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