Table 2.
Maternal Darunavir 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) | 50.00 (27.032, 58.90) | 42.05 (26.83, 50.50) | 95.55 (67.20, 118.95) | 100.15 (±32.04) | 0.47 (0.33, 0.68)* | 0.44 (0.36, 0.54) * |
| C0 (μg/mL) | 0.28 (0.045, 0.60) | 0.25 (0.045, 1.13) | 1.62 (0.045, 3.44) | 2.04 (±1.26) | 0.29 (0.07, 1.16)* | 0.32 (0.10, 1.05) * |
| Cmax (μg/mL) | 4.59 (2.38, 6.12) | 3.67 (3.29, 4.65) | 7.04 (5.70, 10.75) | - | 0.56 (0.41, 0.76)* | 0.54 (0.46, 0.63) * |
| Tmax (hr) | 3 (2, 4) | 2 (2, 4) | 2 (2, 4) | - | - | - |
| C24 (μg/mL) | 0.33 (0.045, 0.47) | 0.27 (0.045, 0.63) | 1.43 (0.73, 1.86) | - | 0.15 (0.08, 0.30)* | 0.21 (0.12, 0.36) * |
| Cmin (μg/mL) | 0.33 (0.045, 0.47) | 0.25 (0.045, 0.45) | 1.34 (0.56, 1.86) | - | 0.15 (0.08, 0.30)* | 0.21 (0.11, 0.38) * |
| CL/F (L/hr) | 16.00 (13.64, 29.74) | 19.04 (15.84, 29.82) | 8.37 (6.73, 11.91) | - | 2.12 (1.47, 3.05)* | 2.28 (1.87, 2.77) * |
| T1/2 (hr) | 4.80 (3.91, 6.07) | 5.18 (3.76, 6.61) | 8.11 (6.19, 10.55) | - | 0.55 (0.44, 0.67)* | 0.62 (0.50, 0.76) * |
*
p<0.10 compared to postpartum
1
Historical data from Prezcobix® (darunavir and cobicistat) package insert, represented as mean (±S.D.)
2
Paired comparisons
GMR, geometric mean ratio; 2T, second trimester, 3T, third trimester; PP, postpartum