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BROWSE SLIDES

Design

* Randomisation stratified on IL-28B (CC or non-CC)
** Liver biopsy or fibroscan < 9.6 kPa or FibroTest = 0.72 + APRI = 2

Treatment regimens

• Co-formulated ombitasvir (OBV)/ paritaprevir (PTV)/ rironavir (r) : 25/150/100 mg qd = 2 tablets
• Weight-based RBV (bid dosing)

Objective

• SVR₁₂ , hypothesis of rate of 70% in experienced and 95% in naïve, 80% power with two-sided significance level of 0.05 to detect a 25% difference between both groups

Baseline characteristics and patient disposition

SVR₁₂ (HCV RNA < 25 IU/mL), % (95% CI)

Virologic failure

• N = 3, in naïve patients on OBV/PTV/rwithout RBV, all 3 with genotype 4d
  • 1 breakthrough at W8
  • 2 relapses before post-treatment W12
  • All 3 had no baseline resistance-associated variants at baseline but developed variants at failure, predominantly D168V (NS3) and L28S or L28V (NS5A)

Adverse events and laboratory abnormalities, n (%)

Summary

• 12 weeks of treatment with o mbitasvir plus paritaprevir plus ritonavir with or without ribavirin achieved high SVR₁₂ and was generally well tolerated , with low rates of anemia and treatment discontinuation in non-cirrhotic previously untreated and previously treated patients with HCV genotype 4 infection.
  • Having RBV in the regimen provides the highest certainty of achieving SVR in patients infected with diverse HCV genotype 4 subtypes
  • Host genetics (IL28B genotype) did not affect response