TABLE 2.
Median value for group (IQR) | 2T/PP comparison b | 3T/PP comparison b | |||||
---|---|---|---|---|---|---|---|
Second trimester n = 16 |
Third trimester n = 20 |
Postpartum n = 13 |
GMR (90% CI) | P-value | GMR (90% CI) | P-value | |
Dose (mg/kg) | 9.19 (8.25–9.81) | 8.59 (8.02–10.14) | 9.30 (8.84–10.00) | – | – | – | – |
AUC0–24 (µg·h/mL) | 38.89 (31.88–53.19) | 44.53 (31.01–56.96) | 38.38 (30.22–57.89) | 0.91 (0.74–1.11) | 0.420 | 1.06 (0.89–1.26) | 0.586 |
CL/F (L/h) | 14.44 (10.66–17.11) | 13.26 (9.59–16.39) | 11.72 (9.82–19.35) | 1.18 (0.98–1.42) | 0.150 | 1.00 (0.85–1.18) | 0.983 |
T max (h) | 2 (1–6) | 2 (1–6) | 2 (1–4) | – | – | – | – |
T ½ (h) | 1.69 (1.51–2.14) | 2.18 (1.83–2.73) | 1.73 (1.62–2.07) | 0.99 (0.83–1.17) | 0.888 | 1.28 (1.09–1.50) | 0.014 |
C max (µg/mL) | 8.66 (5.44–10.23) | 7.69 (5.99–10.32) | 7.92 (5.77–10.30) | 0.90 (0.74–1.09) | 0.348 | 0.92 (0.78–1.09) | 0.409 |
C 0 (µg/mL) | BQL (BQL–BQL) | BQL (BQL–BQL) | BQL (BQL–BQL) | – | – | – | – |
C 12 (µg/mL) | 0.35 (0.12–0.63) | 0.56 (0.18–0.94) | 0.27 (BQL −0.51) | 1.22 (0.69–2.14) | 0.556 | 2.11 (1.28–3.48) | 0.018 |
n (%) C max <8 µg/mL target | 8 (50) | 12 (60) | 7 (54) | – | – | – | – |
n (%) AUC0–24 <35.4 µg·h/mL target | 8 (50) | 8 (40) | 7 (54) | – | – | – | – |
Summary statistics for second/third trimester and postpartum presented as median (IQR), except T max, which is presented as median (range). AUC0-24: area under the concentration versus time curve over the dosing interval; CL/F: apparent oral clearance; T max: time to maximum plasma concentration; t 1/2: half-life; C max: maximum plasma concentration; C 0: pre-dose concentration; C 12: 12 hours post-dose concentration; BQL: below quantification limit.
Comparisons between pregnancy and postpartum presented as univariate mixed-effect model GMRs with a 90% confidence interval and P-value. Values in italic type are significant P-values (<0.1).