Table 2.
Indinavir/ritonavir pharmacokinetic parameters during the second and third trimesters of pregnancy and post-partum
| Second trimester (n = 13) | Third trimester (n = 25) | Post-partum (n = 26) | Historical data Non-pregnant adults [8] | |
|---|---|---|---|---|
| Indinavir † | ||||
| AUC(0,12h) (μg ml−1 h) | 14.9 (10.4–38.7)* | 16.10 (7.50–39.9)* | 27.1 (18.6–44.7) | 18.3 (11.1–33.0) |
| Cmax (μg ml−1) | 3.89 (2.38–10.25) | 3.62 (1.33–7.42)* | 5.37 (3.76–9.41) | 3.8 (2.2–7.8) |
| tmax (median, h) | 2.00 (1.00–2.00) | 2.00 (1.00–4.00) | 2.00 (1.00–4.00) | 1.9 (0.96–3.8) |
| C12 h (μg ml−1) | 0.13 (0.07–0.23)* | 0.13 (0.07–0.60)* | 0.28 (0.14–0.71) | 0.17 (0.10–0.39) |
| Cmin (μg ml−1) | 0.12 (0.07–0.23)* | 0.12 (0.07–0.60)* | 0.28 (0.03–0.71) | 0.17 (0.10–0.39) |
| CL/F (l h−1) | 26.85 (10.34–38.46)* | 24.84 (10.03–53.33)* | 14.79 (8.95–21.51) | 21.9 (12.1–35.8) |
| Met indinavir AUC(0,12 h) target‡ | 10/13 (77%) | 17/25 (68%) | 26/26 (100%) | 9/11 (82%) |
| Met indinavir C12 h target‡ | 10/13 (77%) | 19/25 (76%) | 26/26 (100%) | 11/11 (100%) |
| Ritonavir # | ||||
| AUC(0,12 h) (μg ml−1 h)) | 5.80 (2.82–19.78)* | 5.95 (1.79–21.71)* | 14.6 (5.18–25.37) | 9.2 (3.9–24.8) |
| Cmax (μg ml−1) | 0.92 (0.34–3.68)* | 0.80 (0.26–3.25)* | 2.50 (0.68–3.89) | 1.5 (0.53–3.4) |
| tmax (median, h) | 2.00 (1.00–4.00) | 2.00 (1.00–6.00) | 2.00 (1.00–6.00) | 2.9 (1.4–5.0) |
| C12 h (μg ml−1) | 0.14 (0.09–0.30)* | 0.16 (0.07–0.56)* | 0.32 (0.15–1.14) | 0.24 (0.11–0.94) |
| CL/F (l h−1) | 17.25 (5.06–35.52)* | 16.80 (4.61–55.73)* | 6.87 (3.94–19.31) | 10.9 (4.0–25.6) |
†Values: Median (range), AUC: Area under the concentration−time curve; CL/F: apparent oral clearance (CL/F = Dose[12 h]/AUC[12 h]); ‡AUC(0,12 h) target is 12.9 μg ml−1: estimated 10th percentile for non-pregnant adults; C12 h Target is 0.10 μg ml−1 h: recommended minimum threshold; *P < 0.05, second trimester compared with post-partum and third trimester compared with post-partum, Wilcoxon signed rank test.