Incidence of factor VIII inhibitor development in severe hemophilia A patients treated only with one brand of highly purified plasma-derived concentrate.
The incidence of factor VIII inhibitor was studied in a cohort of 56 previously untreated patients with severe hemophilia A (factor VIII below 1 U/dl). They received only one brand of highly purified factor VIII concentrate (HPSD-VIII) prepared by conventional chromatography with a solvent-detergent step for viral inactivation. Follow-up since the first infusion of HPSD-VIII was from 1 to 76 months (mean = 29) and cumulative exposure days (CED) from 1 to over 100 (median = 26). Five patients (9%) developed an inhibitor after 6 to 19 CED, only one being a high responder (2%), showing a low incidence of inhibitor compared with previous studies using high purity plasma-derived or recombinant products.
Guérois
C
C
Hemophilia Center of Tours, France.
Laurian
Y
Y
Rothschild
C
C
Parquet-Gernez
A
A
Duclos
A M
AM
Négrier
C
C
Vicariot
M
M
Fimbel
B
B
Fressinaud
E
E
Fiks-Sigaud
M
M
D002675:Child, Preschool; D005169:Factor VIII / Q000008:administration & dosage / Q000037:antagonists & inhibitors*; D005500:Follow-Up Studies; D006467:Hemophilia A / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D012189:Retrospective Studies; D016896:Treatment Outcome
D005169:Factor VIII