PLUTO

PLUTO Study: SMV + SOF in genotype 4

Buti M, Aliment Pharmacol Ther 2017;45:468-75

Anti-HCV
Simeprevir
Sofosbuvir
Genotype
4
Treatment history
Naive
IFN-Experienced
Cirrhosis
No

DOWNLOAD THIS SLIDE KIT

BROWSE SLIDES

Design

Objective

  • SVR12 (HCV RNA < 15 IU/ml), with 95% CI, by ITT
  • Superiority if lower limit of the 95% CI > SVR12 rate of 61% of a historical control (SMV + PEG-IFN + RBV) from a composite endpoint in RESTORE study

Baseline characteristics

Adverse events, %

Summary

  • SMV + SOF for 12 weeks resulted in overall 100% SVR12 in genotype 4 HCV infected patients
    • With or without cirrhosis
    • Whether naïve or IFN-PEG + RBV pretreated
  • Treatment was safe and well tolerated, all adverse events being of grade 1 or 2