Body composition and adipokines changes after initial treatment with darunavir-ritonavir plus either raltegravir or tenofovir disoproxil fumarate-emtricitabine: A substudy of the NEAT001/ANRS143 randomised trial

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  • dc.contributor.author Bernardino, Jose I.
  • dc.contributor.author Mocroft, Amanda
  • dc.contributor.author Wallet, Cedrick
  • dc.contributor.author de Wit, Stéphane
  • dc.contributor.author Katlama, Christine
  • dc.contributor.author Reiss, Peter
  • dc.contributor.author Mallon, Patrick W.
  • dc.contributor.author Richert, Laura
  • dc.contributor.author Molina, Jean-Michel
  • dc.contributor.author Knobel Freud, Hernando
  • dc.contributor.author Morlat, Philippe
  • dc.contributor.author Babiker, Abdel
  • dc.contributor.author Pozniac, Anton
  • dc.contributor.author Raffi, Francois
  • dc.contributor.author Arribas, José Ramón
  • dc.contributor.author NEAT001/ANRS143 Trial Study Group
  • dc.date.accessioned 2019-07-11T06:18:07Z
  • dc.date.available 2019-07-11T06:18:07Z
  • dc.date.issued 2019
  • dc.description.abstract BACKGROUND: Comparison of changes in body composition, adipokines and inflammatory markers after initial therapy with a nucleos(t)ide reverse transcriptase inhibitor (N(t)RTI)- sparing or containing regimen are scarce. DESIGN: Randomised Clinical Trial. METHODS: This is the body composition substudy of NEAT 001/ANRS 143, a randomised trial comparing darunavir/ritonavir (DRV/r) plus either raltegravir (RAL) or tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 805 ART naïve HIV-infected adults. The primary endpoint was percentage change in limb fat at week 96. Secondary endpoints were associations among these changes and metabolic markers (IL-6, insulin, leptin, adiponectin, FGF-23). RESULTS: 126 subjects (61 DRV/r + RAL and 65 DRV/r + TDF/FTC) were included. The rate of change in BMI between groups for RAL versus TDF/FTC at week 96 was 1.5% per 48-week period (p = 0.015). The rate of change in limb fat mass, trunk fat mass, total body fat and total lean mass was for RAL versus TDF/FTC at week 96 was 2.5% (p = 0.38), 7.3% ((p = 0.021), 4.9% (p = 0.061) and 1.3% (p = 0.12) respectively. Baseline insulin and leptin levels were correlated with baseline limb fat and trunk fat mass [r = 0.31 (p = 0.0043)/r = 0.28 (p = 0.0011) for limb fat, and r = 0.63 (p<0.0001)/r = 0.50(p<0.0001) for trunk fat]. After adjustment, a 10% faster increase in leptin between baseline and week 48 was associated with a more rapid increase in limb fat at week 48 (0.5% per 48 weeks, p<0.001), total body fat mass (0.6% per 48 weeks, p<0.001), and trunk fat mass (0.3% per 48 weeks, p = 0.0026). CONCLUSIONS: After week 96 a N(t)RTI sparing regimen of DRV/r + RAL produced a numerically greater percentage increase in body composition variables with only change in trunk fat mass and BMI being significant.
  • dc.description.sponsorship NEAT is a project funded to the Instituto Superiori di Sanitá-Rome, by the European Union under the Sixth Framework Programme, project number LSHP-CT-2006-037570. This analysis was also partially funded by a grant from the Ministerio de Sanidad y Asuntos Sociales de España (2009/TRA-054). The trial was also supported by Gilead Sciences, Janssen Pharmaceuticals, and Merck Laboratories, and the French National Institute for Health and Medical Research-France Recherche Nord&Sud SIDA-HIV Hépatites (Inserm-ANRS) is the sponsor and a funder of the trial.
  • dc.format.mimetype application/pdf
  • dc.identifier.citation Bernardino JI, Mocroft A, Wallet C, de Wit S, Katlama C, Reiss P. et al. Body composition and adipokines changes after initial treatment with darunavir-ritonavir plus either raltegravir or tenofovir disoproxil fumarate-emtricitabine: A substudy of the NEAT001/ANRS143 randomised trial. PLoS One. 2019 Jan 28;14(1):e0209911. DOI: 10.1371/journal.pone.0209911
  • dc.identifier.doi http://dx.doi.org/10.1371/journal.pone.0209911
  • dc.identifier.issn 1932-6203
  • dc.identifier.uri http://hdl.handle.net/10230/41981
  • dc.language.iso eng
  • dc.publisher Public Library of Science (PLoS)
  • dc.relation.projectID info:eu-repo/grantAgreement/EC/FP6/037570
  • dc.rights copyright © 2019 Bernardino et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, https://creativecommons.org/licenses/by/4.0/, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
  • dc.rights.accessRights info:eu-repo/semantics/openAccess
  • dc.rights.uri https://creativecommons.org/licenses/by/4.0/
  • dc.subject.other Sida -- Tractament
  • dc.subject.other Cos humà -- Composició
  • dc.title Body composition and adipokines changes after initial treatment with darunavir-ritonavir plus either raltegravir or tenofovir disoproxil fumarate-emtricitabine: A substudy of the NEAT001/ANRS143 randomised trial
  • dc.type info:eu-repo/semantics/article
  • dc.type.version info:eu-repo/semantics/publishedVersion

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