Evidence map›Paper›PMID 41885130›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2026

Resistance Analysis of Weekly Islatravir Plus Lenacapavir in People With HIV at 48 Weeks.

Laurie A VanderVeen, Lisa Selzer, Silvia Chang, Jiani Li, Tracy L Diamond, Ernest Asante-Appiah, Cyril Llamoso, Martin S Rhee, Christian Callebaut

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 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. 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

9 authors.

Laurie A VanderVeenGilead Sciences, Inc., Foster City, CA; and.
Lisa SelzerGilead Sciences, Inc., Foster City, CA; and.
Silvia ChangGilead Sciences, Inc., Foster City, CA; and.
Jiani LiGilead Sciences, Inc., Foster City, CA; and.
Tracy L DiamondMerck & Co., Inc., Rahway, NJ.
Ernest Asante-AppiahMerck & Co., Inc., Rahway, NJ.
Cyril LlamosoMerck & Co., Inc., Rahway, NJ.
Martin S RheeGilead Sciences, Inc., Foster City, CA; and.
Christian CallebautGilead Sciences, Inc., Foster City, CA; and.

Funding

Gilead Sciences, Inc.
6 · The paper itself

Abstract

backgroundIslatravir (ISL), a nucleoside reverse transcriptase translocation inhibitor, and lenacapavir (LEN), a capsid inhibitor, have pharmacokinetic profiles supporting once-weekly (QW) oral dosing. In a phase 2 study, QW ISL + LEN maintained a high rate (94.2%) of viral suppression (VS; HIV-1 RNA <50 copies/mL) at week 48. We report resistance analyses through week 48.

methodsVirologically suppressed participants received ISL (2 mg QW) plus LEN (600 mg days 1 + 2, then 300 mg QW; n = 52) or once-daily bictegravir/emtricitabine/tenofovir alafenamide (50/200/25 mg; n = 52). Proviral DNA sequencing of HIV-1 protease, reverse transcriptase, and integrase was performed at screening; available historical genotypes were collected. Participants with primary nucleoside reverse transcriptase inhibitor (NRTI) or non-NRTI resistance-associated mutations were excluded. Postbaseline resistance analyses were performed for participants with HIV-1 RNA ≥200 copies/mL at virologic failure (≥50 copies/mL at 2 consecutive visits or ≥50 copies/mL at study drug discontinuation/last visit).

resultsOf 104 enrolled participants, 5 randomized with historical genotypes were subsequently found to have primary NRTI and/or non-NRTI resistance-associated mutations: all 5 maintained VS, including 2 participants with M184V/I (1/group). One participant receiving ISL + LEN with low-level viremia on day 1 (HIV-1 RNA 251 copies/mL) met criteria for resistance analysis; no emergent resistance was observed, and they subsequently resuppressed on ISL + LEN. Longitudinal analysis of plasma virus detected identical viruses with no evidence of viral evolution.

conclusionsISL + LEN maintained high rates of VS, including in 1 participant with pre-existing M184V. No participants developed drug resistance. These findings support the ongoing evaluation of QW oral ISL + LEN for HIV-1 treatment.

Indexed as

Anti-HIV AgentsDrug Resistance, ViralHIV-1HIV InfectionsQuinolonesAcetamidesAdultAmidesDeoxyadenosinesFemaleHumansIndazolesMaleMiddle AgedRNA, ViralValineAcetamidesAmidesAnti-HIV AgentsDeoxyadenosinesIndazolesislatravirlenacapavirQuinolonesRNA, ViralValinedrug resistanceHIV resistance genotypeHIV treatmentislatravirlenacapavir

Identifiers

PMID41885130
PMCPMC13372359

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Registered trials

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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.