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Multicenter Study
. 2025 Nov;91(5):106651.
doi: 10.1016/j.jinf.2025.106651. Epub 2025 Nov 7.

Bictegravir/emtricitabine/tenofovir alafenamide for primary HIV infection: Efficacy, safety and impact on viral reservoir (the BIC-PHI clinical trial)

Juan Ambrosioni  1 , Elisa de Lazzari  2 , Sonsoles Sánchez-Palomino  2 , Lucía Bailón  3 , Paula Suanzes  4 , Carmen Busca  5 , Luis Ramos-Ruperto  5 , Eva Orviz  6 , Ángel Rivero  7 , Beatriz Mothe  8 , Jorge Del Romero  6 , Vicenç Falcó  4 , Sònia Vicens-Artés  9 , Elisa Moraga  9 , Anna Cruceta  9 , Josep Mallolas  2 , Josep M Miró  10 ; BIC-PHI Study Group
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Free article
Multicenter Study

Bictegravir/emtricitabine/tenofovir alafenamide for primary HIV infection: Efficacy, safety and impact on viral reservoir (the BIC-PHI clinical trial)

Juan Ambrosioni et al. J Infect. 2025 Nov.
Free article

Abstract

Objectives: We evaluated the efficacy, safety and impact on viral reservoir of rapid bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) initiation during primary HIV infection (PHI).

Methods: Multicenter, single-arm clinical trial in participants with PHI of <3 months (seroconversion or incomplete serological pattern), starting BIC/FTC/TAF in 6 Spanish centers between January-2021 and September-2022. Primary endpoint was proportion of participants with viral load (VL)<50 copies/mL at 48-weeks on the Intention-to-treat-exposed population (ITTe). Cases were compared with randomly-matched retrospective PHI controls, starting other 3-drug Integrase-Strand-Transfer-inhibitor-based regimens. Reservoir was evaluated in PHI cases by Intact Proviral DNA Assay (IPDA).

Results: We included 64 participants, 94% cis-male, aged 32 (26;41) years.; 78% men-who-have-sex-with-men. At BIC/FTC/TAF initiation, Fiebig stages were II (14%), III (11%); IV (5%), V (54%) and VI (16%); VL was 496,520 (110,000;1,285,000) copies/mL; 62% were subtype B; median (IQR) CD4 T cell count was 406 (322;535) cells/µL; 6% had active hepatitis B virus co-infection. All participants started BIC/FTC/TAF at first specialist consultation. 81% (ITTe) and 93% (On-Treatment, OT) had VL<50 copies/mL at 48-weeks. 72% had adverse events, only 3% were grade 3/4; 91% were not-related, none led to BIC/FTC/TAF-discontinuation. 92% of controls (OT) had VL<50 copies/mL at 48-weeks (p=0.914), 11% (17%) modified initial antiretroviral regimen (p>0.001). Intact and defective proviral DNA levels significantly decreased at 48-weeks.

Conclusions: BIC/FTC/TAF showed rapid viral decay, high suppression rates, good tolerability, and reservoir decline in PHI, making it an appealing regimen in this setting.

Keywords: BIC/FTC/TAF; Bictegravir; PHI; Primary HIV infection; Rapid ART initiation; Viral load; Viral reservoir; Viral suppression.

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Conflict of interest statement

Declaration of Competing Interest JA received consulting honoraria and/or research grants from Gilead Sciences, MSD, ViiV Healthcare, HIPRA and Grifols outside of the current work. JMM has received consulting honoraria and/or research grants from Angelini, Contrafect, Genentech, Gilead Sciences, Jansen, Lysovant, Medtronic, MSD, Novartis, Pfizer, and ViiV Healthcare. PS received honoraria and/or speaking fees and/or financial support for attending conferences from Gilead, Janssen-Cilag, Merck Sharp & Dohme, Pfizer, and ViiV Healthcare, as well as a grant from the Catalan Society of Infectious Diseases and Clinical Microbiology (SCMIMC) funded by ViiV Healthcare, all outside the submitted work. BM reports consultancy, advisory and/or speaker fees from AELIX Therapeutics, Gilead Sciences, Janssen, ViiV and MSD, all outside the submitted work. All other authors: none to disclose.

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