For Immediate Release

Results from the PROTECT VIII Extension Study with Jivi® Published in Haemophilia

Study demonstrates long-term safety and efficacy with Jivi (antihemophilic factor [recombinant] PEGylated-aucl), including in a subset of hemophilia A patients who received treatment for five years

WHIPPANY, N.J., Dec. 6, 2019 /PRNewswire/ -- Bayer today announced the publication of an analysis of the PROTECT VIII extension study in which a subset of 33 patients with hemophilia A who received five years of prophylactic treatment with Jivi® (antihemophilic factor [recombinant] PEGylated-aucl) maintained a safety and efficacy profile that was consistent with a prior analysis of the same subset, as well as with an analysis of the pivotal Phase III PROTECT VIII main study.1 The data, which were from all 121 patients who entered the extension study, are available as an e-publication online in the international, peer-reviewed journal Haemophilia.

(PRNewsfoto/Bayer)

"The unique design of the PROTECT VIII main and extension studies, which included three different prophylaxis regimens, closely mimics a real-world treatment setting in which physicians can adjust regimens as needed to control bleeds," said Mark Reding, M.D., associate professor of medicine at the University of Minnesota and lead investigator of the PROTECT VIII study. "The published data provide additional support to help physicians make informed clinical decisions regarding the long-term disease management and treatment of their patients with hemophilia A."    

The PROTECT VIII main study was a partially randomized, open-label trial of 134 males aged 12–65 years with severe hemophilia A. Prophylaxis patients received Jivi 25 IU/kg twice-weekly for a 10-week run-in period. Patients with ≤ 1 spontaneous, joint or muscle bleed during this period were randomized to 45–60 IU/kg every 5 days (Q5D) or 60 IU/kg every 7 days (Q7D) for the main 26-week period; patients enrolling after the randomization arms were full, or with ≥ 2 bleeds in the run-in period, received 30–40 IU/kg twice-weekly (2×W). Twenty patients received Jivi on demand as they had been receiving on-demand FVIII treatment prior to study entry.2 Treatment success in the every 7 days group was not established.

Following completion of the PROTECT VIII main study, patients could enter an optional extension, continuing Jivi on any regimen used in the main study. The majority (97%) of study participants opted into the extension study (126 patients completed the main study; 121 patients entered the extension, of which 107 continued prophylaxis with Jivi). Investigators analyzed annualized bleeding rates (ABRs) and joint ABR, along with safety outcomes.3  

"Dosing of replacement FVIII concentrates can change over time in order to maintain sufficient bleed protection in people living with hemophilia A. This presents a common challenge in the long-term management of this life-long condition," said Aleksandra Vlajnic, M.D., Senior Vice President & Head Medical Affairs Americas at Bayer. "In the PROTECT VIII extension study, median quartile ABR for total bleeds was 1.6 (0.3,4.6) for all patients receiving prophylaxis (n=107), with patients maintaining the same or similar bleeding rates over the five-year study period."

The interim data from the ongoing extension study validated the previously demonstrated efficacy of Jivi in the PROTECT VIII main study, which was maintained for a median (range) follow-up period of 3.9 years (0.8-5.4) at data cut-off date of January 2018. Bleeding rates were maintained for up to five years or more with twice-weekly and every-5-days prophylaxis. The majority of patients who continued prophylaxis (72/107) were treated with extended dosing intervals of every 5 days or every 7 days during the total time in the extension study. Both the ABR for total bleeds and the percentage of patients who experienced at least one bleed were lower in the total prophylaxis group during the last year of the extension, which may suggest that bleeding outcomes improved as regimens were adjusted to accommodate patients' individual needs.

Consistent with prior analyses of the PROTECT VIII study, during the extension study the majority of adverse events (AEs) were mild or moderate in severity, indicating that Jivi was well tolerated in the majority of patients. There were no additional hypersensitivity reactions during the extension period and no patients developed confirmed FVIII inhibitors (titer ≥0.6 Bethesda units).4

In August 2018, the U.S. Food Drug Administration (FDA) based its approval of Jivi on results from the PROTECT VIII main study.5 Additional post-hoc analysis data from the PROTECT VIII study will be presented at the upcoming 61st ASH Annual Meeting & Exposition, December 7-10, 2019 in Orlando, Florida.

  • Prophylactic BAY 94-9027 in the PROTECT VIII Study, Session: 322. Disorders of Coagulation or Fibrinolysis: Poster I, Number 1129, Saturday, December 7, 2019: 5:30-7:30 PM Hall B, Level 2, Orange County Convention Center
  • Efficacy and Safety of BAY 94-9027 (Damoctocog Alfa Pegol) Prophylaxis in Patients with Severe Hemophilia a and Comorbidities: A Post Hoc Analysis of PROTECT VIII Data, Session: 322. Disorders of Coagulation or Fibrinolysis: Poster I, Number 1117, Saturday, December 7, 2019: 5:30-7:30 PM Hall B, Level 2, Orange County Convention Center

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Jivi Indications and Important Safety Information

INDICATIONS                    

  • Jivi is an injectable medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A.
  • Jivi is used to treat and control bleeding in previously treated adults and adolescents (12 years of age and older) with hemophilia A. Your healthcare provider may also give you Jivi when you have surgery. Jivi can reduce the number of bleeding episodes in adults and adolescents with hemophilia A when used regularly (prophylaxis).
  • Jivi is not for use in children below 12 years of age or in previously untreated patients.
  • Jivi is not used to treat von Willebrand disease.

IMPORTANT SAFETY INFORMATION

  • You should not use Jivi if you are allergic to rodents (like mice and hamsters) or to any ingredients in Jivi.
  • Tell your healthcare provider about all of your medical conditions that you have or had.
  • Tell your healthcare provider if you have been told that you have inhibitors to Factor VIII.
  • Allergic reactions may occur with Jivi. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, or nausea.
  • Allergic reactions to polyethylene glycol (PEG), a component of Jivi, are possible.
  • Your body can also make antibodies, called "inhibitors," against Jivi, which may stop Jivi from working properly. Consult your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.
  • If your bleeding is not being controlled with your usual dose of Jivi, consult your doctor immediately. You may have developed Factor VIII inhibitors or antibodies to PEG and your doctor may carry out tests to confirm this.
  • The common side effects of Jivi are headache, cough, nausea, and fever.
  • These are not all the possible side effects with Jivi. Tell your healthcare provider about any side effect that bothers you or that does not go away.

For additional important risk and use information, please see the full Prescribing Information.

You are encouraged to report side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

1 Lalezari S, Reding MT, Pabinger I, et al. BAY 94-9027 prophylaxis is efficacious and well tolerated for up to >5 years with extended dosing intervals: PROTECT VIII extension interim results. Haemophilia. 2019 Oct 17.  doi: 10.1111/hae.13853. [Epub ahead of print]
2 Ibid
3 Ibid
4 Ibid
5 Jivi® [prescribing information]. Whippany, NJ: Bayer; 2018.

COR-JIV-US-0023-1

SOURCE Bayer