Explore data below on Kogenate® FS patients who transitioned to Jivi as part of a clinical trial.
Study Design
112 patients entered prophylactic treatment arms. Two patients enrolled in the prophylactic arms left the main study prematurely during the run-in period. 110 patients completed a 10-week run-in period where they received 25 IU/kg twice weekly. They were then assigned or randomized to a treatment arm based on bleeding tendency. Among patients with low bleeding tendencies, 11 received 30-40 IU/kg twice weekly and 43 patients received 45-60 IU/kg every 5 days for 26 weeks. 13 patients with high bleeding tendencies received 30-40 IU/kg twice weekly for 26 weeks.3
Twice-weekly | Every 5 days | Combined3 | |||
Bleeding Tendency3 | LOW* (n=11) | HIGH† (n=13) | LOW* (n=43) | n=67 | |
Total ABR (weeks 10-36)3 | Median ABR (Q1;Q3)3 | 1.9 (0.0; 5.2) | 4.1 (2.0; 10.6) | 1.9 (0.0; 4.2) | 2.1 (0.0; 5.8) |
Mean (SD)3 | 2.2 (2.7) | 7.2‡ (7.5) | 3.3 (4.3) | 3.9 (5.1) | |
Jivi Median (Range) Prophylaxis Dose/Infusion, IU/kg3 | 30.6 (29-41) | 39.2 (33-42) | 45.3 (39-58) |
Twice-weekly | |||
Bleeding Tendency3 | LOW* (n=11) | HIGH† (n=13) | |
Total ABR (weeks 10-36)3 | Median ABR (Q1;Q3)3 | 1.9 (0.0; 5.2) | 4.1 (2.0; 10.6) |
Mean (SD)3 | 2.2 (2.7) | 7.2‡ (7.5) | |
Jivi Median (Range) Prophylaxis Dose/Infusion, IU/kg3 | 30.6 (29-41) | 39.2 (33-42) |
Every 5 days | |||
Bleeding Tendency3 | LOW* (n=43) | ||
Total ABR (weeks 10-36)3 | Median ABR (Q1;Q3)3 | 1.9 (0.0; 4.2) | |
Mean (SD)3 | 3.3 (4.3) | ||
Jivi Median (Range) Prophylaxis Dose/Infusion, IU/kg3 | 45.3 (39-58) |
Combined3 | |||
Bleeding Tendency3 | n=67 | ||
Total ABR (weeks 10-36)3 | Median ABR (Q1;Q3)3 | 2.1 (0.0; 5.8) | |
Mean (SD)3 | 3.9 (5.1) |
The median Jivi dose per infusion in the overall subject population of PROTECT VIII was within the approved dosing recommendation for the 2x/week arms (30–40 IU/kg) and every-5-day arm (45–60 IU/kg)3
0
inhibitors
in the completed study4
Factor VIII inhibitor (1.7 BU/mL) was reported in one previously treated adult subject. Repeat testing did not confirm the presence of a Factor VIII inhibitor.3
ABR, annualized bleed rate.
*Patients with 0 or 1 spontaneous bleed (defined as a joint or muscle bleed and no identified trauma) during weeks 1-10 of the main study.4
†Patients with 2 or more spontaneous bleeds (defined as joint or muscle bleeds and no identified trauma) during weeks 1-10 of the main study.4
‡n=9/13 of these patients were on prior prophylaxis and had a mean number total ABR of 17.4 before entering the main study.
21 Kogenate FS prophylaxis patients transitioned to Jivi as part of the Protect VIII clinical trial.8
Kogenate FS patients experienced fewer annual bleeds after transitioning to Jivi8*
Kogenate FS ABR prior to study enrollment* | Jivi ABR During Study | |||
---|---|---|---|---|
Median ABR (Q1;Q3)3 |
9 (1.0; 15.0) | 2.1 (0.0; 10.0) | ||
Mean (SD)3 | 10.5 (12.3) | 5.2 (7.2) | ||
Twice-weekly | Every 5 days | |||
Bleeding Tendency8 | LOW (n=3) | HIGH (n=4) | LOW (n=14) | |
Jivi Median (Range) Prophylaxis Dose/Infusion, IU/kg8 |
31.4 (29-33) | 41.2 (37-42) | 45.4 (41-54) |
Kogenate FS ABR prior to study enrollment* | |
---|---|
Median ABR (Q1;Q3)3 |
9 (1.0; 15.0) |
Mean (SD)3 | 10.5 (12.3) |
Jivi ABR During Study | |
---|---|
Median ABR (Q1;Q3)3 |
2.1 (0.0; 10.0) |
Mean (SD)3 | 5.2 (7.2) |
Twice-weekly | ||
---|---|---|
Bleeding Tendency8 | LOW (n=3) | HIGH (n=4) |
Jivi Median (Range) Prophylaxis Dose/Infusion, IU/kg8 |
31.4 (29-33) | 41.2 (37-42) |
---|
Every 5 Days | |
---|---|
Bleeding Tendency8 | LOW (n=14) |
Jivi Median (Range) Prophylaxis Dose/Infusion, IU/kg8 |
45.4 (41-54) |
---|
0
inhibitors
in the subgroup analysis of 21 previously treated patients8
ABR, annualized bleed rate.
*Self-reported bleeds in prior 12 months.6
For patients ≥12 years
|
|
---|---|
Start simply
TWICE WEEKLY
|
For all prophylaxis patients: Recommended starting regimen is Jivi twice weekly (30-40 IU/kg)3*
|
Step up
EVERY 5 DAYS
|
Based on bleeding episodes: Less frequent dosing of Jivi every 5 days (45-60 IU/kg) can be used3*
|
Fine tune
|
Based on bleeding episodes: The dosing frequency may be further adjusted up or down3
|
*100% of patients in the every-5-days and twice-weekly dosing arms remained on the same dosing regimen for the duration of the main study.3
Powerful protection from bleeds with a twice-weekly starting dose and, based on bleeding episodes, the potential to step up to every 5 days and fine tune3
A demonstrated safety profile in previously-treated asolescents and adults4,6
The potential for fewer infusions5:
*Self-reported bleeds in prior 12 months.8-10
The safety and efficacy of Jivi for on-demand treatment in adolescent and adult (12 to 65 years of age) previously treated patients (PTPs) was evaluated for 36 weeks.3,13
91.2%
of bleeds were treated
with ≤2 infusions13
79.5%
1 infusion13
11.7%
2 infusions13
8.8%
3+ infusions13
40.4% of total bleeds were trauma bleeds.13
0 inhibitors
in the main study analysis of 20 previously treated patients.13
One patient in the on-demand group (n=20) experienced mild drug-related adverse events (dry mouth, musculoskeletal discomfort).13
The on-demand arm in the Protect VIII clinical trial and the subgroup analysis both included patients with Hepatitis B, Hepatitis C, and HIV.14
10 Kogenate FS on-demand patients transitioned to Jivi on-demand as part of the clinical trial.13
90.6%
of bleeds were treated
with ≤2 infusions13
73.9%
1 infusion13
16.7%
2 infusions13
9.4%
3+ infusions13
36.0% of total bleeds were trauma bleeds.13
0 inhibitors
in the subgroup analysis of 10 previously treated patients.13
One patient in the on-demand subgroup (n=10) experienced mild drug-related adverse events (dry mouth, musculoskeletal discomfort).14
The on-demand arm in the Protect VIII clinical trial and the subgroup analysis both included patients with Hepatitis B, Hepatitis C, and HIV.14
For more information and data on patients who participated in the Jivi extension study, and to see additional Jivi PK data, including how Jivi compares to other EHLs, visit the Jivi website.
Click here to go to the Resources page where you can download this information.
3. Jivi Prescribing Information. Bayer HealthCare LLC, Whippany, NJ; 2018. 4. Reding MT et al. J Thromb Haemost 2017;15:411-419. 5. Kerlin BA et al. Poster P153. Presented at the 4th Biennial Summit of the Thrombosis & Haemostasis Societies of North America. March 8-10, 2018, San Diego, California. 6. Lalezari S et al. Haemophilia 2019;25:1011-1019. 7. Data on file. Tx Review 0918, Bayer; 2018. 8. Data on file. Jivi Protect VIII Subgroup Analysis. Bayer HealthCare LLC, Whippany, NJ. 13. Data on file. Protect VIII (13024) prior OD Kogenate FS/Helixate FS Cohort Descriptive Analysis. 14. Data on file. Jivi Protect FVIII (13024) Subgroup- prior Kogenate FS/Helixate FS Cohort. Bayer HealthCare LLC, Whippany, NJ.
KOGENATE FS is an Antihemophilic Factor (Recombinant) indicated for:
KOVALTRY Antihemophilic Factor (Recombinant) is a recombinant human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A for:
JIVI antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
KOGENATE FS, KOVALTRY, and JIVI are not indicated for the treatment of von Willebrand disease.
In clinical trials with:
For additional important risk and use information, please see the full Prescribing Information for KOGENATE FS, KOVALTRY, and JIVI.