{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,4,4]],"date-time":"2025-04-04T00:44:14Z","timestamp":1743727454438,"version":"3.37.3"},"reference-count":18,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2024,8,2]],"date-time":"2024-08-02T00:00:00Z","timestamp":1722556800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"International Maternal Pediatric Adolescent AIDS Clinical Trials"},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000071","name":"National Institute of Child Health and Human Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000071","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000025","name":"National Institute of Mental Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000025","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To develop a pragmatic twice daily lamivudine dosing strategy for preterm infants from 24 to 37 completed weeks of gestation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Data were combined from eight pharmacokinetic studies in neonates and infants receiving lamivudine oral solution. A population pharmacokinetic model was developed using non-linear mixed effects regression. Different lamivudine dosing strategies, stratified by gestational age at birth (GA) bands, were simulated in a virtual population of preterm infants, aimed at maintaining lamivudine drug exposures (AUC0-12) within a reference target range of 2.95 to 13.25 \u00b5g\u00b7h\/mL, prior to switching to WHO-weight band doses when \u22654 weeks of age and weighing \u22653 kg.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 154 infants (59% female) contributed 858 lamivudine plasma concentrations. Median (range) GA at birth was 38 (27\u201341) weeks. At the time of first pharmacokinetic sampling infants were older with median postnatal age (PNA) of 6.3 (0.52\u201326.6) weeks. Lamivudine concentrations were described by a one-compartment model, with CL\/F and V\/F allometrically scaled to weight. Maturation of CL\/F was described using an Emax model based on PNA. CL\/F was also adjusted on GA to allow extrapolation for extreme prematurity. Simulations predicted an optimal lamivudine dosing for infants GA \u226524 to &amp;lt;30 weeks of 2 mg\/kg twice daily from birth until weighing 3 kg; and for GA \u226530 to &amp;lt;37 weeks, 2 mg\/kg twice daily for the first 4 weeks of life, followed by 4 mg\/kg twice daily until weighing 3 kg.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Model-based predictions support twice daily pragmatic GA band dosing of lamivudine for preterm infants, but clinical validation is warranted.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jac\/dkae259","type":"journal-article","created":{"date-parts":[[2024,8,2]],"date-time":"2024-08-02T13:09:40Z","timestamp":1722604180000},"page":"2570-2574","source":"Crossref","is-referenced-by-count":1,"title":["Lamivudine dosing for preterm infants exposed to HIV: a population pharmacokinetic modelling and simulation study"],"prefix":"10.1093","volume":"79","author":[{"given":"Adrie","family":"Bekker","sequence":"first","affiliation":[{"name":"Family Centre for Research with Ubuntu, Department of Pediatrics and Child Health, Stellenbosch University , Cape Town ,","place":["South Africa"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edmund V","family":"Capparelli","sequence":"additional","affiliation":[{"name":"Department of Pediatrics and Skaggs School of Pharmacy and Pharmaceutical Science, University of California , San Diego, CA ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Mirochnick","sequence":"additional","affiliation":[{"name":"Division of Neonatology, Department of Pediatrics, Boston University Chobanian and Avedisian School of Medicine , Boston, MA ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diana F","family":"Clarke","sequence":"additional","affiliation":[{"name":"Section of Pediatric Infectious Diseases, Boston Medical Center , Boston, MA ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2559-6034","authenticated-orcid":false,"given":"Mark F","family":"Cotton","sequence":"additional","affiliation":[{"name":"Family Centre for Research with Ubuntu, Department of Pediatrics and Child Health, Stellenbosch University , Cape Town ,","place":["South Africa"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4832-6275","authenticated-orcid":false,"given":"Roger","family":"Shapiro","sequence":"additional","affiliation":[{"name":"Botswana-Harvard AIDS Institute Partnership for HIV Research and Education , Gaborone ,","place":["Botswana"]},{"name":"Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health , Boston, MA ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katie","family":"McCarthy","sequence":"additional","affiliation":[{"name":"FHI 360 , Durham, NC ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jack","family":"Moye","sequence":"additional","affiliation":[{"name":"Division of Extramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health , Bethesda, MD ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Avy","family":"Violari","sequence":"additional","affiliation":[{"name":"Perinatal HIV Research Unit, University of the Witwatersrand , Johannesburg ,","place":["South Africa"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0140-4600","authenticated-orcid":false,"given":"Kulkanya","family":"Chokephaibulkit","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University , Bangkok ,","place":["Thailand"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elaine","family":"Abrams","sequence":"additional","affiliation":[{"name":"ICAP at Columbia University, Mailman School of Public Health, and Vagelos College of Physicians & Surgeons, Columbia University , New York, NY ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martina","family":"Penazzato","sequence":"additional","affiliation":[{"name":"Research for Health Department, Science Division, World Health Organization , Geneva ,","place":["Switzerland"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Theodore D","family":"Ruel","sequence":"additional","affiliation":[{"name":"Division of Pediatric Infectious Diseases and Global Health, University of California, San Francisco , San Francisco, CA ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8106-0974","authenticated-orcid":false,"given":"Tim R","family":"Cressey","sequence":"additional","affiliation":[{"name":"AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University , Chiang Mai ,","place":["Thailand"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2024,8,2]]},"reference":[{"key":"2024093023511001000_dkae259-B1"},{"author":"British HIV Association","key":"2024093023511001000_dkae259-B2"},{"author":"World Health Organization.","key":"2024093023511001000_dkae259-B3"},{"key":"2024093023511001000_dkae259-B4"},{"key":"2024093023511001000_dkae259-B5"},{"key":"2024093023511001000_dkae259-B6","doi-asserted-by":"publisher","first-page":"773","DOI":"10.1111\/apa.15557","article-title":"How should we assess renal function in neonates and infants?","volume":"110","author":"Filler","year":"2021","journal-title":"Acta Paediatr"},{"key":"2024093023511001000_dkae259-B7","doi-asserted-by":"publisher","first-page":"e658","DOI":"10.1016\/S2352-3018(22)00101-1","article-title":"Advancing the prevention and treatment of HIV in children: priorities for research and development","volume":"9","author":"Penazzato","year":"2022","journal-title":"Lancet HIV"},{"key":"2024093023511001000_dkae259-B8","doi-asserted-by":"publisher","first-page":"4297","DOI":"10.1128\/AAC.00332-07","article-title":"Population pharmacokinetics of lamivudine in human immunodeficiency virus-exposed and -infected infants","volume":"51","author":"Tremoulet","year":"2007","journal-title":"Antimicrob Agents Chemother"},{"key":"2024093023511001000_dkae259-B9","doi-asserted-by":"publisher","first-page":"500","DOI":"10.1016\/S0022-3476(98)70057-5","article-title":"A randomized study of combined zidovudine-lamivudine versus didanosine monotherapy in children with symptomatic therapy-naive HIV-1 infection.","volume":"133","author":"McKinney","year":"1998","journal-title":"J Pediatr"},{"key":"2024093023511001000_dkae259-B10","doi-asserted-by":"publisher","first-page":"940","DOI":"10.1097\/INF.0b013e3181e2189d","article-title":"A chewable pediatric fixed-dose combination tablet of stavudine, lamivudine, and nevirapine: pharmacokinetics and safety compared with the individual liquid formulations in human immunodeficiency virus-infected children in Thailand","volume":"29","author":"Vanprapar","year":"2010","journal-title":"Pediatr Infect Dis J"},{"author":"IMPAACT. 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