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