Phase 3, randomized, double-blind, active-controlled, international, multicenter, noninferiority study1,2
Key endpoint: Proportion of patients with VL <50 copies/mL at 48 weeks (noninferiority margin 10% by FDA Snapshot)
*Randomization was stratified by VL and CD4+.
High rates of efficacy at Week 48 (FDA snapshot)
- 4% virologic failure rate (≥50 copies/mL) in the SYMTUZA™ arm vs 3% in the control arm‡1,2
- 4% of patients in the SYMTUZA™ arm had no virologic data vs 8% in the control arm1,2
†Based on a stratum adjusted MH test where stratification factors are HIV-1 RNA level (≤100,000 or >100,000 copies/mL) and CD4+ cell count (<200 or ≥200 cells/µL).
‡Included subjects who had VL ≥50 copies/mL in the Week 48 window (Days 295-378); subjects who discontinued early due to lack or loss of efficacy; subjects who discontinued for reasons other than an adverse event, death, or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥50 copies/mL.
CD4+=cluster of differentiation 4; DRV/c=darunavir/cobicistat; FTC=emtricitabine; MH=Mantel-Haenszel; TDF=tenofovir disoproxil fumarate; VL=viral load.
References: 1. SYMTUZA™ [package insert]. Titusville, NJ: Janssen Therapeutics, Division of Janssen Products, LP. 2. Eron JJ, Orkin C, Gallant J, et al. A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve HIV-1 patients. AIDS. 2018;32:1431-1442.