2022
Acute kidney injury due to myoglobin cast nephropathy in the setting of coronavirus disease 2019-mediated rhabdomyolysis: a case report
Tuan J, Ogbuagu O, Kumar D, Altice F, Fikrig M. Acute kidney injury due to myoglobin cast nephropathy in the setting of coronavirus disease 2019-mediated rhabdomyolysis: a case report. Journal Of Medical Case Reports 2022, 16: 491. PMID: 36578087, PMCID: PMC9795945, DOI: 10.1186/s13256-022-03721-z.Peer-Reviewed Case Reports and Technical NotesConceptsAcute kidney injuryCoronavirus disease 2019Kidney injuryDisease 2019Cast nephropathyEnd-organ damageRenal biopsy findingsSpectrum of diseaseBaseline 6Gastrointestinal symptomsHospital courseBiopsy findingsCase presentationAPoor appetiteRenal failureRenal functionOral intakeUrine outputInitial diagnosisCaucasian manCase reportRhabdomyolysisNephropathyAbnormal tasteOrgan systemsSafety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study
Sridhar S, Joaquin A, Bonaparte MI, Bueso A, Chabanon AL, Chen A, Chicz RM, Diemert D, Essink BJ, Fu B, Grunenberg NA, Janosczyk H, Keefer MC, Rivera M DM, Meng Y, Michael NL, Munsiff SS, Ogbuagu O, Raabe VN, Severance R, Rivas E, Romanyak N, Rouphael NG, Schuerman L, Sher LD, Walsh SR, White J, von Barbier D, de Bruyn G, Canter R, Grillet MH, Keshtkar-Jahromi M, Koutsoukos M, Lopez D, Masotti R, Mendoza S, Moreau C, Ceregido MA, Ramirez S, Said A, Tavares-Da-Silva F, Shi J, Tong T, Treanor J, Diazgranados CA, Savarino S. Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study. The Lancet Infectious Diseases 2022, 22: 636-648. PMID: 35090638, PMCID: PMC8789245, DOI: 10.1016/s1473-3099(21)00764-7.Peer-Reviewed Original ResearchConceptsHigh-dose groupLow-dose groupMedium-dose groupGeometric mean titresAdverse eventsRecombinant protein vaccineCOVID-19 vaccineSecond vaccinationSARS-CoV-2Day 36Antigen doseAdverse reactionsProtein vaccineMedical conditionsVaccine-related serious adverse eventsHigh-risk medical conditionsInteractive response technology systemAntibody geometric mean titresPre-existing medical conditionsCandidate vaccine formulationsCoV2 preS dTMPrevious phase 1Primary immunogenicity objectivePseudovirus neutralization assayUnsolicited adverse events
2021
Qualitative assessment of anti‐SARS‐CoV‐2 spike protein immunogenicity (QUASI) after COVID‐19 vaccination in older people living with HIV
Tuan JJ, Zapata H, Critch‐Gilfillan T, Ryall L, Turcotte B, Mutic S, Andrews L, Roh ME, Friedland G, Barakat L, Ogbuagu O. Qualitative assessment of anti‐SARS‐CoV‐2 spike protein immunogenicity (QUASI) after COVID‐19 vaccination in older people living with HIV. HIV Medicine 2021, 23: 178-185. PMID: 34632695, PMCID: PMC8652674, DOI: 10.1111/hiv.13188.Peer-Reviewed Original ResearchConceptsCOVID-19 vaccineCOVID-19 vaccinationFirst doseSeroconversion ratesSecond doseAcute respiratory syndrome coronavirus 2 infectionSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infectionYale New Haven Health SystemPrior COVID-19 infectionSyndrome coronavirus 2 infectionSafe COVID-19 vaccineIntegrase strand transfer inhibitorsAnti-spike IgGPositive IgG responseTwo-dose seriesCoronavirus 2 infectionVaccine-induced immunityDurability of protectionCOVID-19 infectionStrand transfer inhibitorsAntiretroviral regimenBNT162b2 vaccineNew seroconversionsPositive IgGQualitative antibodyLong-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 medicationRace and ethnicity do not impact eligibility for remdesivir: A single-center experience
Pischel L, Walelo M, Benson J, Osborn R, Schrier R, Tuan J, Barakat L, Ogbuagu O. Race and ethnicity do not impact eligibility for remdesivir: A single-center experience. PLOS ONE 2021, 16: e0250735. PMID: 33956849, PMCID: PMC8101938, DOI: 10.1371/journal.pone.0250735.Peer-Reviewed Original ResearchConceptsClinical trialsExclusion criteriaSingle health care systemObservational cohort studySingle-center experienceClinical trial criteriaTime of presentationMedical record chartsNon-Hispanic whitesEthnic minority enrollmentSimilar ratesHealth care systemCohort studyTrial criteriaMultiple therapiesInclusion criteriaRecord chartsEthnic groupsRemdesivirCare systemTrialsSelf-identified WhiteEligibilityWhite participantsMultiple potential barriers
2020
Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19
Spinner CD, Gottlieb RL, Criner GJ, López J, Cattelan AM, Viladomiu A, Ogbuagu O, Malhotra P, Mullane KM, Castagna A, Chai LYA, Roestenberg M, Tsang OTY, Bernasconi E, Le Turnier P, Chang SC, SenGupta D, Hyland RH, Osinusi AO, Cao H, Blair C, Wang H, Gaggar A, Brainard DM, McPhail MJ, Bhagani S, Ahn MY, Sanyal AJ, Huhn G, Marty FM. Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19. JAMA 2020, 324: 1048-1057. PMID: 32821939, PMCID: PMC7442954, DOI: 10.1001/jama.2020.16349.Peer-Reviewed Original ResearchMeSH KeywordsAdenosine MonophosphateAdministration, IntravenousAgedAlanineAntiviral AgentsBetacoronavirusCoronavirus InfectionsCOVID-19COVID-19 Drug TreatmentDrug Administration ScheduleFemaleHospitalizationHumansMaleMiddle AgedOdds RatioPandemicsPatient AcuityPneumonia, ViralSARS-CoV-2Treatment OutcomeConceptsStandard care groupRemdesivir groupStandard careModerate COVID-19Initiation of treatmentClinical statusCare groupDay 11Acute respiratory syndrome coronavirus 2 infectionSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infectionModerate COVID-19 pneumoniaSyndrome coronavirus 2 infectionSevere coronavirus disease 2019Effect of remdesivirRemdesivir-treated patientsCoronavirus 2 infectionOpen-label trialPlacebo-controlled trialPrimary end pointUncertain clinical importanceCOVID-19 pneumoniaCoronavirus disease 2019COVID-19Significant differencesStatus distribution
2019
Contemporary HCV pangenotypic DAA treatment protocols are exclusionary to real world HIV-HCV co-infected patients
Maughan A, Sadigh K, Angulo-Diaz V, Mandimika C, Villanueva M, Lim JK, Ogbuagu O. Contemporary HCV pangenotypic DAA treatment protocols are exclusionary to real world HIV-HCV co-infected patients. BMC Infectious Diseases 2019, 19: 378. PMID: 31053098, PMCID: PMC6500032, DOI: 10.1186/s12879-019-3974-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAminoisobutyric AcidsAnti-Retroviral AgentsAntiviral AgentsBenzimidazolesCarbamatesCoinfectionCyclopropanesDrug InteractionsFemaleHepacivirusHepatitis CHeterocyclic Compounds, 4 or More RingsHIV InfectionsHumansLactams, MacrocyclicLeucineLiver CirrhosisMaleMiddle AgedProlinePyrrolidinesQuinoxalinesSofosbuvirSulfonamidesTreatment OutcomeViral LoadConceptsHIV-HCVExclusion criteriaClinical trialsHIV-HCV co-infected patientsNew hepatitis C treatmentsHepatitis C virus infectionCo-infected patientsHIV patient populationC virus infectionGlecaprevir/pibrentasvirSofosbuvir/velpatasvirExcellent cure ratesHIV viral loadMajority of patientsHepatitis C treatmentInjection drug useReal-world populationART regimenHCV agentsCurrent regimensDecompensated cirrhosisViral loadPangenotypic activityCure ratePatient population