PREZCOBIX® SAFETY STUDY 130
An open-label, single-arm, 48-week, Phase 3 clinical trial evaluating the safety and efficacy of Once-Daily DRV 800 mg (2 x 400 mg) + COBI 150 mg in HIV-1–infected treatment-naïve adults (n=295) and treatment-experienced adults (n=18) with HIV-1 RNA ≥1000 copies/mL and no darunavir resistance-associated mutations (DRV RAMs). All patients received an investigator-selected optimized background regimen (OBR) consisting of 2 NRTIs chosen based upon resistance testing (if M184V/I mutation present, may add 3TC or FTC)
- Safety and tolerability of Once-Daily DRV/COBI + 2 NRTIs through 24 weeks of treatment
- Safety and tolerability of the regimen through 48 weeks of treatment
- Virologic response (HIV-1 RNA <50 copies/mL) at Weeks 24 and 48 of treatment
- Change from baseline in CD4+ cell counts at Weeks 24 and 48
Baseline Patient Demographics
and Disease Characteristics1
|Baseline disease characteristics|
Mean plasma viral load
(cell count cells/mm3)
Patients with viral load
Patients with CD4+
cell count <200 cells/mm3
3TC=lamivudine; COBI=cobicistat; DRV=darunavir; FTC=emtricitabine; NRTI=nucleoside reverse transcriptase inhibitor; OBR=optimized background regimen.
Reference: 1. Data on file. Janssen Therapeutics, Division of Janssen Products, LP.