{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T13:18:46Z","timestamp":1780406326253,"version":"3.54.1"},"reference-count":17,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,10,6]],"date-time":"2024-10-06T00:00:00Z","timestamp":1728172800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["HIV Medicine"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Treatment for people with HIV\u20101 and end\u2010stage kidney disease (ESKD) on haemodialysis (HD) has previously required complex dose\u2010adjusted regimens, with limited data on the use of a single\u2010tablet regimen in this population. Our aim was to assess the efficacy and safety of once\u2010daily bictegravir\/emtricitabine\/tenofovir alafenamide (B\/F\/TAF) and to evaluate the pharmacokinetics of bictegravir (BIC) in adults with HIV\u20101 and ESKD on HD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We performed an open\u2010label extension (OLE) of an open\u2010label, multicentre, single\u2010group phase 3b study (NCT02600819) of adults with ESKD on HD and HIV\u20101 with virological suppression. Participants switched to elvitegravir\/cobicistat\/F\/TAF (E\/C\/F\/TAF) 150\/150\/200\/10\u2009mg for 96\u2009weeks, following which a subgroup of US participants entered an OLE phase in which they switched to B\/F\/TAF 50\/200\/25\u2009mg for 48\u2009weeks, returning for study visits at weeks 4 and 12, and every 12\u2009weeks thereafter. Study assessments included virological response, safety and pharmacokinetic analysis of BIC.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Ten participants entered the OLE (median age, 55\u2009years). Virological suppression (HIV\u20101 RNA &lt;50 copies\/mL) was maintained in all participants over 48\u2009weeks of B\/F\/TAF treatment. B\/F\/TAF was well tolerated, with no treatment discontinuations. Mean BIC trough concentrations were lower than those previously reported for people with HIV\u20101 with normal kidney function, but remained four\u2010 to seven\u2010fold higher than the established protein\u2010adjusted 95% effective concentration against wild\u2010type HIV\u20101.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>These findings support the use of the once\u2010daily B\/F\/TAF single\u2010tablet regimen for people with HIV\u20101 and ESKD on HD. This regimen offers a convenient treatment option for this population as it reduces the need for dose adjustment, eases pill burden and avoids potential drug\u2013drug interactions associated with alternatives that may impact individuals on multiple medications or awaiting transplantation.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.13721","type":"journal-article","created":{"date-parts":[[2024,10,6]],"date-time":"2024-10-06T23:59:39Z","timestamp":1728259179000},"page":"302-307","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Bictegravir\/emtricitabine\/tenofovir alafenamide in adults with <scp>HIV<\/scp>\u20101 and end\u2010stage kidney disease on chronic haemodialysis"],"prefix":"10.1111","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4938-0644","authenticated-orcid":false,"given":"Joseph J.","family":"Eron","sequence":"first","affiliation":[{"name":"The University of North Carolina at Chapel Hill  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moti","family":"Ramgopal","sequence":"additional","affiliation":[{"name":"Midway Research Center  Fort Pierce Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olayemi","family":"Osiyemi","sequence":"additional","affiliation":[{"name":"Triple O Research Institute P.A  West Palm Beach Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehri","family":"Mckellar","sequence":"additional","affiliation":[{"name":"Duke University Medical Center  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jihad","family":"Slim","sequence":"additional","affiliation":[{"name":"New York Medical College  Valhalla New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edwin","family":"DeJesus","sequence":"additional","affiliation":[{"name":"Orlando Immunology Center  Orlando Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Priyanka","family":"Arora","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christiana","family":"Blair","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason T.","family":"Hindman","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aimee","family":"Wilkin","sequence":"additional","affiliation":[{"name":"Wake Forest University  Winston\u2010Salem North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,10,6]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofw194.90"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cir627"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciu919"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.4065\/82.9.1103"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/0956462418800865"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/ajhp\/zxac339"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(18)30296-0"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)60616-X"},{"issue":"4","key":"e_1_2_10_10_1","first-page":"526","article-title":"Tenofovir alafenamide (TAF) clinical pharmacology","volume":"29","author":"Di Perri G","year":"2021","journal-title":"Infez Med"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000000908"},{"issue":"12","key":"e_1_2_10_12_1","first-page":"CC12","article-title":"Correlation of serum and salivary biochemical parameters in end stage renal disease patients undergoing hemodialysis in pre and post\u2010dialysis state","volume":"8","author":"Seethalakshmi C","year":"2014","journal-title":"J Clin Diagn Res"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-139X.2006.00192.x"},{"key":"e_1_2_10_14_1","unstructured":"US Food and Drug Administration.Office of Clinical Pharmacology Review\u2010BIKTARVY. Accessed October 25 2023https:\/\/www.fda.gov\/media\/155152\/download"},{"key":"e_1_2_10_15_1","unstructured":"Gilead Sciences.Biktarvy 50 mg\/200 mg\/25 mg Film\u2010Coated Tablets: European Summary of Product Characteristics.2023. Accessed July 10 2023https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/biktarvy-epar-product-information_en.pdf"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000001306"},{"key":"e_1_2_10_17_1","unstructured":"Gilead Sciences.BIKTARVY.2022. Accessed July 10 2023https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/210251s013lbl.pdf"},{"key":"e_1_2_10_18_1","unstructured":"US Department of Health and Human Services.Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Accessed May 31 2023.https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/adult-and-adolescent-arv"}],"container-title":["HIV Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hiv.13721","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,1]],"date-time":"2025-02-01T13:22:04Z","timestamp":1738416124000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hiv.13721"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10,6]]},"references-count":17,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025,2]]}},"alternative-id":["10.1111\/hiv.13721"],"URL":"https:\/\/doi.org\/10.1111\/hiv.13721","archive":["Portico"],"relation":{},"ISSN":["1464-2662","1468-1293"],"issn-type":[{"value":"1464-2662","type":"print"},{"value":"1468-1293","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10,6]]},"assertion":[{"value":"2024-06-10","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-09-23","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-10-06","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}