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Bayer Announces Data from Jivi Extension Study

December 12, 2019
Bayer Announces Data from Jivi Extension Study

Bayer recently announced the publication of an analysis of the PROTECT VIII extension study in which a subset of 33 patients with hemophilia A received five years of prophylactic treatment with Jivi®, the company’s long-acting site-specifically PEGylated recombinant factor VIII therapy. Jivi® is indicated for the treatment of hemophilia A in adolescents and adults 12 years of age and over. It is approved for prophylactic, on-demand and perioperative management of bleeding. According to a recent press release, participants in the extension study maintained a safety and efficacy profile that was consistent with a prior analysis of the same subset.

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 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 annualized bleeding rates 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, Consistent with prior analyses of the PROTECT VIII study, during the extension study the majority of adverse events were mild or moderate in severity, indicating that Jivi® was well tolerated in the majority of patients. The data are available as an e-publication in the journal Haemophilia.

“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, MD, 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.”   

Source: PR Newswire, December 6, 2019