{"doi":"10.1101/2020.05.13.091694","title":"Preventive efficacy of a tenofovir alafenamide fumarate nanofluidic implant in SHIV-challenged nonhuman primates","abstract":"Abstract Pre-exposure prophylaxis (PrEP) using antiretroviral oral drugs is effective at preventing HIV transmission when individuals adhere to the dosing regimen. Tenofovir alafenamide (TAF) is a potent antiretroviral drug, with numerous long-acting (LA) delivery systems under development to improve PrEP adherence. However, none has undergone preventive efficacy assessment. Here we show that LA TAF using a novel subcutaneous nanofluidic implant (nTAF) confers partial protection from HIV transmission. We demonstrate that sustained subcutaneous delivery through nTAF in rhesus macaques maintained tenofovir diphosphate concentration at a median of 390.00 fmol/10 6 peripheral blood mononuclear cells, 9 times above clinically protective levels. In a non-blinded, placebo-controlled rhesus macaque study with repeated low-dose rectal SHIV SF162P3 challenge, the nTAF cohort had a 62.50% reduction (95% CI: 1.72% to 85.69%; p =0.068) in risk of infection per exposure compared to the control. Our finding mirrors that of tenofovir disoproxil fumarate (TDF) monotherapy, where 60.00% protective efficacy was observed in macaques, and clinically, 67.00% reduction in risk with 86.00% preventive efficacy in individuals with detectable drug in the plasma. Overall, our nanofluidic technology shows potential as a subcutaneous delivery platform for long-term PrEP and provides insights for clinical implementation of LA TAF for HIV prevention.","journal":"bioRxiv (Cold Spring Harbor Laboratory)","year":2020,"id":119614,"datarank":0.4335557636844247,"base_score":2.8903717578961645,"endowment":2.8903717578961645,"self_citation_contribution":0.4335557636844247,"citation_network_contribution":0.0,"self_endowment_contribution":0.4335557636844247,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":17,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9525,"is_data_producer":false,"deposit_databanks":null,"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":279016,"name":"Antons Sizovs","orcid":"0000-0001-6495-6317","position":1,"is_corresponding":false},{"id":279017,"name":"Kathryn A. Shelton","orcid":"0000-0002-1754-1423","position":2,"is_corresponding":false},{"id":279018,"name":"Zoha Momin","orcid":"0000-0002-2247-7665","position":3,"is_corresponding":false},{"id":280276,"name":"Lane R. Bushman","orcid":null,"position":4,"is_corresponding":false},{"id":279019,"name":"Jiaqiong Xu","orcid":"0000-0002-3463-2327","position":5,"is_corresponding":false},{"id":362382,"name":"Corrine Ying Xuan Chua","orcid":"0000-0002-5724-8715","position":6,"is_corresponding":false},{"id":424235,"name":"Joan E. Nichols","orcid":"0000-0002-3753-6074","position":7,"is_corresponding":false},{"id":280277,"name":"Trevor Hawkins","orcid":null,"position":8,"is_corresponding":false},{"id":255291,"name":"James F. Rooney","orcid":"0000-0003-3261-0711","position":9,"is_corresponding":false},{"id":279020,"name":"Mark A. Marzinke","orcid":"0000-0003-1670-8786","position":10,"is_corresponding":false},{"id":279021,"name":"Jason T. Kimata","orcid":"0000-0002-0504-0090","position":11,"is_corresponding":false},{"id":279022,"name":"Peter L. Anderson","orcid":"0000-0002-1200-8494","position":12,"is_corresponding":false},{"id":279023,"name":"Pramod N. Nehete","orcid":"0000-0002-2815-2677","position":13,"is_corresponding":false},{"id":279024,"name":"Roberto C. Arduino","orcid":"0000-0002-7381-844X","position":14,"is_corresponding":false},{"id":57875,"name":"Mauro Ferrari","orcid":null,"position":15,"is_corresponding":false},{"id":279025,"name":"K. Jagannadha Sastry","orcid":"0000-0002-6987-4422","position":16,"is_corresponding":false},{"id":279026,"name":"Alessandro Grattoni","orcid":"0000-0001-7888-422X","position":17,"is_corresponding":false},{"id":279014,"name":"Fernanda P. Pons‐Faudoa","orcid":"0000-0002-5135-9481","position":0,"is_corresponding":true}],"reference_count":37,"raw_metadata":{"citation_network_status":"fetched"},"created_at":"2026-07-18T23:14:13.002105Z","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":[]}