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Integrase strand-transfer inhibitor use and cardiovascular events in adults with HIV: an emulation of target trials in the HIV-CAUSAL Collaboration and the Antiretroviral Therapy Cohort Collaboration

dc.rights.licenseopenen_US
dc.contributor.authorREIN, Sophia M
dc.contributor.authorLODI, Sara
dc.contributor.authorLOGAN, Roger W
dc.contributor.authorTOULOUMI, Giota
dc.contributor.authorANTONIADOU, Anastasia
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorWITTKOP, Linda
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorBONNET, Fabrice
dc.contributor.authorVAN SIGHEM, Ard
dc.contributor.authorVAN DER VALK, Marc
dc.contributor.authorREISS, Peter
dc.contributor.authorKLEIN, Marina B
dc.contributor.authorYOUNG, James
dc.contributor.authorJARRIN, Inmaculada
dc.contributor.authorD'ARMINIO MONFORTE, Antonella
dc.contributor.authorTAVELLI, Alessandro
dc.contributor.authorMEYER, Laurence
dc.contributor.authorTRAN, Laurent
dc.contributor.authorGILL, Michael J
dc.contributor.authorLANG, Raynell
dc.contributor.authorSURIAL, Bernard
dc.contributor.authorHAAS, Andreas D
dc.contributor.authorJUSTICE, Amy C
dc.contributor.authorRENTSCH, Christopher T
dc.contributor.authorPHILLIPS, Andrew
dc.contributor.authorSABIN, Caroline A
dc.contributor.authorMIRO, Jose M
dc.contributor.authorTRICKEY, Adam
dc.contributor.authorINGLE, Suzanne M
dc.contributor.authorSTERNE, Jonathan A C
dc.contributor.authorHERNAN, Miguel A
dc.date.accessioned2024-01-17T09:26:53Z
dc.date.available2024-01-17T09:26:53Z
dc.date.issued2023-11
dc.identifier.issn2352-3018en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/187293
dc.description.abstractEnBACKGROUND: A recent observational study suggested that the risk of cardiovascular events could be higher among antiretroviral therapy (ART)-naive individuals with HIV who receive integrase strand-transfer inhibitor (INSTI)-based ART than among those who receive other ART regimens. We aimed to emulate target trials separately in ART-naive and ART-experienced individuals with HIV to examine the effect of using INSTI-based regimens versus other ART regimens on the 4-year risk of cardiovascular events. METHODS: We used routinely recorded clinical data from 12 cohorts that collected information on cardiovascular events, BMI, and blood pressure from two international consortia of cohorts of people with HIV from Europe and North America. For the target trial in individuals who had previously never used ART (ie, ART-naive), eligibility criteria were aged 18 years or older, a detectable HIV-RNA measurement while ART-naive (>50 copies per mL), and no history of a cardiovascular event or cancer. Eligibility criteria for the target trial in those with previous use of non-INSTI-based ART (ie, ART-experienced) were the same except that individuals had to have been on at least one non-INSTI-based ART regimen and be virally suppressed (≤50 copies per mL). We assessed eligibility for both trials for each person-month between January, 2013, and January, 2023, and assigned individuals to the treatment strategy that was compatible with their data. We estimated the standardised 4-year risks of cardiovascular events (myocardial infarction, stroke, or invasive cardiovascular procedure) via pooled logistic regression models adjusting for time and baseline covariates. In per-protocol analyses, we censored individuals if they deviated from their assigned treatment strategy for more than 2 months and weighted uncensored individuals by the inverse of their time-varying probability of remaining uncensored. The denominator of the weight was estimated via a pooled logistic model that included baseline and time-varying covariates. FINDINGS: The analysis in ART-naive individuals included 10 767 INSTI initiators and 8292 non-initiators of INSTI. There were 43 cardiovascular events in INSTI initiators (median follow-up of 29 months; IQR 15-45) and 52 in non-initiators (39 months; 18-47): standardised 4-year risks were 0·76% (95% CI 0·51 to 1·04) in INSTI initiators and 0·75% (0·54 to 0·98) in non-INSTI initiators; risk ratio 1·01 (0·57 to 1·57); risk difference 0·0089% (-0·43 to 0·36). The analysis in ART-experienced individuals included 7875 INSTI initiators and 373 965 non-initiators. There were 56 events in INSTI initiators (median follow-up 18 months; IQR 9-29) and 3103 events (808 unique) in non-INSTI initiators (26 months; 15-37) in non-initiators: standardised 4-year risks 1·41% (95% CI 0·88 to 2·03) in INSTI initiators and 1·48% (1·28 to 1·71) in non-initiators; risk ratio 0·95 (0·60 to 1·36); risk difference -0·068% (-0·60 to 0·52). INTERPRETATION: We estimated that INSTI use did not result in a clinically meaningful increase of cardiovascular events in ART-naive and ART-experienced individuals with HIV. FUNDING: National Institute of Allergy and Infectious Diseases and National Institute on Alcohol Abuse and Alcoholism.
dc.language.isoENen_US
dc.title.enIntegrase strand-transfer inhibitor use and cardiovascular events in adults with HIV: an emulation of target trials in the HIV-CAUSAL Collaboration and the Antiretroviral Therapy Cohort Collaboration
dc.title.alternativeLancet HIVen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/s2352-3018(23)00233-3en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed37923486en_US
bordeaux.journalThe Lancet HIVen_US
bordeaux.pagee723-e732en_US
bordeaux.volume10en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue11en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.institutionINRIAen_US
bordeaux.teamGHIGS_BPHen_US
bordeaux.teamSISTM_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDNational Institute of Allergy and Infectious Diseasesen_US
bordeaux.identifier.funderIDNational Institute on Alcohol Abuse and Alcoholismen_US
bordeaux.identifier.funderIDInstitut de Recherche pour le Développementen_US
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exportfalse
dc.rights.ccPas de Licence CCen_US
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