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Eight one sequence crossover, drug-drug interaction studies were conducted to assess the impact on PK values for the 2D regimen, Ombitasvir (25mg daily) + Paritaprevir/Ritonavir (150/100mg).These studies were conducted in healthy volunteers aged 18 to 55 years of age. A total of 12 participants were included in the evaluation of Ketoconazole vs. 2D Regimen.The 2D regimen was administered alone on Day 1. This was followed by a washout period on Days 2 through 7. On Days 8 and 9, Ketoconazole (400mg QD) was administed alone. On Day 10, the 2D regimen was administered with Ketoconazole. On Days 11 through 13, Ketoconazole was administered alone.
DrugCmax GMR (90% CI)AUC GMR (90% CI)Ombitasvir1.16 (1.09-1.23)1.03 (1.00-1.06)Paritaprevir1.19 (0.84-1.68)1.02 (0.82-1.27)Ritonavir1.38 (1.15-1.66)1.25 (1.07-1.46)Escitalopram0.92 (0.85-0.99)0.75 (0.67-0.84)No clinically significant changes in PK parameters were reported. The authors state that escitalopram and the 2D regimen may be co-administered without any dose adjustments.
P Badri, S Dutta, H Wang, et al. Drug interactions with direct acting antiviral combination of paritaprevir/ritonavir ombitasvir. 16th International Workshop On Clinical Pharmacology Of Hiv ; Hepatitis Therapy. Washington, DC. ; 2015.