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
Year: 2025
Type: article
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).
Source: PLoS ONE
Authors: 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
Institutions: Universidad de Granada, Instituto de Investigación Biosanitaria de Granada, Hospital Universitario Virgen de las Nieves, Instituto de Salud Carlos III, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red Enfermedades Infecciosas, Complejo Hospitalario Torrecárdenas, Hospital Universitario de La Princesa, Hospital Son Llatzer, Hospital Clínico San Carlos, Hospital Universitari i Politècnic La Fe, Hospital Universitario de Jerez, Hospital Clínico Universitario de Valencia, Santa Lucía University General Hospital, Hospital Universitario Infanta Leonor, Complejo Hospitalario de Jaén, Instituto Murciano de Investigación Biosanitaria, Hospital Universitario Virgen de la Arrixaca, Universidad de Cádiz, Hospital Universitario Puerto Real, Hospital Universitario Virgen Macarena
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,382
Funders: Gilead Sciences, Universidad de Granada
Award: G2534762368
OpenAlex ID: W4414406517