Switch studies

Switch studies in virologically suppressed patients

GS-US-292-0119

Table of contents

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 C_trough >10-fold above IC 95 (45 ng /mL)

DRV C_trough>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

Back to Table of Contents