Virus safety of solvent/detergent-treated antihaemophilic factor concentrate.
The safety of an antihaemophilic factor concentrate treated with the organic solvent tri-(n-butyl)phosphate and sodium cholate (factor VIII-SD) was assessed for transmission of non-A, non-B (NANB) hepatitis and human immunodeficiency virus (HIV). Patients enrolled in the study had no previous exposure to blood products made from plasma pools, although 5 had received small quantities of single-donor products. All but 1 had normal alanine aminotransferase (ALT) levels, none had markers of HIV infection, and all had been vaccinated against hepatitis B. After treatment with factor VIII-SD, serum ALT levels and HIV antibody were monitored for up to 1 year. 20 patients received 625 to greater than 40,000 U (total 163,000 U, median dose 3900 U), and 17 of these were followed up for at least 6 months: transmission of either NANB hepatitis or HIV was not observed.
D000293:Adolescent; D000410:Alanine Transaminase / Q000097:blood; D002648:Child; D002675:Child, Preschool; D019826:Cholic Acid; D002793:Cholic Acids; D004340:Drug Contamination / Q000517:prevention & control*; D004341:Drug Evaluation; D005169:Factor VIII / Q000008:administration & dosage* / Q000009:adverse effects; D006678:HIV / Q000187:drug effects; D006467:Hemophilia A / Q000628:therapy; D006518:Hepatitis Viruses / Q000187:drug effects; D006801:Humans; D007223:Infant; D010755:Organophosphates; D009943:Organophosphorus Compounds
D002793:Cholic Acids; D010755:Organophosphates; D009943:Organophosphorus Compounds; D005169:Factor VIII; C009524:tributyl phosphate; D000410:Alanine Transaminase; D019826:Cholic Acid