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BROWSE SLIDES

Design

* Randomisation was stratified on age (< 65 or = 65 years old ) and IL28B
** Response -guide therapy

• SMV: 100 mg 1 capsule qd
• PEG-IFNα-2a: 180 m g SC once weekly
• RBV: 600 or 1 000 mg/day according to body weight
• Dosage adjustment of PEG-IFN and RBV permitted

Objective

• Primary endpoint: SVR₁₂ (HCV RNA < 1.2 log₁₀ IU/ml) , with 95% CI, superiority of SMV vs placebo, 90% power

Baseline characteristics, patient disposition and outcome

Adverse events, N or %

Summary

• In treatment-naive patients with HCV genotype 1 and high viral load, oral once-daily SMV in combination with PEG-IFN + RBV significantly improves SVR rates and shortens treatment duration in most patients
  • 91.9% of SMV-treated patients met response-guided therapy criteria and completed treatment at W24; SVR₁₂ in these patients was 92.0%
• Viral relapse occurred infrequently in SMV-treated patients, being observed in 7.6% of SMV-treated patients with undetectable plasma HCV RNA at end of treatment
• Emerging mutations were detected in most SMV-treated patients who experienced treatment failure, with D168V the most frequent emerging mutation
• SMV had a clinically favorable safety and tolerability profile in this patient population