| Abstract P212 – Table 1. Pharmacokinetic parameters and statistical analysis summary of dabigatran alone (day 1) and after single (day 4) and multiple (day 18) doses of darunavir coadministered with cobicistat or ritonavir. Panel 1: treatment A, dabigatran etexilate 150 mg on day 1; treatment B, darunavir/cobicistat 800/150 mg and dabigatran etexilate 150 mg on day 4; treatment C, darunavir/cobicistat 800/150 mg (once daily) on days 5 to 20 and dabigatran etexilate 150 mg on day 18. Panel 2: treatment D, dabigatran etexilate 150 mg on day 1; treatment E, darunavir/ritonavir 800/100 mg and dabigatran etexilate 150 mg on day 4; treatment F, darunavir/ritonavir 800/100 mg (once daily) on days 5 to 20 and dabigatran etexilate 150 mg on day 18. | |||
|---|---|---|---|
| Panel 1 | |||
| Parameter | Treatment A (dabigatran etexilate) | Treatment B (dabigatran etexilate + single‐dose darunavir/cobicistat) | Treatment C (dabigatran etexilate + multiple doses darunavir/cobicistat) |
| n | 14 | 14 | 14 |
| Cmax, mean (SD), ng/mL | 130 (41.6) | 344 (96.8) | 254 (62.5) |
| tmax, median (range), h | 3.00 (1.50 to 5.00) | 4.00 (3.00 to 5.00) | 4.00 (3.00 to 5.02) |
| AUCinf, mean (SD), ng.h/mL | 1207 (325) | 3233 (1054) | 2252 (520) |
| t1/2, mean (SD), h | 9.3 (1.8) | 10.7 (2.7) | 10.7 (3.0) |
| Comparison | Geometric LSM ratio | 90% CI | |
| Cmax, ng/mL | Treatment B vs A | 2.64 | (2.29 to 3.05) |
| Treatment C vs A | 1.99 | (1.72 to 2.30) | |
| AUCinf, ng.h/mL | Treatment B vs A | 2.64 | (2.32 to 3.00) |
| Treatment C vs A | 1.88 | (1.65 to 2.13) | |
| Panel 2 | |||
| Parameter | Treatment D (dabigatran etexilate) | Treatment E (dabigatran etexilate + single‐dose darunavir/ritonavir | Treatment F (dabigatran etexilate + multiple doses darunavir/ritonavir) |
| n | 14 | 14 | 13 |
| Cmax, mean (SD), ng/mL | 186 (65.4) | 301 (95.2) | 266 (116) |
| tmax, median (range), h | 3.00 (1.00 to 5.00) | 4.01 (2.02 to 5.02) | 4.02 (1.52 to 5.00) |
| AUCinf, mean (SD), ng.h/mL | 1565 (509) | 2667 (847) | 2068 (877) |
| t1/2, mean (SD), h | 8.8 (1.1) | 9.8 (2.1) | 8.9 (1.8) |
| Comparison | Geometric LSM ratio | 90% CI | |
| Cmax, ng/mL | Treatment E vs D | 1.64 | (1.21 to 2.23) |
| Treatment F vs D | 1.22 | (0.89 to 1.67) | |
| AUCinf, ng.h/mL | Treatment E vs D | 1.72 | (1.33 to 2.23) |
| Treatment F vs D | 1.18 | (0.90 to 1.53) | |
LSM, least squares mean; SD, standard deviation; t1/2, half‐life; tmax, time at Cmax.