BIC/FTC/TAF safe and effective in patients with HIV aged 50 years and older

Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is safe, effective, and well-tolerated in patients with HIV infection aged 50 years and older, according to study results published in BMC Infectious Diseases.

Previous research indicates a higher risk for age-related comorbidities in older adults with HIV, which can be exacerbated by the effects of antiretroviral therapy (ART). Therefore, researchers conducted a post hoc analysis using data from 2 cohorts across 6 phase 3 clinical trials (ClinicalTrials.gov Identifiers: NCT02607930, NCT02607956, NCT02603120, NCT02603107, NCT02652624, NCT03110380). They aimed to examine the long-term efficacy and safety of BIC/FTC/TAF in patients with HIV aged 50 years and older, including both treatment-naive and virologically suppressed individuals.

Adults (N=1724) who initiated BIC/FTC/TAF were evaluated for virologic outcomes and safety on the basis of age and ART history. Follow-up analyses were performed up to week 240 in the treatment-naive cohort and up to week 48 in the virologically suppressed cohort. Virologic suppression was defined as HIV-1 RNA less than 50 copies/mL.

Treatment-naive patients who were aged 50 years and older (n=96) or younger than 50 years (n=538) when they initiated BIC/FTC/TAF comprised 84.4% and 90.0% men, and 61.5% and 56.5% were White, respectively. Virologically suppressed patients who were aged 50 years and older (n=450) or younger than 50 years (n=640) when they initiated BIC/FTC/TAF comprised 76.0% and 61.4% men, and 64.7% and 57.7% were White, respectively. At baseline, 24.0% of older patients and 17.8% of younger patients who were treatment-naive had more than 100,000 HIV-1 RNA copies/mL.

At week 240, the older and younger treatment-naïve patients had similar rates of achieving virologic suppression (98.5% vs 98.6%; P =.9139) and increases in CD4⁺ T-cell count from baseline (mean change [MC], 291 vs 347 cells/mL; P =.07), respectively. Additionally, they had similar weight gain (MC, 4.8 vs 6.4 kg; P =.087), change in estimated glomerular filtration rate (eGFR; MC, -10.5 vs -7.7 mL/min; P =.3003), and change in hip (MC, 0.3 vs -0.4 g/m²) and spine (MC, 1.3 vs -0.9 g/m²) bone mineral density (BMD), respectively. However, older patients had a greater decrease in total cholesterol (TC) to high-density lipoprotein cholesterol (HDL-C) ratio (MC, -0.3) whereas younger patients had an increase (MC, 0.1; P <.0001).

At week 48, older and younger virologically suppressed patients had similar rates of maintaining virologic suppression (93.6% vs 93.6%; P =1.00) and changes in CD4⁺ T-cell counts (MC, 18 vs 4 cells/mL; P =.18). Additionally, they had similar body weight (MC, 1.5 vs 1.8 kg; P =.2857), eGFR (MC, -0.1 vs 0.0 mL/min; P =.933), TC:HDL-C ratio (MC, -0.9 vs -1.0; P =.9223), hip BMD (MC, 0.2 vs 0.1 g/m²), and spine BMD (MC, 0.5 vs 0.8 g/m²) from baseline, respectively.

Adherence rates in these studies were high, ranging between 96.9% and 99.8%. However, older treatment-naive patients achieved adherence of 95% or greater than younger patients (82.8% vs 66.3%; P =.002), respectively.

No treatment-emergent resistance was observed in either cohort through the end of the study period.

The safety profile of BIC/FTC/TAF was relatively consistent between the older and younger groups, but there was a trend of higher treatment-emergent diabetes observed in the treatment-naive cohort (5.1% vs 1.7%; P =.08) and treatment-emergent hypertension observed in the virologically suppressed cohort (5.2% vs 2.6%; P =.07) among older patients compared with younger patients, respectively.

Study limitations include underrepresentation of patients with HIV who were older than 65 years of age.

The researchers concluded, “B/F/TAF demonstrated sustained efficacy, a favorable safety profile, and high tolerability in PWH ≥50 years of age, including in both the treatment-naïve and virologically suppressed cohorts, underscoring its value as an optimal treatment option for managing HIV in aging populations.”

Disclosure: This research was supported by Gilead Sciences, Inc. Please see the original reference for a full list of disclosures.

References:

Kityo CM, Gupta SK, Kumar PN, et al. Efficacy and safety of B/F/TAF in treatment-naïve and virologically suppressed people with HIV ≥ 50 years of age: integrated analysis from six phase 3 clinical trials. Published online August 22, 2025. doi:10.1186/s12879-025-11476-3