Week 96 efficacy of lopinavir/ritonavir monotherapy in virologically suppressed patients with HIV: a randomized non-inferiority trial (ANRS 140 DREAM)
| dc.rights.license | open | en_US |
| dc.contributor.author | MEYNARD, J. L. | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | MOINOT, Laetitia | |
| dc.contributor.author | LANDMAN, R. | |
| dc.contributor.author | MORAND-JOUBERT, L. | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | BESSEGHIR, Amel | |
| dc.contributor.author | KOLTA, S. | |
| dc.contributor.author | SPIRE, B. | |
| dc.contributor.author | TODESCO, E. | |
| dc.contributor.author | BOUCHAUD, O. | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | FAGARD, Catherine | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | CHENE, Geneviève | |
| dc.contributor.author | GIRARD, P. M. | |
| dc.date.accessioned | 2020-12-08T08:31:08Z | |
| dc.date.available | 2020-12-08T08:31:08Z | |
| dc.date.issued | 2018-06-01 | |
| dc.identifier.issn | 1460-2091 (Electronic) 0305-7453 (Linking) | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/21342 | |
| dc.description.abstractEn | Background: Sparing of antiretroviral drug classes could reduce the toxicity and cost of maintenance treatment for HIV infection. Objectives: To evaluate the non-inferiority of efficacy and the safety of lopinavir/ritonavir (r) monotherapy versus a single-tablet regimen of efavirenz, emtricitabine and tenofovir (EFV/FTC/TDF) over 2 years. Methods: Adults on stable ART with plasma HIV-1 RNA viral load <50 copies/mL for the past 12 months and no documented treatment failure were randomized to receive either lopinavir/r or EFV/FTC/TDF for 2 years. The primary endpoint was the proportion of patients without treatment failure at week 96 (viral load <50 copies/mL at week 96, confirmed at week 98), without study treatment discontinuation, a new AIDS-defining illness, or death. Results: In the ITT analysis, the primary endpoint was reached by, respectively, 64% and 71% of patients in the lopinavir/r (n = 98) and EFV/FTC/TDF arms (n = 97), yielding a difference of -6.8% (lower limit of the 95% two-sided CI: -19.9%). Sanger and UltraDeep sequencing showed the occurrence of PI mutations in the lopinavir/r arm (n = 4) and of NNRTI and/or NRTI mutations in the EFV/FTC/TDF arm (n = 2). No unexpected serious clinical events occurred. Conclusions: Lopinavir/r monotherapy cannot be considered non-inferior to EFV/FTC/TDF. PI resistance rarely emerged in the lopinavir/r arm and did not undermine future PI options. Two years of lopinavir/r monotherapy had no deleterious clinical impact when compared with EFV/FTC/TDF. | |
| dc.language.iso | EN | en_US |
| dc.subject.en | MORPH3Eus | |
| dc.subject.en | CIC1401 | |
| dc.title.en | Week 96 efficacy of lopinavir/ritonavir monotherapy in virologically suppressed patients with HIV: a randomized non-inferiority trial (ANRS 140 DREAM) | |
| dc.title.alternative | J Antimicrob Chemother | en_US |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1093/jac/dky055 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
| dc.identifier.pubmed | 29584910 | en_US |
| bordeaux.journal | The Journal of antimicrobial chemotherapy | en_US |
| bordeaux.page | 1672-1676 | en_US |
| bordeaux.volume | 73 | en_US |
| bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - UMR 1219 | en_US |
| bordeaux.issue | 6 | en_US |
| bordeaux.institution | Université de Bordeaux | en_US |
| bordeaux.team | MORPH3Eus | en_US |
| bordeaux.team | CIC1401 | en_US |
| bordeaux.peerReviewed | oui | en_US |
| bordeaux.inpress | non | en_US |
| hal.export | false | |
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