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

作者：Cissy M. Kityo, Samir K. Gupta, Princy Kumar, Amy R. Weinberg, Bhumi Gandhi‐Patel, Hui Liu, Jason T. Hindman, Jürgen K. Rockstroh · 发表于：BMC Infectious Diseases · 年份：2025 · DOI：10.1186/s12879-025-11476-3 · 被引用次数：2 · 研究领域：HIV/AIDS drug development and treatment、HIV-related health complications and treatments、HIV/AIDS Research and Interventions

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% ve...