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
Powerful long-term protection across all prophylaxis regimens1,3,5
Low ABR maintained through a >5-year extension study3,5
* Data assessed over median duration of 166 weeks.2
† High-bleeding phenotype patients defined as: 2 or more bleeds (joint or muscle and no identified trauma) during the first 10 weeks of low-dose (25 IU/kg) Jivi 2x weekly.3
‡ Patients who remained on the same infusion regimen during weeks 11-36 of the main study in PROTECT VIII.3
§ Low-bleeding phenotype patients defined as: 0 or 1 bleed (joint or muscle and no identified trauma) during the first 10 weeks of low-dose (25 IU/kg) Jivi 2x weekly.3
¶ Patients eligible but not randomized because the randomization arms were full.3
** High and low-bleeding phenotypes were not separated in the 2x weekly extension study, therefore the change in ABR was not differentiated in the analysis.3
ABR, annualized bleed rate; Q1, quartile 1; Q3, quartile 3.
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Over 5 years of proven joint bleed protection2,5*
Low median joint ABR in main study continued to improve over time†
* Data shown is median (Q1; Q3) joint ABR. Data assessed over median duration of 166 weeks in extension study (data cut-off August 2017).2 Median study duration: 3.9 years.2
† Results demonstrate ABR improvements across all prophylaxis groups.2 High and low bleed phenotypes were not separated in the 2x weekly extension study, therefore the change in joint ABR was not differentiated in the analysis.2
ABR, annualized bleed rate; Q1, quartile 1; Q3, quartile 3.
Joint protection that lasts3
* 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.3 The majority of patients (72%) continuing on prophylaxis into the extension had target joints at baseline3
† 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
- Lalezari S et al. Haemophilia. 2019; 25: 1011- 1019 Return to content
- Reding MT et al. J Thromb Haemost 2017; 15: 411- 419. Return to content
- Shah A et al. Ann Hematol 2019; 98(9): 2035-2044. Return to content
- Paik J and Deeks ED. Adis Drug Evaluation. Drugs 2019; 79(10): 1147-115. 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
