EACS 2019 – Long-term follow up after antiretroviral therapy initiation without nucleotide reverse transcriptase inhibitor

  • Cristina Ferrario — Agenzia Zoe
  • Conference Reports
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.


  • At 5-year follow-up, a quarter of patients were still receiving the original antiretroviral therapy (ART).
  • Reasons for discontinuation were most often unrelated to adverse events (AE) or virological failure.

Why this matters?

  • Few long-term data are available on patients having initiated ART with a nucleotide reverse transcriptase inhibitor (NtRTI)-sparing regimen.

Study design

  • NEAT001/ANRS143: randomised controlled trial (RCT), 15 countries, 78 sites, 96-weeks follow-up, comparing darunavir/ritonavir+raltegravir (DRV/r+RAL) vs DRV/r+tenofovir/emtricitabine (TDF/FTC).
  • NEAT001 LONG TERM (NLT) study: n=430 (DRV/r+RAL: n=201; DRV/r+TDF/FTC: n=229), 8 countries, 39 sites, assessing the 5-year outcomes of NEAT001/ANRS143 patients.
  • Data retrospectively collected through anonymised electronic Case Report Forms (eCRF).

Key results

  • 5 years after enrolment, persistence of the initial therapy in a quarter of patients.
  • Prolonged use of DRV/r in half of the cohort.
  • To date, almost half of the participants in both groups are receiving boosted DRV.
  • Low rates of clinical and virologic (HIV RNA >50 c/mL) events between year 2 and 5.
  • At last follow-up: HIV RNA 95% of subjects.
  • Mean weight gain from baseline to last follow-up: 3.15 kg vs 4.08 kg in patients exposed >50% of follow-up to integrase strand transfer inhibitors (INSTI) vs never exposed to INSTI, respectively.
  • A higher increase in creatinine level observed in subjects exposed to TDF >50% of follow-up vs never exposed (9.94 vs 5.93 μmol/L).
  • Change in therapy most often due to need/wish for treatment optimisation than lack of efficacy or adverse events.


  • Retrospective collection of data.
  • Real-life situation in the second part of the follow-up (from week 96 to year 5) vs RCT in the first part.