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BROWSE SLIDES

Design

* Patients and investigators masked to group assignment

Dosage of study drugs

• Grazoprevir (GZR) 100 mg qd
• Elbasvir (EBR) : 20 or 50 mg qd
• RBV (bid dosing) : 800 mg/day if 51-65 kg, 1000 mg/day if 66-80 kg, 1200 mg/day if 81-105 kg, 1400 mg/day if > 105 kg

Primary efficacy endpoint

• SVR₁₂ (HCV RNA < 25 IU/ml), with 2-sided 95% CI, comparison between groups

Treatment groups

Baseline characteristics and patient disposition

SVR₁₂ (HCV RNA < 25 IU/ml), % (95% CI)

SVR₁₂ (HCV RNA < 25 IU/ml) in patients with 12 weeks of treatment, % (95% CI)

Adverse events and laboratory abnormalities

SVR₁₂ according to detection of resistance-associated variants at baseline

* p < 0.001

Summary

• In this phase II study, 12 weeks of oral treatment with grazoprevir and elbasvir, with or without RBV, was well tolerated and led to high rates of SVR₁₂ (87-98%) in previously untreated patients without cirrhosis with HCV genotype 1 monoinfection or HIV/HCV co-infection
  • The addition of RBV was not associated with increased rates of SVR₁₂
  • Similar efficacy was seen in patients with genotype 1a and 1b
  • SVR₁₂ was similar with 12 weeks of treatment in mono and co-infected patients
  • 8 weeks of GZR + EBR + RBV led to suboptimal SVR₁₂ , mainly because of relapse
  • Patients with NS5A baseline resistance-associated variants had lower SVR₁₂
  • Virological relapse was associated with emergence of resistance-associated variants to one or both of the drugs (GZR, EBR) in the regimen
  • Treatment-emergent, clinically significant, adverse events were infrequent
  • No discontinuation for adverse event In HIV co-infected patients, adverse events were less frequently reported, and HIV suppression was maintained