1. Twelve‐month effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV: Real‐world insights from BICSTaR cohorts.
- Author
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Esser, Stefan, Brunetta, Jason, Inciarte, Alexy, Levy, Itzchak, D'Arminio Monforte, Antonella, Lambert, John S., van Welzen, Berend, Teruya, Katsuji, Boffito, Marta, Liu, Chun‐Eng, Altuntas Aydın, Ozlem, Thorpe, David, Heinzkill, Marion, Marongiu, Andrea, Cassidy, Tali, Haubrich, Richard, D'Amato, Lisa, and Robineau, Olivier
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HIV integrase inhibitors , *COMBINATION drug therapy , *PATIENT safety , *RESEARCH funding , *SCIENTIFIC observation , *QUESTIONNAIRES , *HIV infections , *DESCRIPTIVE statistics , *PSYCHOLOGY of HIV-positive persons , *EMTRICITABINE-tenofovir , *LONGITUDINAL method , *DRUG efficacy , *HEALTH outcome assessment , *DRUG tolerance , *EVALUATION - Abstract
Background: Real‐world evidence is an essential component of evidence‐based medicine. The aim of the BICSTaR (BICtegravir Single Tablet Regimen) study is to assess effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in antiretroviral treatment‐naïve (TN) and treatment‐experienced (TE) people with HIV. Methods: BICSTaR is a prospective, observational cohort study. Participants (≥18 years) are being followed for 24 months. A pooled analysis is presented at 12 months, with the primary endpoint of effectiveness (HIV‐1 RNA <50 copies/mL) and secondary endpoints of safety and tolerability (as per protocol). An exploration of patient‐reported outcome measures using standardized questionnaires is included. Results: Between June 2018 and May 2021, 1552 people with HIV were enrolled across 12 countries. The analysed population comprised 1509 individuals (279 TN, 1230 TE); most were white (76%), male (84%) and had one or more comorbid conditions (68%). Median age was 47 years. After 12 months of B/F/TAF treatment, HIV‐1 RNA was <50 copies/mL in 94% (221/236) of TN participants and 97% (977/1008) of TE participants. Median CD4 cell count increased by 214 cells/μL (p < 0.001) in TN participants and 13 cells/μL (p = 0.014) in TE participants; median CD4/CD8 ratios increased by 0.30 and 0.03, respectively (both p < 0.001). Persistence was high at 12 months (TN, 97%; TE, 95%). No resistance to B/F/TAF emerged. Study drug‐related adverse events occurred in 13% of participants through 12 months, leading to B/F/TAF discontinuation in 6%. Conclusions: The findings of this study provide robust real‐world evidence to support the broad use of B/F/TAF in both TN and TE people with HIV. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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