2025
155. Long-Acting Subcutaneous Lenacapavir in People with Multi-Drug Resistant HIV-1: 3-Year Results of the CAPELLA Study
Ogbuagu O, McGowan J, Stapleton A, Wiznia A, Berger D, Creticos C, Hagins D, Osiyemi O, Sims J, Wheeler D, Wang H, Margot N, Dvory-Sobol H, Rhee M, Segal-Maurer S. 155. Long-Acting Subcutaneous Lenacapavir in People with Multi-Drug Resistant HIV-1: 3-Year Results of the CAPELLA Study. Open Forum Infectious Diseases 2025, 12: ofae631.041. PMCID: PMC11776782, DOI: 10.1093/ofid/ofae631.041.Peer-Reviewed Original ResearchInjection site reactionsCD4 cell countHIV-1 RNAHIV-1Site reactionsMultidrug resistanceGilead SciencesVirologic suppressionCell countRates of virologic suppressionMulti-drug resistant HIV-1FDA snapshot algorithmResistant HIV-1Len resistanceTreatment-experiencedVirological outcomesGrade 1/2Study drugMedian ageLenacapavirLens toleranceSafety profileLonger-term dataAdverse eventsCD4P-565. A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes with and without Ibalizumab in a Real-World Setting: United States (PROMISE-US) Study Design and Baseline Characteristics
Kumar P, Rolle C, Emu B, Henry Z, Martorell C, McKinnon J, Slim J, Cash R, Anstett K. P-565. A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes with and without Ibalizumab in a Real-World Setting: United States (PROMISE-US) Study Design and Baseline Characteristics. Open Forum Infectious Diseases 2025, 12: ofae631.763. PMCID: PMC11778372, DOI: 10.1093/ofid/ofae631.763.Peer-Reviewed Original ResearchJournal of Antimicrobial ChemotherapyBaseline characteristicsViral loadMultidrug resistanceAntimicrobial chemotherapyCohort 2Maintenance of virologic suppressionHigher HIV viral loadClinical outcomes of patientsExposure to antiretroviralsGenotypic sensitivity scoreCD4 cell countHIV viral loadCD4 T cellsOutcomes of patientsLong-term efficacyRetrospective observational studyHigh viral loadLong-term useVirologic suppressionInfusion reactionsStudy designT cellsSafety profileClinical outcomes
2024
Tuberculosis Preventive Treatment for Pregnant People With Human Immunodeficiency Virus in South Africa: A Modeling Analysis of Clinical Benefits and Risks
Rosen L, Thielking A, Dugdale C, Montepiedra G, Kalk E, Kim S, LaCourse S, Mathad J, Freedberg K, Horsburgh C, Paltiel A, Wood R, Ciaranello A, Reddy K. Tuberculosis Preventive Treatment for Pregnant People With Human Immunodeficiency Virus in South Africa: A Modeling Analysis of Clinical Benefits and Risks. Clinical Infectious Diseases 2024, ciae508. PMID: 39544107, DOI: 10.1093/cid/ciae508.Peer-Reviewed Original ResearchAdverse pregnancy outcomesHuman immunodeficiency virusRisk of stillbirthFetal/infant deathImmunodeficiency virusHigher risk of LBWMaternal CD4 cell countCD4 cell countMonths of isoniazidRisk of LBWPregnant peopleHigher-risk scenarioTuberculosis preventive treatmentIsoniazid-rifapentineAntiretroviral therapyPregnancy outcomesClinical benefitPrimary outcomeCombined deathPreventive treatmentCell countHigh riskStillbirthPregnancyInternational guidelinesEfficacy 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, 80: 566-574. 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 drugEnhanced Tuberculosis Diagnosis With Computer-aided Chest X-ray and Urine Lipoarabinomannan in Adults With HIV Admitted to Hospital (CASTLE Study): A Cluster Randomized Trial
Burke R, Nyirenda S, Mtenga T, Twabi H, Joekes E, Walker N, Nyirenda R, Gupta-Wright A, Nliwasa M, Fielding K, MacPherson P, Corbett E. Enhanced Tuberculosis Diagnosis With Computer-aided Chest X-ray and Urine Lipoarabinomannan in Adults With HIV Admitted to Hospital (CASTLE Study): A Cluster Randomized Trial. Clinical Infectious Diseases 2024, 80: 1143-1151. PMID: 38748183, PMCID: PMC12135911, DOI: 10.1093/cid/ciae273.Peer-Reviewed Original ResearchCluster randomised trialTB treatment initiationUsual careChest X-rayPlus usual careUsual care armRandomised trialsTB diagnosisUrine lipoarabinomannanAntiretroviral therapyTreatment initiationDiagnostic armZomba Central HospitalIntention-to-treat analysisTB diagnosticsAdmitted to hospitalModified intention-to-treat analysisCare armCD4 cell countDigital chest X-rayUndiagnosed TBPost-recruitmentCause of deathSecondary outcomesPrimary outcomeLong-term impact of immediate versus deferred antiretroviral therapy on kidney health in people with HIV
Pelchen-Matthews A, Mocroft A, Ryom L, Ross M, Sharma S, Coca S, Achhra A, Cornell E, Tracy R, Phillips A, Alonso M, Toulomi G, Agan B, Medland N, Wyatt C, Group I. Long-term impact of immediate versus deferred antiretroviral therapy on kidney health in people with HIV. Kidney International 2024, 106: 136-144. PMID: 38697479, PMCID: PMC11193627, DOI: 10.1016/j.kint.2024.04.010.Peer-Reviewed Original ResearchHuman immunodeficiency virusUrine albumin/creatinine ratioDeferred antiretroviral therapyChronic kidney diseaseStrategic Timing of AntiRetroviral TreatmentAntiretroviral therapyNo significant differenceTreatment armsFollow-upAnnual rate of eGFR declineRate of eGFR declineTiming of AntiRetroviral TreatmentEarly ARTART-naive adultsCD4 cell countImmediate antiretroviral therapySignificant differenceKidney-related deathLong-term safetyKidney healthStandard of careComprehensive follow-upImmunodeficiency virusAlbumin/creatinine ratioEGFR decline
2023
Human Immunodeficiency Virus Status, Tenofovir Exposure, and the Risk of Poor Coronavirus Disease 19 Outcomes: Real-World Analysis From 6 United States Cohorts Before Vaccine Rollout
Lea A, Leyden W, Sofrygin O, Marafino B, Skarbinski J, Napravnik S, Agil D, Augenbraun M, Benning L, Horberg M, Jefferson C, Marconi V, Park L, Gordon K, Bastarache L, Gangireddy S, Althoff K, Coburn S, Gebo K, Lang R, Williams C, Silverberg M. Human Immunodeficiency Virus Status, Tenofovir Exposure, and the Risk of Poor Coronavirus Disease 19 Outcomes: Real-World Analysis From 6 United States Cohorts Before Vaccine Rollout. Clinical Infectious Diseases 2023, 76: 1727-1734. PMID: 36861341, PMCID: PMC10209434, DOI: 10.1093/cid/ciad084.Peer-Reviewed Original ResearchConceptsHuman immunodeficiency virusAdjusted risk ratioCOVID-19 hospitalizationMechanical ventilationTenofovir useHIV statusAcute respiratory syndrome coronavirus 2 infectionSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infectionSevere coronavirus disease 2019 (COVID-19) outcomesSyndrome coronavirus 2 infectionCoronavirus disease 2019 (COVID-19) outcomesHuman immunodeficiency virus statusCohort of PWHCD4 cell countCharlson Comorbidity IndexCoronavirus 2 infectionHIV RNA levelsUnited States cohortBody mass indexCOVID-19 severityCOVID-19 vaccine availabilityReal-world analysisTenofovir exposureComorbidity indexMass index
2022
Sustained virological response after treatment with direct antiviral agents in individuals with HIV and hepatitis C co‐infection
Lodi S, Klein M, Rauch A, Epstein R, Wittkop L, Logan R, Rentsch C, Justice A, Touloumi G, Berenguer J, Jarrin I, Egger M, Puoti M, Monforte A, Gill J, Ceron D, van Sighem A, Linas B, van der Valk M, Hernán M, Collaboration H. Sustained virological response after treatment with direct antiviral agents in individuals with HIV and hepatitis C co‐infection. Journal Of The International AIDS Society 2022, 25: e26048. PMID: 36562643, PMCID: PMC9784654, DOI: 10.1002/jia2.26048.Peer-Reviewed Original ResearchConceptsSustained virological responseHCV RNA testingDAA treatmentSVR ratesVirological responseProbability of SVRHepatitis C virus (HCV) cureRoutine HCV RNA testingActing antiviral (DAA) treatmentDAA treatment initiationCD4 cell countDirect antiviral agentsPresence of cirrhosisHCV RNA testEnd of treatmentClinical strataDAA recipientsHIV-HCVSVR assessmentSVR statusHIV acquisitionClinical characteristicsAntiviral treatmentTreatment initiationHCV genotypes1265. Effectiveness and Durability of Dolutegravir (DTG)-Based Regimens in Older People Living with HIV (PLWH) from the Veterans Aging Cohort Study (VACS)
Yan L, Henegar C, Gordon K, Hicks C, Vannappagari V, Justice A, Aslan M. 1265. Effectiveness and Durability of Dolutegravir (DTG)-Based Regimens in Older People Living with HIV (PLWH) from the Veterans Aging Cohort Study (VACS). Open Forum Infectious Diseases 2022, 9: ofac492.1096. PMCID: PMC9752102, DOI: 10.1093/ofid/ofac492.1096.Peer-Reviewed Original ResearchVeterans Aging Cohort StudyDTG-based regimensAging Cohort StudyViiV HealthcareCohort studyOlder peopleART-experienced individualsCD4 cell countEnd of studyRegimen discontinuationRegimen initiationAntiretroviral regimensVirologic failureART-naïveMultiple comorbiditiesHIV managementOlder PLWHPLWHTreatment responseTreatment statusRegimensTreatment experienceDolutegravirRaltegravirCell countRe-evaluating the health impact and cost-effectiveness of tuberculosis preventive treatment for modern HIV cohorts on antiretroviral therapy: a modelling analysis using data from Tanzania
Zhu J, Lyatuu G, Sudfeld CR, Kiravu A, Sando D, Machumi L, Minde J, Chisonjela F, Cohen T, Menzies NA. Re-evaluating the health impact and cost-effectiveness of tuberculosis preventive treatment for modern HIV cohorts on antiretroviral therapy: a modelling analysis using data from Tanzania. The Lancet Global Health 2022, 10: e1646-e1654. PMID: 36240830, PMCID: PMC9553191, DOI: 10.1016/s2214-109x(22)00372-2.Peer-Reviewed Original ResearchConceptsIsoniazid preventive therapyCD4 cell countAntiretroviral therapyCell countART cohortAverage CD4 cell countHigher CD4 cell countsLarge HIV treatment programHealth impactsTuberculosis preventive treatmentHIV treatment programsLifetime costsIncremental lifetime costLifetime health benefitsCourse of infectionGreater health gainsLong-term healthART initiationTreat guidelinesHIV cohortPreventive therapyTuberculosis riskUS National InstitutesHIV programsSubgroup analysisAnalysis of Severe Illness After Postvaccination COVID-19 Breakthrough Among Adults With and Without HIV in the US
Lang R, Humes E, Coburn SB, Horberg MA, Fathi LF, Watson E, Jefferson CR, Park LS, Gordon KS, Akgün KM, Justice AC, Napravnik S, Edwards JK, Browne LE, Agil DM, Silverberg MJ, Skarbinski J, Leyden WA, Stewart C, Hogan BC, Gebo KA, Marconi VC, Williams CF, Althoff KN. Analysis of Severe Illness After Postvaccination COVID-19 Breakthrough Among Adults With and Without HIV in the US. JAMA Network Open 2022, 5: e2236397. PMID: 36227594, PMCID: PMC9561947, DOI: 10.1001/jamanetworkopen.2022.36397.Peer-Reviewed Original ResearchConceptsBreakthrough COVID-19Breakthrough infectionsHIV statusCohort studySevere illnessMAIN OUTCOMEBreakthrough SARS-CoV-2 infectionCOVID-19 vaccine typesLow CD4 cell countsSARS-CoV-2 infectionCOVID-19Severe immune suppressionCD4 cell countProportion of patientsCells/μLPrevious COVID-19Additional vaccine dosesProportional hazards modelDiscrete-time proportional hazards modelsRisk reduction recommendationsVaccine guidelinesCD4 cellsCumulative incidenceHazard ratioClinical factors
2021
HIV Infection and the Risk of World Health Organization–Defined Sudden Cardiac Death
Freiberg MS, Duncan MS, Alcorn C, Chang C, Kundu S, Mumpuni A, Smith EK, Loch S, Bedigian A, Vittinghoff E, So‐Armah K, Hsue PY, Justice AC, Tseng ZH. HIV Infection and the Risk of World Health Organization–Defined Sudden Cardiac Death. Journal Of The American Heart Association 2021, 10: e021268. PMID: 34493058, PMCID: PMC8649505, DOI: 10.1161/jaha.121.021268.Peer-Reviewed Original ResearchConceptsHIV viral loadCD4 cell countFirst clinical visitHIV infectionViral loadSCD riskCell countWorld Health OrganizationCopies/Elevated HIV viral loadLow CD4 cell countsSudden cardiac death rateVeterans Aging Cohort StudyCox proportional hazards regressionHealth OrganizationConclusions HIV infectionSCD risk factorsCardiac death rateAging Cohort StudyProportional hazards regressionSudden cardiac deathCells/Mean baseline ageRace/ethnicityCohort studyAssociation between HIV and incident pulmonary hypertension in US Veterans: a retrospective cohort study
Duncan MS, Alcorn CW, Freiberg MS, So-Armah K, Patterson OV, DuVall SL, Crothers KA, Re VL, Butt AA, Lim JK, Kim JW, Tindle HA, Justice AC, Brittain EL. Association between HIV and incident pulmonary hypertension in US Veterans: a retrospective cohort study. The Lancet Healthy Longevity 2021, 2: e417-e425. PMID: 34296203, PMCID: PMC8294078, DOI: 10.1016/s2666-7568(21)00116-1.Peer-Reviewed Original ResearchConceptsIncident pulmonary hypertensionHIV viral loadPulmonary artery systolic pressureVeterans Aging Cohort StudyPulmonary hypertension riskPulmonary hypertensionRetrospective cohort studyCohort studyViral loadIncidence rateHypertension incidenceCD4 countHazard ratioHIV statusSystolic pressureHypertension riskHigh riskLow CD4 cell countsHepatitis C virus infectionHigher HIV viral loadChronic obstructive pulmonary diseaseCox proportional hazards regressionC virus infectionCD4 cell countPrevalent heart failureImpact of intensity of behavioral treatment, with or without medication treatment, for opioid use disorder on HIV outcomes in persons with HIV
Kennedy AJ, McGinnis KA, Merlin JS, Edelman EJ, Gordon AJ, Korthuis PT, Skanderson M, Williams EC, Wyse J, Oldfield B, Bryant K, Justice A, Fiellin DA, Kraemer KL. Impact of intensity of behavioral treatment, with or without medication treatment, for opioid use disorder on HIV outcomes in persons with HIV. Journal Of Substance Use And Addiction Treatment 2021, 132: 108509. PMID: 34130128, PMCID: PMC8628025, DOI: 10.1016/j.jsat.2021.108509.Peer-Reviewed Original ResearchConceptsOpioid use disorderVACS Index 2.0Viral loadMOUD receiptART initiationCD4 countART adherenceUse disordersVeterans Aging Cohort Study (VACS) dataBehavioral treatmentHIV clinical outcomesLog viral loadCD4 cell countAntiretroviral treatment initiationCohort study dataPoor health outcomesPre-post changesHIV outcomesTreatment initiationClinical outcomesMedication treatmentMOUD treatmentPWHHealth outcomesCell countA SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study
Edelman EJ, Dziura J, Deng Y, Bold KW, Murphy SM, Porter E, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL. A SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study. Contemporary Clinical Trials 2021, 110: 106379. PMID: 33794354, PMCID: PMC8478961, DOI: 10.1016/j.cct.2021.106379.Peer-Reviewed Original ResearchConceptsTobacco use disorderNicotine replacement therapyUse disordersHIV clinicHybrid type 1 effectiveness-implementation designHIV viral load suppressionCD4 cell countViral load suppressionEffectiveness-implementation studyOptimal treatment approachPharmacist-delivered interventionSequential multiple assignmentHealth of personsImplementation science frameworkSecondary outcomesAntiretroviral treatmentPrimary outcomeClinical pharmacistsReplacement therapySmoking abstinenceTreatment approachesCell countHealth systemHIVContingency managementTrends in Hepatocellular Carcinoma Incidence and Risk Among Persons With HIV in the US and Canada, 1996-2015
Sun J, Althoff KN, Jing Y, Horberg MA, Buchacz K, Gill MJ, Justice AC, Rabkin CS, Goedert JJ, Sigel K, Cachay E, Park L, Lim JK, Kim HN, Re V, Moore R, Sterling T, Peters MG, Achenbach CJ, Silverberg M, Thorne JE, Mayor AM, Crane HM, Kitahata MM, Klein M, Kirk GD. Trends in Hepatocellular Carcinoma Incidence and Risk Among Persons With HIV in the US and Canada, 1996-2015. JAMA Network Open 2021, 4: e2037512. PMID: 33595662, PMCID: PMC7890526, DOI: 10.1001/jamanetworkopen.2020.37512.Peer-Reviewed Original ResearchConceptsHCC incidence ratesHigher HCC riskHepatitis C virusHepatitis B virusModern cART eraCD4 cell countIncidence rateCART eraHCC riskHepatocellular carcinomaCohort studyTriple infectionNorth American AIDS Cohort CollaborationCell countAvailable CD4 cell countHigher HIV RNA levelsLow CD4 cell countsCombination antiretroviral therapy eraDiagnosis of HCCAnti-HCV seropositivityAntiretroviral therapy eraHBV-HCV coinfectionRecent HIV RNAHIV RNA levelsHBV e antigen
2019
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/Impact of early antiretroviral treatment on sexual behaviour: a randomised comparison
Lampe FC, Rodger AJ, Burman W, Grulich A, Friedland G, Sadr WE, Neaton J, Corbelli GM, Emery S, Molina JM, Orkin C, Gatell J, Gerstoft J, Ruxrungtham K, de Souza M, Phillips AN. Impact of early antiretroviral treatment on sexual behaviour: a randomised comparison. AIDS 2019, 33: 2337-2350. PMID: 31764099, PMCID: PMC6882545, DOI: 10.1097/qad.0000000000002359.Peer-Reviewed Original ResearchConceptsEarly antiretroviral treatmentHIV-serodifferent partnersAntiretroviral treatmentMonth 12Month 24CD4 cell countHIV-positive adultsSexual behaviorHIV infectiousnessImmediate armViral suppressionPrimary outcomeHigh prevalenceCondomless sexCell countMSMCells/Lower absolute levelsSexHeterosexual menTreatmentHeterosexualsArmAbsolute levelsPrevalenceGlobal Longitudinal Strain and Immune Status in Patients Living With Human Immunodeficiency Virus
Alenezi F, Bloomfield GS, Okeke NL, Velagapudi P, Abudaqa L, Ijioma N, Dunning A, Alajmi H, Clement ME, Shah SH, Naggie S, Velazquez EJ. Global Longitudinal Strain and Immune Status in Patients Living With Human Immunodeficiency Virus. The American Journal Of Cardiology 2019, 124: 966-971. PMID: 31371060, PMCID: PMC6887515, DOI: 10.1016/j.amjcard.2019.06.013.Peer-Reviewed Original ResearchConceptsLV ejection fractionHIV-1 RNA viral loadNormal LV ejection fractionRNA viral loadHuman immunodeficiency virusViral loadImmunodeficiency virusImmune statusGlobal longitudinal strain analysisNadir CD4 cell countPreclinical left ventricular dysfunctionDuke University Medical CenterCD4 cell countPlasma HIV RNALeft ventricular dysfunctionGlobal longitudinal strainCells/Longitudinal strain analysisUniversity Medical CenterCD4 cell count dataAbnormal GLSNadir CD4CD4 countHIV RNAVentricular dysfunctionImproved discrimination of mortality with Veterans Aging Cohort Study (VACS) Index 2.0 in HIV-positive individuals
Tate JP, Sterne JAC, Justice AC. Improved discrimination of mortality with Veterans Aging Cohort Study (VACS) Index 2.0 in HIV-positive individuals. AIDS 2019, Publish Ahead of Print: &na;. PMID: 30649058, PMCID: PMC6749990, DOI: 10.1097/qad.0000000000002140.Peer-Reviewed Original ResearchConceptsWhite blood countC-statisticBlood countVeterans Aging Cohort Study (VACS) IndexAntiretroviral Therapy Cohort CollaborationDiscrimination of mortalityVACS Index 2.0Antiretroviral therapy initiationCD4 cell countHIV-positive populationHarrell's C-statisticHIV-1 RNAHIV-positive individualsKaplan-Meier plotsCohort CollaborationNadir CD4VAC patientsAntiretroviral therapyCause mortalityCD8 ratioTherapy initiationViral suppressionGeneral healthExcess mortalityLaboratory values
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