CROI 2016 Abstract eBook

Abstract Listing

Oral Abstracts

Results: 121 participants enrolled; 8 did not complete treatment, were non-adherent, or had a serious bacterial infection and were excluded from analyses. Of 113 per-protocol participants, all had HIV VL<50 copies/mL, 81%were male; median age 49 years; median CD4+ T cell count 616/mm 3 . Aspirin was well tolerated. There was one protocol-defined toxicity of bleeding in stool in the placebo arm. Key results are shown in the table. Serum thromboxane was significantly inhibited by aspirin, suggesting high study drug adherence and aspirin efficacy to inhibit cyclooxygenase. There were no consistent differences between the 300mg or 100mg aspirin arms vs. placebo for sCD14, FMD, or any of the other immunologic endpoints, though the 300mg aspirin arm experienced a greater increase in sCD163 than the placebo arm. Interactions by current smoking, sex, age, ART regimen, and baseline marker tertile were assessed with aspirin showing less of an increase in sCD163 among smokers (p=0.047) and women (p=0.031) and greater reductions in D-dimer among smokers (p=0.03). Conclusions: Aspirin for 12 weeks does not appear to have a major impact on immune activation or endothelial function in ART-suppressed HIV-infected individuals. While this study does not support the use of aspirin as an anti-inflammatory in patients with HIV infection, there may be some subgroups that derive benefit, which could be explored in future studies.

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Body Composition Changes on DRV/r + Either RAL or TDF/FTC As First-Line ART Jose I. Bernardino 1 ; Amanda Mocroft 2 ; CedrickWallet 3 ; Jean-Michel Molina 4 ; Hernando Knobell 5 ; Jacques Reynes 6 ; Abdel Babiker 2 ; François Raffi 7 ; Jose R. Arribas 1 ; for the NEAT 001/ ANRS 143 Study Group 1 Inst for Hlth Rsr of La Paz Univ Hosp, Madrid, Spain; 2 Univ Coll London, London, UK; 3 INSERM U897, Univ de Bordeaux, Bordeaux, France; 4 Hopital Saint-Louis, Paris, France; 5 Hosp del Mar Barcelona, Barcelona, Spain; 6 Univ Hosp Montpellier, Montpellier, France; 7 Univ Hosp Nantes, Nantes, France Background: Data on body composition, adipokines and inflammatory markers changes after initial therapy with a nucleos(t)ide reverse transcriptase inhibitor (NtRTI)- sparing or containing regimen are scarce. The effect of tenofovir/emtricitabine (TDF/FTC) vs raltegarvir (RAL), both in association with ritonavir-boosted darunavir (DRV/r) could be relevant for treatment choice. Methods: NEAT001/ANRS143 is a randomised 1:1, open-label, non-inferiority trial comparing DRV/r + RAL or TDF/FTC in 805 ART näive HIV-infected adults. We compared

Oral Abstracts

percentage change in lean mass, limb fat mass, trunk fat mass ant total body fat mass assessed by dual energy X-ray absorptiometry scans (DXA) in a substudy of 146 subjects (random sample). Main endpoint was mean % change of limb fat at W96. Secondary endpoints: relationship between changes in body composition variables, and inflammatory/metabolic markers (IL-6, insulin, leptin, adiponectin, FGF-23). Results: 126 (61 DRV/r + RAL and 65 DRV/r + TDF/FTC) had at least one follow-up DXA available. At baseline: 91%male, 14% black, median age 40 years, median BMI 23.2 Kg/m 2 , HIV-1 RNA load 4.7 log 10 copies/mL,

CD4 count 338 cells/µL. There was no difference in limb fat mass at W96 between arms (Table). At W96 there was a greater increase in the DRV/r + RAL arm in mean trunk fat mass (15.5% in DRV/r + RAL vs. 8.7% in DRV/r + TDF/FTC; p = 0.026) and total body fat mass (4.1% in DRV/r + RAL vs. 0% in DRV/r + TDF/FTC; p = 0.032). These differences remained robust to adjustment for baseline CD4 count and viral load. Baseline insulin and leptin levels were correlated with baseline limb fat/trunk fat mass [r=0.31 (p=0.0043)/r=0.28 (p=0.0011); r=0.63 (p<0.0001)/r=0.50(p<0.0001), respectively]. Adiponectin was correlated with baseline limb fat mass only [r=0.40 (p<0.0001)]. After adjustment, persons with a 10% increase in leptin between baseline and W48 had a 0.5% (95% CI 0.3-0.7; p<0.0001) and 0.3% (95% CI 0.1-0.6; p=0.013) increase in limb fat mass at W48 and W96 respectively and a 0.4% increase in trunk fat at W96 (95% CI 0.1-0.6; p=0.014). There was no association between baseline IL-6 or insulin and changes in limb or trunk fat mass. Conclusions: The NtRTI sparing regimen produced a higher increase in total and trunk fat mass than the TDF/FTC containing regimen. These changes were correlated with changes in leptin levels.

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CROI 2016