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Switch to D/C/F/TAF
EMERALD Study
Reference : Orkin C. Lancet HIV. 2018 Jan;5(1):e23-e34.
Dernière mise à jour : 31/01/2018

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

• Through Week 24, switching from boosted PI + FTC/TDF to D/C/F/TAF resulted in:
  • Low virologic rebound rate cumulative (1.8%)
  • High virologic suppression rate (96.3%)
  • No discontinuations for VF
  • No resistance to any study drug
  • Few serious adverse events and discontinuations due to adverse events
• D/C/F/TAF bone, renal and lipid safety vs control were consistent with known profiles of TAF and cobicistat

Design

Primary endpoint

• Proportion of patients with virologic rebound at W48 ; non-inferiority if lower margin of a two-sided 95% CI for the adjusted difference = - 4%, 89% power
• Virologic rebound: confirmed HIV RNA ≥ 50 c/mL (or single HIV RNA > 50 c/mL at W48), or premature discontinuation, irrespective of reason, with last HIV RNA ≥ 50 c/mL through W48

Baseline characteristics and patient disposition

• 4 patients with virologic rebound genotyped: 1 in D/C/F/TAF (presence of D67D/N) and 3 in continuation group (E138E/G NNRTI mutation in 1)

Virologic rebound rate through W48 according to previous antiretroviral failure

Mean (SE) % change from baseline in bone mineral density (g/cm²)

Mean (SE) % change from baseline in bone biomarkers

Median lipid values

Mean Changes in eGFR (mL/min/1.73 m²) at W48

Adverse events between D0 and W48, %

* Worsening of pre-existing renal insufficiency ; ** Toxic nephropathy, N = 1 ; tubulopathy , N = 1

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