2024
A Randomized Placebo-Controlled Trial of Leronlimab in Mild-To-Moderate COVID-19
Seethamraju H, Yang O, Loftus R, Ogbuagu O, Sammartino D, Mansour A, Sacha J, Ojha S, Hansen S, Arman A, Lalezari J. A Randomized Placebo-Controlled Trial of Leronlimab in Mild-To-Moderate COVID-19. Clinical Therapeutics 2024, 46: 891-899. PMID: 39353749, DOI: 10.1016/j.clinthera.2024.08.019.Peer-Reviewed Original ResearchMild to moderate COVID-19National Early Warning Score 2SARS-CoV-2 infectionPost hoc analysisSARS-CoV-2Randomized placebo-controlled trialHoc analysisHuman IgG4 monoclonal antibodyModerate-to-severe diseaseViral replicationHIV-1 infectionPlacebo-controlled studyProduction of pro-inflammatory cytokinesExcessive production of pro-inflammatory cytokinesMild-to-moderateAdverse event ratesExploratory post hoc analysisTotal symptom scorePathophysiology of SARS-CoV-2 infectionPro-inflammatory cytokinesHeightened immune responsePathophysiology of COVID-19IgG4 monoclonal antibodyPlacebo groupDouble-blindEfficacy 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, ciae423. 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
2021
Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial
Ogbuagu O, Ruane PJ, Podzamczer D, Salazar LC, Henry K, Asmuth DM, Wohl D, Gilson R, Shao Y, Ebrahimi R, Cox S, Kintu A, Carter C, Das M, Baeten JM, Brainard DM, Whitlock G, Brunetta JM, Kronborg G, Spinner CD, team D, Antinori A, Apea V, Asmuth D, Avery A, Benson P, Bergin C, Berhe M, Brar I, Brinson C, Brunetta J, Burack J, Campbell T, Cespedes M, Clarke A, Coleman M, Coll J, Casal M, Creticos C, Crofoot G, Cruickshank F, Cua E, Daar E, de Wet J, DeJesus E, Del Romero Guerrero J, Dinges W, Doblecki-Lewis S, Donovan T, Dosekun O, Flamm J, Gallant J, Gerstoft J, Gilson R, Gladstein J, Grant R, Grossberg R, Haas B, Halperin J, Hardy W, Hare C, Hassler S, Hengel R, Henry W, Hodge T, Hosek S, Hurt C, Iandiorio M, Jessen H, Kegg S, Knecht G, Kronborg G, Krznaric I, LaMarca A, Larsen C, Larsen O, Lazzarin A, Leen C, Lucasti C, Mallon P, Mannheimer S, Markowitz M, Martorell C, Mayer K, Mills A, Molina J, Morris S, Mounzer K, Nwokolo N, Ogbuagu O, Osiyemi O, Petroll A, Philibert P, Phoenix J, Pialoux G, Podzamczer D, Post F, Prins M, Ramgopal M, Rashbaum B, Reeves I, Richmond G, Rieger A, Ruane P, Salazar L, Scarsella A, Schembri G, Scott M, Shalit P, Sinclair G, Sobieszczyk M, Spinner C, Stephens J, Szabo J, Taylor S, Thompson M, Tremblay C, Trottier B, Voskuhl G, Wade B, Wohl D, Workowski K, Yawetz S, Young B. Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet HIV 2021, 8: e397-e407. PMID: 34197772, DOI: 10.1016/s2352-3018(21)00071-0.Peer-Reviewed Original ResearchConceptsTenofovir disoproxil fumaratePre-exposure prophylaxisTenofovir alafenamideDisoproxil fumarateBone mineral densityHIV infectionPlacebo tabletsMineral densityHIV preventionHIV-1 pre-exposure prophylaxisTransgender womenAdult cisgender menNon-inferior efficacyWeek 96 resultsPrimary efficacy outcomeCisgender menPhase 3 trialIncident HIV infectionHIV-1 infectionNon-inferiority trialLong-term safetyMore weight gainRenal safety biomarkersSelf-reported sexual behaviorStudy medication
2018
Dolutegravir/rilpivirine for the treatment of HIV-1 infection
Dowers E, Zamora F, Barakat LA, Ogbuagu O. Dolutegravir/rilpivirine for the treatment of HIV-1 infection. HIV/AIDS - Research And Palliative Care 2018, 10: 215-224. PMID: 30464642, PMCID: PMC6220428, DOI: 10.2147/hiv.s157855.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsHIV-1 infectionDolutegravir/rilpivirineAntiretroviral therapyImportant drug-drug interactionsClinical trial efficacyDrug-drug interactionsImproved safety profileLong-term toxicityDrug package insertsRegimen simplificationMaintenance therapyCombination regimensMedication adherenceSafety profileSafety dataTrial efficacyConference abstractsPackage insertsDrug AdministrationUS FoodPharmacokinetic propertiesGoogle ScholarInfectionLimited dataRilpivirine
2016
Rilpivirine, emtricitabine and tenofovir alafenamide: single-tablet combination for the treatment of HIV-1 infection in selected patients
Ogbuagu O. Rilpivirine, emtricitabine and tenofovir alafenamide: single-tablet combination for the treatment of HIV-1 infection in selected patients. Expert Review Of Anti-infective Therapy 2016, 14: 1113-1126. PMID: 27797606, DOI: 10.1080/14787210.2016.1255551.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsHIV-1 infectionTenofovir alafenamideCombination antiretroviral medicationsEffective antiretroviral regimenKey drug interactionsSingle-tablet combinationAntiretroviral drug therapyTenofovir disoproxil fumarateDifferent patient populationsNon-nucleoside reverseClinical trial dataAntiretroviral regimenRenal safetyAntiretroviral medicationsCreatinine clearanceNeuropsychiatric toxicityDisoproxil fumaratePatient populationTreatment optionsDrug therapyDrug interactionsConference abstractsPubMed databaseTrial dataUS FDA