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Impact of bictegravir/emtricitabine/tenofovir alafenamide on health-related quality of life and economic outcomes in HIV care: Substudy of the BIC-NOW clinical trial

Author

Listed:
  • Sergio Sequera-Arquelladas
  • María J Vivancos
  • David Vinuesa
  • Antonio Collado
  • Ignacio De Los Santos
  • Patricia Sorni
  • Noemi Cabello-Clotet
  • Marta Montero
  • Carlos Ramos Font
  • Alberto Terron
  • Maria José Galindo
  • Onofre Martinez
  • Pablo Ryan
  • Mohamed Omar-Mohamed
  • Helena Albendín-Iglesias
  • Rosario Javier
  • Alberto Romero
  • Coral García Vallecillos
  • Miguel Ángel Calleja
  • Carmen Hidalgo-Tenorio

Abstract

Background: The BICNOW clinical trial evaluated the effectiveness, safety, satisfaction, adherence to treatment, and retention in the system of a rapid initiation strategy with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in naïve HIV-infected individuals. It also assessed the burden of this infection on individuals and healthcare systems using various instruments, participant questionnaires, and pharmacoeconomic evaluations of this antiretroviral therapy (ART). This substudy focused on changes in the health-related quality of life (HRQoL) of participants and on the economic impact of this rapid initiation strategy. Methods and Findings: Patients were recruited for this phase IV, multicenter, open, single-branch clinical trial with 48-week follow-up between November 2020 and July 2022. HRQoL data were gathered using EQ-5D-3L and dichotomized HIV-SI questionnaires. In the cost-utility pharmacoeconomic analysis, data in the literature were used for comparators. The 208 participants had a mean age of 34 (27–44) years, 87·5% were male, 42·9% had completed higher education, and 67·1% were employed. The mean EQ-5D questionnaire score was significantly increased at 48 weeks versus baseline (0·940 ± 0·117 vs. 0·959 ± 0·083, p = 0·012), and the utility value in quality-adjusted life years (QALYs) was 0·877 ± 0·093. There was a significant improvement in the “usual activities” dimension (10·8 vs 4·1% p = 0·036). The Moses extreme reaction test showed a significant difference in all dimensions between participants in AIDS versus non-AIDS stage (p

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  • Sergio Sequera-Arquelladas & María J Vivancos & David Vinuesa & Antonio Collado & Ignacio De Los Santos & Patricia Sorni & Noemi Cabello-Clotet & Marta Montero & Carlos Ramos Font & Alberto Terron & M, 2025. "Impact of bictegravir/emtricitabine/tenofovir alafenamide on health-related quality of life and economic outcomes in HIV care: Substudy of the BIC-NOW clinical trial," PLOS ONE, Public Library of Science, vol. 20(9), pages 1-12, September.
    • Handle: RePEc:plo:pone00:0323167
    DOI: 10.1371/journal.pone.0323167
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    References listed on IDEAS

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