2025
Ibalizumab plus an optimized background regimen in treatment-experienced patients infected with multidrug resistant HIV-1: A phase 3, multicenter, expanded access study.
Emu B, Kumar P, Mills A, Berhe M, Cash B, Kuo K, Anstett K. Ibalizumab plus an optimized background regimen in treatment-experienced patients infected with multidrug resistant HIV-1: A phase 3, multicenter, expanded access study. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2025 PMID: 40465394, DOI: 10.1097/qai.0000000000003699.Peer-Reviewed Original ResearchMultidrug-resistant HIV-1Treatment-emergent adverse eventsCD4+ cell countMultidrug resistanceHIV-1Viral loadTreatment optionsDiscontinuations due to treatment-emergent adverse eventsSuppression of viral replicationSafety of long-term useCell countEffective suppression of viral replicationOptimized background regimenTreatment-experienced patientsBaseline to weekPoor clinical outcomesResistant HIV-1Exposure to drugsStudy initiationBackground regimenLong-term useOpen-labelRNA copies/mLPatterns of resistanceMechanism of action
2024
Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multidrug-Resistant HIV-1: Week 104 Results of a Phase 2/3 Trial
Ogbuagu O, Molina J, Chetchotisakd P, Ramgopal M, Sanchez W, Brunetta J, Castelli F, Crofoot G, Hung C, Ronot-Bregigeon S, Margot N, Wang H, Dvory-Sobol H, Rhee M, Segal-Maurer S. Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multidrug-Resistant HIV-1: Week 104 Results of a Phase 2/3 Trial. Clinical Infectious Diseases 2024, 80: 566-574. PMID: 39206943, DOI: 10.1093/cid/ciae423.Peer-Reviewed Original ResearchMultidrug-resistant HIV-1Optimized background regimenHIV-1 RNA <CD4 cell countHIV-1Food & Drug AdministrationAdverse eventsTreatment of HIV-1 infectionRates of virologic suppressionCD4 cell count <Treatment-related adverse eventsMulti-drug resistant HIV-1Cell countTreatment-experienced peopleCell count <HIV-1 infectionHIV-1 RNAPhase 2/3 trialsImportant treatment optionInjection site reactionsResistant HIV-1US Food & Drug AdministrationBackground regimenVirologic suppressionStudy drug
2023
365. Durable efficacy and robust CD4+ T-cell count improvement observed across age, race, sex, and geographic subgroups of heavily treatment-experienced people with multidrug-resistant HIV-1 after 240 weeks of fostemsavir treatment
Dyson A, Aberg J, Molina J, Cassetti I, Kozal M, Treviño-Pérez S, Latiff G, Lalezari J, Pialoux G, Li B, Prakash M, Clark A, Tenorio A, Pierce A, Lataillade M. 365. Durable efficacy and robust CD4+ T-cell count improvement observed across age, race, sex, and geographic subgroups of heavily treatment-experienced people with multidrug-resistant HIV-1 after 240 weeks of fostemsavir treatment. Open Forum Infectious Diseases 2023, 10: ofad500.435. PMCID: PMC10676856, DOI: 10.1093/ofid/ofad500.435.Peer-Reviewed Original ResearchMultidrug-resistant HIV-1T-cell countsVirologic response ratesCells/mm3Randomized cohortHIV-1Response rateBL CD4Viral loadDisease characteristicsTreatment optionsAdvanced HIV-1Current ARV regimenPlacebo-controlled periodTreatment-experienced peopleT-cell increaseLimited treatment optionsLong-term efficacyOverall response rateLow response rateBackground therapyContinuous CD4Suppressive regimensWeek 96Virologic response
2018
Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1
Emu B, Fessel J, Schrader S, Kumar P, Richmond G, Win S, Weinheimer S, Marsolais C, Lewis S. Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1. New England Journal Of Medicine 2018, 379: 645-654. PMID: 30110589, DOI: 10.1056/nejmoa1711460.Peer-Reviewed Original ResearchConceptsPhase 3 studyHIV-1 infectionViral loadBackground regimenVirologic failureAdverse eventsWeek 25Multidrug-resistant HIV-1 infectionMDR HIV-1 infectionMean baseline viral loadMultidrug-resistant HIV-1Human immunodeficiency virus type 1Immunodeficiency virus type 1Control periodMultiple antiretroviral therapiesViral load decreaseCommon adverse eventsMean CD4 countPrimary end pointSerious adverse eventsBaseline viral loadProportion of patientsHIV-1 RNALimited treatment optionsVirus type 1
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