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Viral safety of a pasteurized, monoclonal antibody‐purified factor VIII concentrate in previously untreated haemophilia A patients
Author(s) -
Philipp C. S.
Publication year - 2001
Publication title -
haemophilia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.213
H-Index - 92
eISSN - 1365-2516
pISSN - 1351-8216
DOI - 10.1046/j.1365-2516.2001.00482.x
Subject(s) - medicine , haemophilia , antibody , haemophilia a , hepatitis b , immunology , virology , adverse effect , titer , monoclonal antibody , antigen , gastroenterology , surgery
The efficacy and viral safety of a pasteurized, immunoaffinity‐purified procoagulant factor VIII protein (FVIII:C; Monoclate‐P) was studied in two multicentre, prospective, open‐label trials in 30 previously untreated patients, 18 with severe (< 1% FVIII:C activity), and 12 with moderate (1% to 5% FVIII:C activity) haemophilia A. Clinical assessments, performed at screening and regularly thereafter for 6 to > 24 months (maximum 34 months), showed that none of 24 assessable patients acquired illnesses consistent with monitored transfusion‐transmissible diseases. No patients acquired hepatitis B surface antigen, or antibodies against hepatitis B core antigen, hepatitis C, or human immunodeficiency virus. Likewise, no patients acquired treatment‐related hepatitis A antibodies or sustained elevations of alanine aminotransferase levels. The safety profile for Monoclate‐P is brought about by a multi‐step safety system that incorporates viral inactivation (through a combination of immunoaffinity chromatography and pasteurization) plus donor screening, plasma testing, and quality assurance. The inhibitor development rate (13% low titre, 10% high titre) was similar to that reported in the literature for other FVIII concentrates (24% to 52%). The most frequently reported adverse events were related to typical infant and childhood diseases. Monoclate‐P was effective in all patients treated according to protocol, except in two, who developed inhibitors.