ArticleInfectious diseases and therapy2026
Impact of Fostemsavir in Individuals with Multidrug-Resistant HIV-1, Stratified by Baseline Viral Load.
Article in Infectious diseases and therapy, 2026. 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. Not yet cited in PubMed.
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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)
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8 authors.
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Abstract
introductionIn populations with undetectable or low viral load (VL) and limited treatment options, antiretrovirals with a new mechanism of action may support HIV-1 treatment success. We evaluated efficacy and safety of fostemsavir-based regimens in participants with limited treatment options and an undetectable or low baseline VL from the phase 3 BRIGHTE study.
methodsBRIGHTE included adults with multidrug-resistant HIV-1 on failing regimens with ≤ 2 fully active antiretrovirals remaining. Participants with 1-2 fully active antiretrovirals entered the randomized cohort and received open-label fostemsavir + optimized background therapy after an 8-day placebo-controlled period. This post hoc analysis assessed virologic suppression (VL < 40 copies/mL; missing = excluded), immunologic outcomes, and safety through week 240 by baseline VL (< 40, 40 to < 400, 400 to < 1000, and ≥ 1000 copies/mL).
resultsIn the randomized cohort (N = 272), 21 (8%) participants had baseline VL < 400 copies/mL, 2 with < 40 copies/mL. By week 24, 13/18 (72%), 8/10 (80%), and 121/219 (55%) participants in the < 400, 400 to < 1000, and ≥ 1000 copies/mL subgroups, respectively, had virologic suppression. At week 240, 14/14 (100%) participants with baseline VL < 400 copies/mL were suppressed. In the overall randomized cohort, CD4
conclusionFindings support considering fostemsavir for regimen optimization in individuals with limited treatment options and undetectable/low VL, especially if safety/tolerability may be a concern.
trial registrationClinicalTrials.gov, NCT02362503.
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