{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T22:38:11Z","timestamp":1787870291721,"version":"build-2784847793"},"reference-count":20,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,1,30]],"date-time":"2025-01-30T00:00:00Z","timestamp":1738195200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,1,30]],"date-time":"2025-01-30T00:00:00Z","timestamp":1738195200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Int AIDS Soc."],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Elvitegravir\/cobicistat\/emtricitabine\/tenofovir alafenamide (E\/C\/F\/TAF) was efficacious and well tolerated in children\/adolescents with HIV (aged \u22656\u00a0years, weighing \u226525\u00a0kg) in a Phase 2\/3 study. Here, we report data from children aged \u22652\u00a0years and weighing \u226514\u2013&lt;25\u00a0kg.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This is an analysis of data from the youngest cohort in an open\u2010label, multicentre, multi\u2010cohort, single\u2010group, international study of children\/adolescents with HIV. Participants in this cohort were children aged \u22652\u00a0years, weighing \u226514\u2013&lt;25\u00a0kg at screening and able to swallow tablets, on stable antiretroviral therapy with virologic suppression (HIV\u20101 RNA &lt;50 copies\/ml for \u22656 consecutive months) and a CD4 count \u2265400 cells\/\u00b5l. Eligible participants received low\u2010dose E\/C\/F\/TAF (90\/90\/120\/6 mg) once daily through Week 48. The study included pharmacokinetic evaluation of the low\u2010dose E\/C\/F\/TAF tablet at Week 2. Safety, efficacy, palatability and acceptability were also evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Between 16 January and 25 November 2019, 27 participants were enrolled with a median (quartile [Q]1, Q3) age of 6 (4, 8)\u00a0years, body weight of 19.3 (17.0, 20.5)\u00a0kg, CD4 count of 1061 (895, 1315) cells\/\u00b5l and CD4 cell percentage of 37.4 (30.6, 40.3). Most (92.6%) participants acquired HIV through vertical transmission. On 6 October 2020 (data\u2010cut), median (Q1, Q3) exposure to E\/C\/F\/TAF was 48.3 (48.0, 60.1) weeks. Pharmacokinetic parameters were within the safe and efficacious range of previous data in adult and paediatric populations. Drug\u2010related treatment\u2010emergent adverse events occurred in 4\/27 (15%) participants. There were no Grade 3\/4 adverse events, or adverse events leading to E\/C\/F\/TAF discontinuation. One participant experienced a serious treatment\u2010emergent adverse event (Grade 2 pneumonia not considered E\/C\/F\/TAF related). Virologic suppression (US FDA Snapshot algorithm) was maintained by 26\/27 (96%) participants at Weeks 24 and 48. At Week 48, most children reported positive palatability (84.6%) and acceptability (96.2%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These data support the use of single\u2010tablet E\/C\/F\/TAF (90\/90\/120\/6 mg) regimen for the treatment of HIV in children aged \u22652\u00a0years and weighing \u226514\u2013&lt;25\u00a0kg.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Number<\/jats:title>\n                    <jats:p>NCT01854775<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jia2.26414","type":"journal-article","created":{"date-parts":[[2025,1,31]],"date-time":"2025-01-31T02:22:02Z","timestamp":1738290122000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacokinetics, safety and efficacy of elvitegravir\/cobicistat\/emtricitabine\/tenofovir alafenamide in children with HIV aged from 2 years and weighing at least 14 kg"],"prefix":"10.1002","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2944-5412","authenticated-orcid":false,"given":"Eva","family":"Natukunda","sequence":"first","affiliation":[{"name":"Department of Paediatrics Joint Clinical Research Centre  Kampala Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aditya H.","family":"Gaur","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases St. Jude Children's Research Hospital  Memphis Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pope","family":"Kosalaraksa","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Faculty of Medicine Khon Kaen University  Khon Kaen Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Hellstr\u00f6m","sequence":"additional","affiliation":[{"name":"Be Part Yoluntu Centre  Paarl South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renate","family":"Strehlau","sequence":"additional","affiliation":[{"name":"Department of Paediatrics and Child Health University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Afaaf","family":"Liberty","sequence":"additional","affiliation":[{"name":"Chris Hani Baragwanath Hospital  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Cox","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rory","family":"Leisegang","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramesh","family":"Palaparthy","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susanne","family":"Crowe","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vinicius","family":"Vieira","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn","family":"Kersey","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natella","family":"Rakhmanina","sequence":"additional","affiliation":[{"name":"Children's National Hospital  Washington DC USA"},{"name":"The George Washington University  Washington DC USA"},{"name":"Elizabeth Glaser Pediatric AIDS Foundation  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,1,30]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"UNAIDS.The urgency of now: AIDS at a crossroads \u2014 2024 global AIDS update.2024. Accessed 31 July 2024. Available from:https:\/\/www.unaids.org\/en\/resources\/documents\/2024\/global\u2010aids\u2010update\u20102024"},{"key":"e_1_2_11_3_1","unstructured":"UNICEF.Global and regional trends.2024. Accessed 31 July 2024. Available from:https:\/\/data.unicef.org\/topic\/hivaids\/global\u2010regional\u2010trends\/"},{"key":"e_1_2_11_4_1","unstructured":"World Health Organization.Global HIV programme. Treatment and care in children and adolescents.2022. Accessed 17 April 2024. Available from:https:\/\/www.who.int\/teams\/global\u2010hiv\u2010hepatitis\u2010and\u2010stis\u2010programmes\/hiv\/treatment\/treatment\u2010and\u2010care\u2010in\u2010children\u2010and\u2010adolescents"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2021-321831"},{"key":"e_1_2_11_6_1","unstructured":"Gilead Sciences Inc.Genvoya\u00ae: US prescribing information.2022. Accessed 17 April 2024. Available from:https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/207561s029lbl.pdf"},{"key":"e_1_2_11_7_1","unstructured":"Gilead Sciences Ireland UC.Genvoya\u00ae: European summary of product characteristics.2020. Accessed 17 April 2024. Available from:https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/genvoya\u2010epar\u2010product\u2010information_en.pdf"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(16)30121-7"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-4642(17)30009-3"},{"issue":"246","key":"e_1_2_11_10_1","first-page":"1","article-title":"2000 CDC growth charts for the United States: methods and development","volume":"11","author":"Kuczmarski RJ","year":"2002","journal-title":"Vital Health Stat"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1155\/2016\/1654938"},{"key":"e_1_2_11_12_1","unstructured":"Department of Health and Human Services.Guidelines for the use of antiretroviral agents in pediatric HIV infection.2024. Accessed 5 December 2024. Available from:https:\/\/clinicalinfo.hiv.gov\/sites\/default\/files\/guidelines\/documents\/pediatric\u2010arv\/guidelines\u2010pediatric\u2010arv.pdf"},{"issue":"8","key":"e_1_2_11_13_1","first-page":"783","article-title":"Antiretroviral therapy in children and adolescents: a look into modern single tablet regimens","volume":"26","author":"Lee C","year":"2021","journal-title":"J Pediatr Pharmacol Ther"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(23)00327-2"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)60616-X"},{"issue":"7","key":"e_1_2_11_16_1","first-page":"14","article-title":"Keeping hospitals afloat","volume":"10","author":"Shearer C","year":"2003","journal-title":"Fam Pract Manag"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2017-00197"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2023.101991"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm11061604"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1038\/ejcn.2016.38"},{"key":"e_1_2_11_21_1","unstructured":"European AIDS Clinical Society.EACS Guidelines v12.1.2024. Updated November 2024. Accessed 13 December 2024. Available from:https:\/\/eacs.sanfordguide.com\/"}],"container-title":["Journal of the International AIDS Society"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jia2.26414","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jia2.26414","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jia2.26414","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T22:12:41Z","timestamp":1783116761000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jia2.26414"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1,30]]},"references-count":20,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025,2]]}},"alternative-id":["10.1002\/jia2.26414"],"URL":"https:\/\/doi.org\/10.1002\/jia2.26414","archive":["Portico"],"relation":{},"ISSN":["1758-2652","1758-2652"],"issn-type":[{"value":"1758-2652","type":"print"},{"value":"1758-2652","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1,30]]},"assertion":[{"value":"2024-04-18","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-01-15","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-01-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e26414"}}