1. Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/ TAF) for the Treatment of People Living with HIV (PLWH): 12-month (12M) Effectiveness, Persistence, and Safety in a Multi-country Cohort Study.
- Author
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Mallolas, Josep, Esposito, Vincenzo, Hocqueloux, Laurent, Lambert, John S, Levy, Itzchak, Wyen, Christoph, Welzen, Berend Van, Ustianowski, Andrew, Kurtaran, Behice, Schreiber, Sandra, Thorpe, David, Heinzkill, Marion, Marongiu, Andrea, Haubrich, Richard, and Loemba, Hugues
- Subjects
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EMTRICITABINE-tenofovir , *HIV-positive persons , *COVID-19 pandemic , *VIROLOGY , *NEUROBEHAVIORAL disorders - Abstract
Introduction: BICSTaR (GS-EU-380-4472/GS-CA-380-4574/GS-IL-380- 5335) is an ongoing, multinational, observational cohort study evaluating real-world effectiveness and safety of B/F/TAF in ART naïve (TN) and ARTexperienced (TE) PLWH. Materials and Methods: This 12M pooled analysis included PLWH starting B/F/TAF in clinical practice from June 2018 to September 2020 (latterly during the COVID-19 pandemic) in Europe/Israel/Canada. Outcomes included virological effectiveness (HIV‐1 RNA <50 copies/ml [missing=excluded]), persistence, drug‐related adverse events (DRAEs), and laboratory parameters. Results: One-thousand one hundred thirty-five PLWH were included (Table 1). The TE group had older median age than TN. Of TE participants, 65%/20%/16% switched from INSTI/NNRTI/PI-based regimens (36% TDF/46% TAF/13% ABC); 12% had prior virologic failure. Baseline resistance was documented in 124/535 participants (NRTI/NNRTI/PI/ INSTI=6%/6%/3%/0.2%). Prevalence of comorbidities (47%/72% TN/TE) and concomitant medication usage was high. At 12M, 97% (149/154) of TN and 96% (771/800) of TE participants had HIV-1 RNA <50 copies/ml, and persistence on B/F/TAF was high [91% (1032/1135)]. In a multivariable analysis, TE participants with neuropsychiatric disorder ongoing at baseline had lower odds for viral suppression (odds ratio=0.45, 95% CI: 0.21-0.96). There was no emergence of resistance to the components of B/F/TAF. DRAEs occurred in 13% (148/1135) of participants; gastrointestinal and neuropsychiatric DRAEs were the most common (3% each). Discontinuations due to DRAEs were low (TN 4%; TE 6%). Serious DRAEs were rare (0.2%; 2 TE participants with depression). Lipidchanges are shown (Figure 1). Conclusion: B/F/TAF was associated with high levels of effectiveness and persistence after 12M in this large real-world cohort of TN and TE PLWH with a high comorbidity burden. Effectiveness was demonstrated across key subgroups (females, older participants, late presenters). Importantly, there were no new or unexpected safety findings. Collectively, these real-world data continue to support the use of B/F/TAF in clinical practice. [ABSTRACT FROM AUTHOR]
- Published
- 2022