{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T19:14:37Z","timestamp":1788290077967,"version":"build-2803163510"},"reference-count":20,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2024,11,26]],"date-time":"2024-11-26T00:00:00Z","timestamp":1732579200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/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":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,4,30]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Complex antiretroviral therapy (ART) regimens, such as those requiring multiple tablets, several doses per day, or both, can negatively affect quality of life and treatment adherence among people with human immunodeficiency virus (HIV).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>ARTISTRY-1 is a phase 2\/3, operationally seamless, randomized, open-label, multicenter, active-controlled study (GS-US-621-6289; NCT05502341). Phase 2 of the study enrolled adults with plasma HIV-1 RNA &amp;lt;50 copies\/mL receiving a complex ART regimen for \u22656 months. Efficacy and safety outcomes were evaluated after a switch to bictegravir (BIC) (75-mg) + lenacapavir (LEN) (25- or 50-mg) regimens, compared with continuing on a complex ART regimen through 24 weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 128 participants were assigned randomly to begin BIC 75 mg + LEN 25 mg (n = 51) or BIC 75 mg + LEN 50 mg (n = 52) or continue on their complex ART regimen (n = 25). At week 24, HIV-1 RNA was \u226550 copies\/mL in 0 of 51, 1 of 52 (1.9%), and 0 of 25 participants in the 3 groups, respectively. CD4 cell counts and percentages remained stable through week 24; the median change from baseline in CD4 cell count (interquartile range) was 18 (\u221239 to 70), \u221216 (\u221280 to 93), and 42 (\u221236 to 90) cells\/\u00b5L, respectively. There were no study discontinuations due to a serious adverse event through week 24. Both BIC + LEN dosing regimens were well tolerated, with similar safety profiles observed between groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These data support the continued evaluation of the combination of BIC and LEN to optimize treatment in people with HIV and virologic suppression who are receiving complex ART regimens.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciae522","type":"journal-article","created":{"date-parts":[[2024,10,30]],"date-time":"2024-10-30T09:20:26Z","timestamp":1730280026000},"page":"881-888","source":"Crossref","is-referenced-by-count":12,"title":["Efficacy and Safety of Switching to Daily Bictegravir Plus Lenacapavir From a Complex HIV Treatment Regimen: A Randomized, Open-Label, Multicenter Phase 2 Study (ARTISTRY-1)"],"prefix":"10.1093","volume":"80","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8537-7103","authenticated-orcid":false,"given":"Karam","family":"Mounzer","sequence":"first","affiliation":[{"name":"The Jonathon Lax Immune Disorders Treatment Center, Philadelphia FIGHT , Philadelphia, Pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4192-7246","authenticated-orcid":false,"given":"Jihad","family":"Slim","sequence":"additional","affiliation":[{"name":"New York Medical College , Valhalla, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moti","family":"Ramgopal","sequence":"additional","affiliation":[{"name":"Midway Immunology and Research Center , Fort Pierce, Florida ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malcolm","family":"Hedgcock","sequence":"additional","affiliation":[{"name":"Spectrum Health , Vancouver, British Columbia ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Bloch","sequence":"additional","affiliation":[{"name":"Holdsworth House Medical Practice , Darlinghurst, New South Wales ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2822-3401","authenticated-orcid":false,"given":"Jorge","family":"Santana","sequence":"additional","affiliation":[{"name":"School of Medicine, University of Puerto Rico , San Juan ,","place":["Puerto Rico"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-7094-7703","authenticated-orcid":false,"given":"Ines","family":"Mendes","sequence":"additional","affiliation":[{"name":"Patient Safety, Gilead Sciences, Inc. , Foster City, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Guo","sequence":"additional","affiliation":[{"name":"Biostatistics, Gilead Sciences, Inc. , Foster City, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-8894-892X","authenticated-orcid":false,"given":"Priyanka","family":"Arora","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Gilead Sciences, Inc. , Foster City, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jairo M","family":"Montezuma-Rusca","sequence":"additional","affiliation":[{"name":"Clinical Development, Gilead Sciences, Inc. , Foster City, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-7071-6942","authenticated-orcid":false,"given":"Peter","family":"Sklar","sequence":"additional","affiliation":[{"name":"Clinical Development, Gilead Sciences, Inc. , Foster City, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jared M","family":"Baeten","sequence":"additional","affiliation":[{"name":"Clinical Development, Gilead Sciences, Inc. , Foster City, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-1113-4977","authenticated-orcid":false,"given":"Sorana","family":"Segal-Maurer","sequence":"additional","affiliation":[{"name":"Medical Affairs, Gilead Sciences, Inc. , Foster City, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,11,26]]},"reference":[{"key":"2025043020395612000_ciae522-B1","author":"Panel on Antiretroviral Guidelines for Adults and Adolescents, Department of Health and Human Services"},{"key":"2025043020395612000_ciae522-B2","doi-asserted-by":"crossref","first-page":"89","DOI":"10.1185\/03007995.2013.844685","article-title":"Single-tablet regimens in HIV: does it really make a difference?","volume":"30","author":"Aldir","year":"2014","journal-title":"Curr Med Res Opin"},{"key":"2025043020395612000_ciae522-B3","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1186\/s12981-018-0204-0","article-title":"A meta-analysis comparing 48-week treatment outcomes of single and multi-tablet antiretroviral regimens for the treatment of people living with HIV","volume":"15","author":"Clay","year":"2018","journal-title":"AIDS Res Ther"},{"key":"2025043020395612000_ciae522-B4","doi-asserted-by":"crossref","first-page":"324","DOI":"10.1089\/aid.2019.0175","article-title":"The dose response: perceptions of people living with HIV in the United States on alternatives to oral daily antiretroviral therapy","volume":"36","author":"Dub\u00e9","year":"2020","journal-title":"AIDS Res Hum Retroviruses"},{"key":"2025043020395612000_ciae522-B5","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1186\/s12879-021-06919-6","article-title":"Durability of single tablet regimen for patients with HIV infection in Southern Taiwan: data from a real-world setting","volume":"22","author":"Chang","year":"2022","journal-title":"BMC Infect Dis"},{"key":"2025043020395612000_ciae522-B6","doi-asserted-by":"crossref","first-page":"100021","DOI":"10.1016\/j.jve.2020.100021","article-title":"Clinical outcomes of HIV-1 infected patients switched from complex multi-tablet regimens to tenofovir alafenamide based single-tablet regimens plus a boosted protease inhibitor in a real-world setting","volume":"6","author":"Rolle","year":"2020","journal-title":"J Virus Erad"},{"key":"2025043020395612000_ciae522-B7","doi-asserted-by":"crossref","first-page":"1297","DOI":"10.1093\/cid\/ciu046","article-title":"Lower pill burden and once-daily antiretroviral treatment regimens for HIV infection: a meta-analysis of randomized controlled trials","volume":"58","author":"Nachega","year":"2014","journal-title":"Clin Infect Dis"},{"key":"2025043020395612000_ciae522-B8","doi-asserted-by":"crossref","first-page":"1397","DOI":"10.1007\/s10461-010-9818-5","article-title":"Once daily dosing improves adherence to antiretroviral therapy","volume":"15","author":"Raboud","year":"2011","journal-title":"AIDS Behav"},{"key":"2025043020395612000_ciae522-B9","doi-asserted-by":"crossref","first-page":"1927","DOI":"10.2147\/PPA.S207908","article-title":"Treatment adherence and persistence among HIV-1 patients newly starting treatment","volume":"13","author":"Hines","year":"2019","journal-title":"Patient Prefer Adherence"},{"key":"2025043020395612000_ciae522-B10","doi-asserted-by":"crossref","first-page":"12","DOI":"10.1186\/s12981-020-00268-1","article-title":"Real-world adherence and persistence for newly-prescribed HIV treatment: single versus multiple tablet regimen comparison among US Medicaid beneficiaries","volume":"17","author":"Cohen","year":"2020","journal-title":"AIDS Res Ther"},{"key":"2025043020395612000_ciae522-B11","author":"European AIDS Clinical Society"},{"key":"2025043020395612000_ciae522-B12","doi-asserted-by":"crossref","first-page":"e02533-18","DOI":"10.1128\/AAC.02533-18","article-title":"Resistance analysis of bictegravir-emtricitabine-tenofovir alafenamide in HIV-1 treatment-naive patients through 48 weeks","volume":"63","author":"Acosta","year":"2019","journal-title":"Antimicrob Agents Chemother"},{"key":"2025043020395612000_ciae522-B13","doi-asserted-by":"crossref","first-page":"e15","DOI":"10.1016\/S2352-3018(22)00291-0","article-title":"Lenacapavir administered every 26 weeks or daily in combination with oral daily antiretroviral therapy for initial treatment of HIV: a randomised, open-label, active-controlled, phase 2 trial","volume":"10","author":"Gupta","year":"2023","journal-title":"Lancet HIV"},{"key":"2025043020395612000_ciae522-B14","doi-asserted-by":"crossref","first-page":"1793","DOI":"10.1056\/NEJMoa2115542","article-title":"Capsid inhibition with lenacapavir in multidrug-resistant HIV-1 infection","volume":"386","author":"Segal-Maurer","year":"2022","journal-title":"N Engl J Med"},{"key":"2025043020395612000_ciae522-B15","author":"Center for Drug Evaluation and Research, US Food and Drug Administration"},{"key":"2025043020395612000_ciae522-B16","doi-asserted-by":"crossref","first-page":"1202","DOI":"10.1111\/j.0006-341X.1999.01202.x","article-title":"Test-based exact confidence intervals for the difference of two binomial proportions","volume":"55","author":"Chan","year":"1999","journal-title":"Biometrics"},{"key":"2025043020395612000_ciae522-B17","doi-asserted-by":"crossref","first-page":"292","DOI":"10.1016\/j.meegid.2016.08.031","article-title":"HIV-1 drug resistance and resistance testing","volume":"46","author":"Clutter","year":"2016","journal-title":"Infect Genet Evol"},{"key":"2025043020395612000_ciae522-B18","doi-asserted-by":"crossref","first-page":"159","DOI":"10.3844\/ajidsp.2006.159.166","article-title":"Metabolic abnormalities associated with the use of protease inhibitors and non-nucleoside reverse transcriptase inhibitors","volume":"2","author":"Rao","year":"2006","journal-title":"Am J Infect Dis"},{"key":"2025043020395612000_ciae522-B19","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1097\/COH.0000000000000713","article-title":"Lenacapavir: a first-in-class HIV-1 capsid inhibitor","volume":"17","author":"Dvory-Sobol","year":"2022","journal-title":"Curr Opin HIV AIDS"},{"key":"2025043020395612000_ciae522-B20","doi-asserted-by":"crossref","first-page":"22","DOI":"10.1186\/s12977-022-00608-1","article-title":"A clinical review of HIV integrase strand transfer inhibitors (INSTIs) for the prevention and treatment of HIV-1 infection","volume":"19","author":"Zhao","year":"2022","journal-title":"Retrovirology"}],"container-title":["Clinical Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/cid\/advance-article-pdf\/doi\/10.1093\/cid\/ciae522\/60812886\/ciae522.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/80\/4\/881\/60812886\/ciae522.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/80\/4\/881\/60812886\/ciae522.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,30]],"date-time":"2025-04-30T20:40:08Z","timestamp":1746045608000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/cid\/article\/80\/4\/881\/7908583"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11,26]]},"references-count":20,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2024,11,26]]},"published-print":{"date-parts":[[2025,4,30]]}},"URL":"https:\/\/doi.org\/10.1093\/cid\/ciae522","relation":{},"ISSN":["1058-4838","1537-6591"],"issn-type":[{"value":"1058-4838","type":"print"},{"value":"1537-6591","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,4,15]]},"published":{"date-parts":[[2024,11,26]]}}}