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

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Abstract

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.

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