COMMIT Study

COMMIT Study: SMV + DCV in genotype 1b

Hezode C, EASL 2016, Abs. SAT-130, J Hepatol 2016;64:S754

Anti-HCV
Simeprevir
Daclatasvir
Genotype
1b
Treatment history
Naive
Cirrhosis
Yes

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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)