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Design

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 < 15 IU/mL), with 2 sided 95% confidence interval, treatment-emergent adverse events

Baseline characteristics

SVR rates by treatment arm, % (95% CI)

SVR₁₂ by baseline fibrosis stage (12 week treatment arms), % (95% CI)

Sensitivity analysis : SVR₁₂ excluding patients with premature discontinuation of study drug with no on-treatment failure or with missing follow-up data in SVR₁₂ window :

• 96% (94/98) for Arm A
• 97% (30/31) for Arm B
• 96% (27/28) for Arm C

Reasons for not achieving SVR₁₂

* Includes 1 patient with compensated cirrhosis miscategorized as non-cirrhotic and assigned in Arm A

Treatment-emergence adverse events

Summary

• High SVR rates were achieved in HCV genotype 4-infected Egyptian patients without cirrhosis or with compensated cirrhosis after 12 weeks of OBV/PTV/r + RBV weeks: SVR₁₂ was 94% and 97%, respectively
• 12 weeks treatment was well tolerated with no treatment discontinuations due to adverse events
• Prolongation of therapy to 24 weeks does not provide additional benefit in patients with cirrhosis, with more serious adverse events and a higher frequency of hemoglobin decrease