Evidence map›Paper›PMID 40296167›Full record

ArticleHIV medicine2025

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, Alessandro Tavelli, Alessandro Cozzi-Lepri, Andrea Giacomelli, Roberto Rossotti, Giacomo Ponta, Nicoletta Bobbio, Alice Ianniello, Antonella Cingolani, Giordano Madeddu and 3 more

Abstract read
In one paragraph

Article in HIV medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Andrea De VitoUnit of Infectious Disease, Department of Medicine, Surgery and Pharmacy, University of Sassari, Sassari, Italy.ORCID https://orcid.org/0000-0002-8265-5400
Alessandro TavelliICONA Foundation, Milan, Italy.ORCID https://orcid.org/0000-0001-5899-451X
Alessandro Cozzi-LepriCentre for Clinical Research, Epidemiology, Modelling and Evaluation (CREME), Institute for Global Health, University College London, London, UK.ORCID https://orcid.org/0000-0002-6339-919X
Andrea GiacomelliIII Infectious Diseases Unit, ASST FBF-Sacco, Milan, Italy.
Roberto RossottiDepartment of Infectious Diseases, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.ORCID https://orcid.org/0000-0003-4965-8789
Giacomo PontaInfectious Diseases Unit, IRCCS San Raffaele Scientific Institute, Vita Salute San Raffaele University, Milan, Italy.
Nicoletta BobbioDepartment of Infectious Diseases, Galliera Hospital, Genoa, Italy.
Alice IannielloDivision I of Infectious and Tropical Diseases, ASL Città di Torino, Turin, Italy.
Antonella CingolaniClinic of Infectious Diseases, Department of Safety and Bioethics, Università Cattolica del Sacro Cuore, Rome, Italy.
Giordano MadedduUnit of Infectious Disease, Department of Medicine, Surgery and Pharmacy, University of Sassari, Sassari, Italy.
Andrea AntinoriNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, National Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Antonella d'Arminio MonforteICONA Foundation, Milan, Italy.ORCID https://orcid.org/0000-0003-0073-1789
ICONA Foundation Study Group

Funding

Gilead SciencesJanssen-CilagMerck Sharp & DohmeViiV Healthcare
6 · The paper itself

Abstract

objectivesMost 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.

methodsWe 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.

resultsAmong 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.

conclusionsSwitching 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.

Indexed as

AdenineAnti-HIV AgentsDrug SubstitutionEmtricitabineHeterocyclic Compounds, 4 or More RingsHIV InfectionsTenofovirAdultAlanineAmidesAntiretroviral Therapy, Highly ActiveCD4 Lymphocyte CountCohort StudiesDrug Therapy, CombinationFemaleHeterocyclic Compounds, 3-RingAdenineAlanineAmidesAnti-HIV AgentsbictegravirEmtricitabineHeterocyclic Compounds, 3-RingHeterocyclic Compounds, 4 or More RingsPiperazinesPyridonesTenofovirtenofovir alafenamideART switchbictegravirdual therapyviral load

Identifiers

PMID40296167
PMCPMC12127237

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.