RT Journal Article T1 Etravirine Pharmacokinetics in HIV-Infected Pregnant Women A1 Mulligan, Nikki A1 Schalkwijk, Stein A1 Best, Brookie M. A1 Colbers, Angela A1 Wang, Jiajia A1 Capparelli, Edmund V. A1 Molto, Jose A1 Stek, Alice M. A1 Taylor, Graham A1 Smith, Elizabeth A1 Tenorio, Carmen Hidalgo A1 Chakhtoura, Nahida A1 van Kasteren, Marjo A1 Fletcher, Courtney V. A1 Mirochnick, Mark A1 Burger, David A1 PANNA Network, A1 IMPAACT 1026s Study Teams, K1 etravirine K1 pregnancy K1 HIV K1 pharmacokinetics K1 perinatal transmission K1 Transplacental passage K1 Darunavir K1 Safety K1 Darunavir/ritonavir K1 Pharmacodynamics K1 Combination K1 Enfuvirtide K1 Raltegravir K1 Efficacy K1 Woman AB Background: The study goal was to describe etravirine pharmacokinetics during pregnancy and postpartum in HIV-infected women.Methods: IMPAACT P1026s and PANNA are on-going, non-randomized, open-label, parallel-group, multi-center phase-IV prospective studies in HIV-infected pregnant women. Intensive steady-state 12-h pharmacokinetic profiles were performed from 2nd trimester through postpartum. Etravirine was measured at two labs using validated ultra performance liquid chromatography (detection limits: 0.020 and 0.026 mcg/mL).Results: Fifteen women took etravirine 200 mg twice-daily. Etravirine AUC(0-12) was higher in the 3rd trimester compared to paired postpartum data by 34% (median 8.3 vs. 5.3 mcg*h/mL, p = 0.068). Etravirine apparent oral clearance was significantly lower in the 3rd trimester of pregnancy compared to paired postpartum data by 52% (median 24 vs. 38 L/h, p = 0.025). The median ratio of cord blood to maternal plasma concentration at delivery was 0.52 (range: 0.19-4.25) and no perinatal transmission occurred.Conclusion: Etravirine apparent oral clearance is reduced and exposure increased during the third trimester of pregnancy. Based on prior dose-ranging and safety data, no dose adjustment is necessary for maternal health but the effects of etravirine in utero are unknown. Maternal health and infant outcomes should be closely monitored until further infant safety data are available. PB Frontiers media sa SN 1663-9812 YR 2016 FD 2016-08-04 LK http://hdl.handle.net/10668/19239 UL http://hdl.handle.net/10668/19239 LA en DS RISalud RD Jul 7, 2025