Oncology Medical News about Hemophilia A

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Postmarketing surveillance study of KOGENATE Bayer with Bio-Set in patients with haemophilia A: evaluation of patients' satisfaction after switch to the new reconstitution system
Haemophilia, 11/05/09

Vidovic N et al. – No de novo or recurrent inhibitor development was observed during the observation period. rFVIII–FS with Bio–Set was well tolerated and well accepted by haemophilia A patients, which may improve treatment compliance.

Exclusive Author Commentary
Karin Achilles, 11/10/09

The problem of treatment compliance in patients with chronic diseases is well known. Effective primary prophylactic treatment in young children and teens with severe hemophilia A depends on good compliance and is critical in preventing episodic bleeds and reducing the risk of joint bleeding and arthropathy. Optimizing the convenience and safety of treatment preparation and administration is one of many approaches to encouraging treatment compliance. The Bio-Set® needleless reconstitution system was designed to help prevent parent and patient needlestick contact. For busy parents, parents who are educating their children in self-care, and teenagers who have assumed the responsibility of self-care, the needleless system may offer benefits of time savings, simplicity, and increased confidence in the safety of factor VIII products. In this study, patients or their caregivers showed an overall preference for KOGENATE® Bayer with Bio-Set® over their previous method of reconstitution based on such issues as worry, safety, ease of use, confidence, and speed of reconstitution. These results confirm those of previous reports identifying those same issues as the basis for the preferences of patients, caregivers, and nurses for the Bio-Set method over a 2-vial transfer needle reconstitution method. The preference for the Bio-Set method was reflected in a high level of treatment satisfaction, compliance that is similar to or better than previous methods, and an intention to continue using the Bio-Set device. These results suggest that improving ease of use, providing safety from needlesticks, and increasing the speed of reconstitution may decrease the burden of prophylactic treatment and help to improve compliance and treatment outcomes.

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