Evidence map›Paper›PMID 41361072›Full record

ArticleCommunications medicine2025

Predictors of virological outcomes after analytical interruption of antiretroviral therapy and HTI vaccination in early treated people with HIV-1._.

Lucia Bailón, Yovaninna Alarcón-Soto, José R Arribas, Adrian Curran, Anuska Llano, Samandhy Cedeño, Roger Paredes, Elena Vendrame, Devi SenGupta, Jeffrey J Wallin and 6 more

Abstract read
In one paragraph

Article in Communications medicine, 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. Review
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

16 authors.

Lucia Bailón *Department of Infectious Diseases and Fundació Lluita contra les Infeccions, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.ORCID http://orcid.org/0000-0001-7277-9314
Yovaninna Alarcón-Soto *Department of Infectious Diseases and Fundació Lluita contra les Infeccions, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.ORCID http://orcid.org/0000-0002-9977-8634
José R ArribasCIBER de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain.
Adrian CurranInfectious Diseases Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Research Institute (VHIR), Barcelona, Spain.
Anuska LlanoUnitat Secretaria Tècnica CEIm Parc Taulí. Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain.
Samandhy CedeñoIrsiCaixa, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.ORCID http://orcid.org/0000-0001-8312-0208
Roger ParedesDepartment of Infectious Diseases and Fundació Lluita contra les Infeccions, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.ORCID http://orcid.org/0000-0002-6553-691X
Elena VendrameGilead Sciences, Inc, Foster City, CA, USA.ORCID http://orcid.org/0000-0002-5595-1773
Devi SenGuptaGilead Sciences, Inc, Foster City, CA, USA.
Jeffrey J WallinGilead Sciences, Inc, Foster City, CA, USA.
Romas GeleziunasGilead Sciences, Inc, Foster City, CA, USA.
Marie P MaliceStatAdvice, Inc, Brussels, Belgium.
Ian McGowanAELIX Therapeutics S.L, Barcelona, Spain.
Christian Brander *CIBER de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain. cbrander@irsicaixa.es.ORCID http://orcid.org/0000-0002-0548-5778
José Moltó *Department of Infectious Diseases and Fundació Lluita contra les Infeccions, Hospital Universitari Germans Trias i Pujol, Badalona, Spain. jmolto@lluita.org.
Beatriz Mothe *Department of Infectious Diseases and Fundació Lluita contra les Infeccions, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.ORCID http://orcid.org/0000-0001-9975-407X

Funding

Supplement to A Multi-omics Approach to Immune Responses in HIV Vaccination and InterventionP01AI178375 · NIAID · UNIVERSITY OF CALIFORNIA AT DAVIS · PI DENNIS J. HARTIGAN-O'CONNOR, Rachel Lena Rutishauser · 2023 to 2026
$8.5M
NIAID NIH HHS P01 AI178375
6 · The paper itself

Abstract

backgroundRandomized, placebo-controlled clinical trials (RCTs) that include analytical treatment interruptions (ATI) are conducted to test the efficacy of HIV cure strategies. Two independent RCTs, AELIX-002 and AELIX-003, evaluated the HTI immunogen-based vaccines alone or combined with the TLR7 agonist vesatolimod in early-treated people with HIV (etPWH). These studies individually demonstrated that higher levels of vaccine-induced HTI-specific T-cell responses were associated with extended time off antiretroviral therapy (ART) during a 24-week ATI.

methodsWe conducted a pooled analysis of both RCTs including the individual data of a total of 88 participants. The association between clinical, immunogenicity and viral data and rebound outcomes during the ATI was evaluated using logistic regression and receiver operating characteristic (ROC) analyses.

resultsWe identify an HTI-specific threshold of 835 spot-forming cells/10

conclusionsThese findings confirm that HTI-specific T-cell magnitude at ATI initiation is the strongest predictor of ATI outcomes observed in AELIX002/003 studies and that a threshold of vaccine-induced HTI-specific T-cell responses can be used as futility criteria before ATI and/or guide participant selection in future HTI-based HIV cure trials aimed at achieving therapy-free remission.

Identifiers

PMID41361072
PMCPMC12775531

What OpenQuestion holds

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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 OpenQuestion graph.