Click to expand section.

Crossover study examining PK characteristics of Jivi® and Eloctate® (N=18)1*

  • AUC, area under the curve (from time zero to last data point); PK, pharmacokinetic.
  • Adapted from Shah et al.
  • Area under the curve is the total amount of a drug that reaches the bloodstream, measured by plasma concentration, over time.2

Jivi® AUC compared to Eloctate® in 18 patients

  • The pre-specified criteria for non-inferiority of Jivi® vs Eloctate® were met
  • Superiority criteria of the Jivi®:Eloctate® ratio were not met (95% CI 0.84–1.46; P=0.46)
  • PEG, polyethylene glycol.
  • Adapted from Shah et al.1

Comparative PK results for Jivi® vs Eloctate®1

  • AUC, area under the curve (from time zero to last data point); CI, confidence interval; PK, pharmacokinetic.
  • Excluding outlier patient, who had anti-PEG antibodies.1
  • Area under the curve is the total amount of a drug that reaches the bloodstream, measured by plasma concentration over time.2
  • Clearance is the time it takes for a drug to be completely eliminated from the body.3
  • Half-life is the time it takes for the amount of a drug in the blood to decrease by one half.4
  • Geometric least squares.1
  • Actual 95% confidence interval is 1.0026 – 1.1516.5

Median time to target FVIII threshold levels with Jivi® vs Eloctate®1

Estimated from a population PK model (excluding outlier, N=17)1*

  • PK, pharmacokinetic.
  • Adapted from Shah et al. A population PK model was developed based on data obtained by a one-stage assay to simulate time to reach FVIII thresholds of 1, 3, 5, 10% FVIII.1

Compared with Eloctate®, Jivi® demonstrated statistically significantly (N=17)*:

  • AUC, area under the curve.
  • Excluding outlier patient, who had anti-PEG antibodies.1
  • Area under the curve is the total amount of a drug that reaches the bloodstream, measured by plasma concentration over time.2
  • Clearance is the time it takes for a drug to be completely eliminated from the body.3
  • Half-life is the time it takes for the amount of a drug in the blood to decrease by one half.4