Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined with Either Raltegravir or Tenofovir Disoproxil Fumarate /Emtricitabine in the Neat 001/Anrs 143 Trial

Journal of Acquired Immune Deficiency Syndromes : JAIDS
Adriana Ammassariand the NEAT 001/ANRS 143 Trial Study Group

Abstract

The NEAT 001/ANRS 143 trial demonstrated non-inferiority of darunavir-ritonavir combined with either raltegravir (RAL+DRV/r) or tenofovir disoproxil fumarate/emtricitabine (TDF/FTC+DRV/r) in HIV-positive, antiretroviral-naive adults. In post-hoc analyses however, RAL+DRV/r showed inferiority in patients with baseline CD4+ <200/mm and HIV-1 RNA ≥100,000 copies/mL. This pre-planned ancillary study was conducted to assess whether differences in adherence might explain efficacy results SETTING:: Phase III, open-label, randomized, multicentre study in 15 European countries (ClinicalTrials.gov, NCT01066962). 774 participants self-reported adherence (modified ACTG questionnaire) over 96 weeks (383 RAL+DRV/r [BID; 5 pills/daily], 391 TDF/FTC+DRV/r [QD; 4 pills/daily]. Primary endpoint was >95% versus <95% adherence to prescribed doses recorded a) over the last 4 days, or b) on the visual analogue scale (VAS) over the last 30 days RESULTS:: Characteristics, except age, were similar between arms; 9% had CD4+ <200 cells/mm and HIV-1 RNA ≥100,000 copies/mL. Adherence >95% in the last 4 days (p=0.029) or at VAS (p=0.0072) was higher with TDF/FTC+DRV/r than with RAL+DRV/r. Adherence >95% over the last 4 days was associated with lower probabi...Continue Reading

References

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