. Author manuscript; available in PMC: 2023 Jul 24.

Published in final edited form as: J Clin Pharmacol. 2023 Jun;63(Suppl 1):S34–S50. doi: 10.1002/jcph.2227

Table 5.

Summary of Pharmacokinetic Studies of Darunavir, Ritonavir, and Cobicistat During Pregnancy and Postpartum

Darunavir/Ritonavir Drug Regimen Used During Pregnancy	Antiretroviral drug	AUC_0-24 (mg • h/L) Second Trimester	AUC_0-24 (mg • h/L) Third Trimester	AUC_0-24 (mg • h/L) Postpartum	GMR – Second Trimester Compared to Postpartum	GMR – Third Trimester Compared to Postpartum	Mean AUC_0-24 Decrease in the Third Trimester of Pregnancy Compared to Postpartum, %
Darunavir/ritonavir 600/100 mg once daily (n = 30)¹¹³	Darunavir	45.8	45.9	61.7	0.74	0.74	−26
Darunavir/ritonavir 600/100 mg once daily (n = 30)¹¹³	Ritonavir	3.9	3.8	5.6	0.72	0.73	−27
Darunavir/ritonavir 800/100 mg once daily (n = 34)¹¹³	Darunavir	64.6	63.5	103.9	0.62	0.61	−39
Darunavir/ritonavir 800/100 mg once daily (n = 34)¹¹³	Ritonavir	3.7	3.7	8.2	0.65	0.67	−37
Darunavir/ritonavir 800/100 mg twice daily (n = 24)³⁹	Darunavir	55.1	51.8	79.6	0.62	0.64	−26
Darunavir/ritonavir 800/100 mg twice daily (n = 24)³⁹	Ritonavir	3.2	4.8	6.7	0.88	0.65	−25
Darunavir/cobicistat 800/150 mg once daily (n = 29)¹¹⁴	Darunavir	50.0	42.1	95.6	0.47	0.44	−56
Darunavir/cobicistat 800/150 mg once daily (n = 29)¹¹⁴	Cobicistat	4.5	3.9	8.5	0.50	0.44	−56

AUC_0-24, area under the plasma concentration–time curve from time 0 to 24 hours; GMR, geometric mean ratio.