{"doi":"10.1093/jpids/piaf062","title":"Longitudinal Evaluation of Bone Safety in Children and Adolescents With HIV-1 Starting Tenofovir Alafenamide-Containing Antiretroviral Therapy","abstract":"BACKGROUND: 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). METHODS: 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 1 (aged 12 to < 18 years, weighing ≥ 35 kg), group 2 (aged 6 to < 12 years, weighing ≥ 25 kg), and group 3 (aged ≥ 2 years, weighing 14 to < 25 kg). 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. RESULTS: 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 < 50 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. CONCLUSIONS: TAF-based regimens demonstrated acceptable medium- to long-term bone safety in children and adolescents with HIV.","journal":"Journal of the Pediatric Infectious Diseases Society","year":2025,"id":545240,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9038,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":614922,"name":"Aditya H. Gaur","orcid":"0000-0002-6639-5231","position":1,"is_corresponding":false},{"id":346914,"name":"Jaime G. Deville","orcid":"0000-0002-7523-0658","position":2,"is_corresponding":false},{"id":374397,"name":"Pope Kosalaraksa","orcid":"0000-0003-4450-2398","position":3,"is_corresponding":false},{"id":346848,"name":"Renate Strehlau","orcid":"0000-0001-9113-6584","position":4,"is_corresponding":false},{"id":1436072,"name":"Elizabeth Castaño","orcid":"0000-0001-9119-8697","position":5,"is_corresponding":false},{"id":448606,"name":"Afaaf Liberty","orcid":null,"position":6,"is_corresponding":false},{"id":1436514,"name":"Susanne Crowe","orcid":null,"position":7,"is_corresponding":false},{"id":1436073,"name":"Ramesh Palaparthy","orcid":"0000-0003-0567-4445","position":8,"is_corresponding":false},{"id":463971,"name":"Vinícius Vieira","orcid":"0000-0002-4901-0424","position":9,"is_corresponding":false},{"id":1280868,"name":"Kathryn Kersey","orcid":null,"position":10,"is_corresponding":false},{"id":413927,"name":"Natella Rakhmanina","orcid":"0000-0002-2246-4581","position":11,"is_corresponding":false},{"id":78485,"name":"Catherine M. Gordon","orcid":"0000-0002-9280-9143","position":12,"is_corresponding":false},{"id":1436071,"name":"Eva Natukunda","orcid":"0000-0002-2944-5412","position":0,"is_corresponding":true}],"reference_count":35,"raw_metadata":null,"created_at":"2026-07-19T02:53:23.001995Z","pmid":"40632108","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}