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BROWSE SLIDES

Design

* Randomisation stratified on genotype (1a vs non-1a)

EBR/GZR 50/100 mg QD ; SOF 400 mg QD
If failure in GT1: retreatment 12 weeks with EBR/GZR + SOF + RBV 800-1400 mg/day

Objective

• SVR₁₂ (HCV RNA < 15 IU /ml) , with 2-sided 95% CI, by ITT

Baseline characteristics, and disposition

* Days from virologic failure to retreatment = 214 (range: 182-260)

SVR₁₂ (HCV RNA < 15 IU/ml), mITT , Genotype 1

SVR₁₂ (HCV RNA < 15 IU/ml), ITT, Genotype 1 with = 6 weeks of treatment, by subg roups

Impact of RAVs on SVR₁₂ in genotype 1

• NS3
  • Prevalence at baseline = 66%
  • No impact on SVR₁₂ : 76% if no baseline NS3 RAVs vs 69% if present
• NS5A
  • Prevalence at baseline in the 6- and 8-week groups = 10%
  • SVR₁₂ : 90% if no baseline RAVs vs 57% if present
• Retreatment group (next generation sequencing analysis, 1% sensitivity threshold) •
• Baseline NS5A RAVs = 14/23 (61%)
• Baseline NS3 RAVs = 17/23 (74%)
• NS3 + NS5A RAVs = 11/23 (48%)
• SVR₁₂ = 23/23 (2 lost to follow-up)

SVR₁₂ (HCV RNA < 15 IU/ml), mITT, Genotype 3

SVR₁₂ (HCV RNA < 15 IU /ml), ITT, Genotype 3, by subgroups

Resistance analysis at failure

Adverse events, N (%)

* Pneumonia on day 40 of treatment, which led to discontinuation of therapy

Summary

• Elbasvir/grazoprevir + sofosbuvir was able to shorten treatment duration to 8 weeks or less among cirrhotic and non-cirrhotic HCV genotype 1 infected patients
• Genotype 3 patients achieved high SVR₁₂ rates with 8-12 weeks of therapy, including patients with cirrhosis
• All virologic failures were due to relapse
• Patients relapsed most commonly with either wild-type virus or with RAVs already present at baseline
• GZR/EBR + SOF was generally safe and well tolerated
• Retreatment of the patients who failed short-duration therapy was successfully achieved through extended treatment duration (12 weeks) and the addition of ribavirin