Evidence map›Paper›PMID 41439671›Full record

ArticleJournal of medical virology2026

Development of a Next-Generation Sequencing Protocol for Assessing Lenacapavir Resistance in HIV-1 Capsid.

Omar El Khalili, Collins Ambe Chenwi, Daniele Spalletta, Greta Marchegiani, Luca Carioti, Hossein Eizadi Moghadam, Ada Bertoli, Vincenzo Spagnuolo, Maria Mercedes Santoro, Francesca Ceccherini-Silberstein and 1 more

Abstract read
In one paragraph

Article in Journal of medical virology, 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

11 authors.

Omar El KhaliliDepartment of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy.
Collins Ambe ChenwiDepartment of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy.
Daniele SpallettaDepartment of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy.ORCID https://orcid.org/0009-0009-4932-5344
Greta MarchegianiDepartment of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy.
Luca CariotiDepartment of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy.ORCID https://orcid.org/0000-0003-1713-8682
Hossein Eizadi MoghadamDepartment of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy.
Ada BertoliDepartment of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy.
Vincenzo SpagnuoloInfectious Diseases Unit, San Raffaele Scientific Institute, Milan, Italy.
Maria Mercedes SantoroDepartment of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy.
Francesca Ceccherini-SilbersteinDepartment of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy.
Maria Concetta BellocchiDepartment of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy.ORCID https://orcid.org/0000-0001-7717-2343

Funding

Gilead SciencesInnovative Health Initiative Joint Undertaking (IHI JU) 101194735
6 · The paper itself

Abstract

Lenacapavir (LEN) is a first-in-class capsid inhibitor (CAI) that targets multiple stages of the HIV-1 lifecycle, showing efficacy in heavily treatment-experienced (HTE) individuals with multidrug-resistance (MDR) and in pre-exposure prophylaxis (PrEP). This study aimed to characterize a novel in-house next-generation sequencing (NGS) protocol targeting HIV-1 capsid (CA) region using both HIV-1 RNA from plasma and HIV-1 DNA from peripheral-blood-mononuclear-cells (PBMCs). A total of 60 samples (41 HIV-1 RNA and 19 HIV-1 DNA) with various HIV-1 subtypes and viremia levels were tested. Overall, molecular amplification was successful in 83.3% of cases (75.6% for HIV-1 RNA and 100% for HIV-1 DNA), while high quality sequences were obtained in 76.7% of samples (65.9% for HIV-1 RNA and 100% for HIV-1 DNA). Among RNA samples with viremia ≥ 500 copies/mL, sequencing success reached 92.6%, showing a statistically significant association with viral load. Subtype-specific analysis showed amplification and sequencing rates of 86.0% and 79.1% for subtype B, and 76.5% and 70.6% for non-B subtypes, with no significant difference. Reproducibility was fully confirmed by pairwise similarity analyses at 10% and 20% frequency cutoff, upon reprocessing 13 HIV-1 RNA samples. This protocol provides an important tool, primarily for subtype B, for personalized HIV-1 treatment with CAI-based strategies, enabling efficient characterization of LEN resistance mutations in the CA region, using both DNA and RNA samples.

Indexed as

Anti-HIV AgentsCapsid ProteinsDrug Resistance, ViralHigh-Throughput Nucleotide SequencingHIV-1AcetamidesDNA, ViralHIV InfectionsHumansIndazolesRNA, ViralViral LoadAcetamidesAnti-HIV AgentsCapsid ProteinsDNA, ViralIndazoleslenacapavirRNA, ViralCapsidHIV‐1lenacapavirnext‐generation sequencingresistance

Identifiers

PMID41439671
PMCPMC12729479

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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.