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.
Highlights
The last few decades saw dramatic changes in the natural history of HIV-1 infection, which has been transformed by the advent of antiretroviral therapy (ART): nowadays, life expectancy of people living with HIV-1 (PLWH) has a quite similar length of general population, and an increasingly large share of HIV-1 population is aging [1,2,3]
Secondary objectives were: (a) Percentage of PLWH presenting virologic failure (HIV-RNA ≥ 37 copies/mL); (b) CD4+, CD8+ and CD4+/CD8+ ratio changes from baseline to week 48; (c) Metabolic profile changes from baseline to week 48; (d) Detection of neurological symptoms or clinical signs objectivable with the neurological examination referable to potential side effects of the drug; (e) Reasons to switch to BIC/FTC/TAF; (f) Adverse events related to BIC/FTC/TAF; (g) Risk factors related to interruption of treatment with BIC/FTC/TAF; (h) Adherence to BIC/FTC/TAF; (i) To evaluate the same primary and secondary objectives in the group of PLWH older than 55 years
We observed a significant increase of PLWH with serum viral load < 37 copies/mL among the overall population, and this trend was noticeable among the over 55 PLWH, even if not reaching statistical significance (p-value = 0.083)
Summary
The last few decades saw dramatic changes in the natural history of HIV-1 infection, which has been transformed by the advent of antiretroviral therapy (ART): nowadays, life expectancy of people living with HIV-1 (PLWH) has a quite similar length of general population, and an increasingly large share of HIV-1 population is aging [1,2,3]. Non-AIDS comorbidities appear earlier, and the pill burden rises sooner in comparison to healthy people. In such context, the option of a single-tablet regimen (STR) with high genetic barrier and low drug-drug interaction profile and toxicity seems to be the optimal choice for elderly PLWH [4,5]. Several pivotal clinical trials tested safety, efficacy and tolerability of BIC/FTC/TAF among experienced PLWH [9,10,11], but clinical data from real-life experience are still lacking, so much that phase 3 trials of new antiretrovirals were accused to not represent the global HIV-1 epidemic [12], especially the elderly population [13]. We aimed to assess efficacy, safety and tolerability of BIC/FTC/TAF among PLWH, with a specific focus on people older than 55 years
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