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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Very high concentrations of active intracellular phosphorylated emtricitabine in neonates (ANRS 12109 trial, step 2)
Antimicrobial Agents and Chemotherapy, Volume 55, No. 6, Year 2011
Notification
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Description
Our objective was to investigate neonatal emtricitabine (FTC) plasma and intracellular pharmacokinetics. The study was designed as a phase I/II prospective trial in two sequential steps evaluating the combination of tenofovir disoproxil fumarate (TDF) and FTC for the prevention of mother-to-child-transmission (PMTCT) of HIV. HIV-1-infected pregnant women received two tablets of TDF (300 mg) and FTC (200 mg) at onset of labor and then one tablet daily for 7 days postpartum. Based on the data obtained in the first part of the Tenofovir/Emtricitabine in Africa and Asia (TEmAA) Study, single doses of 2 mg/kg of FTC and 13 mg/kg of TDF were given to the neonates within 12 h after birth. A total of 540 FTC plasma concentrations and 44 active intracellular phosphorylated metabolite FTC-TP concentrations were taken from the 36 enrolled women and their neonates. Concentrations were measured by the liquid chromatography-tandem mass spectrometry (LC-MS/MS) method and analyzed by a population approach. The proposed dose obtained by simulations based on plasma drug concentrations was confirmed. However, median FTC-TP exposures were, respectively, 5.9 and 6.8 times higher in the fetus and the neonate than in the adult. High FTC-TP concentrations were observed in the four children who had serious adverse events (SAEs), but the link between FTC-TP concentrations and SAEs in children was not formally identified. The exposure to the active form of FTC was high in neonates despite plasma drug concentrations equivalent to those in adults. Our results are similar to those obtained with zidovudine or lamivudine. Copyright © 2011, American Society for Microbiology. All Rights Reserved.
Authors & Co-Authors
Hirt, Déborah
France, Paris
Hopital Cochin Ap-hp
France, Paris
Cnrs Centre National de la Recherche Scientifique
France, Paris
Inserm
Pruvost, A. G.
France, Gif-sur-yvette
Institut de Biologie et de Technologies de Saclay
Ékouévi, Didier Koumavi
Cote D'ivoire, Abidjan
Programme Pac-ci
France, Paris
Inserm
Urien, Saík
France, Paris
Hopital Cochin Ap-hp
France, Paris
Inserm
France, Paris
Université Paris Cité
Arrivé, Élise
France, Paris
Inserm
Koné, Mamourou
Cote D'ivoire, Abidjan
Centre Hospitalier Universitaire de Yopougon
Nerrienet, Eric
Cambodia, Phnom Penh
Institut Pasteur du Cambodge
Nyati, Mandisa M.
South Africa, Johannesburg
Chris Hani Baragwanath Hospital
Gray, Glenda E.
South Africa, Johannesburg
Chris Hani Baragwanath Hospital
Kruy, Leang Sim
Cambodia, Phnom Penh
Hopital Calmette
Blanche, Stéphane
France, Paris
Hôpital Necker Enfants Malades
Dabis, Franćois Ç.Ois
Cote D'ivoire, Abidjan
Programme Pac-ci
Tréluyer, Jean Marc
France, Paris
Hopital Cochin Ap-hp
France, Paris
Inserm
France, Paris
Université Paris Cité
Statistics
Citations: 20
Authors: 13
Affiliations: 11
Identifiers
Doi:
10.1128/AAC.01376-10
ISSN:
00664804
e-ISSN:
10986596
Research Areas
Infectious Diseases
Maternal And Child Health
Study Design
Cross Sectional Study
Cohort Study
Participants Gender
Female