Etravirine pharmacokinetics in HIV-infected pregnant women
Mulligan, Nikki (University of California (Estats Units d'Amèrica))
Schalkwijk, Stein (Radboud University Nijmegen Medical Centre (Nijmegen, Països Baixos))
Best, Brookie M. (University of California (Estats Units d'Amèrica))
Colbers, Angela (Radboud University Nijmegen Medical Centre (Nijmegen, Països Baixos))
Wang, Jiajia (Harvard School of Public Health)
Capparelli, Edmund V. (University of California (Estats Units d'Amèrica))
Moltó Marhuenda, José (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Stek, Alice M. (University of Southern California. School of Medicina (Estats Units d'Amèrica))
Taylor, Graham (Imperial College Healthcare National Health Service Trust (Londres, Regne Unit))
Smith, Elizabeth (National Institute of Allergy and Infectious Diseases (Bethesda, Estats Units d'Amèrica))
Hidalgo-Tenorio, Carmen (Hospital Universitario Virgen de las Nieves (Granada))
Chakhtoura, Nahida (Eunice Kennedy Shriver National Institute of Child Health and Human Development (Bethesda, Estats Units d'Amèrica))
Van Kasteren, Marjo (Saint Elisabeth Hospital (Tilburg, Països Baixos))
Fletcher, Courtney V. (University of Nebraska Medical Center (Omaha, Estats Units d'Amèrica))
Mirochnick, Mark (Boston University School of Medicine (Estats Units d'Amèrica))
Burger, David M. (Radboud University Nijmegen Medical Centre (Nijmegen, Països Baixos))
PANNA Network
IMPAACT Network

Date:	2016
Abstract:	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 AUC0-12 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.
Grants:	European Commission QLK2-CT-2000-00150 European Commission LSHP-CT-2006-03757 European Commission LSHP-CT-2006-01886
Note:	CLINICAL TRIAL REGISTRATION: The IMPAACT protocol P1026s and PANNA study are registered at ClinicalTrials.gov under NCT00042289 and NCT00825929.
Note:	Altres ajuts: National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) UM1AI068632 (IMPAACT LOC), UM1AI068616 (IMPAACT SDMC) i UM1AI106716 (IMPAACT LC)
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	HIV ; Etravirine ; Perinatal transmission ; Pharmacokinetics ; Pregnancy
Published in:	Frontiers in Pharmacology, Vol. 7 Núm. 239 (August 2016) , ISSN 1663-9812

DOI: 10.3389/fphar.2016.00239
PMID: 27540363

10 p, 1.6 MB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Research articles
Articles > Published articles