100%) if > 8 weeks treatment

2 relapses

• Both patients received EBR/GZR/SOF + RBV for 8 weeks
  • Both were treatment-naïve
  • In 1 patient : No NS5A RASs at baseline or failure
  • In 1 patient : NS5A RASs at baseline and failure : Y93H, P58, S62T

Adverse events

* Lung infection, creatinine increased, chest pain, opiate overdose, and cellulitis
** 1 patient discontinued treatment at Day 7 due to cellulitis

Summary

• High efficacy was demonstrated in treatment-naive and treatment-experienced cirrhotic HCV genotype 3-infected patients
  • There were no virologic failures among patients receiving EBR/GZR + SOF ± RBV for 12 or 16 weeks
• Treatment duration longer than 12 weeks is not needed
• Ribavirin is not needed
• High efficacy was seen regardless of
  • presence of baseline NS5A RASs
  • or patient characteristics
• Generally safe and well tolerated