DOWNLOAD THIS SLIDE KIT

BROWSE SLIDES

Design

* Randomisation was stratified by treatment history (experienced vs naive) and for treatment-experienced on prior non-response (null, partial, relapse)
** Metavir > 3 or Ishak > 4, or Fibrotest > 0.72 + APRI > 2 or Fibroscan = 14.6 kPa ; Child-Pugh score = 6

Treatment regimens

• Co-formulated ombitasvir (OBV)/ paritaprevir (PTV)/ rironavir (r): 25/150/100 mg QD = 2 tablets
• RBV: 1000 mg/day if < 75 kg, 1200 mg/day if = 75 kg (bid dosing)

Objective

• SVR₁₂, (HCV RNA < 25 IU/ml) > 95% power to detect superiority with a 2 sided 97.5% lower confidence bound > 67% (historical SVR 12 with PEG-IFN + RBV in genotype 4)

Baseline characteristics

SRV₁₂ rates by treatment arm, ITT, % (97.5% CI)

Sensitivity analysis: SVR 12 excluding patients with premature discontinuation of study drug with no on-treatment failure or with missing follow-up data in SVR 12 window:

• 98% (57/58) for 12 weeks group
• 100% (60/60) for 16 weeks group

NS5A RAVs and impact on SVR₁₂

• At baseline, NS5A RAV in 36/116 (31%) patients
• SRV₁₂
  • 100% (80/80) if no baseline RAV
  • 97% (35/36) if baseline RAV
• 1 patient in Arm A (12 weeks of therapy) did not achieve SVR 12
  • Genotype 4a
  • IL28B CT genotype
  • Fibroscan : 15.6 kPa
  • Prior relapse to PEG-IFN + RBV
  • At baseline: P58L NS5A RAV, no NS3 RAV
  • At failure: emergence of L28M + Y93H NS5A RAVs

Reasons for not achieving SVR₁₂

Treatment-emergent adverse events

Summary

• High SVR rates were achieved in patients with HCV genotype 4 infection and compensated cirrhosis with OBV/PTV/r + RBV administered for 12 weeks or 16 weeks: SVR 12 was 97% and 98%, respectively
  • Superiority to the historical control (PEG-IFN + RBV)
  • 16-week treatment seems to provide no added benefit for patients with HCV genotype 4 infection and compensated cirrhosis
• No post-treatment relapses
• OBV/PTV/r + RBV was well tolerated with no discontinuations due to adverse events
• All serious adverse events were deemed not related to study drugs