Evidence map›Paper›PMID 40985146›Full record

ArticleThe Journal of antimicrobial chemotherapy2025

Effectiveness of first-line lamivudine/dolutegravir antiretroviral therapy in persons with HIV: real-life data from the ICONA Foundation cohort.

Alessandra Vergori, Alessandro Cozzi-Lepri, Sergio Lo Caputo, Alessandro Tavelli, Valentina Mazzotta, Elisabetta Schiaroli, Giancarlo Orofino, Cristina Mussini, Silvia Nozza, Antonella Cingolani and 3 more

Abstract read
In one paragraph

Article in The Journal of antimicrobial chemotherapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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.

Alessandra VergoriClinical and Research Infectious Diseases Department, National Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.ORCID 0000-0001-6944-0686
Alessandro Cozzi-LepriCentre for Clinical Research, Epidemiology, Modelling and Evaluation (CREME), Institute for Global Health, UCL, London, UK.
Sergio Lo CaputoInfection Diseases Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
Alessandro TavelliIcona Foundation, Milan, Italy.ORCID 0000-0001-5899-451X
Valentina MazzottaClinical and Research Infectious Diseases Department, National Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.ORCID 0000-0002-0240-7504
Elisabetta SchiaroliDepartment of Infectious Diseases, University of Perugia, Perugia, Italy.
Giancarlo OrofinoDivision I of Infectious and Tropical Diseases, ASL Città di Torino, Turin, Italy.
Cristina MussiniInfectious Diseases Unit, Azienda Ospedaliero-Universitaria Policlinico di Modena, University of Modena and Reggio Emilia, School of Medicine, Modena, Italy.
Silvia NozzaInfectious Diseases Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; IRCCS Ospedale San Raffaele Università Vita-Salute, Milan, Italy.ORCID 0000-0002-2673-2731
Antonella CingolaniDepartment of Infectious Diseases, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica Del Sacro Cuore, Rome, Italy.
Andrea AntinoriClinical and Research Infectious Diseases Department, National Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.ORCID 0000-0003-2121-4684
Antonella d'Arminio MonforteIcona Foundation, Milan, Italy.
Icona Foundation Study Group

Funding

Gilead SciencesIcona FoundationItalian Ministry of HealthLinea 2-progetto 2Merck Sharpe & DohmeViiV Healthcare
6 · The paper itself

Abstract

objectivesThis analysis aimed to evaluate the rate of failure of first-line lamivudine/dolutegravir in a real-world setting and assess the effectiveness among people with HIV (PWH) at higher risk of suboptimal response.

methodsThe study included PWH from the ICONA cohort who started first-line lamivudine/dolutegravir between 2016 and 2024. The primary endpoint was time to treatment failure (TF), defined as virological failure (VF, two consecutive HIV-RNA of >50 copies/mL >6 months after treatment initiation) or discontinuation due to toxicity/lack virological control/non-adherence or death for any cause. Secondary endpoints were time to treatment discontinuation for any reason (TD) and pure VF. Main exposures of interest were baseline CD4 and HIV-RNA, age, sex at birth and nation of birth. Standard survival analysis and Cox regression models were used.

resultsAmong 446 participants, after a median follow-up of 22 months, 4.3% (n = 19) experienced TF, the 3 year cumulative probability was 5.8% (95% CI: 2.9%-8.7%). Baseline CD4 count was associated with a 3-fold higher risk of TF, which decreased after adjustments. Higher viral loads (>100 000 copies/mL), age >50 years and foreign-born status were also associated with an increased risk of TF. No differences in TF according to sex at birth were found. By 3 years the probabilities of TD and VF were 13.4% (95% CI: 9.1%-17.6%) and 2.3% (95% CI: 0.19%-4.4%), respectively.

conclusionsIn our real-world setting, the TF probability for first-line lamivudine/dolutegravir was below 6% at 3 years, lower than in randomized trials. Our data suggest that, as shown with other regimens, PWH starting lamivudine/dolutegravir with CD4 count of ≤200 cells/mm3, HIV-RNA of >100 000 copies/mL, older age or foreign-born status may be at higher risk of TF, though larger studies are needed to qualify the magnitude of the effect.

Indexed as

Anti-HIV AgentsHIV InfectionsLamivudineAdultCD4 Lymphocyte CountCohort StudiesFemaleHumansMaleMiddle AgedRNA, ViralTreatment FailureTreatment OutcomeViral LoadAnti-HIV AgentsLamivudineRNA, Viral

Identifiers

PMID40985146
PMCPMC12596050

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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 Socratic graph.