HIV: switch from DRV/r to DRV/cobicistat retains efficacy

  • Mena Á & al.
  • HIV Clin Trials
  • 3 Jan 2019

  • curated by Liz Scherer
  • Clinical Essentials
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Takeaway

  • Switching HIV-infected patients on mono or dual therapy (plus lamivudine [3TC]) from a darunavir/ritonavir (DRV/r)- to darunavir/cobicistat (DRV/c)-based regimen maintains viral suppression (VS).

Why this matters

  • A DRV/c mono- or dual-based therapy plus 3TC is an effective, simplified switch regimen for virally suppressed, HIV-infected patients and may help boost adherence, convenience.
    • DRV/c is not recommended for patients with cobicistat intolerance, or in pregnant women.

Key results

  • 162 patients.
  • Intent-to-treat efficacy, on-treatment efficacy at week 48 were 95.1% (95% CI, 90.65%-97.5%), 98.7% (95% CI, 95.5%-99.6%), respectively.
  • 8 DRV/c-based mono or dual therapy discontinuations, 2 viral failures:
    • Patient 1: HIV-RNA was 10,600 copies/mL at week 24; patient withdrew, restarted DRV/c mono therapy plus 2 nucleoside reverse transcriptase inhibitors (NRTIs).
    • Patient 2: HIV-RNA load of 320 copies/mL at week 12 detectable 10 days later (198 copies/mL); 2 NRTIs introduced with undetectable viral load.
  • No severe clinical/laboratory adverse events (AEs) observed.

Study design

  • Observational, prospective, multicenter cohort evaluating efficacy of switching DRV/r-based mono or dual (plus 3TC) to a DRV/c-based therapy while maintaining the previous regimen in HIV-infected patients.
  • Funding: Fondo de Investigación Sanitaria, Fundación Profesor Novoa Santos, A. Carûna.

Limitations

  • Noncomparative.
  • Underpowered to detect uncommon AEs.
  • No pharmacokinetic data.