2019
Effect estimates in randomized trials and observational studies: comparing apples with apples
Lodi S, Phillips A, Lundgren J, Logan R, Sharma S, Cole SR, Babiker A, Law M, Chu H, Byrne D, Horban A, Sterne JAC, Porter K, Sabin C, Costagliola D, Abgrall S, Gill J, Touloumi G, Pacheco AG, van Sighem A, Reiss P, Bucher HC, Giménez A, Jarrin I, Wittkop L, Meyer L, Perez-Hoyos S, Justice A, Neaton JD, Hernán MA. Effect estimates in randomized trials and observational studies: comparing apples with apples. American Journal Of Epidemiology 2019, 188: 1569-1577. PMID: 31063192, PMCID: PMC6670045, DOI: 10.1093/aje/kwz100.Peer-Reviewed Original ResearchEmulating a trial of joint dynamic strategies: An application to monitoring and treatment of HIV‐positive individuals
Caniglia EC, Robins JM, Cain LE, Sabin C, Logan R, Abgrall S, Mugavero MJ, Hernández‐Díaz S, Meyer L, Seng R, Drozd DR, Seage G, Bonnet F, Le Marec F, Moore RD, Reiss P, Sighem A, Mathews WC, Jarrín I, Alejos B, Deeks SG, Muga R, Boswell SL, Ferrer E, Eron JJ, Gill J, Pacheco A, Grinsztejn B, Napravnik S, Jose S, Phillips A, Justice A, Tate J, Bucher HC, Egger M, Furrer H, Miro JM, Casabona J, Porter K, Touloumi G, Crane H, Costagliola D, Saag M, Hernán MA. Emulating a trial of joint dynamic strategies: An application to monitoring and treatment of HIV‐positive individuals. Statistics In Medicine 2019, 38: 2428-2446. PMID: 30883859, PMCID: PMC6499640, DOI: 10.1002/sim.8120.Peer-Reviewed Original ResearchConceptsHIV-positive individualsCopies/First-line treatment regimenAIDS Research NetworkAIDS-free survivalCells/Integrated Clinical SystemsHIV-CAUSAL CollaborationOutcomes of interestRisk difference estimatesDirect effectAntiretroviral therapyHIV RNACD4 thresholdTreatment regimenNew regimenTreatment strategiesHIV researchTarget trialsRegimenTherapyResearch NetworkTrialsSurvivalClinical systems
2018
Commonly Prescribed Antiretroviral Therapy Regimens and Incidence of AIDS-Defining Neurological Conditions
Caniglia EC, Phillips A, Porter K, Sabin CA, Winston A, Logan R, Gill J, Vandenhende MA, Barger D, Lodi S, Moreno S, Arribas JR, Pacheco A, Cardoso SW, Chrysos G, Gogos C, Abgrall S, Costagliola D, Meyer L, Seng R, van Sighem A, Reiss P, Muga R, Hoyos SP, Braun D, Hauser C, Barrufet P, Leyes M, Tate J, Justice A, Hernán MA. Commonly Prescribed Antiretroviral Therapy Regimens and Incidence of AIDS-Defining Neurological Conditions. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2018, 77: 102-109. PMID: 28991888, PMCID: PMC5720915, DOI: 10.1097/qai.0000000000001562.Peer-Reviewed Original ResearchMeSH KeywordsAcquired Immunodeficiency SyndromeAdultAIDS Dementia ComplexAIDS-Related Opportunistic InfectionsAlkynesAmericasAtazanavir SulfateBenzoxazinesCohort StudiesCyclopropanesDarunavirEuropeFemaleHIV Protease InhibitorsHumansLeukoencephalopathy, Progressive MultifocalLopinavirMaleMeningitis, CryptococcalMiddle AgedProspective StudiesReverse Transcriptase InhibitorsToxoplasmosisConceptsNucleoside reverse transcriptase inhibitor (NRTI) backboneReverse transcriptase inhibitor backboneHazard ratioNeurological conditionsInhibitor backbonePooled logistic modelCombined end pointRespective hazard ratiosProgressive multifocal leukoencephalopathyProspective cohort studyAntiretroviral therapy regimensHIV-positive individualsHIV-CAUSAL CollaborationIncidence of AIDSCART initiationHIV dementiaAntiretroviral therapyCART regimenCryptococcal meningitisMultifocal leukoencephalopathyClinical characteristicsCohort studyTherapy regimensAtazanavirLopinavir
2017
Effect of Immediate Initiation of Antiretroviral Treatment in HIV-Positive Individuals Aged 50 Years or Older
Lodi S, Costagliola D, Sabin C, del Amo J, Logan R, Abgrall S, Reiss P, van Sighem A, Jose S, Blanco JR, Hernando V, Bucher HC, Kovari H, Segura F, Ambrosioni J, Gogos CA, Pantazis N, Dabis F, Vandenhende MA, Meyer L, Seng R, Gill MJ, Krentz H, Phillips AN, Porter K, Grinsztejn B, Pacheco AG, Muga R, Tate J, Justice A, Hernán MA. Effect of Immediate Initiation of Antiretroviral Treatment in HIV-Positive Individuals Aged 50 Years or Older. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2017, 76: 311-318. PMID: 28746165, PMCID: PMC5704899, DOI: 10.1097/qai.0000000000001498.Peer-Reviewed Original ResearchConceptsGeneral HIV populationImmediate initiationHIV populationCD4 countCells/US veteransAIDS mortalityAIDS-free individualsNon-AIDS mortalityUS Veteran cohortHIV-positive individualsHIV-CAUSAL CollaborationAntiretroviral therapyCause mortalityAntiretroviral treatmentMedian ageClinical guidelinesVeteran cohortHigh mortalityMortalityCD4Younger participantsRiskBaselineVeteransComparison of dynamic monitoring strategies based on CD4 cell counts in virally suppressed, HIV-positive individuals on combination antiretroviral therapy in high-income countries: a prospective, observational study
Caniglia EC, Cain LE, Sabin CA, Robins JM, Logan R, Abgrall S, Mugavero MJ, Hernández-Díaz S, Meyer L, Seng R, Drozd DR, Seage GR, Bonnet F, Dabis F, Moore RD, Reiss P, van Sighem A, Mathews WC, del Amo J, Moreno S, Deeks SG, Muga R, Boswell SL, Ferrer E, Eron JJ, Napravnik S, Jose S, Phillips A, Justice AC, Tate JP, Gill J, Pacheco A, Veloso VG, Bucher HC, Egger M, Furrer H, Porter K, Touloumi G, Crane H, Miro JM, Sterne JA, Costagliola D, Saag M, Hernán MA, Collaboration H, Systems C. Comparison of dynamic monitoring strategies based on CD4 cell counts in virally suppressed, HIV-positive individuals on combination antiretroviral therapy in high-income countries: a prospective, observational study. The Lancet HIV 2017, 4: e251-e259. PMID: 28411091, PMCID: PMC5492888, DOI: 10.1016/s2352-3018(17)30043-7.Peer-Reviewed Original ResearchConceptsCD4 cell countHIV-positive individualsVirological failureHazard ratioCell countViral loadRisk ratioObservational studyTime-varying CD4 cell countHIV RNA viral loadAntiretroviral therapy regimenCombination antiretroviral therapyRNA viral loadAIDS Research NetworkMortality hazard ratioIntegrated Clinical SystemsHIV-CAUSAL CollaborationLong-term safetyCell count differencesAntiretroviral therapyCD4 countTherapy regimenProspective studyImmunological outcomesClinical guidelines
2016
Efavirenz versus boosted atazanavir-containing regimens and immunologic, virologic, and clinical outcomes
Cain LE, Caniglia EC, Phillips A, Olson A, Muga R, Pérez-Hoyos S, Abgrall S, Costagliola D, Rubio R, Jarrín I, Bucher H, Fehr J, van Sighem A, Reiss P, Dabis F, Vandenhende MA, Logan R, Robins J, Sterne JAC, Justice A, Tate J, Touloumi G, Paparizos V, Esteve A, Casabona J, Seng R, Meyer L, Jose S, Sabin C, Hernán MA. Efavirenz versus boosted atazanavir-containing regimens and immunologic, virologic, and clinical outcomes. Medicine 2016, 95: e5133. PMID: 27741139, PMCID: PMC5072966, DOI: 10.1097/md.0000000000005133.Peer-Reviewed Original ResearchConceptsCD4 cell countEfavirenz regimenVirologic failureVirologic outcomesSurvival differencesNucleoside reverse transcriptase inhibitor (NRTI) backboneCell countReverse transcriptase inhibitor backboneAtazanavir-containing regimensAIDS-free survivalHuman immunodeficiency virusImmune deficiency syndromeHIV-CAUSAL CollaborationAtazanavir regimenHazard ratioClinical outcomesImmunodeficiency virusProspective studyDeficiency syndromeMean changeRegimensEfavirenzTime-varying covariatesInhibitor backboneRegimenWhen to Monitor CD4 Cell Count and HIV RNA to Reduce Mortality and AIDS-Defining Illness in Virologically Suppressed HIV-Positive Persons on Antiretroviral Therapy in High-Income Countries
Caniglia EC, Sabin C, Robins JM, Logan R, Cain LE, Abgrall S, Mugavero MJ, Hernandez-Diaz S, Meyer L, Seng R, Drozd DR, Seage GR, Bonnet F, Dabis F, Moore RR, Reiss P, van Sighem A, Mathews WC, del Amo J, Moreno S, Deeks SG, Muga R, Boswell SL, Ferrer E, Eron JJ, Napravnik S, Jose S, Phillips A, Olson A, Justice AC, Tate JP, Bucher HC, Egger M, Touloumi G, Sterne JA, Costagliola D, Saag M, Hernán MA. When to Monitor CD4 Cell Count and HIV RNA to Reduce Mortality and AIDS-Defining Illness in Virologically Suppressed HIV-Positive Persons on Antiretroviral Therapy in High-Income Countries. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2016, 72: 214-221. PMID: 26895294, PMCID: PMC4866894, DOI: 10.1097/qai.0000000000000956.Peer-Reviewed Original ResearchConceptsCD4 cell countHIV-positive individualsAntiretroviral therapyCell countAIDS-defining illnessAntiretroviral-naive individualsAIDS Research NetworkMortality hazard ratioHIV-positive personsIntegrated Clinical SystemsHIV-CAUSAL CollaborationVirologic outcomesHIV RNAVirologic failureHazard ratioClinical outcomesProspective studyRisk ratioHigh-income countriesEligible individualsMonths strategyMonthsIllnessDeathTherapy
2015
Using observational data to emulate a randomized trial of dynamic treatment-switching strategies: an application to antiretroviral therapy
Cain LE, Saag MS, Petersen M, May MT, Ingle SM, Logan R, Robins JM, Abgrall S, Shepherd BE, Deeks SG, Gill M, Touloumi G, Vourli G, Dabis F, Vandenhende MA, Reiss P, van Sighem A, Samji H, Hogg RS, Rybniker J, Sabin CA, Jose S, del Amo J, Moreno S, Rodríguez B, Cozzi-Lepri A, Boswell SL, Stephan C, Pérez-Hoyos S, Jarrin I, Guest JL, Monforte A, Antinori A, Moore R, Campbell CN, Casabona J, Meyer L, Seng R, Phillips AN, Bucher HC, Egger M, Mugavero MJ, Haubrich R, Geng EH, Olson A, Eron JJ, Napravnik S, Kitahata MM, Van Rompaey SE, Teira R, Justice AC, Tate JP, Costagliola D, Sterne JA, Hernán MA, Systems A. Using observational data to emulate a randomized trial of dynamic treatment-switching strategies: an application to antiretroviral therapy. International Journal Of Epidemiology 2015, 45: 2038-2049. PMID: 26721599, PMCID: PMC5841611, DOI: 10.1093/ije/dyv295.Peer-Reviewed Original ResearchConceptsAntiretroviral therapyCopies/Antiretroviral Therapy Cohort CollaborationTime-varying covariatesTight control groupAdjusted hazard ratioAntiretroviral therapy regimenAIDS Research NetworkIntegrated Clinical SystemsHIV-CAUSAL CollaborationDeath eventsCohort CollaborationHazard ratioTherapy regimenRandomized trialsInverse probability weightingInclusion criteriaMortality analysisClinical treatmentAIDSTherapyDeath analysisDeathTrialsComparative effectsComparative effectiveness of immediate antiretroviral therapy versus CD4-based initiation in HIV-positive individuals in high-income countries: observational cohort study
Lodi S, Phillips A, Logan R, Olson A, Costagliola D, Abgrall S, van Sighem A, Reiss P, Miró JM, Ferrer E, Justice A, Gandhi N, Bucher HC, Furrer H, Moreno S, Monge S, Touloumi G, Pantazis N, Sterne J, Young JG, Meyer L, Seng R, Dabis F, Vandehende MA, Pérez-Hoyos S, Jarrín I, Jose S, Sabin C, Hernán MA, Collaboration H. Comparative effectiveness of immediate antiretroviral therapy versus CD4-based initiation in HIV-positive individuals in high-income countries: observational cohort study. The Lancet HIV 2015, 2: e335-e343. PMID: 26423376, PMCID: PMC4643831, DOI: 10.1016/s2352-3018(15)00108-3.Peer-Reviewed Original ResearchConceptsNeed of ARTHIV RNA viral loadCD4 countAntiretroviral therapyHIV-positive individualsMean survival timeImmediate initiationHIV diagnosisCohort studyViral loadRelative riskHigh-income countriesProportion of individualsSurvival timeInitiation of ARTART initiation strategiesImmediate antiretroviral therapyLow CD4 countMedian CD4 countObservational cohort studyAIDS-free survivalHIV-1 infectionDiagnosis of HIVViral load measurementsHIV-CAUSAL Collaboration
2014
Antiretroviral penetration into the CNS and incidence of AIDS-defining neurologic conditions
Caniglia EC, Cain LE, Justice A, Tate J, Logan R, Sabin C, Winston A, van Sighem A, Miro JM, Podzamczer D, Olson A, Arribas JR, Moreno S, Meyer L, del Romero J, Dabis F, Bucher HC, Wandeler G, Vourli G, Skoutelis A, Lanoy E, Gasnault J, Costagliola D, Hernán MA. Antiretroviral penetration into the CNS and incidence of AIDS-defining neurologic conditions. Neurology 2014, 83: 134-141. PMID: 24907236, PMCID: PMC4117168, DOI: 10.1212/wnl.0000000000000564.Peer-Reviewed Original ResearchConceptsHigher CPE scoreLower CPE scoreAntiretroviral therapy regimenProgressive multifocal leukoencephalopathyCPE scoreHIV dementiaHazard ratioCryptococcal meningitisMultifocal leukoencephalopathyTherapy regimenAntiretroviral therapy-naive individualsCNS penetration-effectiveness (CPE) scoreTherapy-naive individualsRespective hazard ratiosCases of toxoplasmosisHIV-CAUSAL CollaborationIncidence of AIDSAntiretroviral penetrationAntiretroviral regimenBaseline regimensInitial regimenNeurologic conditionsNeurologic disordersCNS penetrationRegimen
2012
The effect of efavirenz versus nevirapine-containing regimens on immunologic, virologic and clinical outcomes in a prospective observational study
Cain LE, Phillips A, Lodi S, Sabin C, Bansi L, Justice A, Tate J, Logan R, Robins JM, Sterne JA, van Sighem A, de Wolf F, Bucher HC, Elzi L, Touloumi G, Vourli G, Esteve A, Casabona J, del Amo J, Moreno S, Seng R, Meyer L, Pérez-Hoyos S, Muga R, Abgrall S, Costagliola D, Hernán MA. The effect of efavirenz versus nevirapine-containing regimens on immunologic, virologic and clinical outcomes in a prospective observational study. AIDS 2012, 26: 1691-1705. PMID: 22546987, PMCID: PMC3647467, DOI: 10.1097/qad.0b013e328354f497.Peer-Reviewed Original ResearchConceptsAIDS-free individualsCD4 cell countEfavirenz regimensVirologic failureVirologic outcomesCell countMore nucleoside reverseNevirapine-containing regimensTreat hazard ratiosTypes of regimensProspective observational studyHIV-CAUSAL CollaborationEffect of efavirenzEfavirenz regimenNevirapine regimenNevirapine regimensHazard ratioNucleoside reverseClinical outcomesProspective studyInverse probability weightingLower incidenceObservational studyRegimensLower mortalityImpact of Antiretroviral Therapy on Tuberculosis Incidence Among HIV-Positive Patients in High-Income Countries
del Amo J, Moreno S, Bucher HC, Furrer H, Logan R, Sterne J, Pérez-Hoyos S, Jarrín I, Phillips A, Lodi S, van Sighem A, de Wolf W, Sabin C, Bansi L, Justice A, Goulet J, Miró JM, Ferrer E, Meyer L, Seng R, Toulomi G, Gargalianos P, Costagliola D, Abgrall S, Hernán MA. Impact of Antiretroviral Therapy on Tuberculosis Incidence Among HIV-Positive Patients in High-Income Countries. Clinical Infectious Diseases 2012, 54: 1364-1372. PMID: 22460971, PMCID: PMC3404691, DOI: 10.1093/cid/cis203.Peer-Reviewed Original ResearchMeSH KeywordsAdultAIDS-Related Opportunistic InfectionsAnti-HIV AgentsCD4 Lymphocyte CountCohort StudiesDeveloped CountriesDrug Therapy, CombinationEuropeFemaleHIV InfectionsHIV SeropositivityHumansImmune Reconstitution Inflammatory SyndromeIncidenceMaleMiddle AgedMycobacterium tuberculosisPneumocystis cariniiPneumonia, PneumocystisRNA, ViralTuberculosisUnited StatesViral LoadConceptsImmune reconstitution inflammatory syndromeCD4 cell countCells/μL.HIV RNA levelsHazard ratioTuberculosis incidenceCART initiationCell countAntiretroviral therapyTime-varying CD4 cell countBaseline CD4 cell countAIDS-free individualsEffects of CARTLow tuberculosis incidenceMonths of ARTReconstitution inflammatory syndromeHIV-positive patientsRNA levelsHIV-positive individualsHuman immunodeficiency virusHIV-CAUSAL CollaborationInflammatory syndromeImmunodeficiency virusInverse probability weightingPositive individuals
2011
When to initiate combined antiretroviral therapy to reduce mortality and AIDS-defining illness in HIV-infected persons in developed countries: an observational study.
Cain L, Logan R, Robins J, Sterne J, Sabin C, Bansi L, Justice A, Goulet J, van Sighem A, de Wolf F, Bucher H, von Wyl V, Esteve A, Casabona J, del Amo J, Moreno S, Seng R, Meyer L, Perez-Hoyos S, Muga R, Lodi S, Lanoy E, Costagliola D, Hernan M. When to initiate combined antiretroviral therapy to reduce mortality and AIDS-defining illness in HIV-infected persons in developed countries: an observational study. Annals Of Internal Medicine 2011, 154: 509-15. PMID: 21502648, PMCID: PMC3610527, DOI: 10.7326/0003-4819-154-8-201104190-00001.Peer-Reviewed Original ResearchConceptsCD4 cell countCombined end pointHazard ratioCell countCells/LAntiretroviral therapyCells/L.CD4 cell count thresholdBaseline CD4 cell countEnd pointVeterans Health Administration systemInitiation of cARTThreshold CD4 countCorresponding hazard ratiosMortality hazard ratioAIDS-free survivalProspective observational dataHIV-CAUSAL CollaborationMost clinical guidelinesHealth Administration systemUse of CD4Marginal structural modelsCell count thresholdCART initiationDynamic marginal structural models