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BROWSE SLIDES

Design

* Randomisation stratified on response to prior PEG-IFN + RBV (null responders, partial responders or relapsers)
** Metavir = F3 or Ishak = 4 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
• Dasabuvir (DSV) : 250 mg bid
• RBV : 1000 or 1200 mg/day (bid dosing) according to body weight (< or = 75 kg)

Objective

• SVR₁₂ (HCV RNA < 25 IU /ml) by intention to treat analysis : non inferiority of both groups to historical SVR₁₂ of telaprevir + PEG-IFN + RBV (lower limit of the 95% CI > upper limit of the CI for the historical rate minus a 10.5% noninferiority margin (64%))

Baseline characteristics and patient disposition

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

Both groups were noninferior and superior to the historical SVR₁₂ with TVR + PEG-IFN + RBV

Adverse events, n (%)

Summary

• The ITT SVR₁₂ rates in genotype 1b HCV infected patients receiving the 12-week regimen of OBV/PTV/r + DSV with or without RBV (96.6%–100%, respectively) were superior to the historical rate of telaprevir + PEG-IFN + RBV
  • No benefit of addition of RBV, with significantly more adverse events, bilirubin increase and anemia
• Adverse events in both groups of 12-week regimens were generally mild and manageable.
• Overall, only 2 (1.1%) patients discontinued treatment because of adverse events, and the 5 serious adverse events reported in 4 patients were considered to be unrelated to study drug
• Limitations
  • open-label study design
  • exclusion of patients with cirrhosis, HBV or HIV co-infection