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- Title
Characterization of viral rebounds on dual etravirine/raltegravir maintenance therapy (ANRS-163 ETRAL trial).
- Authors
Soulie, Cathia; Assoumou, Lambert; Abdi, Basma; Sayon, Sophie; Nguyen, Thuy; Valantin, Marc-Antoine; Beniguel, Lydie; Ferre, Virginie; Alloui, Chakib; Montes, Brigitte; Avettand-Fenoel, Véronique; Delaugerre, Constance; Descamps, Diane; Martinez, Esteban; Reynes, Jacques; Peytavin, Gilles; Costagliola, Dominique; Katlama, Christine; Calvez, Vincent; Marcelin, Anne-Geneviève
- Abstract
<bold>Background: </bold>The ANRS-163 ETRAL trial, a switch study to an etravirine 200 mg/raltegravir 400 mg twice-daily regimen in 165 patients with HIV-1 infection, showed durable efficacy until Week 96. The aim of this work was to investigate in detail the virological rebounds (VRs), defined as at least one plasma HIV viral load (VL) >50 copies/mL.<bold>Methods: </bold>Quantification of HIV-DNA level was assessed at baseline, Week 48 and Week 96 (n = 157). VLs were measured in seminal plasma at Week 48 (n = 26). Genotypic resistance testing by ultra-deep sequencing (UDS) for reverse transcriptase (RT) and integrase regions was performed at baseline and at the time of VR.<bold>Results: </bold>In this study, 19 patients experienced VR, with 2 patients having virological failure (VF; two consecutive VLs >50 copies/mL). For the first patient with VF, UDS detected minority resistant variants only in RT (K103N, 9.6%; Y181C, 4.9%) at baseline. Some RT variants became dominant at VF (K101E, 86.3%; Y181C, 100.0%; G190A, 100.0%) and others emerged in integrase (Y143C, 2.4%; Q148R, 6.2%; N155H, 18.8%). For the second patient with VF, neither RT nor integrase mutations were detected at baseline and VF. Median HIV-DNA level was similar at baseline, Week 48 and Week 96 (2.17, 2.06 and 2.11 log10 copies/106 cells, respectively). Only one patient had a detectable seminal HIV VL (505 copies/mL).<bold>Conclusions: </bold>The dual etravirine/raltegravir regimen as maintenance therapy was effective and the emergence of mutations in cases of VF was similar to that seen in other dual-regimen studies. No HIV-DNA level modification was evidenced by Week 96.
- Subjects
ANTI-HIV agents; HIV infections; RESEARCH; HETEROCYCLIC compounds; VIRAL load; RESEARCH methodology; ORGANIC compounds; MEDICAL cooperation; EVALUATION research; COMPARATIVE studies; DRUG resistance in microorganisms; HIV; PHARMACODYNAMICS
- Publication
Journal of Antimicrobial Chemotherapy (JAC), 2020, Vol 75, Issue 7, p1943
- ISSN
0305-7453
- Publication type
journal article
- DOI
10.1093/jac/dkaa090