{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T19:34:34Z","timestamp":1775849674577,"version":"3.50.1"},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2023,9,19]],"date-time":"2023-09-19T00:00:00Z","timestamp":1695081600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Spanish AIDS Research Network"},{"name":"Fight Infections Foundation"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,11,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To evaluate the efficacy and safety of the two-pill regimen bictegravir\/emtricitabine\/tenofovir alafenamide (BIC\/FTC\/TAF) plus darunavir\/cobicistat as a switching strategy in heavily treatment-experienced people living with HIV (PLWH).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Multicentre, prospective, single-arm pilot clinical trial. Participants were virologically suppressed adults receiving a stable antiretroviral regimen of at least three pills from at least three drug families due to previous virological failures and\/or toxicities with no documented resistance to integrase strand transfer inhibitors or darunavir (\u226515 points, Stanford). Clinical and laboratory assessments were performed at 0, 4, 12, 24, 36 and 48 weeks. HIV-1 proviral DNA was amplified and sequenced by Illumina at baseline. Plasma bictegravir concentrations were determined in 22 patients using UHPLC-MS\/MS. The primary study endpoint was viral load (VL)&amp;lt;\u200a50 copies\/mL at Week 48 (ITT).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We enrolled 63 participants (92% men) with median baseline CD4 count of 515 cells\/mm3 (IQR: 334.5\u2013734.5), 24 years on ART (IQR: 15.9\u201327.8). The median number of pills was 4 (range: 3\u201310). At baseline, proviral DNA was amplified in 39 participants: 33\/39 had resistance mutations. Three participants discontinued owing to toxicity. At 48 weeks, 95% had VL\u200a&amp;lt;\u200a50 copies\/mL by ITT and 100% by PP analysis. A modest increase was observed in the bictegravir plasma concentration, and a significant decrease in estimated glomerular filtration rate was observed only at Week 4, probably related to interaction with renal transporters.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Our data suggest that BIC\/FTC\/TAF\u200a+\u200adarunavir\/cobicistat is an effective, well-tolerated regimen that may improve convenience and, potentially, long-term success in stable heavily pre-treated PLWH.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jac\/dkad285","type":"journal-article","created":{"date-parts":[[2023,9,19]],"date-time":"2023-09-19T22:33:19Z","timestamp":1695162799000},"page":"2696-2701","source":"Crossref","is-referenced-by-count":9,"title":["Switching to bictegravir\/emtricitabine\/tenofovir alafenamide (BIC\/FTC\/TAF) plus darunavir\/cobicistat in heavily antiretroviral-experienced, virologically suppressed HIV-infected adults receiving complex regimens"],"prefix":"10.1093","volume":"78","author":[{"given":"Daniel","family":"Podzamczer","sequence":"first","affiliation":[{"name":"FLScience, Fight Infections Foundation , Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8411-1952","authenticated-orcid":false,"given":"Arkaitz","family":"Imaz","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Instituto de Investigaci\u00f3n Biom\u00e9dica de Bellvitge (IDIBELL), Hospitalet del Llobregat, Hospital Universitario de Bellvitge, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana","family":"Lopez-Lirola","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital universitario de Canarias , San Crist\u00f3bal de la Laguna, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hernando","family":"Knobel","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital del Mar , Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9878-2458","authenticated-orcid":false,"given":"Mar","family":"Masi\u00e1","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Universitario general de Elche , Elche, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chiara","family":"Fanciulli","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Instituto de Investigaci\u00f3n Sanitaria Gregorio Mara\u00f1\u00f3n (IiSGM), Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Infecciosas (CIBERINFEC), Hospital General Universitario Gregorio Mara\u00f1\u00f3n , Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina","family":"Hern\u00e1ndez","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Pr\u00edncipe de Asturias , Alcal\u00e1 de Henares, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda","family":"Lagarde","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Universitario 12 de Octubre , Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angela","family":"Gutierrez","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Universitario de la Princesa , Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adri\u00e0","family":"Curran","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Universitario Vall d\u2019Hebron , Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luis","family":"Morano","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Universitario \u00c1lvaro Cunqueiro , Vigo, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marta","family":"Montero-Alonso","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Universitario y Polit\u00e9cnico La Fe , Valencia, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7323-114X","authenticated-orcid":false,"given":"Jes\u00fas","family":"Troya","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Universitario Infanta Leonor , Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ra\u00fal","family":"Rigo","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Instituto de Investigaci\u00f3n Biom\u00e9dica de Bellvitge (IDIBELL), Hospitalet del Llobregat, Hospital Universitario de Bellvitge, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda","family":"Casadell\u00e0","sequence":"additional","affiliation":[{"name":"Microbial Genomics Group, IrsiCaixa\u2014Institut de Recerca de la SIDA , Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonio","family":"Navarro-Alcaraz","sequence":"additional","affiliation":[{"name":"Microbial Genomics Group, IrsiCaixa\u2014Institut de Recerca de la SIDA , Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fernando","family":"Ardila","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Instituto de Investigaci\u00f3n Biom\u00e9dica de Bellvitge (IDIBELL), Hospitalet del Llobregat, Hospital Universitario de Bellvitge, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariona","family":"Parera","sequence":"additional","affiliation":[{"name":"Microbial Genomics Group, IrsiCaixa\u2014Institut de Recerca de la SIDA , Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Enrique","family":"Bernal","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Universitario Reina Sof\u00eda , Murcia, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia","family":"Echeverria","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Universitari Germans Trias i Pujol , Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vicente","family":"Estrada","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Cl\u00ednico San Carlos , Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carmen","family":"Hidalgo-Tenorio","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Universitario Virgen de las Nieves , Granada, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4778-790X","authenticated-orcid":false,"given":"Juan","family":"Macias","sequence":"additional","affiliation":[{"name":"Instituto de Biomedicina de Sevilla, Departamento de Medicina, CIBERINFEC, Unidad de Enfermedades Infecciosas y Microbiolog\u00eda, IBiS\/Hospital Universitario Virgen de Valme\/CSIC\/Universidad de Sevilla , Sevilla, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paula","family":"Prieto","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Universitari de la Santa Creu i Sant Pau , Barcelona, 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C\u00f3rdoba (IMIBIC), Universidad de C\u00f3rdoba (UCO) , C\u00f3rdoba , Spain"},{"name":"CIBERINFEC, ISCIII\u2014CIBER de Enfermedades Infecciosas Instituto de Salud Carlos III , Madrid , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2023,9,19]]},"reference":[{"key":"2023110823034268000_dkad285-B1","author":"Panel on Antiretroviral Guidelines for Adults and Adolescents"},{"key":"2023110823034268000_dkad285-B2","author":"EACS"},{"key":"2023110823034268000_dkad285-B3","author":"Panel de expertos de GeSIDA y Divisi\u00f3n de control de VIH, ITS, Hepatitis virales y Tuberculosis. 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