Table 1.
Patient characteristics at the time of PK sampling and lopinavir and ritonavir pharmacokinetic parameters during the third trimester of pregnancy in Thai women.
| Characteristics at PK Visit# | Original Analysis (n=26) | Final Analysis (n=38) |
|---|---|---|
| Weight (kg) | 61 (45–88) | 61 (45–88) |
| BMI (kg/m2) | 26 (21–36) | 25 (21–36) |
| Gestational age (Weeks) | 33 (30–38) | 33 (30–38) |
| Duration of LPV/r use (Weeks) | 2 (2–4) | 2 (2–7) |
| Lopinavir (GM 90% CI)* | ||
| AUC0–12 (µg.hr/mL) | 61.7 (56.2–67.7) | 64.6 (59.7–69.8) |
| Cmax (mcg/mL) | 7.8 (7.1–8.6) | 8.1 (7.5–8.7) |
| Tmax (median, hours) | 3.8 (1.0–8.0) | 2.2 (1.0–8.0) |
| Cpredose (mcg/mL) | 4.2 (3.8–4.7) | 4.4 (4.0–4.8) |
| C12hour (mcg/mL) | 2.6 (2.3–3.0) | 2.7 (2.4–3.1) |
| T1/2(median, hours) | 5.4 (2.9–9.6) | 5.5 (2.9–9.6) |
| CL/F (L/hr) | 6.4 (5.9–7.1) | 6.2 (5.7–6.7) |
| LPV AUC < 52.0 mcg.hr/mL | 5/26 (19%, 90% CI: 8%, 36%) |
7/38 (18%, 90% CI: 9%, 32%) |
| LPV AUC > 83.0 mcg.hr/mL | 2/26 (8%, 90% CI: 1%, 22%) |
6/38 (16%, 90% CI: 7%, 29%) |
| Ritonavir | ||
| AUC0–12 (mcg.hr/mL) | 3.1 (2.7–3.5) | 3.2 (2.8–3.5) |
| Cmax (mcg/mL) | 0.53 (0.46–0.62) | 0.54 (0.48–0.61) |
| Tmax (median, hours) | 3.9 (1.0–6.3) | 3.9 (1.0–6.3) |
| Cpredose (mcg/mL) | 0.17 (0.14–0.20) | 0.17 (0.15–0.20) |
| C12hour (mcg/mL) | 0.07 (0.06–0.09) | 0.08 (0.07–0.09) |
| T1/2(median, hours) | 3.0 (1.9–6.4) | 3.1 (1.9–6.4) |
| CL/F (L/hr) | 32. 3 (28.4–36.9) | 31.5 (28.3–35.0) |
#
Values: Median (range) unless otherwise stated.
*
Geometric Mean, 90% Confidence Interval.
AUC: Area under the curve. CL/F: apparent oral clearance