Featured Publications
661. Ibalizumab Efficacy and Safety Through 48 Weeks of Treatment: Results of an Expanded Access Protocol (TMB-311)
Emu B, DeJesus E, Berhe M, Leider J, Creticos C, Weinheimer S, Cohen Z. 661. Ibalizumab Efficacy and Safety Through 48 Weeks of Treatment: Results of an Expanded Access Protocol (TMB-311). Open Forum Infectious Diseases 2019, 6: s303-s303. PMCID: PMC6811265, DOI: 10.1093/ofid/ofz360.729.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsWeeks of treatmentCopies/mLViral loadCopies/Cohort 2Multidrug-resistant HIV-1 infectionDay 0HIV-1 RNA levelsImmune reconstitution inflammatory syndromeLog10 copies/mLHIV-1 viral loadPivotal phase 3 studiesCohort 2 patientsDurable viral suppressionMajor eligibility criteriaReconstitution inflammatory syndromeWeek 24 visitCD4 cell countMedian viral loadTreatment-experienced patientsCells/mm3Phase 3 studyInjection site reactionsLog10 copies/
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
2017
Forty-eight-Week Safety and Efficacy On-Treatment Analysis of Ibalizumab in Patients with Multi-Drug Resistant HIV-1
Emu B, Fessel W, Schrader S, Kumar P, Richmond G, Win S, Weinheimer S, Marsolais C, Lewis S. Forty-eight-Week Safety and Efficacy On-Treatment Analysis of Ibalizumab in Patients with Multi-Drug Resistant HIV-1. Open Forum Infectious Diseases 2017, 4: s38-s39. PMCID: PMC5632088, DOI: 10.1093/ofid/ofx162.093.Peer-Reviewed Original ResearchResistant HIV-1Week 24Long-term safetyWeek 48HIV-1Copies/MDR patientsLoading doseDurable efficacyMulti-drug resistant HIV-1Median viral load reductionMDR HIV-1Open-label studyTreatment-experienced patientsPhase 3 studyIntravenous loading doseUnexpected safety concernsValuable treatment optionWeeks of treatmentViral load reductionHumanized monoclonal antibodyARV classesBackground regimenCD4 depletionVirologic suppression
This site is protected by hCaptcha and its Privacy Policy and Terms of Service apply