![]() ![]() īAY 81-8973 is a full-length, unmodified, recombinant human FVIII that has the same amino acid sequence as Bayer’s sucrose-formulated recombinant FVIII (rFVIII-FS Kogenate ® FS, Bayer, Berkeley, CA, USA) but produced with certain, more advanced manufacturing technologies. Hemophilia treaters may target threshold levels of 1, 3, 5, or 10 IU/dL FVIII, or higher, while selecting a dosing regimen for prophylaxis. The desired threshold level for a given patient can vary based on the bleeding phenotype, activity level, genetic mutation, and other variables. Thus, maintenance of FVIII above threshold levels for long periods is perceived to be beneficial. Although the appropriate level of FVIII to prevent bleeding in individual patients varies, increased time spent with low FVIII levels is considered an important determinant of breakthrough bleeding during prophylaxis. ![]() However, insufficient levels of infused FVIII resulting from suboptimal adherence to prophylaxis or individual differences in FVIII pharmacokinetics (PK) may result in breakthrough bleeding during prophylaxis. In most developed countries with adequate resources, FVIII prophylaxis is standard care for patients with hemophilia A. Treatment of hemophilia A typically requires factor VIII (FVIIII) replacement therapy. The same FVIII trough threshold level could be achieved with lower doses of BAY 81-8973 versus rAHF-PFM.Ĭ: NCT02483208. ConclusionsīAY 81-8973 showed a superior PK profile versus rAHF-PFM. Using both assays, geometric mean (coefficient of variation ) AUC last was significantly higher, and t ½ was significantly longer, for BAY 81-8973 versus rAHF-PFM (one-stage, AUC last: 1660 IU ResultsĮighteen patients were randomized and analyzed. A population PK model was developed to simulate various treatment scenarios. PK parameters, including area under the curve from time zero to the last data point (AUC last primary outcome) and half-life ( t ½) were calculated. FVIII levels were measured in plasma over 48 h using one-stage and chromogenic assays. In this phase I, open-label, crossover study, men aged 18–65 years with severe hemophilia A and ≥150 exposure days to FVIII were randomized to receive a single intravenous infusion of 50 IU/kg BAY 81-8973 or rAHF-PFM, followed by crossover to a single infusion of the other treatment. The aim of this study was to compare the pharmacokinetic (PK) profile of BAY 81-8973 with antihemophilic factor (recombinant) plasma/albumin-free method (rAHF-PFM) Patients/Methods BAY 81-8973 is a full-length, unmodified, recombinant human factor VIII (FVIII) for the treatment of hemophilia A. ![]()
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