title: Zero incidence of inhibitor development in previously treated haemophilia A, HIV-negative patients upon exposure to a plasma-derived high-purity and double viral inactivated factor VIII concentrate.
abstract: Thirty-six haemophilia A, HIV-negative, previously treated patients were changed therapy to a highpurity and double-inactivated (solvent/detergent and dry-heating) previously unused factor VIII concentrate. The mean age of these patients was 27 years at the time of the change. Twenty-three patients were severe haemophiliacs (FVIII:C < 0.02 IU mL-1), seven moderate (FVIII:C between 0.02 and 0.05 IU mL-1) and six mild (FVIII:C > 0.05 IU mL-1). The mean follow-up with this single product was 16 months, with 82 accumulated exposure days and the mean consumption was 117,300 IU of FVIII corresponding to a mean of six batches per patient. No patient developed FVIII inhibitors (upper limit of the CI95: 7.98%), resulting in an incidence rate of 0/48 patient-years (upper limit of the CI95: 77/1000 patient-years). The change in therapy to this new factor VIII concentrate was not associated with the appearance of inhibitors.
authors.affiliation: Unidad de Coagulopatías Congénitas, Hospital La Fe, Valencia, Spain.
authors.forename: J A
authors.initials: JA
authors.lastname: Aznar
authors.forename: J I
authors.initials: JI
authors.lastname: Lorenzo
authors.forename: R
authors.initials: R
authors.lastname: Molina
authors.forename: S
authors.initials: S
authors.lastname: Haya
authors.forename: F
authors.initials: F
authors.lastname: Querol
authors.forename: M A
authors.initials: MA
authors.lastname: Dasí
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D005169:Factor VIII / Q000037:antagonists & inhibitors / Q000302:isolation & purification / Q000627:therapeutic use*; D018023:HIV Seronegativity; D006467:Hemophilia A / Q000188:drug therapy*; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies; D014775:Virus Activation
chemical_list: D005169:Factor VIII