Patient-Reported Outcomes in First-Line Antiretroviral Therapy: Results
From NEAT001/ANRS143 Trial Comparing Darunavir/Ritonavir in Combination
With Tenofovir/Emtricitabine or Raltegravir
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.Generalestimatingequationswereusedtomodelchangeover96weeksinPROsfrombaseline.Results:Ofthe805participants,797(99substudy.BaselinePROdataweresimilarforthe2randomizedgroups.HealthstatusimprovedovertimewithameanincreaseinEQ−5Dvisualanaloguescale(VAS)of8.0byW96[95to9.4;P,0.001],andnostatisticallysignificantdifferencesbetweengroups(differenceof0.3onVASscore(95globalPvalue 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