title: Long-term efficacy and safety of a pasteurized, plasma-derived factor VIII concentrate (Beriate® P) in patients with haemophilia A.
abstract: BACKGROUND
  Beriate(®) P was first introduced in Germany in 1990 as factor VIII (FVIII):C(®) HS Behring and subsequent product improvements yielded an albumin-free formulation with a specific activity of approximately 170 IU/mg protein. In 1992, the concentration was raised to 100 IU FVIII/mL in the reconstituted product, with a mean specific activity of 270 IU/mg protein. Pathogen safety is achieved by careful donor selection and a combination of pasteurization and chromatographic purification steps.
  
  
  METHODS
  We analysed the efficacy and safety of Beriate(®) P in the clinical setting from 1996 to 2005 with a focus on surgical patients. Of the 36 patients (mean age: 38 years; range 1-72 years), 29 had severe haemophilia A, two had moderate haemophilia, two had mild haemophilia, and three had sub-clinical haemophilia. Most patients (n=28) had more than 100 exposure days, representing a total of 202 patient-years with a consumption of 27,811,500 IU of Beriate(®) P.
  
  
  RESULTS
  There was no evidence of seroconversion towards relevant viruses, no inhibitor development (35 previously treated patients, one previously untreated patient), no abnormal immunological findings or allergic reactions. In all 36 patients treated for acute bleeding and prophylaxis, and 24 surgeries (15 total joint replacements, eight orthopaedic procedures, one cholecystectomy) in 16 patients with severe haemophilia A, efficacy of Beriate(®) P was always rated as "excellent" or "good", and no thrombosis was reported.
  
  
  CONCLUSIONS
  Beriate(®) P has an excellent efficacy and safety profile. Many patients who were initiated on Beriate(®) P at our centre remain on the treatment today.
authors.affiliation: Department of Internal Medicine - Angiology and Clotting Disorders, Haemophilia Treatment Centre, Vivantes Klinikum im Friedrichshain, Berlin, Germany. Electronic address: robert.klamroth@vivantes.de.
authors.forename: Robert
authors.initials: R
authors.lastname: Klamroth
authors.affiliation: Department of Internal Medicine - Angiology and Clotting Disorders, Haemophilia Treatment Centre, Vivantes Klinikum im Friedrichshain, Berlin, Germany.
authors.forename: Saskia
authors.initials: S
authors.lastname: Gottstein
authors.affiliation: Department of Internal Medicine - Angiology and Clotting Disorders, Haemophilia Treatment Centre, Vivantes Klinikum im Friedrichshain, Berlin, Germany.
authors.forename: Marija
authors.initials: M
authors.lastname: Orlovic
authors.affiliation: Department of Internal Medicine - Angiology and Clotting Disorders, Haemophilia Treatment Centre, Vivantes Klinikum im Friedrichshain, Berlin, Germany.
authors.forename: Christl
authors.initials: C
authors.lastname: Heinrichs
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D058731:Blood Safety; D002648:Child; D002675:Child, Preschool; D004203:Disinfection; D005169:Factor VIII / Q000009:adverse effects / Q000037:antagonists & inhibitors / Q000627:therapeutic use*; D006467:Hemophilia A / Q000628:therapy*; D006801:Humans; D007223:Infant; D008875:Middle Aged; D010949:Plasma / Q000821:virology; D055815:Young Adult
chemical_list: D005169:Factor VIII
keywords: Beriate(®) P; Coagulation factor; Factor VIII; Haemophilia A; Plasma derived; Recombinant