Table 3.
Maternal Cobicistat Pharmacokinetic Parameters, Median (IQR)
| Parameter | Second Trimester n = 16 | Third Trimester n = 26 | Postpartum n = 19 | Non-pregnant Adults with HIV1 | GMR2 (90% CI) 2T/PP, n=12 | GMR2 (90% CI) 3T/PP, n=18 |
|---|---|---|---|---|---|---|
| AUC0–24 (μg*hr/mL) | 4.46 (3.21, 5.69) | 3.91 (3.15, 6.24) | 8.52 (6.28, 11.39) | 7.6 (± 3.7) | 0.50 (0.36, 0.69)* | 0.44 (0.35, 0.55)* |
| C0 (ng/mL) | 4.1 (2.5, 10.8) | 7.2 (2.5, 26.3) | 28.5 (2.5, 171.0) | - | 0.28 (0.07, 1.10) | 0.31 (0.09, 1.07)* |
| Cmax (ng/mL) | 713.5 (525.0, 1050.5) | 662.5 (497.0, 969.0) | 1190.0 (838.0, 1300.0) | 990 (± 300) | 0.63 (0.51, 0.78)* | 0.58 (0.48, 0.70)* |
| Tmax (hr) | 2 (1, 3) | 2 (1, 4) | 2 (1, 4) | - | - | - |
| C24 (ng/mL) | 4.4 (2.45, 8.9) | 5.5 (2.45, 8.8) | 16.5 (7.2, 50.1) | 0.03 (±0.1) | 0.40 (0.23, 0.69)* | 0.26 (0.16, 0.43)* |
| Cmin (ng/mL) | 3.3 (2.45, 7.7) | 5.5 (2.45, 8.8) | 12.0 (7.2, 30.9) | - | 0.32 (0.20, 0.53)* | 0.29 (0.16, 0.52)* |
| CL/F (L/hr) | 33.67 (26.39, 46.68) | 38.38 (24.05, 47.60) | 17.61 (13.17, 23.88) | - | 2.01 (1.45, 2.77)* | 2.27 (1.82, 2.83)* |
| T1/2 (hr) | 2.87 (2.28, 3.43) | 2.81 (2.27, 3.31) | 3.43 (2.99, 4.53) | - | 0.86 (0.70, 1.06)* | 0.75 (0.65, 0.86)* |
*
p<0.10 compared to postpartum
1
Historical data from TYBOST® (cobicistat) package insert, represented as mean (±S.D.)
2
Paired comparisons
GMR, geometric mean ratio; 2T, second trimester, 3T, third trimester; PP, postpartum