Phase 3, randomized, open-label, international, multicenter, noninferiority study of switching virologically suppressed adults to SYMTUZA™1,2
- Proportion of patients with virologic rebound at Week 48 (noninferiority margin 4%)2
- Proportion of subjects who have VL <50 copies/mL at 48 weeks (FDA Snapshot)2
*bPI at screening, darunavir + cobicistat or ritonavir, atazanavir + cobicistat or ritonavir, or lopinavir + ritonavir.
†Except no history of VF on darunavir-based regimens, and if historical genotypes were available, absence of darunavir resistance-associated mutations.
‡At least one plasma HIV-1 RNA measurement VL <50 copies/mL occurring within 2-12 months prior to the screening visit while on the stable ARV regimen and had HIV-1 RNA <50 copies /mL at the
§Randomization was stratified by bPI used at screening.
High rates of virologic response maintained at Week 481,2
1% virologic failure rate in the SYMTUZA™ arm vs 1% in the control arm1,2¶
- There were no discontinuations for efficacy reasons2
- 4% of patients in the SYMTUZA™ arm had no virologic data vs 6% in the control arm1,2
#Based on MH test adjusting for bPI at screening (ATV with RTV or COBI, DRV with RTV or COBI, LPV with RTV).
¶Included subjects who had ≥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 ≥50 copies/mL.
ARV=antiretroviral; ATV=atazanavir; bPI=boosted protease inhibitor; COBI=cobicistat; DRV=darunavir; FTC=emtricitabine; LPV=lopinavir; MH=Mantel-Haenszel; RTV=ritonavir; TDF=tenofovir disoproxil fumarate; VF=virologic failure; VL=viral load.
References: 1. SYMTUZATM [package insert]. Titusville, NJ: Janssen Therapeutics, Division of Janssen Products, LP. 2. Orkin C, Molina JM, Negredo E, et al. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018;5(1):e23-e34. 3. Data on file. Janssen Therapeutics, Division of Janssen Products, LP.