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Design

* Randomisation was stratified on diabetes ( yes or no ) and hemodialysis status (yes or no )
** based on eGFR (MDRD equation) : 15-29 ml/min = CKD 4 ; < 15 ml/min = CKD 5
GZR 100 mg qd , EBR 50 mg qd , GZR/EBR 100mg/50 mg fixed dose combination 1 pill qd

Objective

• SVR₁₂ (HCV RNA < 15 IU/ml) > 45% in immediate and PK groups : reference rate, with 2-sided significance level of 0.05

Baseline characteristics

SVR₁₂ (HCV RNA < 15 IU/ml) , % (95% CI), mITT

* Genotype 1b, non cirrhotic, CKD stage 5, NS5A RAV at baseline : L31M, at failure : L31M + Y93H

Virologic outcome

• SVR₁₂ (99%) > to historical control (45%), p < 0.001
• SVR rates similar in patients with unfavourable baseline charcateristics (African American, IL28B non-CC, cirrhosis), and in in all subgroups including haemodialysis and non- haemodialysis

Resistance associated variants at baseline

• NS3 : 36/112 (32.1%) patients : SVR₁₂ in 36/36
• NS5A : 17/115 (14.8%) of patients : SVR₁₂ in 16/17

Adverse events and laboratory abnormalities, N (%)

* Erythropoietin use : 23% of GZR + EBR group vs 35% of placebo

Renal function monitored events

Summary

• Once daily GZR + EBR for 12 weeks achieved SVR₁₂ of 99% for treatment of HCV genotype 1 infection among patients with chronic kidney disease stage 4-5
  • SVR₁₂ of 100% in naïve patients
  • SVR₁₂ of 95% in experienced patients
• Efficacy was consistent across different subpopulation
  • Genotypes 1a and 1b
  • Diabetes
  • Hemodialysis
• Failure to achieve SVR₁₂ was rare
  • One patient with genotype 1b relapsed
• Once daily GZR + EBR for 12 weeks was well-tolerated