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dc.contributor.authorVera E. Bukkemsen_US
dc.contributor.authorElise J. Smoldersen_US
dc.contributor.authorGonzague Jourdainen_US
dc.contributor.authorDavid M. Burgeren_US
dc.contributor.authorAngela P. Colbersen_US
dc.contributor.authorTim R. Cresseyen_US
dc.date.accessioned2020-10-14T08:45:40Z-
dc.date.available2020-10-14T08:45:40Z-
dc.date.issued2020-01-01en_US
dc.identifier.issn15524604en_US
dc.identifier.issn00912700en_US
dc.identifier.other2-s2.0-85091281263en_US
dc.identifier.other10.1002/jcph.1746en_US
dc.identifier.urihttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85091281263&origin=inwarden_US
dc.identifier.urihttp://cmuir.cmu.ac.th/jspui/handle/6653943832/70964-
dc.description.abstract© 2020 The Authors. The Journal of Clinical Pharmacology published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology Tenofovir disoproxil fumarate (TDF) is recommended as part of antiretroviral therapy (ART) for pregnant women with HIV and as monotherapy for pregnant women with hepatitis B virus (HBV) monoinfection at high risk of transmitting infection to their infants. Tenofovir (TFV) plasma exposures are reduced during pregnancy; however, concomitant antiretrovirals and the viral infection itself can also influence TFV pharmacokinetics. Our aim was to compare TFV pharmacokinetics in pregnant women receiving TDF-based ART, with or without a ritonavir-boosted protease inhibitor (r/PI), to pregnant women with HBV receiving TDF monotherapy. Non-r/PI regimens were primarily integrase strand transfer inhibitors or nonnucleoside reverse transcriptase inhibitor–based regimens. Data were combined from a pharmacokinetic study of pregnant women with HIV on ART (PANNA), and a study assessing TFV pharmacokinetics in pregnant women with HBV (iTAP). A total of 196 pregnant women, 59 with HIV (32 receiving r/PIs) and 137 with HBV monoinfection were included. Intraindividual TFV area under the plasma concentration–time curve from time 0 to 24 hours was 25%, 26%, and 21% lower during the third trimester compared to 1 month postpartum in women with HIV using TDF and an r/PI or TDF and non-r/PI and women with HBV receiving TDF monotherapy, respectively. TFV area under the plasma concentration–time curve from time 0 to 24 hours was similar in pregnant women receiving non-r/PI to pregnant women with HBV receiving TDF monotherapy (1.84 vs 1.86 µg • h/mL); however, pregnant women receiving TDF with an r/PI had higher exposures (2.41 µg • h/mL; P <.01). Pregnancy reduces TFV exposure and the relative size was not impacted by concomitant antiretroviral drugs or viral infection, but a drug-drug interaction between TDF and r/PI remains during pregnancy, leading to higher exposures than those on TDF and non-r/PI or TDF monotherapy.en_US
dc.subjectMedicineen_US
dc.subjectPharmacology, Toxicology and Pharmaceuticsen_US
dc.titleEffect of Pregnancy and Concomitant Antiretrovirals on the Pharmacokinetics of Tenofovir in Women With HIV Receiving Temofovir Disoproxil Fumarate-Based Antiretroviral Therapy Versus Women With HBV Receiving Temofovir Disoproxil Fumarate Monotherapyen_US
dc.typeJournalen_US
article.title.sourcetitleJournal of Clinical Pharmacologyen_US
article.stream.affiliationsUniversity of Liverpoolen_US
article.stream.affiliationsIsala Clinicsen_US
article.stream.affiliationsRadboud University Nijmegen Medical Centreen_US
article.stream.affiliationsChiang Mai Universityen_US
article.stream.affiliationsFrench National Institute for Development Research (IRD)en_US
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