{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,21]],"date-time":"2026-01-21T21:44:35Z","timestamp":1769031875660,"version":"3.49.0"},"reference-count":31,"publisher":"Public Library of Science (PLoS)","issue":"9","license":[{"start":{"date-parts":[[2025,9,22]],"date-time":"2025-09-22T00:00:00Z","timestamp":1758499200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","award":["ISR-ES-19-10727"],"award-info":[{"award-number":["ISR-ES-19-10727"]}],"id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The BICNOW clinical trial evaluated the effectiveness, safety, satisfaction, adherence to treatment, and retention in the system of a rapid initiation strategy with bictegravir\/emtricitabine\/tenofovir alafenamide (BIC\/FTC\/TAF) in na\u00efve HIV-infected individuals. It also assessed the burden of this infection on individuals and healthcare systems using various instruments, participant questionnaires, and pharmacoeconomic evaluations of this antiretroviral therapy (ART). This substudy focused on changes in the health-related quality of life (HRQoL) of participants and on the economic impact of this rapid initiation strategy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methods and Findings<\/jats:title>\n                    <jats:p>Patients were recruited for this phase IV, multicenter, open, single-branch clinical trial with 48-week follow-up between November 2020 and July 2022. HRQoL data were gathered using EQ-5D-3L and dichotomized HIV-SI questionnaires. In the cost-utility pharmacoeconomic analysis, data in the literature were used for comparators. The 208 participants had a mean age of 34 (27\u201344) years, 87\u00b75% were male, 42\u00b79% had completed higher education, and 67\u00b71% were employed. The mean EQ-5D questionnaire score was significantly increased at 48 weeks versus baseline (0\u00b7940\u2009\u00b1\u20090\u00b7117 vs. 0\u00b7959\u2009\u00b1\u20090\u00b7083, p\u2009=\u20090\u00b7012), and the utility value in quality-adjusted life years (QALYs) was 0\u00b7877\u2009\u00b1\u20090\u00b7093. There was a significant improvement in the \u201cusual activities\u201d dimension (10\u00b78 vs 4\u00b71% p\u2009=\u20090\u00b7036). The Moses extreme reaction test showed a significant difference in all dimensions between participants in AIDS versus non-AIDS stage (p\u2009&lt;\u20090\u00b7001). HIV-SI results revealed a significantly smaller percentage of participants with bothersome symptoms at 48 weeks (75\u00b74 vs. 62\u00b72%, p\u2009=\u20090\u00b7035). The pharmacoeconomic study indicated a value of \u20ac6,550\u00b721\/QALY gained with this ART.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>BIC\/FTC\/TAF is an appropriate rapid initiation strategy in na\u00efve PLHIV that improves their quality of life. It is pharmacoeconomically feasible and offers superior long-term health outcomes in comparison to other approaches. (NCT06177574).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0323167","type":"journal-article","created":{"date-parts":[[2025,9,22]],"date-time":"2025-09-22T17:32:06Z","timestamp":1758562326000},"page":"e0323167","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Impact of bictegravir\/emtricitabine\/tenofovir alafenamide on health-related quality of life and economic outcomes in HIV care: Substudy of the BIC-NOW clinical trial"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2780-8475","authenticated-orcid":true,"given":"Sergio","family":"Sequera-Arquelladas","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda J.","family":"Vivancos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Vinuesa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1677-8170","authenticated-orcid":true,"given":"Antonio","family":"Collado","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ignacio De Los","family":"Santos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia","family":"Sorni","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noemi","family":"Cabello-Clotet","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3432-5394","authenticated-orcid":true,"given":"Marta","family":"Montero","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4906-4921","authenticated-orcid":true,"given":"Carlos Ramos","family":"Font","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alberto","family":"Terron","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Jos\u00e9","family":"Galindo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Onofre","family":"Martinez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pablo","family":"Ryan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohamed","family":"Omar-Mohamed","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helena","family":"Albend\u00edn-Iglesias","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rosario","family":"Javier","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alberto","family":"Romero","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Coral Garc\u00eda","family":"Vallecillos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miguel \u00c1ngel","family":"Calleja","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carmen","family":"Hidalgo-Tenorio","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2025,9,22]]},"reference":[{"issue":"1","key":"pone.0323167.ref001","doi-asserted-by":"crossref","first-page":"84","DOI":"10.1186\/s12955-022-01978-y","article-title":"Problems undermining the health-related quality of life of people living with HIV in Spain: a qualitative study to inform the development of a novel clinic screening tool","volume":"20","author":"K Safreed-Harmon","year":"2022","journal-title":"Health Qual Life Outcomes"},{"issue":"1","key":"pone.0323167.ref002","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1186\/s12916-016-0640-4","article-title":"Beyond viral suppression of HIV - the new quality of life frontier","volume":"14","author":"JV Lazarus","year":"2016","journal-title":"BMC Med"},{"issue":"9","key":"pone.0323167.ref003","doi-asserted-by":"crossref","first-page":"795","DOI":"10.1056\/NEJMoa1506816","article-title":"Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection","volume":"373","author":"insight Start Study Group","year":"2015","journal-title":"N Engl J Med"},{"key":"pone.0323167.ref004","unstructured":"EACS Guidelines 2023. In: EACS Guidelines [Internet]. 2023 [cited 21 Apr 2024]. Available: https:\/\/eacs.sanfordguide.com"},{"issue":"12","key":"pone.0323167.ref005","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0081355","article-title":"Closing the gap: increases in life expectancy among treated HIV-positive individuals in the United States and Canada","volume":"8","author":"H Samji","year":"2013","journal-title":"PLoS One"},{"key":"pone.0323167.ref006","unstructured":"EuroQol Research Foundation. EQ-5D instruments. 2018. Available from: https:\/\/euroqol.org"},{"key":"pone.0323167.ref007","article-title":"Development and validation of a self-completed HIV symptom index","author":"AC Justice","year":"2001","journal-title":"J Clin Epidemiol"},{"issue":"1","key":"pone.0323167.ref008","doi-asserted-by":"crossref","first-page":"834","DOI":"10.1186\/s12913-019-4613-0","article-title":"Economic evaluation studies in the field of HIV\/AIDS: bibliometric analysis on research development and scopes (GAPRESEARCH)","volume":"19","author":"BX Tran","year":"2019","journal-title":"BMC Health Serv Res"},{"issue":"6","key":"pone.0323167.ref009","doi-asserted-by":"crossref","first-page":"107164","DOI":"10.1016\/j.ijantimicag.2024.107164","article-title":"Bictegravir\/emtricitabine\/tenofovir alafenamide as first-line treatment in na\u00efve HIV patients in a rapid-initiation model of care: BIC-NOW clinical trial","volume":"63","author":"C Hidalgo-Tenorio","year":"2024","journal-title":"Int J Antimicrob Agents"},{"issue":"1","key":"pone.0323167.ref010","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1177\/0272989X0102100102","article-title":"A comparison of United Kingdom and Spanish general population time trade-off values for EQ-5D health states","volume":"21","author":"X Badia","year":"2001","journal-title":"Med Decis Making"},{"issue":"7","key":"pone.0323167.ref011","first-page":"891","article-title":"Cost-effectiveness and budget impact of dolutegravir\/lamivudine for treatment of human immunodeficiency virus (HIV-1) infection in the United States","volume":"27","author":"K Butler","year":"2021","journal-title":"J Manag Care Spec Pharm"},{"issue":"12","key":"pone.0323167.ref012","doi-asserted-by":"crossref","first-page":"3110","DOI":"10.1093\/cid\/ciz1213","article-title":"Darunavir\/Cobicistat\/Emtricitabine\/Tenofovir Alafenamide in a Rapid-Initiation Model of Care for Human Immunodeficiency Virus Type 1 Infection: Primary Analysis of the DIAMOND Study","volume":"71","author":"GD Huhn","year":"2020","journal-title":"Clin Infect Dis"},{"issue":"12","key":"pone.0323167.ref013","doi-asserted-by":"crossref","first-page":"1957","DOI":"10.1097\/QAD.0000000000002979","article-title":"Dolutegravir\/lamivudine as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV","volume":"35","author":"C-P Rolle","year":"2021","journal-title":"AIDS"},{"key":"pone.0323167.ref014","volume-title":"Esperanza de vida a diferentes edades [Internet]","author":"Instituto Nacional de Estad\u00edstica (INE)"},{"key":"pone.0323167.ref015","unstructured":"Ministerio de Sanidad - \u00c1reas - Vigilancia epidemiol\u00f3gica. n.d. [cited 22 Apr 2024]. Available: https:\/\/www.sanidad.gob.es\/ciudadanos\/enfLesiones\/enfTransmisibles\/sida\/vigilancia\/home.htm"},{"issue":"11","key":"pone.0323167.ref016","doi-asserted-by":"crossref","DOI":"10.1016\/S2214-109X(15)00069-8","article-title":"Disability weights for the Global Burden of Disease 2013 study","volume":"3","author":"JA Salomon","year":"2015","journal-title":"Lancet Glob Health"},{"issue":"3","key":"pone.0323167.ref017","doi-asserted-by":"crossref","first-page":"571","DOI":"10.1007\/s00038-014-0553-y","article-title":"DALY calculation in practice: a stepwise approach","volume":"59","author":"B Devleesschauwer","year":"2014","journal-title":"Int J Public Health"},{"issue":"5","key":"pone.0323167.ref018","doi-asserted-by":"crossref","first-page":"402","DOI":"10.1093\/heapol\/czl018","article-title":"Calculating QALYs, comparing QALY and DALY calculations","volume":"21","author":"F Sassi","year":"2006","journal-title":"Health Policy Plan"},{"key":"pone.0323167.ref019","unstructured":"CER\u2019s Reference Case for Economic Evaluations: Principles and Rationale ICER; n.d. [cited March 26, 2024]. https:\/\/icer.org\/wp-content\/uploads\/2020\/10\/ICER_Reference_Case_013120.pdf"},{"issue":"3","key":"pone.0323167.ref020","doi-asserted-by":"crossref","first-page":"973","DOI":"10.1214\/aoms\/1177704020","article-title":"Rank Tests of Dispersion","volume":"34","author":"LE Moses","year":"1963","journal-title":"Ann Math Statist"},{"issue":"2","key":"pone.0323167.ref021","doi-asserted-by":"crossref","first-page":"205","DOI":"10.1007\/s10198-018-0955-5","article-title":"Population norms for the EQ-5D-3L: a cross-country analysis of population surveys for 20 countries","volume":"20","author":"MF Janssen","year":"2019","journal-title":"Eur J Health Econ"},{"issue":"9","key":"pone.0323167.ref022","doi-asserted-by":"crossref","first-page":"1467","DOI":"10.1007\/s10198-021-01326-9","article-title":"General population normative data for the EQ-5D-3L in the five largest European economies","volume":"22","author":"MF Janssen","year":"2021","journal-title":"Eur J Health Econ"},{"issue":"1","key":"pone.0323167.ref023","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1097\/QAD.0000000000001671","article-title":"Benefits and risks of rapid initiation of antiretroviral therapy","volume":"32","author":"N Ford","year":"2018","journal-title":"AIDS"},{"issue":"6","key":"pone.0323167.ref024","doi-asserted-by":"crossref","first-page":"1978","DOI":"10.1007\/s10461-024-04298-y","article-title":"Health-Related Quality of Life in People with Advanced HIV Disease, from 1996 to 2021: Systematic Review and Meta-analysis","volume":"28","author":"I Portilla-Tamarit","year":"2024","journal-title":"AIDS Behav"},{"issue":"7","key":"pone.0323167.ref025","doi-asserted-by":"crossref","first-page":"953","DOI":"10.1097\/QAD.0000000000001417","article-title":"Improved quality of life with immediate versus deferred initiation of antiretroviral therapy in early asymptomatic HIV infection","volume":"31","author":"AR Lifson","year":"2017","journal-title":"AIDS"},{"issue":"6","key":"pone.0323167.ref026","doi-asserted-by":"crossref","first-page":"610","DOI":"10.1111\/tmi.13565","article-title":"Global, regional and national disability-adjusted life years due to HIV from 1990 to 2019: findings from the Global Burden of Disease Study 2019","volume":"26","author":"J Wu","year":"2021","journal-title":"Trop Med Int Health"},{"key":"pone.0323167.ref027","unstructured":"World Health Organization. Global health estimates: Leading causes of DALYs. n.d. [cited 20 May 2024]. Available: https:\/\/www.who.int\/data\/gho\/data\/themes\/mortality-and-global-health-estimates\/global-health-estimates-leading-causes-of-dalys"},{"issue":"10","key":"pone.0323167.ref028","doi-asserted-by":"crossref","DOI":"10.1093\/cid\/cix848","article-title":"2017 HIVMA of IDSA Clinical Practice Guideline for the Management of Chronic Pain in Patients Living With HIV","volume":"65","author":"RD Bruce","year":"2017","journal-title":"Clin Infect Dis"},{"issue":"4","key":"pone.0323167.ref029","doi-asserted-by":"crossref","first-page":"67","DOI":"10.1097\/01.NURSE.0000513611.64023.0b","article-title":"HIV pain management challenges and alternative therapies","volume":"47","author":"A Mello","year":"2017","journal-title":"Nursing"},{"issue":"4","key":"pone.0323167.ref030","doi-asserted-by":"crossref","first-page":"746","DOI":"10.1002\/hec.3633","article-title":"Estimating a cost-effectiveness threshold for the Spanish NHS","volume":"27","author":"L Vallejo-Torres","year":"2018","journal-title":"Health Econ"},{"issue":"5","key":"pone.0323167.ref031","doi-asserted-by":"crossref","DOI":"10.1007\/s11908-021-00750-5","article-title":"Evidence Regarding Rapid Initiation of Antiretroviral Therapy in Patients Living with HIV","volume":"23","author":"SM Michienzi","year":"2021","journal-title":"Curr Infect Dis Rep"}],"updated-by":[{"DOI":"10.1371\/journal.pone.0341486","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2026,1,20]],"date-time":"2026-01-20T00:00:00Z","timestamp":1768867200000}}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0323167","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T23:09:30Z","timestamp":1767913770000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0323167"}},"subtitle":[],"editor":[{"given":"Giuseppe Vittorio","family":"De Socio","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2025,9,22]]},"references-count":31,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2025,9,22]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0323167","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,22]]}}}