Switching to a Bictegravir Single Tablet Regimen in Elderly People Living with HIV-1: Data Analysis from the BICTEL Cohort

Abstract

Bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF) is a recommended once-daily single tablet regimen for the treatment of people living with HIV-1 (PLWH). We aimed to assess efficacy, safety and tolerability of BIC/FTC/TAF among PLWH, with a specific focus on people older than 55 years. Thus, we recruited an observational retrospective real-life cohort including all PLWH who underwent a therapeutic switch to BIC/FTC/TAF, independently from the provenience treatment regimen. After 48 weeks of follow-up, 147 PLWH were included and 93 were older than 55 years. PLWH with HIV-RNA < 37 copies/mL increased from 140 to 146 (p < 0.033). Among the overall population, we observed an increase in CD4+ T cells count by 30.1% (p-value < 0.001), in CD8+ T cells count by 7.1% (p-value = 0.004) and in CD4+/CD8+ ratio by 21.5% (p-value < 0.001). Lipidic profile was characterized by decreasing total cholesterol/HDL ratio by 8% (p-value < 0.001) and LDL by 6.8% (p-value = 0.007). Total body weight increased by 1.8% (p-value = 0.014) and BMI by 4.2% (p-value < 0.001), even remaining within the healthy range. Hepatic and renal profile were not altered by the switch, nor were adverse events and/or discontinuations events detected. In conclusion, BIC/FTC/TAF is effective, safe and well tolerated in real life and among PLWH older than 55.

Twelve‐month effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV: Real‐world insights from BICSTaR cohorts

“…The B/F/TAF regimen achieved high levels of viral suppression across all groups of people investigated (78-100% with HIV-1 RNA <50 copies/mL; M=E analysis). This supports previously published data from both randomized controlled trials (RCTs) and other real-world studies of B/F/TAF [23,25,28]. Baseline viral load was >100 000 copies/mL in two-thirds of TN participants with advanced HIV, which may have contributed to the observed difference in effectiveness in this group of people.…”

“…A growing number of real-world studies in a number of countries have evaluated B/F/TAF, providing evidence for its effectiveness, tolerability and safety in routine clinical practice [23][24][25][26][27][28][29][30]. Most of these data are from small and/or retrospective, country-specific studies.…”

Bictegravir/Emtricitabine/Tenofovir Alafenamide in a Multicentre Cohort: Real-Life Experience From Spain

“…Patient characteristics at baseline are also similar to those observed in previous real-life studies carried out in Europe. 22,25 However, some differences were observed. For example, the percentage of male patients and MSM was higher (87% and 72%, respectively) in the study of Ambrosioni and colleagues.…”

Similar CD4/CD8 Ratio Recovery After Initiation of Dolutegravir Plus Lamivudine Versus Dolutegravir or Bictegravir-Based Three-Drug Regimens in Naive Adults With HIV

“…The current interest in the study of the CD4/CD8 ratio is reflected in the different works that evaluate the evolution of this marker according to baseline predictors ( 12 – 14 ), and the impact achieved on this outcome with both pharmacological ( 15 ) and non-pharmacological strategies ( 16 ). Although data are showing a greater benefit in terms of CD4/CD8 ratio recovery after ART initiation with INSTI-based regimens, there are still little data on the different impact of starting 2DR vs. 3DR on this biomarker, and the vast majority have focused on the switch setting ( 8 – 11 ).…”