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.

Adolescence Alanine Aminotransferase/BLOOD Child Child, Preschool *Cholic Acids Drug Contamination/*PREVENTION & CONTROL Drug Evaluation Factor VIII/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Hemophilia/THERAPY Hepatitis Viruses/DRUG EFFECTS Human HIV/DRUG EFFECTS Infant *Organophosphorus Compounds *Phosphoric Acid Esters JOURNAL ARTICLE

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