Background: The QD STR D/C/F/TAF 800/150/200/10mg was non-inferior to bPI + F/TDF at 48 weeks in EMERALD. Efficacy and safety of D/C/F/TAF through wk 96 is presented.
Methods: EMERALD (NCT02269917) is a randomized, active controlled, open label, international, multicenter noninferiority trial. Virologically suppressed (VL<50c/mL for ≥2 mths) ART experienced (previous non-DRV VF allowed) HIV-1 infected adults were randomized (2:1) to switch to D/C/F/TAF or continue bPI + F/TDF over 48 wks. Patients could then continue on D/C/F/TAF or switch from bPI + F/TDF to D/C/F/TAF at wk 52 (Late switch, 44 wks D/C/F/TAF exposure) in a single arm extension phase until wk 96. The % of patients with virologic rebound (confirmed VL≥50c/mL) cumulative through wk 48 and wk 96 were primary and secondary endpoints, respectively.
Results: Of 1141 randomized and
treated patients (58%
had received ≥5 previous ARVs including
15% had previous non-DRV VF), 1080 continued in the extension phase (N=728 D/C/F/TAF;
N=352 late switch). Few patients had virologic rebound
cumulative through wk 96 in the D/C/F/TAF arm (3.1%, 24/763). Virologic rebound
occurred in 2.3% (8/352) in the late switch arm over 44 weeks D/C/F/TAF
treatment. Many rebounders (14/24 and 2/8) resuppressed by wk 96. At wk
96 a high % of patients in the D/C/F/TAF arm (90.7%, 692/763) were suppressed
(VL<50c/mL). In the late switch arm 93.8% (330/352) maintained virologic
suppression after 44 weeks of treatment. No DRV, primary PI, TFV or FTC RAMs
were seen post baseline. Few serious AEs and AE related discontinuations
occurred in either arm (Table 1). Improvements in renal and bone parameters
were maintained in the D/C/F/TAF arm and seen in the late switch arm (wk 5296), with a small change in TC/HDL-C ratio (Table 1).
Conclusion: Switching to D/C/F/TAF maintained high virologic suppression rates (>90%) at wk 96 with no resistance development, and was well tolerated over 96 wks with bone, renal and lipid safety consistent with known TAF and cobicistat profiles. Efficacy and safety results in the late switch arm were consistent with wk 48 results in the D/C/F/TAF arm. D/C/F/TAF combines the efficacy and high genetic barrier to resistance of DRV with the safety benefits of TAF, even in patients with a history of non-DRV VF.
J. Eron Jr.,
D. Cunningham, Janssen: Investigator , Research grant . Gilead: Investigator , Research grant .
F. Pulido, Janssen: Consultant , Investigator and Scientific Advisor , Consulting fee , Research support and Speaker honorarium .
F. Post, Gilead: Consultant and Grant Investigator , Consulting fee and Grant recipient . Viiv: Grant Investigator , Grant recipient . Janssen: Consultant , Consulting fee . MSD: Consultant , Consulting fee .
S. De Wit, Janssen: Investigator , Research grant .
E. Lathouwers, Janssen: Employee and Shareholder , Salary .
V. Hufkens, Janssen: Employee and Shareholder , Salary .
R. Petrovic, Janssen R&D: Independent Contractor , Consulting fee .
E. Van Landuyt, Janssen: Employee and Shareholder , Salary .