Table 3.

Summary of Integrase Strand Transfer Inhibitor pharmacokinetic studies during pregnancy.

Antiretroviral	Study design	Participants	AUCt (μg*hr/mL)	Cmin (μg/mL)	Comments
Dolutegravira [59]	Longitudinal, steady state, intensive PK sampling over 24 hours	2nd trimester: n=9	58.4 (47.6 – 64.5)	0.86 (0.78 – 1.05)	No statistically significant differences were observed. Individual AUCx above the 10th percentile of non-pregnant adults (37.5 mcg/mL): 2nd trimester: 6 of 9 participants 3rd trimester: 12 of 15 participants Postpartum: 8 of 9 participants
		3rd trimester: n=15	48.7 (40.3 – 57.6)	1.03 (0.87 – 1.24)
		Postpartum: n=10	71.1 58.0 – 83.1)	0.70 (0.60 – 0.86)
Raltegravirb [62]	Longitudinal, steady state, intensive PK sampling over 12 hours after an observed dose while fasting	2nd trimester: n=16	6.6 (2.1 – 18.5)	0.047 (<0.01 – 0.162)	AUCx was statistically lower in both the 2nd and 3rd trimester compared to postpartum. Cmin was statistically lower in the 2nd trimester compared to postpartum. No differences were observed between 2nd and 3rd trimesters.
		3rd trimester: n=41	5.4 (1.4 – 35.4)	0.057 (<0.01 – 0.607)
		Postpartum: n=38	11.6 (1.6 – 39.9)	0.0474 (<0.01 – 0.917)
Raltegravirc [63]	Longitudinal, steady state, intensive PK sampling over 12 hours after an observed dose with breakfast	3rd trimester: n=21	5.0 (3.56, 7.01)	0.077 (0.043, 0.137)	90% confidence intervals of the geometric mean ratios (3nd trimester:postpartum) of all PK parameters included 1, except AUCτ [0.71 (0.53 - 0.96)]. 11 of 17 patients (65%) with paired visits had lower exposure during the 3rd trimester vs. postpartum.
		Postpartum: n=18	7.11 (4.91, 10.31)	0.120 (0.074, 0.193)

Abbreviations: AUCx, area under the concentration time curve for the dosing interval; C_min, minimum concentration observed; PK, pharmacokinetic.

^aData are presented as geometric mean (interquartile range).

^bData are presented as median (range).

^cData are presented as geometric mean (95% confidence interval).