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)
Primary objective1
- Safety and tolerability of Once-Daily DRV/COBI + 2 NRTIs through 24 weeks of treatment
Secondary objectives1
- 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
- Pharmacokinetics/pharmacodynamics
Baseline Patient Demographics
and Disease Characteristics1
All patients
n=313
| Demographics | ||||
|---|---|---|---|---|
| Age (years) | ||||
| Median | 35 | |||
| Range | 18-72 | |||
| Sex | ||||
| Male | 89.1% | |||
| Female | 10.9% | |||
| Race/Ethnicity | ||||
| White | 59.7% | |||
| Black | 34.5% | |||
| Hispanic | 21.7% | |||
| Asian | 1.3% | |||
| Baseline disease characteristics | ||||
|
Mean plasma viral load (log10 copies/mL) |
4.8 | |||
|
Median CD4+ (cell count cells/mm3) |
361.0 | |||
|
Patients with viral load >100,000 copies/mL |
41.9% | |||
|
Patients with CD4+ cell count <200 cells/mm3 |
18.8% | |||
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.