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BROWSE SLIDES

Design

* Response-guided therapy

• SMV: 100 mg 1 capsule qd
• PEG-IFNα-2a: 180 mg SC once weekly
• RBV: 600 or 1000 mg/day according to body weight
• Dosage adjustment of PEG-IFN and RBV permitted

Objective

• Primary efficacy endpoint: SVR₁₂ (HCV RNA < 1.2 log₁₀ IU/ml) , with 2-sided 95% CI, significant difference vs null hypothesis proportion = 50% of success, 90% power

Baseline characteristics, and disposition

Virologic response, ITT

* One sample test for binomial distribution versus null hypothesis proportion = 50 %

• Prevalence of baseline NS3 polymorphisms: position 170 (40.8%), 122 (36.7%), 80 (14.3%)
• At viral relapse: 3/4 patients without baseline polymorphisms had emergence of D168V

Adverse events (entire treatment period)

Summary

• In treatment-experienced patients with HCV genotype 1 infection who relapsed after previous IFN-based therapy, re-treatment with 12 weeks of oral SMV QD in combination with PEG-IFN + RBV achieves high SVR rate
• SMV was generally well tolerated the incidences of serious adverse events or grade 3/4 rash or anemia were low, as were the rates of treatment discontinuations due to these adverse events