{"doi":"10.1093/cid/ciaa1160","title":"Sex Hormone Therapy and Tenofovir Diphosphate Concentration in Dried Blood Spots: Primary Results of the Interactions Between Antiretrovirals And Transgender Hormones Study","abstract":"BACKGROUND: Sex hormone and preexposure prophylaxis (PrEP) drug interactions among transgender women (TGW), transgender men (TGM), and cisgender men (CGM) are not fully understood. METHODS: TGM and TGW on at least 6 months of stable sex hormone therapy containing testosterone or estradiol (respectively) were enrolled in a 4-week study of directly observed dosing of daily oral coformulated emtricitabine and tenofovir disoproxil fumarate (FTC/TDF). TFV-DP in dried blood spots and sex hormones in serum were measured at weekly intervals. TFV-DP was compared with 2- and 4-week samples from Directly Observed Therapy Dried Blood Spots (DOT-DBS) Study (NCT02022657). RESULTS: From May 2017 to June 2018, 24 TGM and 24 TGW were enrolled. Testosterone (total and free) and estradiol concentrations were comparable before and after 4 weeks of PrEP use in TGM and TGW, respectively. Historical controls included 17 cisgender women (CGW) and 15 CGM. TFV-DP concentrations at week 4 were comparable between TGW and TGM (mean difference, -6%; 95% confidence interval [CI], -21% to 12%; P = .47), comparable between TGW and CGM (mean difference, -12%; 95% CI, -27% to 7%; P = .21) and were lower among TGM compared with CGW (mean difference, -23%; 95% CI, -36% to -7%; P = .007). All persons in all groups were projected to reach the TFV-DP threshold that has been associated with high protection from human immunodeficiency virus. CONCLUSIONS: CGM, TGM, and TGW had comparable TFV-DP concentrations in dried blood spots after 4 weeks of directly observed daily FTC/TDF PrEP use. Serum hormone concentrations were not affected by FTC/TDF PrEP use. CLINICAL TRIALS REGISTRATION: NCT04050371.","journal":"Clinical Infectious Diseases","year":2020,"id":62610,"datarank":2.116140158807176,"base_score":3.9318256327243257,"endowment":3.9318256327243257,"self_citation_contribution":0.5897738449086489,"citation_network_contribution":1.526366313898527,"self_endowment_contribution":0.5897738449086489,"citer_contribution":1.526366313898527,"corpus_percentile":null,"corpus_rank":null,"citation_count":50,"citer_count":36,"citers_with_citation_signal":32,"citers_with_endowment":32,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9426,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT04050371","NCT02022657"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":332901,"name":"Marion Pellegrini","orcid":null,"position":1,"is_corresponding":false},{"id":332902,"name":"Patricia Defechereux","orcid":null,"position":2,"is_corresponding":false},{"id":279022,"name":"Peter L. Anderson","orcid":"0000-0002-1200-8494","position":3,"is_corresponding":false},{"id":331247,"name":"Michelle Yu","orcid":"0000-0002-1512-1994","position":4,"is_corresponding":false},{"id":316641,"name":"David V. Glidden","orcid":"0000-0001-5888-1419","position":5,"is_corresponding":false},{"id":332903,"name":"Joshua D. O’Neal","orcid":null,"position":6,"is_corresponding":false},{"id":318052,"name":"Jenna Yager","orcid":"0000-0001-7841-1465","position":7,"is_corresponding":false},{"id":109414,"name":"Shalender Bhasin","orcid":"0000-0002-3982-6200","position":8,"is_corresponding":false},{"id":255173,"name":"Jae Sevelius","orcid":"0000-0002-8318-038X","position":9,"is_corresponding":false},{"id":331248,"name":"Madeline B. Deutsch","orcid":"0000-0003-3456-9388","position":10,"is_corresponding":false},{"id":59405,"name":"Robert M. Grant","orcid":"0000-0002-0851-7085","position":0,"is_corresponding":true}],"reference_count":30,"raw_metadata":null,"created_at":"2026-07-18T21:10:35.996198Z","pmid":"32766890","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":[]}