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In this prospective, open label, two period, randomized, cross over trial sixteen healthy adult patients were given ten days of atazanavir/cobicistat (ATV/c) 300mg/150 mg plus daclatasvir 30 mg daily followed by a washout period of ten days. Then these same patients were given ten days of atazanavir/ritonavir (ATV/r) 300mg/100mg plus daclatasvir 30 mg daily. In a second arm of this study, patients received atazanavir/ritonavir plus daclatasvir for ten days, received a washout period of ten days, and then received atazanavir/cobicistat plus daclatasvir for ten days. At steady state, PK analysis was done for daclatasvir. Geometric means ratios of daclatasvir AUC, Cmax and Ctrough with 90% confidence intervals were calculated comparing the effect of atazanavir/cobistat with the effect of atazanavir/ritonavir.
Geometric Means Ratios (90% CI) of daclatasvir AUC, Cmax and Ctrough with ATV/c compared with ATV/r were 101% (92%-111%), 97% (89%-106%), and 101%(89%-115%), respectively
Smolders EJ, de_Kanter CTMM, K Velthoven-Graafland, Colbers EPH, Drenth JPH, et al. Daclatasvir 30 mg/day is the correct dose for patients taking atazanavir/cobicistat. abstract p_43. 17th International Workshop On Clinical Pharmacology Of Hiv And Hepatitis Therapy. Washington DC, USA. ; 2016.
In this prospective, open label, two period, randomized, cross over trial sixteen healthy adult patients were given ten days of atazanavir/cobicistat (ATV/c) 300mg/150 mg plus daclatasvir 30 mg daily followed by a washout period of ten days. Then these same patients were given ten days of atazanavir/ritonavir (ATV/r) 300mg/100mg plus daclatasvir 30 mg daily. In a second arm of this study, patients received atazanavir/ritonavir plus daclatasvir for ten days, received a washout period of ten days, and then received atazanavir/cobicistat plus daclatasvir for ten days. At steady state, PK analysis was done for daclatasvir. Geometric means ratios of daclatasvir AUC, Cmax and Ctrough with 90% confidence intervals were calculated comparing the effect of atazanavir/cobistat with the effect of atazanavir/ritonavir.
Geometric Means Ratios (90% CI) of daclatasvir AUC, Cmax and Ctrough with ATV/c compared with ATV/r were 101% (92%-111%), 97% (89%-106%), and 101%(89%-115%), respectively
Garimella T, You X, Wang R, Huang SP, Kandoussi H, Biffano M, Eley T. A review of daclatasvir drug-drug interactions. Advances In Therapy. 2016; 11: 1867-1884.