Patient Self-Reported Adherence To Ritonavir-Boosted Darunavir Combined With Either Raltegravir Or Tenofovir Disoproxil Fumarate/Emtricitabine In The Neat001/Anrs143 Trial

Background: The NEAT001/ANRS143 trial demonstrated noninferiority of ritonavir-boosted darunavir combined with either ral-tegravir (RAL + DRV/r) or tenofovir disoproxil fumarate/ emtricitabine (TDF/FTC + DRV/r) in HIV-positive, antiretroviralnaive adults. In post hoc analyses, however, RAL + DRV/r showed inferiority in patients with baseline CD4+,200/mm(3) and HIV-1 RNA $ 100,000 copies per milliliter. This preplanned ancillary study was conducted to assess whether differences in adherence might explain efficacy results.Setting: Phase III, open-label, randomized, multicenter study in 15 European countries (ClinicalTrials. gov, NCT01066962).Methods: Seven hundred seventy-four participants self-reported adherence (modified AIDS Clinical Trials Group questionnaire) over 96 weeks [383 RAL + DRV/r (twice daily; 5 pills/day), 391 TDF/FTC + DRV/r (once daily; 4 pills/day)]. Primary endpoint was $ 95% versus,95% adherence to prescribed doses recorded (1) over the last 4 days or (2) on the visual analogue scale over the last 30 days.Results: Characteristics, except age, were similar between arms; 9% had CD4+,200 cells/mm(3) and HIV-1 RNA $ 100,000 copies per milliliter. Adherence $ 95% in the last 4 days (P = 0.029) or at the visual analogue scale (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 probability of virological failure (P = 0.015). Adherence in patients with baseline CD4+,200 cells/mm(3) and HIV-1 RNA $ 100,000 copies per milliliter was similar to the rest of the population, and not significantly associated with efficacy measures, with no significant differences between arms.Conclusion: Adherence was high and slightly better in the TDF/ FTC + DRV/r than in the RAL + DRV/r arm. No convincing evidence was found that higher failure rate in the RAL + DRV/r arm in the subgroup with worse baseline viroimmunological status is caused by adherence differences.