OSIRIS

OSIRIS Study: SMV + PEG-IFN + RBV in genotype 4

Asselah T. PLoS One 2017 Jan 5;12(1):e0168713

Anti-HCV
Simeprevir
Ribavirin
PEG-IFN╬▒ 2a
Genotype
4
Treatment history
Naive
Cirrhosis
No

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Design

  • SMV 150 mg qd
  • PEG-IFNα-2a 180 mg once weekly ; RBV: 1000 mg/ day if <75 kg; 1200 mg/ day if > 75 kg)

Objective

  • SVR12 (HCV RNA < 15 IU/ml)

Baseline characteristics

SRV12 by baseline characteristics in the 12W group

SRV12 by baseline characteristics in the 24W group

Adverse events

  • 2 serious adverse events, not related to SMV: acute sinusitis (N = 1) and phlebitis (N = 1)
  • 3 grade 3/4 adverse events were considered related to SMV (all grade 3, all in W24 group): asthenia (N = 2) and increased serum bilirubin (N = 1)

Summary

  • Overall, 51% of patients with genotype 4 met the eligibility criteria for shortening treatment duration (W2 virologic response), and were assigned to receive 12 weeks of SMV + PEG-IFN + RBV
    • SVR12 was 97% (33 /34) in this sub-group
    • Genotype 4 subtype, sex, geographical region, and race did not appear to affect eligibility
  • SVR12 was 82 % in patients assigned to receive 24 weeks of SMV + PEG-IFN + RBV
  • The safety profile of SMV in patients with genotype 4 is comparable to previous data in patients with genotype 1