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https://hdl.handle.net/2440/119056
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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 1460-2091 |
Statement of Responsibility: | 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 Humans HIV-1 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 Mutation Adult Middle Aged Female Male |
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: | http://dx.doi.org/10.1093/jac/dkv427 |
Appears in Collections: | Aurora harvest 8 Pharmacology publications |
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