Get to know Jivi®

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The main clinical study and extension study of Jivi® were designed to reflect
real-world treatment4,6

Jivi dosing was tailored to patients' bleeding tendencies4

Diagram of main clinical study and long-term extension study illustrating treatment frequency variations between high and low bleeding tendencies.
  • IU, international units; kg, kilograms.
  • *112 patients entered prophylactic treatment arms; an additional 20 patients entered a control arm of on-demand treatment. Two patients in the prophylactic arms left the study prematurely during the run-in period.1
  • †Defined as joint or muscle bleeds and no identified trauma.1,4
  • †112 patients entered prophylactic treatment arms; an additional 20 patients entered a control arm of on-demand treatment. Two patients in the prophylactic arms left the main study prematurely during the run-in period.1
  • §121 of 134 patients included in the main PROTECT VIII trial continued in the extension study, receiving either on demand treatment (n=14) or prophylaxis (n=107).8
  • ¶Patients who switched dosing frequency at least once after the first week of the extension study were analyzed in a separate variable frequency group.8
  • **As of January 2018 interim analysis.4,8

Effective bleed protection with Jivi® in the main clinical study1

Table of ABR results from the main clinical study.
  • 88.2% reduction in ABR versus on-demand treatment1
  • ABR, annualized bleed rate.
  • *n=11; n=13 (twice weekly: low; high).1
  • †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.1,4
  • ‡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.1,4
  • §Nine of the 13 subjects in this group were on prior prophylaxis and observed to have a mean number of 17.4 bleeds in the 12 months prior to study entry.1
  • n=43 (every 5 days).1

ABRs assessed with Jivi® in the long-term extension study10

Table of ABR results from the long-term extension study.
  • *As of 1/31/2018 cut off.10
  • ‡Patients who switched dosing frequency at least once after the first week of the extension study were analyzed in a separate variable frequency group.6
  • ABR, annualized bleed rate.

Jivi® provided effective treatment of bleeds1

Graphic illustrating that 90% of bleeds were resolved with two or fewer infusions per week. Graphic indicating that 83% of prophylaxis patients assessed treatment of bleeds as 'Excellent' or 'Good'
  • *n=112 on prophylaxis.1
  • †Treatment of bleeds from week 0 through week 36.1
  • ‡Two patients discontinued after a single dose of Jivi and were not included in the efficacy analysis.1
  • §On a scale of: Excellent, Good, Moderate, Poor.1

Target joint resolution with Jivi® 8

Results from 82 patients who were in the prophylaxis group in the main study and who continued into the extension study. (median time of 1421 days [range: 700-2071]8)

Image representing historic target joint resolution. Graphic indicating that 95% of historic target joints were resolved. 107 of 113 historic target joints were resolved at of the time of analysis (data cut-off 8/28/2019). The median target joint ABR was 0 at the end of the main study and 0 at the extension study cutoff date (8/28/2019). The mean target joint ABR was 1.28 at the end of the main study and 1.06 at the extension study cutoff date (8/28/2019).
Analysis consisted of8:
  • Numbers of historic target joints recorded at study entry
  • Numbers of resolved target joints (≤2 spontaneous bleeds during the last 12 months)
Image representing historic and new target joint resolution. Graphic indicating that 91% of historic or new target joints were resolved. 111 of 122 historic or new target joints were resolved at of the time of analysis (data cut-off 8/28/2019). The median target joint ABR was 0 at the end of the main study and 0 at the extension study cutoff date (8/28/2019). The mean target joint ABR was 1.28 at the end of the main study and 1.06 at the extension study cutoff date (8/28/2019).
Analysis consisted of8:
  • Numbers of historic target joints, as judged by the investigator, recorded at study entry
  • Numbers of new target joints that developed on-study (≥3 spontaneous bleeds within 6 months)
  • Numbers of resolved target joints (≤2 spontaneous bleeds during the last 12 months)
  • *Patients remaining on the same prophylaxis regimen during the last 90 days of treatment. Median joint ABRs were 0.00 for twice-weekly and 0.00 for every-5-day dosing interval.9
  • †As defined by the International Society of Thrombosis and Hemostasis (ISTH).8


Jivi® is an extended-half-life rFVIII with unique step-wise dosing & the potential for fewer infusions1,2

Start simply. For all prophylaxis patients the recommended starting regimen is Jivi twice weekly (30-40 IU/kg). Step up. Based on bleeding episodes, less frequent dosing of Jivi every 5 days (45-60 IU/kg) can be used. Fine tune. Based on bleeding episodes, the dosing frequency may be further adjusted up or down. 8 of 10 patients reduced their dosing frequency versus the pre-study prophylaxis regimen.
  • IU, international units; kg, kilograms; rFVIII, recombinant Factor VIII.
  • ‡40/47 patients in the every-5-day and twice-weekly dosing arms for whom prior prophylaxis dosing records were available.5

Long-term safety data with Jivi® in adolescents and adults1,2,4

No confirmed cases of inhibitors against Factor VIII occurred. Allergic reactions occurred in 2 out of 134 patients. In 1 patient, the allergic reaction was related to polyethylene glycol (PEG), a component of Jivi. The four most common side effects are headache, cough, nausea, fever. Serious drug-related adverse events occurred in 2 patients (1.7%). No increasing plasma PEG levels over time. Our bodies have known mechanisms for removing PEG. It is excreted through the kidney (via urine) and liver (via feces). Up to more than 5 years of safety data in previously treated patients 12 years of age and older.
  • Jivi is indicated for previously treated adolescents and adults aged 12 years and older with hemophilia A.1
  • *A 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 (BU, Bethesda units; mL, milliliters).1
  • †In at least 5% of patients.1
  • ‡As of January 2018 interim analysis.4,6