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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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
12 Feb 2025
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| In: |
HIV research & clinical practice
Year: 2025, Jahrgang: 26, Heft: 1, Pages: 1-14 |
| ISSN: | 2578-7470 |
| DOI: | 10.1080/25787489.2025.2456890 |
| Online-Zugang: | Verlag, kostenfrei, Volltext: https://doi.org/10.1080/25787489.2025.2456890
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| Verfasserangaben: | 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 and Josep Mallolas |
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| 245 | 1 | 0 | |a Bictegravir/emtricitabine/tenofovir alafenamide in clinical practice for people with HIV |b final 24-month effectiveness and safety outcomes in key populations in the observational BICSTaR cohort |c 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 and Josep Mallolas |
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| 520 | |a 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. | ||
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| 650 | 4 | |a BICSTaR | |
| 650 | 4 | |a bictegravir | |
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| 700 | 1 | |a Berrevoets, Marvin |e VerfasserIn |4 aut | |
| 700 | 1 | |a Uriel, Alison |e VerfasserIn |4 aut | |
| 700 | 1 | |a Thorpe, David |e VerfasserIn |4 aut | |
| 700 | 1 | |a Heinzkill, Marion |e VerfasserIn |4 aut | |
| 700 | 1 | |a Marongiu, Andrea |e VerfasserIn |4 aut | |
| 700 | 1 | |a Ramroth, Johanna |e VerfasserIn |4 aut | |
| 700 | 1 | |a D’Amato, Lisa |e VerfasserIn |4 aut | |
| 700 | 1 | |a Mallolas, Josep |e VerfasserIn |4 aut | |
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