Jivi vs. Eloctate - PK Comparison

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Jivi® rFVIII levels remain elevated and sustained over time

  • The pharmacokinetics (PK) of Jivi® were investigated in 29 severe hemophilia A patients (≥12 years of age) following a single 60 IU/kg dose
  • Pharmacokinetics is the activity of drugs in the body over a period of time

PK was primarily measured by*

  • Clearance—the speed at which a drug is removed from the body
  • Area under the curve—the total amount of a drug that reaches the bloodstream, measured by plasma concentration, over time
  • Half-life—the amount of time that it takes for the concentration of a drug to be reduced by half; used to determine how long a drug remains active in the body

Jivi® is a PEGylated rFVIII with an extended half-life§ of 17.9 hours

Half-life of 17.9 hours
  • IU, international units; kg, kilograms; PEG, polyethylene glycol; rFVIII, recombinant Factor VIII.
  • Other PK parameters measured were maximum drug concentration in plasma after a single dose, mean residence time after an IV administration, and apparent volume of distribution at steady state.
  • Clearance measured 1.63 mL/h/kg.
  • Area under the curve measured 4060 IU*h/dL.
  • Half-life is defined as the time it takes for the amount of a drug in the blood to decrease by one half.
  • †With a single, 60 IU/kg dose.

Jivi® vs Eloctate® PK comparison

  • Jivi® and Eloctate® compared PK parameters in a crossover study of 18 male patients aged 18-65 with severe hemophilia A. Patients were each given a single dose of either Jivi® or Eloctate®, then halfway through the study, following a washout, patients switched to a single dose of the other treatment
  • One patient with preexisting anti-PEG antibodies had significantly different PK results. This patient was determined to be an outlier. Including this outlier patient in the analysis (N=18), there were no PK differences observed. The outlier patient was excluded from further analysis

Jivi® vs Eloctate® PK Comparison

In the 17 patients (excluding the outlier), there were 3 statistically significant PK differences:

Compared with Eloctate®

  • Jivi® gave patients a HIGHER AMOUNT of medication available for clotting over time*
  • Jivi® REMAINED LONGER in the body
  • Jivi® had a LONGER HALF-LIFE

Jivi® demonstrated more time before reaching minimum FVIII levels

Jivi® median time to minimum FVIII levels (compared to Eloctate®) in a population PK analysis (excluding the outlier patient, N=17)§

Horizontal bar chart illustrating time before reaching minimum FVIII levels. The minimum FVIII levels is the factor concentration just above any level that may raise the risk of bleeds. All patients have a different minimum factor level that meets their needs. Ask your doctor which FVIII level is right for you.
  • PK, pharmacokinetics; FVIII, factor VIII.
  • Jivi® had a higher mean area under the curve (+25%).
  • Jivi® had lower mean clearance (-20%).
  • Jivi® had a longer mean half-life (+7%).
  • 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, and 10% FVIII.

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

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For N=18 patients, including the PK outlier patient, Jivi® demonstrated noninferiority to Eloctate® for AUC(0-tlast)*

Ask your doctor if Jivi®
is right for you.
  • PK, pharmacokinetics; FVIII, factor VIII.
  • Jivi® had a higher mean area under the curve (+25%).
  • Jivi® had lower mean clearance (-20%).
  • Jivi® had a longer mean half-life (+7%).
  • 10%: 63 hours on Jivi® vs 52 hours on Eloctate®; 5%: 79 hours on Jivi® vs 67 hours on Eloctate®; 3%: 91 hours on Jivi® vs 79 hours on Eloctate®; 1%: 117 hours on Jivi® vs 104 hours on Eloctate®.

  • PK, pharmacokinetics.