. Author manuscript; available in PMC: 2020 Mar 1.

Published in final edited form as: J Clin Pharmacol. 2018 Oct 25;59(3):386–393. doi: 10.1002/jcph.1331

Table 3:

M8, M8/NFV and NFV+M8 PK Comparison of 3rd Trimester vs. Postpartum (N=16) – Table 3 describes the pharmacokinetics of M8, M8/NFV and NFV+M8 PK Comparison during the 3^rd trimester, compared to postpartum.

Parameter	3rd trimester: median (IQR) (n = 18) 1875mg BID	Postpartum: median (IQR) (n=16) 1250mg BID	Geometric mean ratio 3^rd trimester/ postpartum (90% CI)	P-value^*
M8 AUC_0–12 μg-h/mL [μM-h]	3.9 (2.7–7.4) [6.7 (4.7–12.6)]	8.6 (6.5–11.6) [14.8 (11.2–19.8)]	0.53 (0.38–0.75)	0.03
M8 C_min (μg/mL)	0.11 (0.05–0.15)	0.14 (0.04–0.21)	0.78 (0.40–1.26)	0.24
M8 C_max (μg/mL)	0.66 (0.48–1.12)	1.20 (1.07–1.71)	0.54 (0.40–0.73)	0.005
M8/NFV AUC ratio	0.11 (0.08–0.22)	0.30 (0.17–0.35)	0.51 (0.42–0.63)	0.001
NFV+M8 AUC_0–12, μM-h	71.6 (54.3–93.1)	73.3 (66.3–91.7)	0.93 (0.68–1.26)	0.60

p-value for Wilcoxon rank-sum test; IQR = interquartile range, BID = twice daily, AUC_0–12 = area under concentration vs time curve (0 to 12 hours post-dose), Cl/F = molar clearance, C_min= minimum concentration, C_max= maximum concentration, CI = confidence interval.