Infect Dis Ther. 2025 Nov 24. doi: 10.1007/s40121-025-01252-w. Online ahead of print.
ABSTRACT
INTRODUCTION: Patient-reported outcomes (PROs) provide important insights into individuals’ health and well-being. We report PROs from six observational cohort studies in treatment-experienced people with HIV switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in routine clinical practice.
METHODS: Data were pooled from the BICtegravir Single Tablet Regimen (BICSTaR) cohort studies (Asia/Canada/EU/Israel/Japan) and a similarly designed Chinese cohort study (GS-CN-380-5759). Quality of life (QoL; mental/physical health) and HIV treatment satisfaction were self-reported by participants using the generic (non-HIV-specific) 36-item Short Form Health Survey questionnaire and HIV Treatment Satisfaction Questionnaire (HIVTSQ; status [s]/change), respectively. Descriptive statistics and linear mixed models adjusted for potential confounders and interactions, with bootstrapped confidence intervals, were used to analyse PROs through 24 months (12 months for treatment satisfaction).
RESULTS: Of 3724 treatment-experienced participants included, 64.2% were Asian, 89.0% male; median age was 41 years. Baseline Mental Component Summary (MCS) scores were below the population average despite receiving antiretroviral therapy, whereas Physical Component Summary (PCS) scores were above average. At 24 months, observed median MCS score improved from baseline (+ 0.6 [interquartile range [IQR] – 4.3 to + 5.9; p = 0.018]) and median PCS score remained stable (- 0.1 [IQR – 3.3 to + 3.3; p = 0.998]). In all key populations, predicted adjusted MCS/PCS scores showed small improvements or remained stable over time. Treatment satisfaction was high at baseline (median HIVTSQs score 55 [IQR 49-60]), with participants reporting improved treatment satisfaction following the switch to B/F/TAF compared with their previous regimen (+ 27 [19-30] at 12 months). Similar improvements were observed across all key populations.
CONCLUSION: In this large cohort of people with HIV who switched to B/F/TAF in routine clinical practice, mental and physical health scores improved or remained stable over time and treatment satisfaction improved. Further studies are required to elucidate the clinical relevance of PRO tools and how they relate to QoL in people with HIV. Video abstract available for this article.
TRIAL REGISTRATION: ClinicalTrials.gov identifiers NCT03580668 (Canada study) and NCT04009057 (Israel study); EudraCT trial identifier, EUPAS22185 (Europe study). Video abstract available for this article. Quality of life and treatment satisfaction in people with HIV switching to bictegravir/emtricitabine/tenofovir alafenamide: Pooled analysis from observational cohort studies – a video abstract.
PMID:41284214 | DOI:10.1007/s40121-025-01252-w
