{"doi":"10.1056/nejmoa2407001","title":"Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women","abstract":null,"journal":"New England Journal of Medicine","year":2024,"id":608945,"datarank":17.72028421688272,"base_score":6.161207321695077,"endowment":6.161207321695077,"self_citation_contribution":0.9241810982542616,"citation_network_contribution":16.79610311862846,"self_endowment_contribution":0.9241810982542616,"citer_contribution":16.79610311862846,"corpus_percentile":null,"corpus_rank":null,"citation_count":473,"citer_count":200,"citers_with_citation_signal":200,"citers_with_endowment":200,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":634065,"name":"Moupali Das","orcid":"0000-0001-5034-8185","position":1,"is_corresponding":false},{"id":385889,"name":"Quarraisha Abdool Karim","orcid":"0000-0002-0985-477X","position":2,"is_corresponding":false},{"id":438005,"name":"Khatija Ahmed","orcid":"0000-0003-0309-1641","position":3,"is_corresponding":false},{"id":1098132,"name":"Joanne Batting","orcid":null,"position":4,"is_corresponding":false},{"id":678228,"name":"William Brumskine","orcid":"0000-0002-1092-9919","position":5,"is_corresponding":false},{"id":307186,"name":"Katherine Gill","orcid":"0000-0002-3372-9506","position":6,"is_corresponding":false},{"id":874487,"name":"Ishana Harkoo","orcid":null,"position":7,"is_corresponding":false},{"id":889747,"name":"Manjeetha Jaggernath","orcid":null,"position":8,"is_corresponding":false},{"id":319101,"name":"Godfrey Kigozi","orcid":null,"position":9,"is_corresponding":false},{"id":363888,"name":"Noah Kiwanuka","orcid":"0000-0003-2471-9290","position":10,"is_corresponding":false},{"id":853695,"name":"Philip Kotze","orcid":null,"position":11,"is_corresponding":false},{"id":407346,"name":"Limakatso Lebina","orcid":"0000-0001-6825-0573","position":12,"is_corresponding":false},{"id":1564617,"name":"Cheryl E. 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Baeten","orcid":"0000-0001-8242-8438","position":38,"is_corresponding":false},{"id":459398,"name":"Flavia Matovu Kiweewa","orcid":"0000-0002-0046-4353","position":39,"is_corresponding":false},{"id":273592,"name":"Linda‐Gail Bekker","orcid":"0000-0002-0755-4386","position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women","abstract":"BACKGROUND: There are gaps in uptake of, adherence to, and persistence in the use of preexposure prophylaxis for human immunodeficiency virus (HIV) prevention among cisgender women. METHODS: We conducted a phase 3, double-blind, randomized, controlled trial involving adolescent girls and young women in South Africa and Uganda. Participants were assigned in a 2:2:1 ratio to receive subcutaneous lenacapavir every 26 weeks, daily oral emtricitabine-tenofovir alafenamide (F/TAF), or daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF; active control); all participants also received the alternate subcutaneous or oral placebo. We assessed the efficacy of lenacapavir and F/TAF by comparing the incidence of HIV infection with the estimated background incidence in the screened population and evaluated relative efficacy as compared with F/TDF. RESULTS: Among 5338 participants who were initially HIV-negative, 55 incident HIV infections were observed: 0 infections among 2134 participants in the lenacapavir group (0 per 100 person-years; 95% confidence interval [CI], 0.00 to 0.19), 39 infections among 2136 participants in the F/TAF group (2.02 per 100 person-years; 95% CI, 1.44 to 2.76), and 16 infections among 1068 participants in the F/TDF group (1.69 per 100 person-years; 95% CI, 0.96 to 2.74). Background HIV incidence in the screened population (8094 participants) was 2.41 per 100 person-years (95% CI, 1.82 to 3.19). HIV incidence with lenacapavir was significantly lower than background HIV incidence (incidence rate ratio, 0.00; 95% CI, 0.00 to 0.04; P<0.001) and than HIV incidence with F/TDF (incidence rate ratio, 0.00; 95% CI, 0.00 to 0.10; P<0.001). HIV incidence with F/TAF did not differ significantly from background HIV incidence (incidence rate ratio, 0.84; 95% CI, 0.55 to 1.28; P = 0.21), and no evidence of a meaningful difference in HIV incidence was observed between F/TAF and F/TDF (incidence rate ratio, 1.20; 95% CI, 0.67 to 2.14). Adherence to F/TAF and F/TDF was low. No safety concerns were found. Injection-site reactions were more common in the lenacapavir group (68.8%) than in the placebo injection group (F/TAF and F/TDF combined) (34.9%); 4 participants in the lenacapavir group (0.2%) discontinued the trial regimen owing to injection-site reactions. CONCLUSIONS: No participants receiving twice-yearly lenacapavir acquired HIV infection. HIV incidence with lenacapavir was significantly lower than background HIV incidence and HIV incidence with F/TDF. (Funded by Gilead Sciences; PURPOSE 1 ClinicalTrials.gov number, NCT04994509.).","is_dataset_classified":null,"base_score":6.126869184114185,"endowment":6.126869184114185,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"39046157","pmcid":null,"openalex_id":"https://openalex.org/W4400958746","authors":[],"funders":[],"total_grants":0,"fwci":138.5533,"citation_percentile":0.99997931,"influential_citations":0,"citation_trend":[{"year":2024,"count":72},{"year":2025,"count":251},{"year":2026,"count":134}],"oa_status":"closed","license":"http://www.nejmgroup.org/legal/terms-of-use.htm","oa_locations":[{"url":"http://www.nejm.org/doi/pdf/10.1056/NEJMoa2407001","host_type":"publisher"},{"url":"https://doi.org/10.1056/nejmoa2407001","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/39046157","host_type":"repository"}],"fields_of_study":["HIV/AIDS Research and Interventions","HIV/AIDS drug development and treatment","HIV Research and Treatment","Adolescent","Adult","Female","Humans","Young Adult","Adenine","Administration, Oral","Anti-HIV Agents","Double-Blind Method","Drug Administration Schedule","Emtricitabine","Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination","HIV Infections","Incidence","Injections, Subcutaneous","Pre-Exposure Prophylaxis","South Africa","Tenofovir","Uganda","Injection Site Reaction","Drug Monitoring"],"mesh_terms":["Emtricitabine","Tenofovir","Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination","Injection Site Reaction","Assessment of Medication Adherence","Adenine","Administration, Oral","Adolescent","Adult","Alanine","Double-Blind Method","Drug Administration Schedule","Female","Humans","Injections, Subcutaneous","South Africa","Uganda","HIV Infections","Incidence","Drug Monitoring","Anti-HIV Agents","Medication Adherence","Young Adult","Pre-Exposure Prophylaxis"],"keywords":["Human immunodeficiency virus (HIV)","Psychology","Gerontology","Environmental science","Medicine","Virology"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Gender equality"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-07-31T00:57:28.246393Z","pmid":null,"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":[]}