{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T18:11:44Z","timestamp":1788459104535,"version":"build-2803163510"},"reference-count":16,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2015,5,11]],"date-time":"2015-05-11T00:00:00Z","timestamp":1431302400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["U01 AI068632, AI068632, U01 AI41110 , U01 AI068616 , contract number N01-DK-9-001\/HHSN267200800001C"],"award-info":[{"award-number":["U01 AI068632, AI068632, U01 AI41110 , U01 AI068616 , contract number N01-DK-9-001\/HHSN267200800001C"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["HIV Medicine"],"published-print":{"date-parts":[[2015,9]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>Tenofovir disoproxil fumarate (<jats:styled-content style=\"fixed-case\">TDF<\/jats:styled-content>) is increasingly used in the highly active antiretroviral therapy (<jats:styled-content style=\"fixed-case\">HAART<\/jats:styled-content>) regimens of pregnant women, but limited data exist on the pregnancy pharmacokinetics of chronically dosed <jats:styled-content style=\"fixed-case\">TDF<\/jats:styled-content>. This study described tenofovir pharmacokinetics during pregnancy and postpartum.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">I<\/jats:styled-content>nternational <jats:styled-content style=\"fixed-case\">M<\/jats:styled-content>aternal <jats:styled-content style=\"fixed-case\">P<\/jats:styled-content>ediatric and <jats:styled-content style=\"fixed-case\">A<\/jats:styled-content>dolescent <jats:styled-content style=\"fixed-case\">AIDS C<\/jats:styled-content>linical <jats:styled-content style=\"fixed-case\">T<\/jats:styled-content>rials (<jats:styled-content style=\"fixed-case\">IMPAACT<\/jats:styled-content>) <jats:styled-content style=\"fixed-case\">P<\/jats:styled-content>1026s is a prospective, nonblinded pharmacokinetic study of <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u2010infected pregnant women that included a cohort receiving 300\u2009mg <jats:styled-content style=\"fixed-case\">TD<\/jats:styled-content>F once daily. Steady\u2010state 24\u2010hour pharmacokinetic profiles were measured at the second and third trimesters, postpartum, and in maternal and umbilical cord samples collected at delivery. Tenofovir was measured by liquid chromatography\u2212mass spectrometry (<jats:styled-content style=\"fixed-case\">LC<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">MS<\/jats:styled-content>). The target area under the concentration versus time curve from time 0 to 24\u2009h post dose (<jats:italic>AUC<\/jats:italic>) was \u2265\u20091.99\u2009\u03bcg h\/mL (nonpregnant historical control 10th percentile).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The median tenofovir <jats:italic>AUC<\/jats:italic> was decreased during the second (1.9\u2009\u03bcg h\/mL) and third (2.4\u2009\u03bcg h\/mL; <jats:italic>P<\/jats:italic>\u2009=\u20090.005) trimesters versus postpartum (3.0\u2009\u03bcg h\/mL). Tenofovir <jats:italic>AUC<\/jats:italic> exceeded the target for two of four women (50%) in the second trimester, 27 of 37 women [73%; 95% confidence interval (<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>) 56%, 86%] in the third trimester, and 27 of 32 women (84%; 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 67%, 95%) postpartum (<jats:italic>P<\/jats:italic>\u2009&gt;\u20090.05). Median second\/third\u2010trimester troughs were lower (39\/54\u2009ng\/mL) than postpartum (61\u2009ng\/mL). Median third\u2010trimester weight was greater for subjects below the target <jats:italic>AUC<\/jats:italic> versus those above the target (97.9 versus 74.2\u2009kg, respectively; <jats:italic>P<\/jats:italic>\u2009=\u20090.006). The median ratio of cord blood to maternal concentrations was 0.88. No infants were HIV infected.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This study found lower tenofovir <jats:italic>AUC<\/jats:italic> and troughs during pregnancy. Transplacental passage with chronic <jats:styled-content style=\"fixed-case\">TDF<\/jats:styled-content> use during pregnancy was high. Standard <jats:styled-content style=\"fixed-case\">TDF<\/jats:styled-content> doses appear to be appropriate for most HIV\u2010infected pregnant women but therapeutic drug monitoring with dose adjustment should be considered in pregnant women with high weight (&gt;\u200990\u2009kg) or inadequate <jats:styled-content style=\"fixed-case\">HIV RNA<\/jats:styled-content> response.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.12252","type":"journal-article","created":{"date-parts":[[2015,5,11]],"date-time":"2015-05-11T07:57:14Z","timestamp":1431331034000},"page":"502-511","source":"Crossref","is-referenced-by-count":71,"title":["Pharmacokinetics of tenofovir during pregnancy and postpartum"],"prefix":"10.1111","volume":"16","author":[{"given":"BM","family":"Best","sequence":"first","affiliation":[{"name":"School of Medicine\u2010Rady Children's Hospital and Skaggs School of Pharmacy &amp; Pharmaceutical Sciences University of California San Diego  San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S","family":"Burchett","sequence":"additional","affiliation":[{"name":"Harvard Medical School Children's Hospital Boston  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Preventive Medicine Rush University Medical Center  Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A","family":"Stek","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology University of Southern California School of Medicine  Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C","family":"Hu","sequence":"additional","affiliation":[{"name":"Division of Epidemiology and Biostatistics University of Arizona Mel &amp; Enid Zuckerman College of Public Health  Tucson AZ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J","family":"Wang","sequence":"additional","affiliation":[{"name":"Harvard School of Public Health Center for Biostatistics in AIDS Research  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E","family":"Hawkins","sequence":"additional","affiliation":[{"name":"Social and Scientific Systems  Silver Springs MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M","family":"Byroads","sequence":"additional","affiliation":[{"name":"Frontier Science &amp; Technology Research Foundation  Amherst NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"DH","family":"Watts","sequence":"additional","affiliation":[{"name":"Eunice Kennedy Shriver National Institute of Child Health &amp; Human Development (NICHD)  Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E","family":"Smith","sequence":"additional","affiliation":[{"name":"National Institute of Allergy and Infectious Diseases (NIAID)  Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"CV","family":"Fletcher","sequence":"additional","affiliation":[{"name":"College of Pharmacy University of Nebraska Medical Center  Omaha NE USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"EV","family":"Capparelli","sequence":"additional","affiliation":[{"name":"School of Medicine\u2010Rady Children's Hospital and Skaggs School of Pharmacy &amp; Pharmaceutical Sciences University of California San Diego  San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M","family":"Mirochnick","sequence":"additional","affiliation":[{"name":"Boston University School of Medicine  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) P1026s Team","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,5,11]]},"reference":[{"key":"e_1_2_6_2_1","unstructured":"Panel on Treatment of HIV\u2010Infected Pregnant Women and Prevention of Perinatal Transmission.Recommendations for Use of Antiretroviral Drugs in Pregnant HIV\u20101\u2010Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. 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