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BROWSE SLIDES

Design

* Randomisation was stratified by cirrhosis status (yes vs no) and study site (country)
** Fibroscan® > 12.5 kPa, or liver biopsy (F4), or Fibrotest® > 0.75 or APRI > 2

• EBR/GZR: 50/100 mg 1 tablet QD

Objective

• SVR₁₂ (HCV RNA < 15 IU/mL), by ITT

Baseline characteristics and SVR₁₂

* Two patients did not receive the active treatment (EBV/GZR) after the placebo treatment

• SVR₁₂ in all participants: 94.4%
• Race, gender and age had no impact on SVR₁₂
• Cirrhotic patients had the same SVR₁₂ rate than non-cirrhotic patients: 93.3% vs 94.7%

SVR₁₂ by genotype (%)

Impact of baseline NS5A RASs on SVR₁₂

Adverse events and laboratory abnormalities, N (%)

* Data given for the EBR/GZR period
** Suicide, Evan's syndrome, contusion, enteritis, gastric lymphoma, atrial fibrillation, ankle fracture, uterine hemorrhage. Only atrial fibrillation was considered related to EBR/GZR

Summary

• Treatment with a 12-week regimen of EBR/GZR achieved a global rate of SVR₁₂ of 94% in a heterogeneous population with GT1, 4 and 6
• Low rates of SVR₁₂ were observed in GT6 patients (66.7%)
• Cirrhosis, gender and race had no impact on SVR₁₂
• RASs decreased SSVR₁₂ rate in genotypes 1a and 6
• Treatment was safe and well tolerated