{"doi":"10.1093/ofid/ofad178","title":"A Randomized Clinical Trial of Transgender Women Switching to B/F/TAF: The (mo)BETTA Trial","abstract":"Abstract Background Cardiometabolic disease in transgender women (TW) is affected by gender-affirming hormonal therapies (GAHTs), HIV, and antiretroviral therapy (ART). We evaluated the 48-week safety/tolerability of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) vs continued ART in TW on GAHT. Methods TW on GAHT and suppressive ART were randomized 1:1 to switch to B/F/TAF (Arm A) or continue current ART (Arm B). Cardiometabolic biomarkers, sex hormones, bone mineral density (BMD) and lean/fat mass by DXA scan, and hepatic fat (controlled continuation parameter [CAP]) were measured. Wilcoxon rank-sum/signed-rank and χ2 tests compared continuous and categorical variables. Results TW (Arm A n = 12, Arm B n = 9) had a median age of 45 years. Ninety-five percent were non-White; 70% were on elvitegravir or dolutegravir, 57% TAF, 24% abacavir, and 19% TDF; 29% had hypertension, 5% diabetes, and 62% dyslipidemia. There were no adverse events. Arm A/B had 91%/89% undetectable HIV-1 RNA at week 48 (w48). Baseline (BL) osteopenia (Arm A/B 42%/25%) and osteoporosis (17%/13%) were common, without significant changes. BL lean/fat mass were similar. At w48, Arm A had stable lean mass but increased limb (3 lbs) and trunk (3 lbs) fat (within-arm P < .05); fat in Arm B remained stable. No changes occurred in lipid or glucose profiles. Arm B had a greater w48 decrease (−25 vs −3 dB/m; P = .03) in CAP. BL and w48 concentrations of all biomarkers were similar. Conclusions In this cohort of TW, switch to B/F/TAF was safe and metabolically neutral, though greater fat gain occurred on B/F/TAF. Further study is needed to better understand cardiometabolic disease burden in TW with HIV.","journal":"Open Forum Infectious Diseases","year":2023,"id":361976,"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":8,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9509,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1098403,"name":"Ana N. Hyatt","orcid":"0000-0001-8041-4331","position":1,"is_corresponding":false},{"id":1098404,"name":"Han Feng","orcid":"0000-0003-3163-8931","position":2,"is_corresponding":false},{"id":247282,"name":"Paula Debroy","orcid":"0000-0001-9887-0300","position":3,"is_corresponding":false},{"id":380905,"name":"Aaren Kettelhut","orcid":"0000-0001-6501-9843","position":4,"is_corresponding":false},{"id":272534,"name":"Hongyu Miao","orcid":"0000-0002-4131-3164","position":5,"is_corresponding":false},{"id":498093,"name":"Liming Peng","orcid":"0000-0002-2327-3605","position":6,"is_corresponding":false},{"id":109414,"name":"Shalender Bhasin","orcid":"0000-0002-3982-6200","position":7,"is_corresponding":false},{"id":1114744,"name":"Susan S. Bell","orcid":"0000-0003-4046-4638","position":8,"is_corresponding":false},{"id":1114745,"name":"Nahid Rianon","orcid":"0000-0003-0075-5836","position":9,"is_corresponding":false},{"id":109430,"name":"Todd T. Brown","orcid":"0000-0001-8599-278X","position":10,"is_corresponding":false},{"id":295813,"name":"Nicholas Funderburg","orcid":"0000-0003-3113-1217","position":11,"is_corresponding":false},{"id":240258,"name":"Jordan E. Lake","orcid":"0000-0002-0640-5514","position":0,"is_corresponding":true}],"reference_count":39,"raw_metadata":null,"created_at":"2026-07-19T01:14:15.063476Z","pmid":"37096146","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":[]}