Evidence map›Paper›PMID 35502922›Full record

Trial reportAntimicrobial agents and chemotherapy2022

Week 96 Genotypic and Phenotypic Results of the Fostemsavir Phase 3 BRIGHTE Study in Heavily Treatment-Experienced Adults Living with Multidrug-Resistant HIV-1.

Margaret Gartland, Pedro Cahn, Edwin DeJesus, Ricardo Sobhie Diaz, Robert Grossberg, Michael Kozal, Princy Kumar, Jean-Michel Molina, Fernando Mendo Urbina, Marcia Wang and 9 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.2field-weighted citation impact, top 19% of its field
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

13 citing papers in PubMed, 18 citations in OpenAlex.

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  13. Fostemsavir resistance in clinical context: a narrative review.Therapeutic advances in infectious disease
    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

19 authors at 11 institutions in 6 countries.

Margaret GartlandViiV Healthcare, Research Triangle Park, North Carolina, USA.ORCID 0000-0002-1200-3706
Pedro CahnFundación Huesped, Buenos Aires, Argentina.
Edwin DeJesusOrlando Immunology Center, Orlando, Florida, USA.
Ricardo Sobhie DiazInfectious Diseases Division, Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.ORCID 0000-0002-8395-7304
Robert GrossbergMontefiore Medical Center, Bronx, New York, USA.
Michael KozalDepartment of Internal Medicine, Infectious Diseases Section, Yale University School of Medicine, New Haven, Connecticut, USA.
Princy KumarDepartment of Medicine and Microbiology, Georgetown University Medical Center, Washington, DC, USA.
Jean-Michel MolinaUniversity of Paris, Saint-Louis and Lariboisière Hospitals, Assistance Publique Hôpitaux de Paris, Paris, France.
Fernando Mendo UrbinaHospital Nacional Edgardo Rebagliati Martins, Lima, Peru.
Marcia WangGlaxoSmithKline, Collegeville, Pennsylvania, USA.
Fangfang DuGlaxoSmithKline, Collegeville, Pennsylvania, USA.
Shiven ChabriaViiV Healthcare, Branford, Connecticut, USA.
Andrew ClarkViiV Healthcare, Brentford, United Kingdom.
Louise GarsideGlaxoSmithKline, Brentford, United Kingdom.
Mark KrystalViiV Healthcare, Branford, Connecticut, USA.ORCID 0000-0001-8905-2584
Frank ManninoGlaxoSmithKline, Collegeville, Pennsylvania, USA.
Amy PierceViiV Healthcare, Research Triangle Park, North Carolina, USA.
Peter AckermanViiV Healthcare, Branford, Connecticut, USA.
Max LatailladeViiV Healthcare, Branford, Connecticut, USA.
GlaxoSmithKline (United States) · USFundación Huésped · ARGeorgetown University · USGlaxoSmithKline (United Kingdom) · GBHospital Nacional Cayetano Heredia · PEMontefiore Medical Center · USOrlando Immunology Center · USUniversidade Federal de São Paulo · BRUniversité Paris Cité · FRViiV Healthcare (United Kingdom) · GBYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

In the phase 3 BRIGHTE study in heavily treatment-experienced adults with multidrug-resistant HIV-1, fostemsavir plus optimized background therapy (OBT) resulted in sustained rates of virologic suppression through 96 weeks. HIV-1 RNA <40 copies/mL was achieved in 163/272 (60%) Randomized Cohort (RC) participants (with 1 or 2 remaining approved fully active antiretrovirals) and 37/99 (37%) Non-randomized Cohort (NRC) participants (with 0 fully active antiretrovirals). Here we report genotypic and phenotypic analyses of HIV-1 samples from 63/272 (23%) RC participants and 49/99 (49%) NRC participants who met protocol-defined virologic failure (PDVF) criteria through Week 96. The incidence of PDVF was as expected in this difficult-to-treat patient population and, among RC participants, was comparable regardless of the presence of predefined gp120 amino acid substitutions that potentially influence phenotypic susceptibility to temsavir (S375H/I/M/N/T, M426L, M434I, M475I) or baseline temsavir 50% inhibitory concentration fold change (IC

Indexed as

Anti-HIV AgentsDrug Resistance, Multiple, ViralHIV-1HIV InfectionsOrganophosphatesPiperazinesAdultHumansAnti-HIV AgentsfostemsavirOrganophosphatesPiperazinesantiretroviral agentsattachment inhibitorfostemsavirheavily treatment experiencedHIV-1multiple antiretroviral drug resistanceoptimized background therapy

Identifiers

PMID35502922
PMCPMC9211436
OpenAlexW4225308611

What OpenQuestion holds

Textmetadata
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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.