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Patient-Reported Outcomes in First-Line Antiretroviral Therapy: Results From NEAT001/ANRS143 Trial Comparing Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine or Raltegravir

dc.rights.licenseopenen_US
dc.contributor.authorGEORGE, E. C.
dc.contributor.authorBUCCIARDINI, R.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorRICHERT, Laura
dc.contributor.authorDEDES, N.
dc.contributor.authorFRAGOLA, V.
dc.contributor.authorNIEUWKERK, P.
dc.contributor.authorSPIRE, B.
dc.contributor.authorVOLNY-ANNE, A.
dc.contributor.authorWEST, B.
dc.contributor.authorMOLINA, J. M.
dc.contributor.authorHORBAN, A.
dc.contributor.authorFOX, J.
dc.contributor.authorPOZNIAK, A.
dc.contributor.authorVELLA, S.
dc.contributor.authorTERMOTE, M.
dc.contributor.authorRAFFI, F.
dc.date.accessioned2020-11-10T12:56:07Z
dc.date.available2020-11-10T12:56:07Z
dc.date.issued2018-12-01
dc.identifier.issn1944-7884 (Electronic) 1525-4135 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/12204
dc.description.abstractEnBackground: There are few data comparing patient-reported outcomes (PROs) in randomized trials of initial antiretroviral therapy. We present results from a substudy of the NEAT001/ ANRS143 trial. Methods: The randomized trial compared first-line DRV/r 800/100 mg once daily plus RAL 400 mg twice daily and DRV/r plus TDF/ FTC 245/200 mg once daily. Changes in PROs were assessed with 3 questionnaires: EuroQoL 5 domains (EQ-5D), Center for Epidemiologic Studies Depression (CES-D) scale, and HIV Treatment Satisfaction Questionnaire. Major depressive disorder (MDD) was defined as CES-D $ 16. General estimating equations were used to model change over 96 weeks in PROs from baseline. Results: Of the 805 participants, 797 (99%) contributed to the substudy. Baseline PRO data were similar for the 2 randomized groups. Health status improved over time with a mean increase in EQ-5D visual analogue scale (VAS) of 8.0 by W96 [95% confidence interval (CI): 6.5 to 9.4; P, 0.001], and no statistically significant differences between groups (difference of 0.3 on VAS score (95% CI: 21.7 to 2.3); P = 0.7, global P value $ 0.05 for all domains over follow-up). There was no significant difference between groups on CES-D [difference of 20.1 (95% CI: 21.3 to 1.1); P = 0.9], or MDD during follow-up, adjusted for baseline MDD (odds ratio = 0.98, 95% CI: 0.82 to 1.18; P = 0.9). RAL + DRV/r group had lower level of convenience (P = 0.03) and fitted less well into patients' lifestyle (P = 0.007) than the TDF/FTC + DRV/r regimen, and was associated with lower treatment satisfaction [median score: 53 RAL + DRV/r vs 55 TDF/FTC + DRV/r (P = 0.001)]. Conclusion: PROs improved after starting antiretroviral therapy, with no statistically significant difference between groups. The lower satisfaction with RAL + DRV/r may be explained by twicedaily administration.
dc.language.isoENen_US
dc.subject.enSISTM
dc.subject.enMORPH3Eus
dc.title.enPatient-Reported Outcomes in First-Line Antiretroviral Therapy: Results From NEAT001/ANRS143 Trial Comparing Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine or Raltegravir
dc.title.alternativeJ Acquir Immune Defic Syndren_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1097/qai.0000000000001844en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
bordeaux.journalJaidsen_US
bordeaux.page519-526en_US
bordeaux.volume79en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - U1219en_US
bordeaux.issue4en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamSISTMen_US
bordeaux.teamSISTM_BPH
bordeaux.teamMORPH3Eusen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.exportfalse
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Jaids&rft.date=2018-12-01&rft.volume=79&rft.issue=4&rft.spage=519-526&rft.epage=519-526&rft.eissn=1944-7884%20(Electronic)%201525-4135%20(Linking)&rft.issn=1944-7884%20(Electronic)%201525-4135%20(Linking)&rft.au=GEORGE,%20E.%20C.&BUCCIARDINI,%20R.&RICHERT,%20Laura&DEDES,%20N.&FRAGOLA,%20V.&rft.genre=article


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