2022
De novo emergence of a remdesivir resistance mutation during treatment of persistent SARS-CoV-2 infection in an immunocompromised patient: a case report
Gandhi S, Klein J, Robertson AJ, Peña-Hernández MA, Lin MJ, Roychoudhury P, Lu P, Fournier J, Ferguson D, Mohamed Bakhash SAK, Catherine Muenker M, Srivathsan A, Wunder EA, Kerantzas N, Wang W, Lindenbach B, Pyle A, Wilen CB, Ogbuagu O, Greninger AL, Iwasaki A, Schulz WL, Ko AI. De novo emergence of a remdesivir resistance mutation during treatment of persistent SARS-CoV-2 infection in an immunocompromised patient: a case report. Nature Communications 2022, 13: 1547. PMID: 35301314, PMCID: PMC8930970, DOI: 10.1038/s41467-022-29104-y.Peer-Reviewed Original ResearchConceptsSARS-CoV-2 infectionVirologic responsePersistent SARS-CoV-2 infectionResistance mutationsPre-treatment specimensB-cell deficiencyRemdesivir resistanceRemdesivir therapyViral sheddingCase reportAntiviral agentsPatientsCombinatorial therapyInfectionTherapyWhole-genome sequencingTreatmentImportance of monitoringDe novo emergenceFold increaseRNA-dependent RNA polymeraseNovo emergencePotential benefitsMutationsIndolent
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 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
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