Format

Send to

Choose Destination
PLoS One. 2019 Jan 28;14(1):e0209911. doi: 10.1371/journal.pone.0209911. eCollection 2019.

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.

Author information

1
Department of Internal Medicine, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.
2
University College London, London, United Kingdom.
3
University of Bordeaux INSERM, Bordeaux Population Health Research Center, UMR 1219, Bordeaux, France.
4
CHU Saint Pierre, Université Libre de Bruxeles, Brussels, Belgium.
5
Hôpital Pitié Salpétrière, Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.
6
Department of Global Health and Division of Infectious Diseases, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
7
School of Medicine, University College Dublin, Dublin, Ireland.
8
Hôpital Saint-Louis, University of Paris Diderot, Paris, INSERM U941, France.
9
Department of Infectious Diseases, Hospital del Mar, Universidad Autónoma de Barcelona, Spain.
10
Service de Medicine Interne et Maladies Infectieuses, CHU Bordeaux, Université de Bordeaux, Inserm U 1219, Bourdeaux, France.
11
MRC Clinical Trials Unit at UCL, London, United Kingdom.
12
Chelsea and Westminster hospital NHS Foundation Trust, London, United Kingdom.
13
Department of infectious diseases, CHU de Nantes and CIC 1413, INSERM, Nantes, France.

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.

Conflict of interest statement

I have read the journal's policy and the authors of this manuscript have the following competing interests: JIB reports grants from Ministerio de Sanidad, Servicio Sociales e Iguadad (TRA-054), during the conduct of the study; personal fees from Gilead Sciences, ViiV Healthcare, MSD, and Janssen. JRA reports grants and personal fees from Gilead, personal fees from Janssen, ViiV and Merck. CW reports grants from European Commission and Inserm-ANRS, non-financial support from Gilead, Janssen Pharmaceuticals and Merck during the conduct of the study; grants from Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Janssen Pharmaceuticals, MSD, Pfizer, Roche, Tibotec, and ViiV Healthcare to the author's institution outside the submitted work. LR reports grants from European Commission and Inserm-ANRS, non-financial support from Gilead, Janssen Pharmaceuticals and Merck during the conduct of the study; grants from Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Janssen Pharmaceuticals, MSD, Pfizer, Roche, Tibotec, and ViiV Healthcare to the author's institution, outside the submitted work. AB reports grants from EU Fifth Framework Programme (though NEAT network of excellence), grants from ANRS, France, grants from Medical Research Council, UK, during the conduct of the study. AM reports personal fees from ViiV, Pfizer, BI, Gilead, Merck, BMS and Wragge LLC, outside the submitted work. JMM reports grants from Merck and Gilead, personal fees from Merck, Gilead,BMS, ViiV, TEVA, and Janssen outside the submitted work. CK reports having received consultancy fees and/or travel grants from Merck, Gilead, BMS, ViiV, BMS, and Janssen. PWM reports grants and personal fees from Gilead Sciences, ViiV Healthcare, Janssen Cilag, and MSD outside the submitted work. PM reports personal fees from Gilead and MSD Board, personal fees from ViiV health care consultancy, outside the submitted work. PR reports grants from Gilead, ViiV Healthcare, Janssen Pharmaceutica, Bristol Myers Squibb, and Merck & Co. FR received research funding or honoraria from or consulted for Gilead Sciences, Janssen Pharmaceuticals, MSD, and Merck. AP reports grants from SSAT, and NEAT, during the conduct of the study; personal fees from Janssen, Gilead, Merck, outside the submitted work; and was vice chair of NEAT and was on BHIVA and EACS ART guidelines committees at time of study. All other authors declare no conflicts of interest. This does not alter the authors’ adherence to PLOS ONE policies on sharing data and materials.

Supplemental Content

Full text links

Icon for Public Library of Science Icon for PubMed Central
Loading ...
Support Center