Evidence map›Paper›PMID 41874003›Full record

Trial reportAIDS (London, England)2026

Baseline and week 48 resistance analysis in participants receiving bictegravir + lenacapavir in the phase 2 ARTISTRY-1 study.

Nina Pennetzdorfer, Vidula Naik, Jairo Mauricio Montezuma-Rusca, Peter Sklar, Christian Callebaut, Nicolas A Margot

Abstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in AIDS (London, England), 2026. 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. Resistance Analysis of Weekly Islatravir Plus Lenacapavir in People With HIV at 48 Weeks.Journal of acquired immune deficiency syndromes (1999) · 2026
    Trial
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

6 authors.

Nina PennetzdorferClinical Virology, Gilead Sciences, Inc.
Vidula NaikClinical Virology, Gilead Sciences, Inc.
Jairo Mauricio Montezuma-RuscaClinical Development, Gilead Sciences, Inc., Foster City, CA, USA.
Peter SklarClinical Development, Gilead Sciences, Inc., Foster City, CA, USA.
Christian CallebautClinical Virology, Gilead Sciences, Inc.
Nicolas A MargotClinical Virology, Gilead Sciences, Inc.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundARTISTRY-1 is an operationally seamless Phase 2/3 study evaluating the safety and efficacy of once-daily oral lenacapavir (LEN) + bictegravir (BIC) in virologically suppressed participants without known integrase strand-transfer inhibitor (INSTI) resistance, compared to a complex multi-tablet regimen.

methodsBaseline HIV-1 resistance-associated mutations (RAMs) were assessed via historical genotypic reports (HGR) and proviral DNA genotyping (GenoSure Archive, Monogram Biosciences). The impact of baseline RAMs on Week 48 efficacy in the Phase 2 part of the study was evaluated. Post-baseline genotypic and phenotypic resistance was assessed in participants with confirmed virologic rebound (HIV-1 RNA ≥50 copies/ml; analyzed if ≥200 copies/ml).

resultsBaseline HIV-1 genotypic data from HGR and/or proviral DNA analyses were available for 98% (125/128) of participants. RAMs for nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and protease inhibitors (PIs) were found in 81%, 65%, and 46% of participants, respectively; 11% had primary INSTI RAMs by proviral DNA genotyping. Baseline RAMs had no impact on Week 48 efficacy. One participant with baseline resistance to NRTIs, NNRTIs, and PIs, and detectable baseline viral load met the criteria for resistance testing. A novel capsid polymorphism (N74T) emerged in this individual, with no impact on LEN susceptibility.

conclusionsDespite high frequencies of baseline resistance, substantial rates of viral suppression were maintained through Week 48 and no on-treatment resistance to study drugs was detected. These findings support the development of once-daily BIC+LEN STR to improve and optimize treatment options in individuals on complex ART.

Indexed as

Anti-HIV AgentsDrug Resistance, ViralHIV-1HIV InfectionsQuinolonesAcetamidesAmidesGenotypeHeterocyclic Compounds, 3-RingHumansIndazolesPiperazinesPyridonesAcetamidesAmidesAnti-HIV AgentsbictegravirHeterocyclic Compounds, 3-RingIndazoleslenacapavirPiperazinesPyridonesQuinolonesbictegravirHIVHIV resistance analysislenacapavir

Identifiers

PMID41874003
PMCPMC13336754

What Socratic holds

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LicenceCC BY-NC-ND
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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 Socratic graph.