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Design

* 12 weeks in the first 17 patients ; due to observations of breakthrough, next 89 patients treated for 12 or 24 weeks based on patient wish and investigator discretion

Objective

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

Baseline characteristics

* Significantly more patients with cirrhosis received 24 weeks of treatment

SVR₁₂, % (ITT)

Treatment failure, N=9

Viral breakthrough, N=7

Adverse events, %

Summary

• SMV + DCV demonstrated efficacy in treatment-naïve HCV genotype 1b infected patients with advanced fibrosis or compensated cirrhosis (F3 or F4)
  • SVR₁₂ was 92%
  • Viral breakthrough was observed in 6.6% of patients (4/17 of those treated for 12 weeks), in the absence of baseline RAVs
• Emerging SMV and DCV RAVs were detected at time of failure in all patients with viral breakthrough
• The combination was well tolerated
  • 3% of patients discontinued treatment due to adverse events
• In conclusion, SMV + DCV is not an optimal regimen
  • High SVR₁₂ rate
  • But viral breakthrough not predictable (not related to PK, nor pre-existing RAVs at baseline)