STUDY DESIGN

EVOTAZ (atazanavir and cobicistat): THE ONLY COBICISTAT-BOOSTED PI WITH
COMPARATIVE PHASE III CLINICAL DATA1,2

Study 114 is a randomized, double-blind, Phase III clinical trial (N=692)

study design
  • Study 114 is a randomized, double-blind, Phase III clinical trial (N=692) that evaluated the efficacy and safety of REYATAZ 300 mg once-daily coadministered with either cobicistat 150 mg (n=344) or ritonavir 100 mg (n=348) in combination with emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg once-daily in treatment-naive adults.1
  • Patients had a baseline estimated CrCL >70 mL/min, a mean baseline plasma HIV-1 RNA of 4.8 log10 copies/mL, and a mean baseline CD4+ cell count of 352 cells/mm3.1

Patient characteristics

chart of study design - patient characteristics. chart of study design - patient characteristics.

Data are No. (%) of patients or mean value ± SD, unless otherwise indicated.

aIncludes American Indian or Alaska Native, Native Hawaiian or Pacific Islander, unknown, or other.
bCalculated as the weight in kilograms divided by the height in meters squared.
cHepatitis B virus surface antigen.

Patients at baseline1

  • 40% had a viral load >100,000 copies/mL
    • Mean plasma HIV-1 RNA was 4.8 log10 copies/mL (range: 3.2-6.4)
  • 17% had CD4+ cell counts ≤200 cells/mm3
    • Mean CD4+ cell count was 352 cells/mm3 (range: 1-1455)

ATV=atazanavir; COBI=cobicistat; eGFR=estimated glomerular filtration rate; FTC=emtricitabine; RTV=ritonavir; TDF=tenofovir disoproxil fumarate.