ArticleInfectious diseases and therapy2023
Week 240 Efficacy and Safety of Fostemsavir Plus Optimized Background Therapy in Heavily Treatment-Experienced Adults with HIV-1.
Article in Infectious diseases and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02362503 (A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of Fostemsavir), which is not on this map. Cited by 20 papers.
What it found
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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.
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.
A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of Fostemsavir (BMS-663068/GSK3684934) in Heavily Treatment Experienced Subjects Infected With Multi-drug Resistant HIV-1 (BRIGHTE Study)
Who cites it
20 citing papers in PubMed, 17 citations in OpenAlex.
- Similar Efficacy, Safety, and Immune Improvement Through 96 Weeks in Individuals With Limited HIV-1 Treatment Options Using Twice-Daily Dolutegravir- or Fostemsavir-based Regimens.Open forum infectious diseases · 2026Trial
- Exploring the impact of baseline and on-treatment variables on durability of responses to fostemsavir through weeks 96 and 192 in the phase 3 BRIGHTE study.HIV medicine · 2026Trial
- Trial
- Efficacy and safety of doravirine/islatravir in heavily treatment-experienced participants living with HIV-1: results from a randomized trial.AIDS (London, England) · 2026Trial
- Long-term safety and impact of immune recovery in heavily treatment-experienced adults receiving fostemsavir for up to 5 years in the phase 3 BRIGHTE study.Frontiers in immunology · 2024Trial
- Impact of Fostemsavir in Individuals with Multidrug-Resistant HIV-1, Stratified by Baseline Viral Load.Infectious diseases and therapy · 2026Article
- Comprehensive mapping of the virus and host factors that guide the paths of HIV-1 escape from a therapeutic.Cell reports · 2026Article
- Combined Use of Ibalizumab and Lenacapavir for the Treatment of Multidrug-resistant HIV-1: A Case Series.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Observational
- Fostemsavir Decreases the Levels of Anti-gp120 CD4-Induced Antibodies in Heavily Treatment-Experienced People With HIV.The Journal of infectious diseases · 2026Article
- EZ-DMS - A Simple and Accessible Protocol and Software Package for Deep Mutational Scanning of Virus Proteins.bioRxiv : the preprint server for biology · 2026Article
- Machine learning quantifies immuno-virological interactions: a TRIPOD+AI compliant prediction model for HIV-1 salvage therapy outcomes.Frontiers in immunology · 2026Article
- Comprehensive Mapping of the Virus and Host Factors that Guide the Paths of HIV-1 Escape from a Therapeutic.bioRxiv : the preprint server for biology · 2025Article
- All-Cause Mortality in People With Four-Class Drug-Resistant HIV: A Matched Cohort Analysis With Data From the PRESTIGIO Registry.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Article
- High HIV-1 viremia and low anti-Env antibody responses are associated with delayed treatment response to fostemsavir in highly treatment-experienced individuals.Antiviral research · 2025Article
- Immunological and virological response to fostemsavir in routine US clinical care: An OPERA cohort study.HIV medicine · 2025Article
- Heavily treatment-experienced patients with HIV: are new mechanisms of action enough?The Journal of international medical research · 2024Review
- Long-term outcome in a person with pandrug-resistant HIV: the added value of a multidisciplinary approach.JAC-antimicrobial resistance · 2024Article
- Mechanism of action, resistance, interaction, pharmacokinetics, pharmacodynamics, and safety of fostemsavir.BMC infectious diseases · 2024Review
- Fostemsavir resistance in clinical context: a narrative review.Therapeutic advances in infectious diseaseReview
Corrections and comments
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Authors and funding
16 authors at 10 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionEfficacy and safety of the attachment inhibitor fostemsavir + optimized background therapy (OBT) were evaluated through 48 and 96 weeks in the phase 3 BRIGHTE trial in heavily treatment-experienced (HTE) adults failing their current antiretroviral regimen. Here, we report 240-week efficacy and safety of fostemsavir + OBT in adults with multidrug-resistant human immunodeficiency virus (HIV)-1 in BRIGHTE.
methodsHeavily treatment-experienced adults failing their current regimen entered the randomized cohort (RC; 1-2 fully active antiretrovirals available) or non-randomized cohort (NRC; no fully active antiretrovirals available) and received open-label fostemsavir + OBT (starting Day 8 in RC and Day 1 in NRC). Endpoints included proportion with virologic response (HIV-1 RNA < 40 copies/mL, Snapshot), immunologic efficacy, and safety.
resultsAt Week 240, 45% and 22% of the RC and NRC, respectively, had virologic response (Snapshot); 7% of the RC and 5% of the NRC had missing data due to coronavirus disease 2019 (COVID-19)-impacted visits. In the observed analysis, 82% of the RC and 66% of the NRC had virologic response. At Week 240, mean change from baseline in CD4+ T-cell count was 296 cells/mm
conclusionThrough ~5 years, fostemsavir + OBT demonstrated durable virologic and immunologic responses with no new safety concerns between Weeks 96 and 240, supporting this regimen as a key therapeutic option for HTE people with multidrug-resistant HIV-1.
trial registrationClinicalTrials.gov, NCT02362503.
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Registered trials
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.