Bictegravir/emtricitabine/tenofovir alafenamide in people with HIV aged ≥50: low discontinuation rates and favorable metabolic outcomes over 36 months

Purpose: Real-world evidence on the long-term safety
and efficacy of switching to bictegravir/emtricitabine/
tenofovir alafenamide (B/F/TAF) in this population
remains limited. We evaluated virological, immunological,
and metabolic outcomes of B/F/TAF in aging PWH
with sustained virological suppression.
Method: We conducted a multicenter retrospective
cohort study within the SHiNe-SHiC network, including
188 PWH aged ≥50 years who switched to B/F/TAF. Data
from four centers in Sardinia and Sicily were analyzed.
Demographic, clinical, viro-immunological, and biochemical
data were collected at baseline, 12, 24, and
36 months. Rates of treatment discontinuation (TD) were
assessed using survival analysis.
Results: Among 188 participants (median age 58 years
[IQR 54–63]; 18.6% >65 years), 69.1% were cisgender
men. Comorbidities were frequent: dyslipidemia (59.0%),
hypertension (44.1%), and psychiatric disorders (14.9%).
A total of 22.3% used ≥5 non-ART medications (Table 1).
During 8726 person-months of follow-up, 11 treatment
discontinuations occurred (rate: 1.26/1000 personmonths;
95% CI: 0.70–2.28). The cumulative probability
of discontinuation was 2.66% at 12 months (95% CI: 1.12–
6.28) and 5.14% at 36 months (Figure 1).
Discontinuation causes included adverse events (n=4),
person decision (n=3), simplification (n=3), and one
virological failure.
Virological suppression was maintained in 92.5% of participants
at 36 months (Figure 2) and CD4 count did not
significantly change.
Lipid parameters showed significant reductions: total
cholesterol (p=0.0003), LDL (p=0.0158), and triglycerides
(p=0.0255). Total cholesterol/HDL ratio improved
significantly at all timepoints (p=0.0214). No clinically
significant changes were observed in creatinine, AST,
ALT, or HDL levels (Table 2).
Conclusions: Switching to B/F/TAF in virologically suppressed
PWH aged ≥50 years was associated with sustained
virological control, stable immunological
parameters, and favorable metabolic outcomes, including improvements in lipid profiles. The low discontinuation
and virological failure rates support the use of B/F/TAF
as an effective and safe strategy in aging PWH, including
those with polypharmacy and comorbidities.