Table 3:

Ritonavir Pharmacokinetics Comparison of 2nd Trimester (N=9) versus postpartum (N=24); and 3rd 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
RTV AUC0–12 (μg*hr/mL)	3.19 (2.67, 6.10)	4.83 (3.23, 7.00)	6.68 (5.07, 11.2)	0.88 [0.61, 1.27]	0.547	0.65 [0.52, 0.82]	0.007
RTV CL/F (L/hr)	14.2 (12.3, 15.6)	15.6 (13.9, 19.4)	7.72 (6.20, 10.3)	1.14 [0.79, 1.64]	0.383	1.53 [1.22, 1.92]	0.008
RTV V/F (Liters)	245.0 (194.4, 389.3)	210.7 (131.0, 328.9)	89.6 (48.3, 163.5)	1.41 [0.73, 2.72]	0.547	2.12 [1.42, 3.16]	0.012
RTV T1/2 (hours)	7.21 (5.16, 17.5)	6.51 (3.67, 12.33)	4.73 (3.85, 6.35)	1.24 [0.78, 1.97]	0.383	1.50 [0.95, 2.37]	0.226
RTV Cmin (μg/mL)	0.12 (0.05, 0.34)	0.20 (0.08, 0.29)	0.29 (0.05, 0.44)	1.26 [0.76, 2.11]	0.313	0.90 [0.48, 1.69]	0.164
RTV Clast (μg/mL)	0.16 (0.12, 0.40)	0.20 (0.11, 0.39)	0.35 (0.19, 0.64)	0.85 [0.67, 1.08]	0.469	0.64 [0.40, 1.04]	0.065
RTV Cmax (μg/mL)	0.40 (0.35, 0.66)	0.62 (0.45, 0.89)	0.92 (0.65, 1.43)	0.92 [0.68, 1.23]	0.547	0.67 [0.54, 0.83]	0.004
RTV C0 (μg/mL)	0.23 (0.11, 0.34)	0.32 (0.16, 0.51)	0.47 (0.08, 0.71)	1.80 [1.02, 3.18]	0.078	0.88 [0.56, 1.37]	0.143
RTV C12 (μ/mL)	0.16 (0.12, 0.40)	0.20 (0.11, 0.39)	0.34 (0.18, 0.60)	0.85 [0.67, 1.08]	0.469	0.67 [0.41, 1.11]	0.116

^*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; C_min= minimum concentration; V/F = apparent volume of distribution; T_1/2 = elimination half-life; C_last = 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).