TABLE 2.
Comparison of amprenavir pharmacokinetics in the 2nd trimester versus postpartum and in the 3rd trimester versus postpartuma
| PK parameter | Median value for group (IQR) |
2T/PP comparison |
3T/PP comparison |
||||
|---|---|---|---|---|---|---|---|
| 2T (n = 8) | 3T (n = 28) | PP (n = 22) | GMR (90% CI) | P value | GMR (90% CI) | P value | |
| APV AUC0–12 (μg · h/ml) | 43.50 (38.50, 50.40) | 32.15 (21.45, 39.70) | 51.60 (45.20, 59.60) | 0.68 (0.44, 1.04) | 0.22 | 0.60 (0.49, 0.72) | <0.001 |
| APV CL/F (liters/h) | 13.79 (11.91, 15.58) | 18.66 (15.11, 28.23) | 11.63 (10.07, 13.27) | 1.48 (0.96, 2.27) | 0.22 | 1.68 (1.38, 2.03) | <0.001 |
| APV T1/2 (h) | 8.67 (5.90, 13.57) | 12.98 (8.50, 31.62) | 14.26 (8.22, 28.25) | 0.41 (0.009, 17.97) | 1.00 | 1.02 (0.42, 2.49) | 0.637 |
| APV Cmin (μg/ml) | 1.91 (0.34, 2.39) | 1.48 (0.86, 1.80) | 2.42 (1.36, 3.08) | 0.37 (0.10, 1.40) | 0.16 | 0.97 (0.55, 1.71) | 0.01 |
| APV Clast (μg/ml) | 2.05 (1.56, 2.65) | 1.67 (1.13, 2.24) | 2.80 (1.93, 3.82) | 0.39 (0.10, 1.54) | 0.22 | 0.60 (0.45, 0.81) | 0.004 |
| APV Cmax (μg/ml) | 5.61 (4.47, 6.64) | 5.12 (3.60, 6.26) | 6.75 (4.31, 9.24) | 0.83 (0.56, 1.22) | 0.16 | 0.74 (0.58, 0.93) | 0.03 |
| APV C0 (μg/ml) | 2.19 (1.05, 3.13) | 1.70 (1.34, 2.28) | 3.14 (1.56, 4.94) | 0.71 (0.40, 1.27) | 0.47 | 0.91 (0.50, 1.65) | <0.001 |
| APV C12 (μg/ml) | 2.12 (1.39, 2.67) | 1.64 (1.16, 2.21) | 2.87 (2.34, 3.41) | 0.48 (0.14, 1.65) | 0.44 | 0.56 (0.43, 0.72) | <0.001 |
a
P values were determined by a Wilcoxon rank sum test. 2T, second trimester; 3T, third trimester; PP, postpartum; IQR, interquartile range; AUC0–12, area under the concentration-versus-time curve from time zero to 12 h postdose; CL/F, apparent oral clearance; Cmin, minimum concentration; Cmax, maximum concentration; T1/2, elimination half-life; Clast, last observed quantifiable concentration; C0, initial concentration at time zero; C12, concentration at 12 h postdose. Values in boldface type are significant P values (<0.1).