GENVOYA(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)tablets(二十三)
94
(0.85,1.04)
20 once daily given 2 hours before elvitegravir 150 once daily Cobicistat
150 once daily 11 1.16
(1.04,1.30) 1.10
(1.02,1.19) 1.13
(0.96,1.34)
20 once daily given 12 hours after elvitegravir 11 1.03
(0.92,1.15) 1.05
(0.93,1.18) 1.10
(0.92,1.32)
Rifabutin 150 once every other day 150 once daily Cobicistat
150 once daily 12 0.91
(0.84,0.99) 0.79
(0.74,0.85) 0.33
(0.27,0.40)
Rosuvastatin 10 single dose 150 once daily Cobicistat
150 once daily 10 0.94
(0.83,1.07) 1.02
(0.91,1.14) 0.98
(0.83,1.16)
Sertraline 50 single dose 150 once daily† Cobicistat 150 once daily† 19 0.88
(0.82,0.93) 0.94
(0.89,0.98) 0.99
(0.93,1.05)
Sofosbuvir/ Velpatasvir 400/100 once daily 150 once daily† Cobicistat
150 once daily† 24 0.87
(0.80,0.94) 0.94
(0.88,1.00) 1.08
(0.97,1.20)
Table 10 Drug Interactions: Changes in Pharmacokinetic Parameters for Tenofovir Alafenamide (TAF) in the Presence of the Coadministered Drug*
Coadministered Drug Dose of Coadministered Drug (mg) TAF (mg) N Mean Ratio of TAF Pharmacokinetic
Parameters (90% CI); No effect = 1.00
Cmax AUC Cmin
NC = Not Calculated
* All interaction studies conducted in healthy volunteers. † Study conducted with GENVOYA.
Cobicistat 150 once daily 8 once daily 12 2.83
(2.20,3.65) 2.65
(2.29,3.07) NC
Ledipasvir/ Sofosbuvir 90/400 once daily 10 once daily† 30 0.90
(0.73,1.11) 0.86
(0.78,0.95) NC
Sertraline 50 single dose 10 once daily† 19 1.00
(0.86,1.16) 0.96
(0.89,1.03) NC
Sofosbuvir/ Velpatasvir 400/100 once daily 10 once daily† 24 0.80
(0.68,0.94) 0.87
(0.81,0.94) NC
Table 11 Drug Interactions: Changes in Pharmacokinetic Parameters for Coadministered Drug in the Presence of GENVOYA or the Individual Components*
Coadministered Drug Dose of Coadministered
Drug (mg) Elvitegravir Dose (mg) CYP3A Inhibitor Cobicistat Dose (mg) Tenofovir Alafenamide (mg) N Mean Ratio of Coadministered Drug Pharmacokinetic Parameters (90% CI);
No effect = 1.00
Cmax AUC Cmin
N/A = Not Applicable; NC = Not Calculated
* All interaction studies conducted in healthy volunteers. † Study conducted with GENVOYA. ‡ The predominant circulating inactive metabolite of sofosbuvir. § Study conducted with STRIBILD. ¶ Study conducted with DESCOVY (emtricitabine/tenofovir alafenamide). # Comparison based on rifabutin 300 mg once daily.
Buprenorphine 16 – 24 once daily 150 once daily 150 once daily N/A 17 1.12
(0.98,1.27) 1.35
(1.18,1.55) 1.66
(1.43,1.93)
Norbuprenorphine 1.24
(1.03,1.49) 1.42
(1.22,1.67) 1.57
(1.31,1.88)
Carbamazepine 200 twice daily 150 once daily 150 once daily N/A 12 1.40
( |
