Table 3.
Steady-State Pharmacokinetic Parameters of Cobicistat-Boosted Elvitegravir, Darunavir, and Atazanavir During Pregnancy and Postpartum, and in Nonpregnant HIV-Infected Adults
| Parameter | Second Trimester | Third Trimester | Postpartum | Nonpregnant Adults | Levels in Pregnancy vs Postpartum |
|---|---|---|---|---|---|
| Elvitegravir (150/150 mg daily)61 | N = 17a | N = 26a | N = 25a | 450 (260)b | ↓ |
| Cmin, ng/mL | 16.8 (10.9-21.8) | 18.3 (5.0-61.3) | 185.6 (48.5-377.1) | 1700 (400) | |
| Cmax, ng/mL | 1447.1 (1133.6-1579.0) | 1432.8 (705.7-1570.4) | 1713.1 (955.7-2284.6) | 23 000 (7500) | |
| AUC0-24, ng • h/mL | 15 283 (11 939-19 038) | 14 4004 (9119-18 798) | 21 039 (13 532-32 788) | ||
| Darunavir (800/150 mg daily)64 | N = 16a | N = 25a | N = 18a | N = 298c | ↓ |
| Cmin, ng/mL | 440 (50-1550) | 490 (50-3470) | 1450 (50-5530) | 2043 ± 1257 | |
| Cmax, ng/mL | 4610 (1820-9700) | 4140 (1980-7010) | 7060 (930-12 390) | 100 152 ± 32 042 | |
| AUC0-24, ng • h/mL | 47 220 (13 500-93 600) | 43 620 (12 700-89 300) | 96 030 (4500-231 780) | ||
| Atazanavir (300/150 mg daily)9 | N = 3a | N = 5a | N = 5a | N = 22c | ↓ |
| Cmin, ng/mL | 160 (140-220) | 120 (90-190) | 450 (420-610) | 800 ± 720 | |
| Cmax, ng/mL | 2700 (2000-3200) | 1780 (900-2780) | 3210 (1930-3900) | 3910 ± 1940 | |
| AUC0-24, ng • h/mL | 21 200 (20 600-22 500) | 17 000 (8900-27 500) | 27 400 (24 000-36 400) | 46 130 ± 26 180 |
AUC0-24, area under the plasma concentration–time curve from time zero to 24 hours after dosing; Cmax, maximum plasma concentration; Cmin, minimum plasma concentration.
a
Results presented as median (interquartile range).
b
Results presented as geometric mean (standard deviation [SD]).
c
Results presented as mean ± SD.