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
Mediterranean Journal of Infection, Microbes and Antimicrobials
; 11(SUPPL 1):364-365, 2022.
Article
in English
| EMBASE | ID: covidwho-1925369
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 andMethods:
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.
bictegravir plus emtricitabine plus tenofovir alafenamide; emtricitabine plus tenofovir alafenamide; endogenous compound; nonnucleoside reverse transcriptase inhibitor; TATA binding protein associated factor; adult; adverse drug reaction; Canada; clinical practice; cohort analysis; comorbidity; conference abstract; controlled study; coronavirus disease 2019; depression; drug safety; Europe; female; human; Human immunodeficiency virus 1; Human immunodeficiency virus infected patient; Israel; mental disease; meta analysis; nonhuman; pandemic; prevalence; side effect
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Collection:
Databases of international organizations
Database:
EMBASE
Type of study:
Cohort study
/
Experimental Studies
/
Observational study
/
Prognostic study
Language:
English
Journal:
Mediterranean Journal of Infection, Microbes and Antimicrobials
Year:
2022
Document Type:
Article
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