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 Feb 27;12(3):ofaf087.
doi: 10.1093/ofid/ofaf087. eCollection 2025 Mar.

Three-Year Effectiveness of Bictegravir/Emtricitabine/Tenofovir Alafenamide as a Switch Strategy in the Real World

Alejandro de Gea-Grela  1 , Rafael Micán  1   2 , Rosa de Miguel  1   2 , Lucía Serrano  1 , Cristina Marcelo  1 , María Luisa Montes  1   2 , Luis Ramos-Ruperto  1 , Carmen Busca  1   2 , María Del Mar Arcos-Rueda  1 , Rocío Montejano  1   2 , Jose Ramon Arribas  1   2 , Juan Gonzalez-García  1   2 , José Ignacio Bernardino  1   2 , Luz Martín-Carbonero  1   2
Affiliations
Clinical Trial

Three-Year Effectiveness of Bictegravir/Emtricitabine/Tenofovir Alafenamide as a Switch Strategy in the Real World

Alejandro de Gea-Grela et al. Open Forum Infect Dis. .

Abstract

Background: We previously described the effectiveness of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as a switch strategy in real life in people with HIV (PWH) at 48 weeks. We did not find that previous nucleoside reverse transcriptase inhibitor (NRTI) resistance-associated mutations (RAMs) had an impact on efficacy. Herein we report response rates after 3 years of follow-up.

Methods: This retrospective review comprised PWH who were treatment experienced and switched to B/F/TAF in a single-center cohort. HIV RNA <50 copies/mL was analyzed at 96 and 144 weeks in an intention-to-treat analysis (missing = failure) and per-protocol analysis; patients with missing data or changes for reasons other than virologic failure were excluded.

Results: An overall 506 PWH were included: 16.2% were women, the median age was 52.3 years, the median time of HIV infection was 18.9 years, and 13.6% had documented preexisting NRTI RAMs. At 96 weeks of follow-up in the intention-to-treat and per-protocol analyses, HIV RNA <50 copies/mL was seen in 73.1% and 95.4%, respectively. At 144 weeks, these figures were 68.2% and 94%. There were no statistically significant differences between patients with and without previous NRTI RAMs. A total of 140 patients were excluded for the per-protocol analysis at week 144: 46 were lost to follow-up, 32 discontinued treatment due to toxicity, 34 simplified to dual antiretroviral therapy, 7 switched for other reasons, and 20 patients died (no death was B/F/TAF related).

Conclusions: Through 3 years of follow-up, switching to B/F/TAF maintained high rates of virologic suppression in long-term PWH. These results were seen even in patients with preexisting NRTI RAMs.

Keywords: HIV; antiretroviral treatment; bictegravir; resistance mutation; treatment experienced.

PubMed Disclaimer

Conflict of interest statement

Potential conflicts of interest. R. Micán, R. d. M., M. L. M., L. R.-R., C. B. A., R. Montejano, J. R. A., J. G.-G., J. I. B., and L. M.-C. have received personal fees from Gilead, MSD, Janssen and VIIV. A. d. G.-G., M. d. M. A.-R., and C. M. has received personal fees from Gilead. L. S. has no conflict of interest.

References

    1. Pham HT, Mesplède T. Bictegravir in a fixed-dose tablet with emtricitabine and tenofovir alafenamide for the treatment of HIV infection: pharmacology and clinical implications. Expert Opin Pharmacother 2019; 20:385–97. - PubMed
    1. Molina JM, Ward D, Brar I, et al. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet HIV 2018; 5:e357–65. - PubMed
    1. Hagins D, Kumar P, Saag M, et al. Switching to bictegravir/emtricitabine/tenofovir alafenamide in Black Americans with HIV-1: a randomized phase 3b, multicenter, open-label study. J Acquir Immune Defic Syndr 2021; 88:86–95. - PMC - PubMed
    1. Sax PE, Pozniak A, Montes ML, et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet 2017; 390:2073–82. - PubMed
    1. Daar ES, DeJesus E, Ruane P, et al. Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, phase 3, non-inferiority trial. Lancet HIV 2018; 5:e347–56. - PubMed

Publication types