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Type: Journal article
Title: Antiretroviral resistance at virological failure in the NEAT 001/ANRS 143 trial: raltegravir plus darunavir/ritonavir or tenofovir/emtricitabine plus darunavir/ritonavir as first-line ART
Author: Lambert-Niclot, S.
George, E.
Pozniak, A.
White, E.
Schwimmer, C.
Jessen, H.
Johnson, M.
Dunn, D.
Perno, C.
Clotet, B.
Plettenberg, A.
Blaxhult, A.
Palmisano, L.
Wittkop, L.
Calvez, V.
Marcelin, A.
Raffi, F.
Dedes, N.
Chěne, G.
Allavena, C.
et al.
Citation: Journal of Antimicrobial Chemotherapy, 2016; 71(4):1056-1062
Publisher: Oxford University Press
Issue Date: 2016
ISSN: 0305-7453
Statement of
S. Lambert-Niclot, E. C. George, A. Pozniak, E.White, C. Schwimmer ... Mark A. Boyd ... et al. (on behalf of the NEAT 001/ANRS 143 Study Group)
Abstract: Objectives: To describe the pattern of drug resistance at virological failure in the NEAT001/ANRS143 trial (first-line treatment with ritonavir-boosted darunavir plus either tenofovir/emtricitabine or raltegravir). Methods: Genotypic testing was performed at baseline for reverse transcriptase (RT) and protease genes and for RT, protease and integrase (IN) genes for patients with a confirmed viral load (VL) >50 copies/mL or any single VL >500 copies/mL during or after week 32. Results: A resistance test was obtained for 110/805 (13.7%) randomized participants qualifying for resistance analysis (61/401 of participants in the raltegravir arm and 49/404 of participants in the tenofovir/emtricitabine arm). No resistance-associated mutation (RAM) was observed in the tenofovir/emtricitabine plus darunavir/ritonavir arm, and all further analyses were limited to the raltegravir plus darunavir arm. In this group, 15/55 (27.3%) participants had viruses with IN RAMs (12 N155H alone, 1 N155H + Q148R, 1 F121Y and 1 Y143C), 2/53 (3.8%) with nucleotide analogue RT inhibitor RAMs (K65R, M41L) and 1/57 (1.8%) with primary protease RAM (L76V). The frequency of IN mutations at failure was significantly associated with baseline VL: 7.1% for a VL of <100 000 copies/mL, 25.0% for a VL of ≥100 000 copies/mL and <500 000 copies/mL and 53.8% for a VL of ≥500 000 copies/mL (PTREND = 0.007). Of note, 4/15 participants with IN RAM had a VL < 200 copies/mL at time of testing. Conclusions: In the NEAT001/ANRS143 trial, there was no RAM at virological failure in the standard tenofovir/emtricitabine plus darunavir/ritonavir regimen, contrasting with a rate of 29.5% (mostly IN mutations) in the raltegravir plus darunavir/ritonavir NRTI-sparing regimen. The cumulative risk of IN RAM after 96 weeks of follow-up in participants initiating ART with raltegravir plus darunavir/ritonavir was 3.9%.
Keywords: NEAT 001/ANRS 143 Study Group
HIV Infections
Anti-HIV Agents
CD4 Lymphocyte Count
Treatment Outcome
Treatment Failure
Antiretroviral Therapy, Highly Active
Microbial Sensitivity Tests
Viral Load
Follow-Up Studies
Drug Resistance, Viral
Middle Aged
Rights: © The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved.
DOI: 10.1093/jac/dkv427
Published version:
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