Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Sep 22;20(9):e0323167.
doi: 10.1371/journal.pone.0323167. eCollection 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

Sergio Sequera-Arquelladas  1 , María J Vivancos  2 , David Vinuesa  3 , Antonio Collado  4 , Ignacio De Los Santos  5 , Patricia Sorni  6 , Noemi Cabello-Clotet  7 , Marta Montero  8 , Carlos Ramos Font  9 , Alberto Terron  10 , Maria José Galindo  11 , Onofre Martinez  12 , Pablo Ryan  13 , Mohamed Omar-Mohamed  14 , Helena Albendín-Iglesias  15 , Rosario Javier  1 , Alberto Romero  16 , Coral García Vallecillos  1 , Miguel Ángel Calleja  17 , Carmen Hidalgo-Tenorio  1
Affiliations
Clinical Trial

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

Sergio Sequera-Arquelladas et al. PLoS One. .

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 < 0·001). HIV-SI results revealed a significantly smaller percentage of participants with bothersome symptoms at 48 weeks (75·4 vs. 62·2%, p = 0·035). The pharmacoeconomic study indicated a value of €6,550·21/QALY gained with this ART.

Conclusions: BIC/FTC/TAF is an appropriate rapid initiation strategy in naïve PLHIV that improves their quality of life. It is pharmacoeconomically feasible and offers superior long-term health outcomes in comparison to other approaches. (NCT06177574).

PubMed Disclaimer

Conflict of interest statement

CHT has received honararia for consulting or speaking at educational events from Janssen, Gilead, MSD and ViiV.

Figures

Fig 1
Fig 1. Trend flow.
Valid questionnaires per visit.
Fig 2
Fig 2. EQ-5D-VAS Results.
With trend lines and p values.
Fig 3
Fig 3. Graph of HIV-SI Results.
Bars indicate percentage of bothersome outcomes.
See this image and copyright information in PMC

References

    1. Safreed-Harmon K, Fuster-RuizdeApodaca MJ, Pastor de la Cal M, Lazarus JV. Problems undermining the health-related quality of life of people living with HIV in Spain: a qualitative study to inform the development of a novel clinic screening tool. Health Qual Life Outcomes. 2022;20(1):84. doi: 10.1186/s12955-022-01978-y - DOI - PMC - PubMed
    1. Lazarus JV, Safreed-Harmon K, Barton SE, Costagliola D, Dedes N, Del Amo Valero J, et al. Beyond viral suppression of HIV - the new quality of life frontier. BMC Med. 2016;14(1):94. doi: 10.1186/s12916-016-0640-4 - DOI - PMC - PubMed
    1. insight Start Study Group, Lundgren JD, Babiker AG, Gordin F, Emery S, Grund B, et al. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med. 2015;373(9):795–807. doi: 10.1056/NEJMoa1506816 - DOI - PMC - PubMed
    1. EACS Guidelines 2023. In: EACS Guidelines [Internet]. 2023. [cited 21 Apr 2024]. Available: https://eacs.sanfordguide.com
    1. Samji H, Cescon A, Hogg RS, Modur SP, Althoff KN, Buchacz K, et al. Closing the gap: increases in life expectancy among treated HIV-positive individuals in the United States and Canada. PLoS One. 2013;8(12):e81355. doi: 10.1371/journal.pone.0081355 - DOI - PMC - PubMed

MeSH terms

Associated data