Bictegravir/emtricitabine/tenofovir alafenamide in clinical practice for people with HIV: final 24-month effectiveness and safety outcomes in key populations in the observational BICSTaR cohort
Background: BICtegravir Single Tablet Regimen (BICSTaR) is an observational cohort study evaluating the effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve (TN) and treatment-experienced (TE) people with HIV. Objective: To present final pooled 24-...
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Taylor & Francis Group
2025-12-01
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| Series: | HIV Research & Clinical Practice |
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| Online Access: | http://dx.doi.org/10.1080/25787489.2025.2456890 |
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| author | Benoit Trottier Chia-Jui Yang Dai Watanabe Giulia Marchetti Daniel Elbirt Eoghan De Barra Alper Gündüz Sun Hee Lee Roger Vogelmann Olivier Robineau Chiaw Yee Choy Marvin Berrevoets Alison Uriel David Thorpe Marion Heinzkill Andrea Marongiu Johanna Ramroth Lisa D’Amato Josep Mallolas |
| author_facet | Benoit Trottier Chia-Jui Yang Dai Watanabe Giulia Marchetti Daniel Elbirt Eoghan De Barra Alper Gündüz Sun Hee Lee Roger Vogelmann Olivier Robineau Chiaw Yee Choy Marvin Berrevoets Alison Uriel David Thorpe Marion Heinzkill Andrea Marongiu Johanna Ramroth Lisa D’Amato Josep Mallolas |
| author_sort | Benoit Trottier |
| collection | DOAJ |
| description | Background: BICtegravir Single Tablet Regimen (BICSTaR) is an observational cohort study evaluating the effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve (TN) and treatment-experienced (TE) people with HIV. Objective: To present final pooled 24-month outcomes for the full cohort. Methods: Prospective data were pooled from TN and TE adults with HIV initiating B/F/TAF in routine clinical practice across 14 countries (data collection: 25/06/2018–29/12/2023). Outcomes at 24 months included virologic suppression (HIV-1 RNA <50 copies/mL), immunologic effectiveness (change in CD4 cell count and CD4/CD8 ratio), persistence, and safety. Outcomes were also analysed in key populations. Results: Of 2,074 (483 TN, 1,591 TE) participants included, most were male (85%), White (70%), and had ≥1 comorbidity (66%). Median (Q1, Q3) age was 45 (35, 54) years. At 24 months, 94% of TN and 96% of TE participants had HIV-1 RNA <50 copies/mL (missing = excluded analysis). These values were 88% and 86%, respectively, in a discontinuation = failure analysis. Effectiveness remained high across all key populations at 24 months. Median (Q1, Q3) CD4 count increased by 257 (127, 447) cells/µL in TN and 40 (–70, 153) cells/µL in TE participants (both p < 0.001). There was no reported treatment-emergent resistance to B/F/TAF. Persistence was high at 24 months (TN, 95%; TE, 91%). Drug-related adverse events occurred in 11% of TN and 12% of TE participants, leading to B/F/TAF discontinuation in 5%. Conclusions: B/F/TAF was generally well tolerated over 24 months, with high effectiveness and persistence observed among a broad range of people with HIV. |
| format | Article |
| id | doaj-art-e4ced191ce4f48cfacdb597b9217ae6e |
| institution | OA Journals |
| issn | 2578-7470 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | HIV Research & Clinical Practice |
| spelling | doaj-art-e4ced191ce4f48cfacdb597b9217ae6e2025-08-20T02:04:07ZengTaylor & Francis GroupHIV Research & Clinical Practice2578-74702025-12-0126110.1080/25787489.2025.24568902456890Bictegravir/emtricitabine/tenofovir alafenamide in clinical practice for people with HIV: final 24-month effectiveness and safety outcomes in key populations in the observational BICSTaR cohortBenoit Trottier0Chia-Jui Yang1Dai Watanabe2Giulia Marchetti3Daniel Elbirt4Eoghan De Barra5Alper Gündüz6Sun Hee Lee7Roger Vogelmann8Olivier Robineau9Chiaw Yee Choy10Marvin Berrevoets11Alison Uriel12David Thorpe13Marion Heinzkill14Andrea Marongiu15Johanna Ramroth16Lisa D’Amato17Josep Mallolas18Département de Recherche, Clinique de Médecine Urbaine du Quartier LatinDepartment of Internal Medicine, Far Eastern Memorial HospitalAIDS Medical Center, NHO Osaka National HospitalDepartment of Health Sciences, University of MilanKaplan Medical Center and Faculty of Medicine, Hebrew University of JerusalemDepartment of International Health and Tropical Medicine, RCSI University of Medicine and Health Sciences, Beaumont HospitalDepartment of Infectious Diseases and Clinical Microbiology, Başakşehir Çam and Sakura City Training and Research Hospital, University of Health SciencesDepartment of Internal Medicine, Pusan National University School of Medicine and Pusan National University HospitalMannheimer Onkologie-PraxisEA2694, University of Lille, Centre Hospitalier de TourcoingDepartment of Infectious Diseases, National Centre for Infectious Diseases (NCID)Department of Internal Medicine and Infectious Diseases, Elisabeth-TweeSteden HospitalInfectious Diseases and Tropical Medicine, North Manchester General HospitalGlobal HIV Medical Affairs, Gilead Sciences Europe LtdMedical Affairs, Gilead Sciences GmbHReal World Evidence, Gilead Sciences Europe Ltd, Stockley ParkReal World Evidence, Gilead Sciences Europe Ltd, Stockley ParkClinical Operations, Gilead Sciences SrlHIV Unit, Hospital Clinic of Barcelona, University of BarcelonaBackground: BICtegravir Single Tablet Regimen (BICSTaR) is an observational cohort study evaluating the effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve (TN) and treatment-experienced (TE) people with HIV. Objective: To present final pooled 24-month outcomes for the full cohort. Methods: Prospective data were pooled from TN and TE adults with HIV initiating B/F/TAF in routine clinical practice across 14 countries (data collection: 25/06/2018–29/12/2023). Outcomes at 24 months included virologic suppression (HIV-1 RNA <50 copies/mL), immunologic effectiveness (change in CD4 cell count and CD4/CD8 ratio), persistence, and safety. Outcomes were also analysed in key populations. Results: Of 2,074 (483 TN, 1,591 TE) participants included, most were male (85%), White (70%), and had ≥1 comorbidity (66%). Median (Q1, Q3) age was 45 (35, 54) years. At 24 months, 94% of TN and 96% of TE participants had HIV-1 RNA <50 copies/mL (missing = excluded analysis). These values were 88% and 86%, respectively, in a discontinuation = failure analysis. Effectiveness remained high across all key populations at 24 months. Median (Q1, Q3) CD4 count increased by 257 (127, 447) cells/µL in TN and 40 (–70, 153) cells/µL in TE participants (both p < 0.001). There was no reported treatment-emergent resistance to B/F/TAF. Persistence was high at 24 months (TN, 95%; TE, 91%). Drug-related adverse events occurred in 11% of TN and 12% of TE participants, leading to B/F/TAF discontinuation in 5%. Conclusions: B/F/TAF was generally well tolerated over 24 months, with high effectiveness and persistence observed among a broad range of people with HIV.http://dx.doi.org/10.1080/25787489.2025.2456890real-world evidencebictegravirantiretroviral therapyart-experiencedart-naïvebicstarb/f/taf |
| spellingShingle | Benoit Trottier Chia-Jui Yang Dai Watanabe Giulia Marchetti Daniel Elbirt Eoghan De Barra Alper Gündüz Sun Hee Lee Roger Vogelmann Olivier Robineau Chiaw Yee Choy Marvin Berrevoets Alison Uriel David Thorpe Marion Heinzkill Andrea Marongiu Johanna Ramroth Lisa D’Amato Josep Mallolas Bictegravir/emtricitabine/tenofovir alafenamide in clinical practice for people with HIV: final 24-month effectiveness and safety outcomes in key populations in the observational BICSTaR cohort HIV Research & Clinical Practice real-world evidence bictegravir antiretroviral therapy art-experienced art-naïve bicstar b/f/taf |
| title | Bictegravir/emtricitabine/tenofovir alafenamide in clinical practice for people with HIV: final 24-month effectiveness and safety outcomes in key populations in the observational BICSTaR cohort |
| title_full | Bictegravir/emtricitabine/tenofovir alafenamide in clinical practice for people with HIV: final 24-month effectiveness and safety outcomes in key populations in the observational BICSTaR cohort |
| title_fullStr | Bictegravir/emtricitabine/tenofovir alafenamide in clinical practice for people with HIV: final 24-month effectiveness and safety outcomes in key populations in the observational BICSTaR cohort |
| title_full_unstemmed | Bictegravir/emtricitabine/tenofovir alafenamide in clinical practice for people with HIV: final 24-month effectiveness and safety outcomes in key populations in the observational BICSTaR cohort |
| title_short | Bictegravir/emtricitabine/tenofovir alafenamide in clinical practice for people with HIV: final 24-month effectiveness and safety outcomes in key populations in the observational BICSTaR cohort |
| title_sort | bictegravir emtricitabine tenofovir alafenamide in clinical practice for people with hiv final 24 month effectiveness and safety outcomes in key populations in the observational bicstar cohort |
| topic | real-world evidence bictegravir antiretroviral therapy art-experienced art-naïve bicstar b/f/taf |
| url | http://dx.doi.org/10.1080/25787489.2025.2456890 |
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