Switch studies in virologically suppressed patients

Switch to E/C/F/TAF + DRV/r
GS-US-292-0119 Study
Original article : Huhn GD, JAIDS 2017; 74:193.200
Dernière mise à jour : 17/01/2017

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • Simplifying therapy from ~5 pills/day to once-daily, 2-pill E/C/F/TAF + DRV
    • Provided efficacious plasma exposures of EVG, DRV, and TAF
    • Maintained virologic suppression through Week 24
    • Was superior to staying on baseline regimen at Week 48 at both < 50 and < 20 c/mL
  • Switch to TAF improved proximal tubular proteinuria without change in eGFR
  • E/C/F/TAF + DRV was safe, well tolerated, and associated with greater treatment satisfaction
  • For treatment-experienced individuals with ≥ 2 class resistance on complex, high-pill burden regimens, switching to E/C/F/TAF
    + DRV provides a simple, once-daily, two-pill option with superior efficacy and comparable tolerability

Design

Objective

  • Primary Endpoint: proportion with treatment success (HIV RNA < 50 c/mL) at W24, ITT, FDA snapshot: non-inferiority of E/C/F/TAF with a lower margin of 12%, by 2-sided 95% CI

Baseline characteristics and disposition at W48

Pharmacokinetic substudy Results (N = 15)

  • Once-daily dosing of E/C/F/TAF (150/150/200/10 mg) + DRV 800 mg
    • EVG Ctrough >10-fold above IC 95 (45 ng /mL)
    • DRV Ctrough>22-fold above EC 50 (55 ng /mL)
    • TAF exposures in efficacious range demonstrated in pivotal Phase 3 studies
    • COBI exposure associated with robust boosting
    • TFV exposure (mean [%CV] AUC 367 [33] ng *h/mL) well below levels observed following TDF-containing regimens

Efficacy and Safety Results


* 91% if prior DRV/r dose 800 QD vs 100% if prior DRV/r dose 600/100 BID

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