Skip to content

ARTEMIS STUDY

  • A randomized, controlled, open-label, 192-week, Phase 3, noninferiority clinical trial comparing darunavir 800 mg (two 400-mg tablets) coadministered with ritonavir 100 mg once daily (n=343) vs LPV/r 800/200 mg/day (n=346) in treatment-naïve adult patients with HIV-1 RNA ≥5000 copies/mL
  • All patients also received a fixed-dose combination of tenofovir disoproxil fumarate (TDF) 300 mg + emtricitabine (FTC) 200 mg once daily
  • Randomization was stratified by screening plasma viral load (<100,000 copies/mL or ≥100,000 copies/mL) and screening CD4+ cell count (<200 cells/mm3 or ≥200 cells/mm3)1

Primary objective1

  • Demonstrate noninferiority in virologic response (<50 copies/mL, ITT-TLOVR) of DRV/r 800/100 mg + TDF/FTC vs LPV/r 400/100 mg twice daily or 800/200 mg/day + TDF/FTC over 48 weeks
    • Noninferiority was determined using a 12% margin (delta): The lower limit of the 95% confidence interval of the difference in virologic response between the treatment groups could not cross -12%

Secondary objectives1

  • Durability of virologic response over 192 weeks
  • Superiority in virologic response in the event of noninferiority being confirmed

Baseline Patient Demographics and Disease Characteristics1

         Once-Daily
DRV/r 800/100 mg
+ TDF/FTC (n=343) 		LPV/r
800/200 mg/day
+ TDF/FTC (n=346)
Demographics
Median age (years) 34 33
Gender
  Male 70% 70%
  Female 30% 30%
Race/Ethnicity
  White 40% 45%
  Black 23% 21%
  Hispanic 23% 22%
  Asian 13% 11%
Baseline disease characteristics
  Mean plasma viral load (log10 copies/mL) 4.86 4.84
  Median CD4+ cell count (cells/mm3) 228 218
  Patients with viral load ≥ 100,000   copies/mL  34% 35%
  Patients with CD4+ cell count <200   cells/mm3 41% 43%

DRV/r=darunavir coadministered with ritonavir; ITT-TLOVR=intent-to-treat, time-to-loss of virologic response; LPV/r=lopinavir/ritonavir; TDF/FTC= tenofovir disoproxil fumarate/emtricitabine.

Reference: 1. Data on file. Janssen Therapeutics, Division of Janssen Products, LP.