{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,9]],"date-time":"2026-11-09T20:16:13Z","timestamp":1794255373125,"version":"4.9.0"},"reference-count":27,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T00:00:00Z","timestamp":1761868800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>Background: The aging of people living with HIV (PLWH) necessitates antiretroviral regimens (ART) with high efficacy, a favorable safety profile, and minimal drug\u2013drug interactions. We evaluated the real-world performance of bictegravir\/emtricitabine\/tenofovir alafenamide (B\/F\/TAF) in PLWH aged \u2265 50 years, stratified by prior treatment experience. Methods: This retrospective cohort study included ART-na\u00efve and virologically suppressed treatment-experienced PLWH aged \u2265 50 years who started B\/F\/TAF. Primary endpoints were virological suppression (HIV-1 RNA &lt; 50 copies\/mL) at 12 months \u00b1 1 month and 24 months \u00b1 1 month, and safety. Changes in immunological (CD4+ count, CD4+\/CD8+ ratio), metabolic, and hepatic parameters were assessed. Results: Among 214 patients (37 na\u00efve, 177 experienced; mean age 60.6 years), high virological suppression rates were observed in both na\u00efve (85.7%) and experienced (93.9%) cohorts at 24 months. Immunologically, na\u00efve patients experienced a robust increase in CD4+ counts (from 176 to 450 cells\/\u03bcL, p &lt; 0.001). A key finding was a significant increase in the CD4+\/CD8+ ratio in the experienced cohort, which normalized from 0.95 at baseline to 1.12 at 24 months (p &lt; 0.001). The regimen demonstrated a favorable safety profile: metabolic parameters remained stable, and hepatic enzymes significantly improved in na\u00efve patients. Transient elastography confirmed no worsening of liver fibrosis or steatosis in experienced patients. The overall discontinuation rate was 19.2%, driven by different reasons between cohorts (e.g., comorbidities in na\u00efve, strategic simplification in experienced). Conclusions: This real-world study confirms that B\/F\/TAF is a versatile cornerstone for the management of older PLWH. It demonstrates high efficacy in initiating treatment and is a safe, effective, and durable platform for treatment simplification. Its favorable metabolic and hepatic profile makes it particularly suitable for an aging population with a high burden of comorbidities, ensuring long-term treatment success.<\/jats:p>","DOI":"10.3390\/v17111449","type":"journal-article","created":{"date-parts":[[2025,11,3]],"date-time":"2025-11-03T13:47:58Z","timestamp":1762177678000},"page":"1449","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Effectiveness and Safety of Bictegravir\/Emtricitabine\/Tenofovir Alafenamide in People Living with HIV Aged 50 Years and Older: A Retrospective Analysis of Na\u00efve and Treatment-Experienced Individuals"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8105-5139","authenticated-orcid":false,"given":"Marcello","family":"Trizzino","sequence":"first","affiliation":[{"name":"Infectious and Tropical Diseases Unit, Sicilian Regional Reference Center for the Fight Against AIDS, AOU Policlinico \u201cP. Giaccone\u201d, 90133 Palermo, Italy"},{"name":"Palermo Fast-Track City, Casa dei Diritti, 90100 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1871-4285","authenticated-orcid":false,"given":"Luca","family":"Pipit\u00f2","sequence":"additional","affiliation":[{"name":"Infectious and Tropical Diseases Unit, Sicilian Regional Reference Center for the Fight Against AIDS, AOU Policlinico \u201cP. Giaccone\u201d, 90133 Palermo, Italy"},{"name":"Palermo Fast-Track City, Casa dei Diritti, 90100 Palermo, Italy"},{"name":"Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties \u201cG D\u2019Alessandro\u201d, University of Palermo, 90133 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Floriana","family":"Di Figlia","sequence":"additional","affiliation":[{"name":"Infectious and Tropical Diseases Unit, Sicilian Regional Reference Center for the Fight Against AIDS, AOU Policlinico \u201cP. Giaccone\u201d, 90133 Palermo, Italy"},{"name":"Palermo Fast-Track City, Casa dei Diritti, 90100 Palermo, Italy"},{"name":"Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties \u201cG D\u2019Alessandro\u201d, University of Palermo, 90133 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Bonura","sequence":"additional","affiliation":[{"name":"Infectious and Tropical Diseases Unit, Sicilian Regional Reference Center for the Fight Against AIDS, AOU Policlinico \u201cP. Giaccone\u201d, 90133 Palermo, Italy"},{"name":"Palermo Fast-Track City, Casa dei Diritti, 90100 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Zimmerhofer","sequence":"additional","affiliation":[{"name":"Infectious and Tropical Diseases Unit, Sicilian Regional Reference Center for the Fight Against AIDS, AOU Policlinico \u201cP. Giaccone\u201d, 90133 Palermo, Italy"},{"name":"Palermo Fast-Track City, Casa dei Diritti, 90100 Palermo, Italy"},{"name":"Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties \u201cG D\u2019Alessandro\u201d, University of Palermo, 90133 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Cicero","sequence":"additional","affiliation":[{"name":"Infectious and Tropical Diseases Unit, Sicilian Regional Reference Center for the Fight Against AIDS, AOU Policlinico \u201cP. Giaccone\u201d, 90133 Palermo, Italy"},{"name":"Palermo Fast-Track City, Casa dei Diritti, 90100 Palermo, Italy"},{"name":"Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties \u201cG D\u2019Alessandro\u201d, University of Palermo, 90133 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Gio\u00e8","sequence":"additional","affiliation":[{"name":"Infectious and Tropical Diseases Unit, Sicilian Regional Reference Center for the Fight Against AIDS, AOU Policlinico \u201cP. Giaccone\u201d, 90133 Palermo, Italy"},{"name":"Palermo Fast-Track City, Casa dei Diritti, 90100 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1992-1796","authenticated-orcid":false,"given":"Antonio","family":"Cascio","sequence":"additional","affiliation":[{"name":"Infectious and Tropical Diseases Unit, Sicilian Regional Reference Center for the Fight Against AIDS, AOU Policlinico \u201cP. Giaccone\u201d, 90133 Palermo, Italy"},{"name":"Palermo Fast-Track City, Casa dei Diritti, 90100 Palermo, Italy"},{"name":"Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties \u201cG D\u2019Alessandro\u201d, University of Palermo, 90133 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,10,31]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1016\/j.ijid.2016.10.004","article-title":"HIV and aging","volume":"53","author":"Wing","year":"2016","journal-title":"Int. J. Infect. Dis."},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"The Lancet Healthy Longevity (2022). Ageing with HIV. Lancet Healthy Longev., 3, e119.","DOI":"10.1016\/S2666-7568(22)00041-1"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.1097\/QAI.0b013e31825a3668","article-title":"HIV and aging: State of knowledge and areas of critical need for research. A report to the NIH Office of AIDS Research by the HIV and Aging Working Group","volume":"60","author":"High","year":"2012","journal-title":"J. Acquir. Immune Defic. Syndr."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"1703","DOI":"10.1016\/j.jiph.2023.08.023","article-title":"Causes of hospitalization and predictors of in-hospital mortality among people living with HIV in Sicily-Italy between 2010 and 2021","volume":"16","author":"Zinna","year":"2023","journal-title":"J. Infect. Public Health"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"102661","DOI":"10.1016\/j.jiph.2025.102661","article-title":"Malignancies in people living with HIV: A 25-years observational study from a tertiary hospital in Italy","volume":"18","author":"Anastasia","year":"2025","journal-title":"J. Infect. Public Health"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"1142","DOI":"10.1002\/ijc.35493","article-title":"Cancer incidence in people with HIV in Italy: Comparison of the ICONA COHORT with general population data","volume":"157","author":"Piselli","year":"2025","journal-title":"Int. J. Cancer"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"475","DOI":"10.1007\/s11904-019-00464-3","article-title":"Aging with HIV","volume":"16","author":"Guaraldi","year":"2019","journal-title":"Curr. HIV\/AIDS Rep."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1111\/hiv.13319","article-title":"Bictegravir\/emtricitabine\/tenofovir alafenamide in older individuals with HIV: Results of a 96-week, phase 3b, open-label, switch trial in virologically suppressed people \u2265 65 years of age","volume":"24","author":"Maggiolo","year":"2022","journal-title":"HIV Med."},{"key":"ref_9","doi-asserted-by":"crossref","unstructured":"Lazzaro, A., Cacciola, E.G., Borrazzo, C., Innocenti, G.P., Cavallari, E.N., Mezzaroma, I., Falciano, M., Fimiani, C., Mastroianni, C.M., and Ceccarelli, G. (2021). Switching to a Bictegravir Single Tablet Regimen in Elderly People Living with HIV-1: Data Analysis from the BICTEL Cohort. Diagnostics, 12.","DOI":"10.3390\/diagnostics12010076"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"986","DOI":"10.47391\/JPMA.22-63","article-title":"Triglyceride Glucose (TyG) Index: A surrogate biomarker of insulin resistance","volume":"72","author":"Nayak","year":"2022","journal-title":"J. Pak. Med. Assoc."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"1484","DOI":"10.1016\/j.lpm.2019.10.017","article-title":"L\u2019index FIB-4 pour faire le diagnostic de fibrose h\u00e9patique avanc\u00e9e au cours de la st\u00e9atose h\u00e9patique [FIB-4 index to rule-out advanced liver fibrosis in NAFLD patients]","volume":"48","author":"Mallet","year":"2019","journal-title":"La Presse M\u00e9dicale"},{"key":"ref_12","first-page":"70","article-title":"Decrease in drug-drug interactions between antiretroviral drugs and concomitant therapies in older people living with HIV-1 switching to bictegravir\/emtricitabine\/tenofovir alafenamide","volume":"48","author":"Calza","year":"2025","journal-title":"New Microbiol."},{"key":"ref_13","first-page":"29","article-title":"Drug-drug interactions of Integrase Strand Transfer Inhibitors among older people living with HIV: Interazioni farmacologiche degli inibitori delle integrase tra le persone anziane che vivono con HIV","volume":"7","author":"Wang","year":"2022","journal-title":"J HIV Ageing"},{"key":"ref_14","doi-asserted-by":"crossref","unstructured":"Kawashima, A., Trung, H.T., Watanabe, K., Takano, M., Deguchi, Y., Kinoshita, M., Uemura, H., Yanagawa, Y., Gatanaga, H., and Kikuchi, Y. (2023). Pharmacokinetics of Bictegravir in Older Japanese People Living with HIV-1. Microbiol. Spectr., 11.","DOI":"10.1128\/spectrum.05079-22"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"2782","DOI":"10.1093\/jac\/dkaf297","article-title":"Population pharmacokinetics of bictegravir in real-world people with HIV","volume":"80","author":"Ekobena","year":"2025","journal-title":"J. Antimicrob. Chemother."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1025","DOI":"10.1002\/cpt.2178","article-title":"Physiologically-Based Pharmacokinetic Modeling Combined with Swiss HIV Cohort Study Data Supports No Dose Adjustment of Bictegravir in Elderly Individuals Living With HIV","volume":"109","author":"Stader","year":"2021","journal-title":"Clin. Pharmacol. Ther."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"102946","DOI":"10.1016\/j.jiph.2025.102946","article-title":"Switch to bictegravir\/emtricitabine\/tenofovir alafenamide in people living with HIV aged 65 years or older: BICOLDER study\u2014IMEA IMEA 057","volume":"18","author":"Allavena","year":"2025","journal-title":"J. Infect. Public Health"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"e27330","DOI":"10.1097\/MD.0000000000027330","article-title":"Real-world efficacy and safety of switching to bictegravir\/emtricitabine\/tenofovir alafenamide in older people living with HIV","volume":"100","author":"Rolle","year":"2021","journal-title":"Medicine"},{"key":"ref_19","doi-asserted-by":"crossref","unstructured":"Kityo, C.M., Gupta, S.K., Kumar, P.N., Weinberg, A.R., Gandhi-Patel, B., Liu, H., Hindman, J.T., and Rockstroh, J.K. (2025). Efficacy and safety of B\/F\/TAF in treatment-na\u00efve and virologically suppressed people with HIV \u2265 50 years of age: Integrated analysis from six phase 3 clinical trials. BMC Infect. Dis., 25.","DOI":"10.1186\/s12879-025-11476-3"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"766","DOI":"10.3390\/idr15060069","article-title":"Bictegravir\/Tenofovir Alafenamide\/Emtricitabine: A Real-Life Experience in People Living with HIV (PLWH)","volume":"15","author":"Gidari","year":"2023","journal-title":"Infect. Dis. Rep."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"970","DOI":"10.1111\/hiv.70037","article-title":"Safety and effectiveness of switch to bictegravir\/emtricitabine\/tenofovir alafenamide following dual regimen therapy in people with HIV: Insights from the Icona cohort","volume":"26","author":"Tavelli","year":"2025","journal-title":"HIV Med."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"1013","DOI":"10.1007\/s40265-018-0934-2","article-title":"Darunavir\/Cobicistat\/Emtricitabine\/Tenofovir Alafenamide: A Review in HIV-1 Infection","volume":"78","author":"Deeks","year":"2018","journal-title":"Drugs"},{"key":"ref_23","doi-asserted-by":"crossref","unstructured":"Trizzino, M., Gaudiano, R., Arena, D.M., Pipit\u00f2, L., Gio\u00e8, C., and Cascio, A. (2025). Switching to Bictegravir\/Emtricitabine\/Tenofovir Alafenamide Fumarate Regimen and Its Effect on Liver Steatosis Assessed by Fibroscan. Viruses, 17.","DOI":"10.3390\/v17030440"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"302","DOI":"10.1111\/hiv.13721","article-title":"Bictegravir\/emtricitabine\/tenofovir alafenamide in adults with HIV-1 and end-stage kidney disease on chronic haemodialysis","volume":"26","author":"Eron","year":"2024","journal-title":"HIV Med."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"102734","DOI":"10.1016\/j.jiac.2025.102734","article-title":"Efficacy and safety of switching to long-acting cabotegravir + rilpivirine versus continuing bictegravir\/emtricitabine\/tenofovir alafenamide in Japanese participants: 12-month results from the phase 3b randomized SOLAR trial","volume":"31","author":"Adachi","year":"2025","journal-title":"J. Infect. Chemother."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"64","DOI":"10.1007\/s10461-024-04490-0","article-title":"Improvements in Patient-Reported Outcomes After 12 Months of Maintenance Therapy with Cabotegravir + Rilpivirine Long-Acting Compared with Bictegravir\/Emtricitabine\/Tenofovir Alafenamide in the Phase 3b SOLAR Study","volume":"29","author":"Mussini","year":"2024","journal-title":"AIDS Behav."},{"key":"ref_27","doi-asserted-by":"crossref","unstructured":"Trizzino, M., Pipit\u00f2, L., Salvo, P.F., Zimmerhofer, F., Cicero, A., Baldin, G., Conti, C., Gio\u00e8, C., Di Giambenedetto, S., and Cascio, A. (2025). Real-World Experience with Long-Acting Injectable Cabotegravir\/Rilpivirine in HIV Patients with Unsuppressed Viral Load. 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