Why Jivi?
EHL FVIIIs are NOT the same – the difference is Jivi
See how Jivi can help your patients get more out of life
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* Please refer to local prescribing information. Not all patients are candidates for 1x weekly dosing. In non-EU countries other FVIII treatments may be available which also offer 1x weekly dosing.
† During the last 12 months of the extension.2
‡ At extension completion, patients received Jivi for a median (range) total time of 3.9 (0.8–7.0) years with 223 (23–698) exposure days
§ Based on head to head studies comparing the pharmacokinetic profiles of Jivi vs rFVIIIFc (n=18) and Jivi vs rurioctocog alfa pegol (n=18)
Powerful protection from bleeds with fewer infusions2*
ABR reduction demonstrated across 7-year extension study2*
* At extension completion, patients received Jivi for a median (range) total time of 3.9 (0.8–7.0) years with 223 (23–698) exposure days.
† n=82 (this includes 3 patients who switched to prophylaxis at the start of the extension from on-demand regimen in the pre- and main study).
ABR, annualized bleed rate.
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Up to 7 years of proven joint protection2*
Median total joint ABR halved after switching to Jivi from other FVIII prophylaxis treatments2*†
* At extension completion, patients received Jivi for a median (range) total time of 3.9 (0.8–7.0) years with 223 (23–698) exposure days.
† n=82 (this includes 3 patients who switched to prophylaxis at the start of the extension from on-demand regimen in the pre- and main study).
ABR, annualized bleed rate.
* Numbers of historic target joints were recorded at study entry (as judged by the investigator), new target joints that developed on study (ISTH definition: ≥3 spontaneous bleeds within 6 months) and resolved target joints (ISTH definition: a recorded target joint with ≤2 spontaneous bleeds during last 12 months) were analysed in patients known to have received prophylaxis before study entry and who continued on prophylaxis into the extension.6 The majority of patients (72%) continuing on prophylaxis into the extension had target joints at baseline2
† 122 target joints (113 historic and 9 new) were recorded in 62 patients, 111 of which were resolved.6
ISTH, International Society on Thrombosis and Haemostasis.
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Study design: Phase 1, open-label, crossover study to directly compare the AUC (primary endpoint) of two EHL therapies in patients with hemophilia A aged 18–65.4
PK outlier: One patient with pre-existing anti-PEG antibodies had significantly reduced AUC. This subject was determined to be an outlier and was excluded from further PK analyses.4
* AUC last defined as AUC from time 0 to last data point.4
† Based on head-to-head studies comparing the pharmacokinetic profiles of Jivi vs. rFVIII-Fc and Jivi vs. rurioctocog alfa pegol
AUC, area under the curve (from time zero to last data point); CI, confidence interval; Fc, fragment crystallizable region of human immunoglobin G; PK, pharmacokinetic.
* The 50 IU/kg doses administered in this study were calculated based on the nominal potencies (1000 IU) as provided on the label of the vials. This differed from that of the actual potencies, being 1030 IU/vial for damoctocog alfa pegol and 1141 IU/vial for rurioctocog alfa pegol. This resulted in actual administered doses of approximately 3% and 14.1% higher than the planned 50 IU/kg doses for damoctocog alfa pegol and rurioctocog alfa pegol, respectively. In the analysis of PK parameters, the dose based on actual potency of the two products was compared
† Geometric least square mean AUC, area under the curve; PK, pharmacokinetic
* Adapted from Shah et al. 2019. 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; excluding outlier, n=174
† Median time to threshold.4
‡ The values given here are developed from a PK pop model. Benefit gained from a longer time to threshold is not based on clinical experience.
§ Based on head-to-head studies comparing the pharmacokinetic profiles of Jivi vs. rFVIII-Fc and Jivi vs. rurioctocog alfa pegol
Fc, fragment crystallizable region of human immunoglobin G; PK, pharmacokinetic.
* The 50 IU/kg doses administered in this study were calculated based on the nominal potencies (1000 IU) as provided on the label of the vials. This differed from that of the actual potencies, being 1030 IU/vial for damoctocog alfa pegol and 1141 IU/vial for rurioctocog alfa pegol. This resulted in actual administered doses of approximately 3% and 14.1% higher than the planned 50 IU/kg doses for damoctocog alfa pegol and rurioctocog alfa pegol, respectively. In the analysis of PK parameters, the dose based on actual potency of the two products was compared.
† The values given here are estimated from a popPK model based on data obtained by a one-stage assay to simulate time to reach FVIII thresholds of 1, 3, 5, and 10% FVIII. Benefits gained from a longer time to threshold is not based on clinical experience. AUC, area under the curve (from time zero to last data point); PK, pharmacokinetic; popPK, population PK.
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References
- Jivi Summary of Product Characteristics Return to content
- Reding MT et al. Haemophilia 2021; 00: 1–10. Return to content
- Reding MT et al. J Thromb Haemost 2017; 15: 1147-1156 Return to content
- Shah A et al. Ann Hematol 2019; 98(9): 2035-2044. Return to content
- Lalezari S et al. Haemophilia. 2019; 25: 1011-1019 Return to content
- Reding MT et al. Haemophilia 2020;26:e201–e204. Return to content
- Solms A, et al. Ann Hematol 2020; 99, 2689–2698 Return to content
- Berntorp E et al. Blood Rev; 2021: https://doi.org/10.1016/j.blre.2021.100852 (epub ahead of print). Return to content
- Martin AP et al. Haemophilia. 2020; 26(4): 711-717. Return to content
- National Hemophilia Foundation. Playing it safe: Bleeding disorders, sports and exercise. Available from https://www.hemophilia.org/sites/default/files/document/files/playing-it-safe_0.pdf (accessed May 2021). Return to content
