Table 2:

Darunavir Pharmacokinetics Comparison of 2nd Trimester (N=9) versus postpartum (N=24); and 3^rd Trimester (N=24) versus postpartum (N=24)

PK Parameter	#Second trimester (2T); (n=9)	#Third trimester (3T); (n=24)	#Postpartum (PP); (n=24)	Geometric mean Ratio, GMR (90% CI); 2T/PP, n=8	p-value	Geometric mean Ratio, GMR (90% CI); 3T/PP, n=23	p-value
DRV AUC0–12 (μg*hr/mL)	55.1 (46.4, 57.7)	51.8 (41.2, 57.7)	79.6 (66.6, 103.0)	0.62 [0.44, 0.88]	0.055	0.64 [0.55, 0.73]	<0.001
DRV CL/F (L/hr)	14.2 (12.3, 15.6)	15.6 (13.9, 19.4)	7.72 (6.19, 10.32)	1.77 [1.24, 2.51]	0.039	2.01 [1.17, 2.35]	<0.001
DRV V/F (Liters)	152.7 (137.0, 259.2,	174.6 (143.3, 233.7)	101.2 (62.1, 133.6)	1.58 [1.23, 2.04]	0.016	2.01 [1.53, 2.65]	<0.001
DRV T1/2 (hours)	7.95 (6.21, 9.82)	7.65 (6.57, 9.04)	8.66 (6.72, 10.38)	0.90 [0.74, 1.08]	0.313	1.01 [0.83, 1.22]	0.637
DRV Cmin (μg/mL)	2.84 (1.21, 3.23)	2.39 (1.72, 2.82)	1.12 (0.52, 5.01)	2.52 [0.68, 9.35]	0.578	0.90 [0.52, 1.58]	0.011
DRV Clast (μg/mL)	2.84 (2.24, 3.23)	2.52 (2.06, 2.90)	4.51 (3.72, 5.28)	0.66 [0.39, 1.12]	0.109	0.59 [0.50, 0.69]	<0.001
DRV Cmax (μg/mL)	6.22 (5.30, 8.42)	6.55 (5.38, 7.43)	8.96 (7.93, 10.85)	0.81 [0.64, 1.01]	0.148	0.71 [0.62, 0.81]	<0.001
DRV C0 (μg/mL)	2.91 (1.55, 5.61)	3.57 (2.79, 4.09)	3.56 (2.14, 6.42)	2.97 [0.75, 11.8]	0.469	1.00 [0.56, 1.81]	0.045
DRV C12 (μg/mL)	2.84 (2.24, 3.23)	2.52 (2.06, 2.91)	4.51 (3.72, 5.30)	0.66 [0.39, 1.12]	0.109	0.58 [0.49, 0.69]	<0.001

^*p-value for Wilcoxon rank-sum test; AUC_0–12 = area under concentration (AUC) vs time curve (0 to 12 hours post-dose), Cl/F = apparent oral clearance, V/F = apparent volume of distribution; T_1/2 = elimination half-life; Clast = last observed quantifiable concentration; C₀ = initial concentration at time zero; C₁₂ = concentration at 12 hours post-dose; C_min= minimum concentration, C_max= maximum concentration; CI = confidence interval.

^#Values are medians (interquartile ranges).