{"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":1787870294292,"version":"build-2784847793"},"reference-count":42,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2023,2,23]],"date-time":"2023-02-23T00:00:00Z","timestamp":1677110400000},"content-version":"vor","delay-in-days":22,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Int AIDS Soc."],"published-print":{"date-parts":[[2023,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Tenofovir alafenamide (TAF) is approved for paediatric use in fixed\u2010dose combination tablets, but efficacy and safety data in children are limited. We conducted a systematic review on the efficacy\/effectiveness and safety of TAF in infants, children and adolescents living with HIV.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We searched MEDLINE, Embase, the Cochrane Library, clinical trial registries, reference lists and relevant conferences to identify literature published January 2009\u2013March 2021. We included clinical trials and observational studies assessing the efficacy\/effectiveness or safety of TAF through \u22656 months of treatment in participants aged 0\u201319 years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results and discussion<\/jats:title>\n                    <jats:p>\n                      Overall 3626 abstracts and 371 full papers were screened. Four single\u2010arm, innovator\u2010funded trials (341 participants) and a pooled analysis of those trials were identified. All four trials included treatment\u2010experienced and virally suppressed children or adolescents. One trial also included treatment\u2010na\u00efve adolescents with baseline viral load &gt;1000 copies\/ml. The risk of bias was rated as low in one study and unclear in the other three owing to missing data on study design (all conference presentations). At 48 weeks, 92% (46\/50) of treatment\u2010na\u00efve participants were virally suppressed (one trial). Among treatment\u2010experienced participants with viral load at 48 weeks, 214 of 224 participants were virally suppressed. Across the studies, one grade 3\/4 adverse event was considered drug\u2010related (intermediate uveitis). There were three discontinuations for adverse events (grade 2 anxiety and insomnia, grade 1 iridocyclitis [drug\u2010related] and grade 1 pulmonary tuberculosis [unrelated to treatment]). One accidental death occurred across the four studies. In the pooled analysis of 223 participants, the median change in bone mineral density\n                      <jats:italic>z<\/jats:italic>\n                      \u2010score (height\u2010 and age\u2010adjusted) from baseline to 48 weeks was \u22120.12 (interquartile range [IQR] \u22120.46, 0.17) to 0.05 (IQR not reported) for spine, and \u22120.09 (IQR \u22120.33, 0.07) to 0.09 (IQR not reported) for total body less head. Weight\u2010for\u2010age\n                      <jats:italic>z<\/jats:italic>\n                      \u2010scores increased by 0.25 from baseline to 48 weeks.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Four single\u2010arm trials were identified in this systematic review, with initial evidence suggesting good viral suppression and no obvious safety concerns in children and adolescents on TAF\u2010containing regimens over 24\u201348 weeks. However, further comparative and longer\u2010term safety data are needed in children and adolescents, including on weight and metabolic changes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jia2.26037","type":"journal-article","created":{"date-parts":[[2023,2,23]],"date-time":"2023-02-23T23:30:02Z","timestamp":1677195002000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Effectiveness and safety of tenofovir alafenamide in children and adolescents living with HIV: a systematic review"],"prefix":"10.1002","volume":"26","author":[{"given":"John","family":"O'Rourke","sequence":"first","affiliation":[{"name":"Consultants to the World Health Organization  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3214-7755","authenticated-orcid":false,"given":"Claire L.","family":"Townsend","sequence":"additional","affiliation":[{"name":"Consultants 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UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3176-5295","authenticated-orcid":false,"given":"Ali","family":"Judd","sequence":"additional","affiliation":[{"name":"MRC Clinical Trials Unit at UCL University College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marissa","family":"Vicari","sequence":"additional","affiliation":[{"name":"International AIDS Society  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9461-2520","authenticated-orcid":false,"given":"Julie","family":"Jesson","sequence":"additional","affiliation":[{"name":"Centre for Epidemiology and Research in POPulation Health (CERPOP) Inserm, Universit\u00e9 de Toulouse Universit\u00e9 Paul Sabatier  Toulouse 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