TABLE 2.
Pharmacokinetic parameters for dapivirine in breast milk, blood plasma, and cervicovaginal fluid samples
| Parametera | Value for: |
|||
|---|---|---|---|---|
| Breast milk | Blood plasma | Breast milk/blood plasma ratio | Cervicovaginal fluid | |
| Cmax (pg/ml) | ||||
| Mean (SD) | 723.1 (317.1) | 330.8 (85.5) | 2.2 (1.0) | 49,566.9 (47,034.1) |
| Median | 676.0 | 327.0 | 2.0 | 36,245.0 |
| IQR | 443.0, 924.5 | 274.5, 378.0 | 1.5, 2.5 | 22,170.0, 58,435.0 |
| Min, max | 297.0, 1,420.0 | 199.0, 559.0 | 1.3, 5.1 | 4,540, 200,000 |
| tmax (h) | ||||
| Mean (SD) | 266.2 (105.8) | 212.8 (95.1) | 83.4 (102.5) | |
| Median | 335.4 | 172.0 | 24.8 | |
| IQR | 171.1, 339.0 | 169.0, 333.8 | 6.0, 168.6 | |
| Min, Max | 6.0, 358.3 | 6.0, 338.1 | 3.0, 340.2 | |
| AUC0–336 (pg · h/ml) | ||||
| Mean (SD) | 168,283.5 (68,318.0) | 95,778.6 (29,030.7) | 1.8 (0.6) | 8,227,682.7 (8,764,783.6) |
| Median | 152,604.9 | 93,717.7 | 1.7 | 5,555,367.1 |
| IQR | 119,122.5, 191,806.4 | 77,318.8, 106,607.9 | 1.4, 1.9 | 2,426,211.9, 9,331,004.4 |
| Min, max | 88,625.8, 324,138.0 | 59,402.3, 181,492.4 | 1.1, 3.8 | 1,145,204.1, 36,357,657.9 |
| t1/2 (h) | ||||
| Mean (SD) | 45.8 (28.9) | 42.2 (19.0) | 9.5 (4.7) | |
| Median | 39.0 | 35.2 | 7.8 | |
| IQR | 27.1, 53.4 | 29.8, 46.4 | 6.3, 12.3 | |
| Min, max | 18.9, 141.1 | 22.7, 93.4 | 3.6, 22.7 | |
a
IQR, interquartile range; min, minimum; max, maximum.