Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial
Por:
Ammassari, A, Stohr, W, Antinori, A, Molina, JM, Schwimmer, C, Domingo, P, Thalme, A, Di Pietro, M, Wallet, C, Pozniak, A, Richert, L, Raffi, F, NEAT001 ANRS143 Trial Study Grp
Publicada:
1 dic 2018
Resumen:
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.
Filiaciones:
Ammassari, A:
INMI L Spallanzani IRCCS, HIV AIDS Unit, I-00149 Rome, Italy
Stohr, W:
UCL, MRC, Clin Trials Unit, London, England
Antinori, A:
INMI L Spallanzani IRCCS, HIV AIDS Unit, I-00149 Rome, Italy
Molina, JM:
Univ Paris Diderot, Hop St Louis, Dept Infect Dis, INSERM,U941, Paris, France
Schwimmer, C:
Univ Bordeaux, Bordeaux Populat Hlth Res Ctr, INSERM, UMR 1219, Bordeaux, France
Domingo, P:
Hosp Santa Creu & St Paul, Infect Dis Unit, Barcelona, Spain
Thalme, A:
Karolinska Univ Hosp, Dept Infect Dis, Stockholm, Sweden
Di Pietro, M:
S Maria Annunziata Hosp, Infect Dis Unit, Florence, Italy
Wallet, C:
Univ Bordeaux, Bordeaux Populat Hlth Res Ctr, INSERM, UMR 1219, Bordeaux, France
Pozniak, A:
Chelsea & Westminster NHS Trust St Stephens Ctr, London, England
Richert, L:
Univ Bordeaux, Bordeaux Populat Hlth Res Ctr, INSERM, UMR 1219, Bordeaux, France
Raffi, F:
CHU, Infect & Trop Dis Dept, INSERM, CIC 1413, Nantes, France
Green Published
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