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Introduction <p>Older adults with HIV, particularly those ≥ 50 years of age, face unique health challenges due to a higher prevalence of comorbidities and polypharmacy, which can impact medication adherence and increase the risk of adverse events. We assessed the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with HIV (PWH) ≥ 50 years of age across treatment-naïve and virologically suppressed cohorts over a long-term follow-up.</p> Methods <p>This post hoc analysis included participants ≥ 50 and &lt; 50 years of age from six phase 3 trials of B/F/TAF, comprising 2 treatment-naïve studies and 4 virologically suppressed studies. Outcomes were assessed through Week 240 for the treatment-naïve cohort and Week 48 for the virologically suppressed cohort. Key measures included virologic outcomes (HIV-1 RNA &lt; 50 or ≥ 50 copies/mL), CD4 T-cell changes, adherence, metabolic and renal parameters, treatment-emergent adverse events, and treatment-emergent diabetes and hypertension.</p> Results <p>The treatment-naïve cohort included 96 participants ≥ 50 years of age and 538 participants &lt; 50 years of age, while the virologically suppressed cohort included 450 participants ≥ 50 years of age and 640 participants &lt; 50 years of age. By Week 240, virologic suppression was achieved in 98.5% of treatment-naïve participants ≥ 50 years of age and in 98.6% of those &lt; 50 years of age, as determined using missing = excluded analysis. By Week 48, virologic failure was 0.9% versus 1.4% in participants ≥ 50 years of age versus &lt; 50 years of age, respectively, and virologic suppression was maintained in 93.6% of virologically suppressed participants in both the ≥ 50 and &lt; 50 years of age groups, as assessed using the US Food and Drug Administration snapshot algorithm. Across age groups, the treatment-naïve and virologically suppressed cohorts demonstrated comparable outcomes beyond viral load through Weeks 240 and 48, respectively, including CD4 T-cell changes, adherence rates of ≥ 95%, body weight, lipid profiles, renal function, bone health, treatment-emergent adverse events, and the incidence of treatment-emergent diabetes and hypertension.</p> Conclusions <p>These results highlight the durability, long-term efficacy, safety, and overall benefits of B/F/TAF in PWH ≥ 50 years of age.</p>

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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

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  • 发表日期：

    2025年8月22日

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  • Cissy M. Kityo,
  • Samir K. Gupta,
  • Princy N. Kumar,
  • Amy R. Weinberg,
  • Bhumi Gandhi-Patel,
  • Hui Liu,
  • Jason T. Hindman,
  • Jürgen K. Rockstroh

摘要

Introduction

Older adults with HIV, particularly those ≥ 50 years of age, face unique health challenges due to a higher prevalence of comorbidities and polypharmacy, which can impact medication adherence and increase the risk of adverse events. We assessed the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with HIV (PWH) ≥ 50 years of age across treatment-naïve and virologically suppressed cohorts over a long-term follow-up.

Methods

This post hoc analysis included participants ≥ 50 and < 50 years of age from six phase 3 trials of B/F/TAF, comprising 2 treatment-naïve studies and 4 virologically suppressed studies. Outcomes were assessed through Week 240 for the treatment-naïve cohort and Week 48 for the virologically suppressed cohort. Key measures included virologic outcomes (HIV-1 RNA < 50 or ≥ 50 copies/mL), CD4 T-cell changes, adherence, metabolic and renal parameters, treatment-emergent adverse events, and treatment-emergent diabetes and hypertension.

Results

The treatment-naïve cohort included 96 participants ≥ 50 years of age and 538 participants < 50 years of age, while the virologically suppressed cohort included 450 participants ≥ 50 years of age and 640 participants < 50 years of age. By Week 240, virologic suppression was achieved in 98.5% of treatment-naïve participants ≥ 50 years of age and in 98.6% of those < 50 years of age, as determined using missing = excluded analysis. By Week 48, virologic failure was 0.9% versus 1.4% in participants ≥ 50 years of age versus < 50 years of age, respectively, and virologic suppression was maintained in 93.6% of virologically suppressed participants in both the ≥ 50 and < 50 years of age groups, as assessed using the US Food and Drug Administration snapshot algorithm. Across age groups, the treatment-naïve and virologically suppressed cohorts demonstrated comparable outcomes beyond viral load through Weeks 240 and 48, respectively, including CD4 T-cell changes, adherence rates of ≥ 95%, body weight, lipid profiles, renal function, bone health, treatment-emergent adverse events, and the incidence of treatment-emergent diabetes and hypertension.

Conclusions

These results highlight the durability, long-term efficacy, safety, and overall benefits of B/F/TAF in PWH ≥ 50 years of age.