{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T22:38:14Z","timestamp":1787870294524,"version":"build-2784847793"},"reference-count":41,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2025,7,9]],"date-time":"2025-07-09T00:00:00Z","timestamp":1752019200000},"content-version":"vor","delay-in-days":8,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Gilead Sciences, Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,8,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Adult participants taking tenofovir alafenamide (TAF) in clinical trials had a better bone safety profile than those taking tenofovir disoproxil fumarate. Herein, we report medium- to long-term effects of TAF-containing regimens on bone health in children and adolescents with human immunodeficiency virus (HIV).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This post hoc pooled analysis of data from 2 phase 2\/3 clinical studies (NCT01854775 and NCT02285114) evaluated the pharmacokinetics, safety, and efficacy of TAF-based regimens in children and adolescents with HIV-1. Participants were categorized into group\u00a01 (aged 12 to\u2009&amp;lt;\u200918\u00a0years, weighing\u2009\u2265\u200935\u00a0kg), group\u00a02 (aged 6 to\u2009&amp;lt;\u200912\u00a0years, weighing\u2009\u2265\u200925\u00a0kg), and group\u00a03 (aged\u2009\u2265\u20092\u00a0years, weighing 14 to\u2009&amp;lt;\u200925\u00a0kg). Evaluations included virologic suppression, height Z-score, Tanner stage, bone mineral density (BMD) of the spine and total body less head (TBLH; absolute and height-for-age Z-score adjusted [HAZ-adjusted] for both), bone serum markers, bone-related adverse events, and pharmacokinetic assessments.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Overall, 169 participants were enrolled and treated (78, 61, and 30 in groups 1, 2, and 3, respectively). Median (range) exposure to study drug was 320.3 (8.3-492.3), 290.1 (24.0-393.9), and 168.3 (9.0-193.0) weeks in groups 1, 2, and 3, respectively. Virologic suppression (HIV-1 RNA\u2009&amp;lt;\u200950 copies\/mL) rates were high across all groups. Spine and TBLH absolute BMD increased over time in all groups, and spine and TBLH HAZ-adjusted BMD Z-scores increased or remained stable in all groups. There were no significant changes in bone serum markers, and no treatment-related fractures or bone-related adverse events.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>TAF-based regimens demonstrated acceptable medium- to long-term bone safety in children and adolescents with HIV.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jpids\/piaf062","type":"journal-article","created":{"date-parts":[[2025,7,8]],"date-time":"2025-07-08T07:33:29Z","timestamp":1751960009000},"source":"Crossref","is-referenced-by-count":3,"title":["Longitudinal Evaluation of Bone Safety in Children and Adolescents With HIV-1 Starting Tenofovir Alafenamide-Containing Antiretroviral Therapy"],"prefix":"10.1093","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2944-5412","authenticated-orcid":false,"given":"Eva","family":"Natukunda","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Joint Clinical Research Centre , Kampala ,","place":["Uganda"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6639-5231","authenticated-orcid":false,"given":"Aditya H","family":"Gaur","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, St. Jude Children\u2019s Research Hospital , Memphis, TN ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaime Gerardo","family":"Deville","sequence":"additional","affiliation":[{"name":"Mattel Children\u2019s Hospital, University of California , Los Angeles, Los Angeles, CA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4450-2398","authenticated-orcid":false,"given":"Pope","family":"Kosalaraksa","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Khon Kaen University , Khon Kaen ,","place":["Thailand"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renate","family":"Strehlau","sequence":"additional","affiliation":[{"name":"VIDA Nkanyezi Research Unit, Department of Paediatrics, University of the Witwatersrand , Johannesburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Casta\u00f1o","sequence":"additional","affiliation":[{"name":"Department of Medicine, Hospital del Ni\u00f1o , Panama City ,","place":["Panama"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Afaaf","family":"Liberty","sequence":"additional","affiliation":[{"name":"Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital , Johannesburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susanne","family":"Crowe","sequence":"additional","affiliation":[{"name":"Biostatistics, Clinical Data Science, Gilead Sciences, Inc. ,","place":["Foster City, CA, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramesh","family":"Palaparthy","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Gilead Sciences, Inc. , Foster City, CA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4901-0424","authenticated-orcid":false,"given":"Vinicius Adriano","family":"Vieira","sequence":"additional","affiliation":[{"name":"Virology Clinical Development, Gilead Sciences, Inc. , Foster City, CA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn","family":"Kersey","sequence":"additional","affiliation":[{"name":"Clinical Development, Gilead Sciences, Inc. , Foster City, CA ,","place":["United 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