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

Elizabeth George (1) , Raffaella Bucciardini (2) , Laura Richert (3, 4) , Nikos Dedes (5) , Vincenzo Fragola (2) , Pythia Nieuwkerk (6) , Bruno Spire (7) , Alain Volny-Anne (5) , Brian West (5) , Jean-Michel Molina (8) , Andrzej Horban (9) , Julie Fox (10) , Anton Pozniak (10) , Stefano Vella (2) , Monique Termote (3) , François Raffi (11, 12)

1 MRC CTU - Medical Research Council Clinical Trials Unit
2 ISS - Istituto Superiore di Sanità = National Institute of Health
3 BPH - Bordeaux population health
4 SISTM - Statistics In System biology and Translational Medicine
5 European AIDS Treatment Group [Bruxelles]
6 Amsterdam School of Public Health [the Netherlands]
7 SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD - Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale
8 USPC - Université Sorbonne Paris Cité
9 Medical University of Warsaw - Poland
10 NHS Foundation Trust [London]
11 CIC Nantes - Centre d’Investigation Clinique de Nantes
12 Service des maladies infectieuses et tropicales [CHU Nantes]

BACKGROUND: There are few data comparing patient reported outcomes (PROs) in randomized trials of initial antiretroviral therapy (ART). We present results from a substudy of the NEAT001/ANRS143 trial. METHODS: The randomized trial compared first-line DRV/r 800/100mg once daily plus RAL 400mg twice daily and DRV/r plus TDF/FTC 245/200mg once daily. Changes in PROs were assessed with 3 questionnaires: EuroQoL 5 domains (EQ-5D), Centre for Epidemiologic Studies Depression scale (CES-D), and HIV Treatment Satisfaction (HIVTSQ). 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 PROs data were similar for the two randomized groups. Health status improved over time with a mean increase in EQ-5D visual analogue scale of 8.0 by W96 (95%CI 6.5-9.4; p<0.001), and no statistically significant differences between groups (difference of 0.3 on VAS score (95%CI -1.7, 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 -0.1 (95%CI -1.3, 1.1); p=0.9), or MDD during follow-up, adjusted for baseline MDD (OR=0.98, 95%CI 0.82-1.18; 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 ART, with no statistically significant difference between groups. The lower satisfaction with RAL+DRV/r may be explained by twice-daily administration.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal.

Domaines: Maladies infectieuses

Elizabeth George, Raffaella Bucciardini, Laura Richert, Nikos Dedes, Vincenzo Fragola, et al.. Patient-Reported Outcomes in First-Line Antiretroviral Therapy: Results from NEAT001/ANRS143 Trial Comparing Darunavir/Ritonavir in Combination with Tenofovir/Emtricitabine or Raltegravir. Journal of Acquired Immune Deficiency Syndromes - JAIDS, 2018, ⟨10.1097/QAI.0000000000001844⟩. ⟨hal-01888891⟩