{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T11:23:15Z","timestamp":1787570595205,"version":"build-2736575974"},"reference-count":15,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences, Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Antiviral Therapy"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>ARTISTRY-1 is an ongoing Phase 2\/3 study evaluating the safety and efficacy of once-daily oral bictegravir (BIC) + lenacapavir (LEN) in virologically suppressed (VS; HIV-1 RNA &lt;50 copies\/mL) participants on complex antiretroviral (ARV) regimens. Here, we report Week 96 extension-phase data after transition to BIC\/LEN single-tablet regimen (STR).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Participants without known integrase strand-transfer inhibitor (INSTI) resistance were randomized (2:2:1) to BIC + LEN (75mg + 25mg or 75mg + 50mg) or stable background regimen, respectively. At the end of randomized treatment (mean of 69 weeks from baseline), participants could choose to enter the extension period and receive BIC\/LEN 75\/50 mg STR. Baseline resistance-associated mutations (RAMs) were evaluated from cumulative historical genotypic reports (HGRs) and Day 1 proviral DNA genotyping using a composite baseline sequence. Resistance testing was performed for confirmed virologic rebound.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 128 randomized\/dosed participants, 119 entered the extension period and received BIC\/LEN STR for a median time of 96 weeks (range 11\u2013109) from end of randomization to cutoff date. Baseline RAMs were common (nucleoside reverse transcriptase inhibitor 82%, non-nucleoside reverse transcriptase inhibitor 66%, protease inhibitor 47%; INSTI RAMs 9% (proviral DNA)). Two participants met criteria for resistance testing before resuppressing, with no treatment-emergent capsid or integrase RAMs. All 119 participants were suppressed at last observed visit.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Durable viral suppression was maintained for up to 96 weeks in the Phase 2 extension, with all participants in the extension phase maintaining virologic suppression and no treatment-emergent resistance to study drugs, supporting long-term virologic durability of BIC\/LEN STR in VS individuals on complex ART.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13596535261481194","type":"journal-article","created":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T12:59:14Z","timestamp":1787317154000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Week 96 resistance analysis in participants receiving bictegravir\/lenacapavir in the phase 2 ARTISTRY-1 study"],"prefix":"10.1177","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5468-8715","authenticated-orcid":false,"given":"Nina","family":"Pennetzdorfer","sequence":"first","affiliation":[{"name":"Gilead Sciences, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vidula","family":"Naik","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8391-1242","authenticated-orcid":false,"given":"Jairo Mauricio","family":"Montezuma-Rusca","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Sklar","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Callebaut","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas A.","family":"Margot","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,8,21]]},"reference":[{"key":"e_1_3_4_2_2","unstructured":"U. S. Department of Health and Human Services (DHHS). Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. Available at: https:\/\/clinicalinfo.hiv.gov\/sites\/default\/files\/guidelines\/documents\/adult-adolescent-arv\/guidelines-adult-adolescent-arv.pdf. Accessed: 24 September. 2025."},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-021-06919-6"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jve.2020.100021"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02533-18"},{"key":"e_1_3_4_6_2","unstructured":"(EACS) EACS. European AIDS Clinical Society (EACS) Guidelines for the Clinical Management and Treatment of HIV Infected Adults in Europe 2026; 20: 1\u201361."},{"key":"e_1_3_4_7_2","article-title":"Antiretroviral Drugs for Treatment and Prevention of HIV in Adults: 2024 Recommendations of the International Antiviral Society-USA Panel","author":"Gandhi RT","year":"2024","unstructured":"Gandhi RT, Hoy JF, Landovitz RJ, et al. Antiretroviral Drugs for Treatment and Prevention of HIV in Adults: 2024 Recommendations of the International Antiviral Society-USA Panel. JAMA 2024.","journal-title":"JAMA"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02057-20"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkaa060"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciae522"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000004495"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaf161"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofaf446"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.1126\/science.abb4808"},{"key":"e_1_3_4_15_2","unstructured":"Malcolm Hedgcock MB Slim J Ramgopal M et al. Switch to BIC + LEN in Virologically Suppressed People With HIV on Complex Regimens: Week 96 Outcomes. 2026; (Poster 518)."},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(26)00307-7"}],"container-title":["Antiviral Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13596535261481194","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/13596535261481194","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13596535261481194","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T10:46:21Z","timestamp":1787568381000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/13596535261481194"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8]]},"references-count":15,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,8]]}},"alternative-id":["10.1177\/13596535261481194"],"URL":"https:\/\/doi.org\/10.1177\/13596535261481194","relation":{},"ISSN":["1359-6535","2040-2058"],"issn-type":[{"value":"1359-6535","type":"print"},{"value":"2040-2058","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8]]},"article-number":"13596535261481194"}}