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Randomized Controlled Trial
. 2018 Dec 1;79(4):519-526.
doi: 10.1097/QAI.0000000000001844.

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

Elizabeth C George  1 , Raffaella Bucciardini  2 , Laura Richert  3 , Nikos Dedes  4 , Vincenzo Fragola  2 , Pythia Nieuwkerk  5 , Bruno Spire  6 , Alain Volny-Anne  4 , Brian West  4 , Jean-Michel Molina  7   8 , Andrzej Horban  9 , Julie Fox  10 , Anton Pozniak  11 , Stefano Vella  2 , Monique Termote  3 , François Raffi  12 ; NEAT 001/ANRS 143 Study Group
Affiliations
Randomized Controlled Trial

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

Elizabeth C George et al. J Acquir Immune Defic Syndr. .

Abstract

Background: 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: -1.7 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 -0.1 (95% CI: -1.3 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 twice-daily administration.

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Conflict of interest statement

Competing interests

FR has received research funding or honoraria from, or consulted for, Abbvie, Bristol-Myers Squibb, Gilead Sciences, Janssen, MSD, and ViiV Healthcare. BS has received honorarium fees from Gilead, MSD and Jansen-Cilag. AP has received research funding and honoraria from Merck, Janssen, Gilead and Viiv. J-MM has sat on advisory boards for Gilead, Merck, Janssen, Viiv BMS and Teva and received research funding from Gilead. ND has received financial support and been a board member of Gilead, Merck and Janssen. ECG, RB, PN, MT, SV, AV-A, VF, BW, JF, BW, AH and LR declare no competing interests.

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