Approaching the ideal: therapeutic requirements for factor VIII concentrates.
The requirements that a factor VIII concentrate should fulfil, as adopted by the Belgian Health Council, are reviewed. Lack of immunogenicity is an important issue; the Belgian experience suggests that a prospective randomized trial allows rather rapid detection of grossly increased immunogenicity. An alternative is provided by prospective cohort studies, using a uniform protocol to evaluate the behavior of each product, and an independent data monitoring centre. Residual infectivity is illustrated by an outbreak of hepatitis A in heavily treated patients. A prospective randomized trial in Belgium is planned to evaluate the benefits and risks of a double-virus inactivated product.
D001530:Belgium / Q000453:epidemiology; D005169:Factor VIII / Q000276:immunology / Q000592:standards*; D015483:HIV Antibodies / Q000097:blood*; D006506:Hepatitis A / Q000453:epidemiology / Q000276:immunology; D006508:Hepatitis Antibodies / Q000097:blood*; D006801:Humans; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors
D015483:HIV Antibodies; D006508:Hepatitis Antibodies; D005169:Factor VIII