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. 2025 Jun;26(6):970-977.
doi: 10.1111/hiv.70037. Epub 2025 Apr 28.

Safety and effectiveness of switch to bictegravir/emtricitabine/tenofovir alafenamide following dual regimen therapy in people with HIV: Insights from the Icona cohort

Andrea De Vito  1   2 , Alessandro Tavelli  3   4 , Alessandro Cozzi-Lepri  5 , Andrea Giacomelli  6 , Roberto Rossotti  7 , Giacomo Ponta  8 , Nicoletta Bobbio  9 , Alice Ianniello  10 , Antonella Cingolani  11 , Giordano Madeddu  1 , Andrea Antinori  12 , Antonella d'Arminio Monforte  3 ; ICONA Foundation Study Group
Collaborators, Affiliations

Safety and effectiveness of switch to bictegravir/emtricitabine/tenofovir alafenamide following dual regimen therapy in people with HIV: Insights from the Icona cohort

Andrea De Vito et al. HIV Med. 2025 Jun.

Abstract

Objectives: Most treatment switches are for simplification from three-drug (3DR) to dual regimens (2DR). However, a proportion of people with HIV may switch back to 3DR, like bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) after 2DR.

Methods: We included people with HIV enroled in the Icona cohort who switched to B/F/TAF after 2DR INSTI-based (3TC/DTG, RPV/DTG, RPV/CAB, or DOR + DTG). Virological rebound (VR), virological suppression (VS), and treatment discontinuation (TD) due to toxicity or failure were evaluated using Kaplan-Meier curves. Random intercept and slopes before and after the switch were used to evaluate the trajectories of triglycerides, cholesterol, CD4, and CD4/CD8. Viro-immunological analyses were stratified according to HIV-RNA at switch.

Results: Among the 3662 people with HIV who started a 2DR INSTI-based regimen, 71 (1.9%) switched to B/F/TAF; 60 had been followed up after the switch, for a median of 10.9 months (interquartile range: 3.6-24.7). Forty people with HIV switched with HIV-RNA <50 copies/mL (uVL), 20 with HIV-RNA ≥50 copies/mL (dVL). Among the uVL group, one participant experienced VR (HIV-RNA: 99, 71 followed by 29 copies/mL). Among the dVL group, the 1-year cumulative probability of undetectable VL was 75% (95% confidence interval [CI] 57.6-95.1). Fourteen people with HIV interrupted B/F/TAF for simplification (50.0%), toxicity (28.6%), VR (14.2%), and patient's choice (7.1); the 1-year cumulative probability of TD for toxicity/failure was 10.7% (95% CI 14.5-24.5). We observed an increase in the CD4/CD8 ratio (+0.02 CD4/CD8/month, p = 0.026) only in the dVL group.

Conclusions: Switching from 2DR-INSTI to B/F/TAF is infrequent; this switch results in a low rate of toxicity and failure, along with a favourable immunovirological and lipid profile. CD4/CD8 gain is observed in those switching with detectable HIV-RNA.

Keywords: ART switch; bictegravir; dual therapy; viral load.

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Conflict of interest statement

Alessandro Tavelli, Alessandro Cozzi‐Lepri, Alice Ianniello, Antonella d'Arminio Monforte, Nicoletta Bobbio, Giacomo Ponta declare no conflicts of interest. Andrea De Vito received fees for attending advisory boards from ViiV. Andrea Giacomelli received fees for attending advisory boards from ViiV. Speakers' honoraria from Gilead, Janssen, MSD, and ViiV. Roberto Rossotti received grants, fees for speaker's bureau, and advisory board activities from ViiV Healthcare, MSD, Gilead Sciences, Johnson & Johnson, and SD Biosensor. Antonella Cingolani received funding for scientific advisory boards, travel, or speaker honoraria from Gilead Sciences, ViiV Healthcare, Janssen‐Cilag, and MSD. Giordano Madeddu received speaker's honoraria and fees for attending advisory boards from Viiv, Gilead, MSD, Janssen, and Tera Technologies. Andrea Antinori served as a paid consultant to Astra Zeneca, Bavarian Nordic, Gilead Sciences, GSK, Janssen‐Cilag, MSD, Moderna, Pfizer, and ViiV Healthcare and received institutional research grants from Astra Zeneca, Gilead Sciences, and ViiV Healthcare.

Figures

FIGURE 1
FIGURE 1
(a) Kaplan–Meier curves of the cumulative probability of virological rebound (VR) after bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) switch in virologically suppressed people with HIV at baseline; (b) Kaplan–Meier curves of the cumulative probability of virological suppression (VS) after B/F/TAF switch in people with HIV with detectable HIV‐RNA at baseline; (c) Kaplan–Meier curves of the cumulative probability of TD of B/F/TAF for toxicity or failure.
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