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Ritonavir-boosted darunavir combined with raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults infected with HIV-1: 96 week results from the NEAT001/ANRS143 randomised non-inferiority trial.

hal.structure.identifierMaladies infectieuses et tropicales
dc.contributor.authorRAFFI, François
dc.contributor.authorBABIKER, Abdel G
hal.structure.identifierFonctions et dysfonctions épithéliales - UFC (EA 4267) [FDE]
dc.contributor.authorRICHERT, Laura
hal.structure.identifierInstitut Universitaire d'Hématologie [IUH]
hal.structure.identifierInserm
hal.structure.identifierService des Maladies Infectieuses et Tropicales [CHU Saint Louis]
dc.contributor.authorMOLINA, Jean-Michel
dc.contributor.authorGEORGE, Elizabeth C
dc.contributor.authorANTINORI, Andrea
hal.structure.identifierDevelopment and Differentiation
dc.contributor.authorARRIBAS, Jose R
dc.contributor.authorGRARUP, Jesper
dc.contributor.authorHUDSON, Fleur
hal.structure.identifierInstitut de biochimie et génétique cellulaires [IBGC]
dc.contributor.authorSCHWIMMER, Christine
hal.structure.identifierInstitut des Sciences Chimiques de Rennes [ISCR]
dc.contributor.authorSAILLARD, Juliette
dc.contributor.authorWALLET, Cédrick
hal.structure.identifierStockholm University Library [SUB]
dc.contributor.authorJANSSON, Per O
hal.structure.identifierService de maladies infectieuses et tropicales [Nantes]
dc.contributor.authorALLAVENA, Clotilde
dc.contributor.authorVAN LEEUWEN, Remko
hal.structure.identifierService de médecine interne et maladies infectieuses
dc.contributor.authorDELFRAISSY, Jean-François
hal.structure.identifierAménagement, Développement, Environnement, Santé et Sociétés [ADES]
dc.contributor.authorVELLA, Stefano
hal.structure.identifierEpidémiologie et Biostatistique [Bordeaux]
dc.contributor.authorCHÊNE, Geneviève
dc.contributor.authorPOZNIAK, Anton
dc.date.issued2014-11-29
dc.identifier.issn1474-4422
dc.description.abstractEnStandard first-line antiretroviral therapy for HIV-1 infection includes two nucleoside or nucleotide reverse transcriptase inhibitors (NtRTIs), but these drugs have limitations. We assessed the 96 week efficacy and safety of an NtRTI-sparing regimen. Between August, 2010, and September, 2011, we enrolled treatment-naive adults into this randomised, open-label, non-inferiority trial in treatment-naive adults in 15 European countries. The composite primary outcome was change to randomised treatment before week 32 because of insufficient virological response, no virological response by week 32, HIV-1 RNA concentration 50 copies per mL or higher at any time after week 32; death from any cause; any new or recurrent AIDS event; or any serious non-AIDS event. Patients were randomised in a 1:1 ratio to receive oral treatment with 400 mg raltegravir twice daily plus 800 mg darunavir and 100 mg ritonavir once daily (NtRTI-sparing regimen) or tenofovir-emtricitabine in a 245 mg and 200 mg fixed-dose combination once daily, plus 800 mg darunavir and 100 mg ritonavir once daily (standard regimen). This trial was registered with ClinicalTrials.gov, number NCT01066962. Of 805 patients enrolled, 401 received the NtRTI-sparing regimen and 404 the standard regimen, with median follow-up of 123 weeks (IQR 112-133). Treatment failure was seen in 77 (19%) in the NtRTI-sparing group and 61 (15%) in the standard group. Kaplan-Meier estimated proportions of treatment failure by week 96 were 17·8% and 13·8%, respectively (difference 4·0%, 95% CI -0·8 to 8·8). The frequency of serious or treatment-modifying adverse events were similar (10·2 vs 8·3 per 100 person-years and 3·9 vs 4·2 per 100 person-years, respectively). Our NtRTI-sparing regimen was non-inferior to standard treatment and represents a treatment option for patients with CD4 cell counts higher than 200 cells per μL. European Union Sixth Framework Programme, Inserm-ANRS, Gilead Sciences, Janssen Pharmaceuticals, Merck Laboratories.
dc.language.isoen
dc.publisherElsevier
dc.subject.meshAdenine
dc.subject.meshAdult
dc.subject.meshHIV Infections
dc.subject.meshHIV-1
dc.subject.meshHumans
dc.subject.meshKaplan-Meier Estimate
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshOrganophosphonates
dc.subject.meshPyrrolidinones
dc.subject.meshRitonavir
dc.subject.meshSulfonamides
dc.subject.meshAnti-HIV Agents
dc.subject.meshTreatment Outcome
dc.subject.meshCD4 Lymphocyte Count
dc.subject.meshCholesterol, HDL
dc.subject.meshCholesterol, LDL
dc.subject.meshDeoxycytidine
dc.subject.meshDrug Resistance, Viral
dc.subject.meshDrug Therapy, Combination
dc.subject.meshFemale
dc.title.enRitonavir-boosted darunavir combined with raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults infected with HIV-1: 96 week results from the NEAT001/ANRS143 randomised non-inferiority trial.
dc.typeArticle de revue
dc.subject.halSciences du Vivant [q-bio]
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologie
bordeaux.journalThe Lancet Neurology
bordeaux.page1942-51
bordeaux.volume384
bordeaux.issue9958
bordeaux.peerReviewedoui
hal.identifierhal-01108186
hal.version1
hal.popularnon
hal.audienceInternationale
hal.origin.linkhttps://hal.archives-ouvertes.fr//hal-01108186v1
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