PROTECT VIII extension study of Jivi in haemophilia A published in Haemophilia journal.- Bayer

Bayer 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.

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. 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 less than 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 more than 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. Treatment success in the every 7 days group was not established.

See: "BAY 94?9027 prophylaxis is efficacious and well tolerated for up to >5 years with extended dosing intervals: PROTECT VIII extension interim results" Shadan Lalezari et al. Haemophilia 17 October 2019 https://doi.org/10.1111/hae.13853