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BROWSE SLIDES

Design

* Randomisation was stratified on cirrhosis ( presence or absence), genotype (2 or 3) and HCV RNA (< or = 6 log 10 IU/ml)

• SOF : 400 mg qd
• PEG-IFNα-2a : 180 m g SC once weekly
• RBV weight based ( bid dosing ) : 1000 mg/ day if < 75 kg or 1200 mg/ day if = 75 kg
• RBV fixed-dose : 400 mg bid

Objective

• Non inferiority of SOF + RBV : SVR₁₂ ( 2-sided significance level of 5%, lower margin of the 95% CI for the difference = -15%, 95% power)

Baseline characteristics and patient disposition

* Excluded from efficacy analysis

HCV RNA < 25 IU/ml

Virologic breakthrough during treatment

• 1 in SOF + RBV group vs 18 (7%) in PEG-IFN + RBV group

Relapse in patients with HCV RNA < 25 IU/ml at end of completed treatment

• 74 / 24 9 ( 30 %) in SOF + RBV group vs 46/217 (21%) in PEG-IFN + RBV group

Multivariate analysis of factors associated with SVR₁₂ in SOF + RBV group

Resistance testing (sequencing) in SOF + RBV group

• 74 relapses :
  • No SOF-associated mutation (S282T)
  • No change in susceptibility to SOF in patients with NS5B substitutions

Adverse events , n (%)

Summary

• In this open-label, randomised trial of previously untreated patients with genotype 2 or 3 infection, the rate SVR₁₂ was the same among patients who were assigned 12 weeks of SOF + RBV or 24 weeks of PEG-IFN + RBV (67% in each group)
  • In genotype 2, SVR₁₂ was higher with SOF + RBV (97% vs 78%)
  • In genotype 2, SVR₁₂ was similarly low in both groups (56% vs 63%)
• SOF + RBV was associated with fewer adverse events than PEG-IFN + RBV
  • Influenza-like constitutional symptoms and neuropsychiatric events were less common among patients receiving SOF + RBV than among those receiving PEG-IFN + RBV.
  • Although the rates of anemia was similar in both groups, neutropenia and thrombocytopenia were not observed in the SOF + RBV group
• No virologic resistance was detected in patients who did not have a sustained virologic response