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


  • Cristina Ferrario — Agenzia Zoe
  • Conference Reports
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Takeaway

  • 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.

Limitations

  • 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.