VIRAL SAFETY OF SOLVENT/DETERGENT-TREATED AHF IN PATIENTS WITH HEMOPHILIA

The safety of an Antihemophilic Factor concentrate (Factor VIII-SD) treated with the organic solvent tri(n-butyl) phosphate (TNBP) and sodium cholate is being assessed with respect to transmission of non-A, non-B hepatitis virus (NANBHV) and human immunodeficiency virus (HIV). TNBP/cholate treatment has been previously shown to inactivate at least 10,000 infectious doses each of hepatitis B virus (HBV) and NANBHV using a chimpanzee model, and 30,000 tissue culture infectious doses of HIV.

Patients enrolled in the study have had no previous exposure to blood products made from plasma pools, although some have received small quantities of single-donor products. They have normal alanine amino transferase (ALT) levels and no markers of prior HIV infection and have all been vaccinated against HBV. Each has been treated, as required, with an individual lot of Factor VIII-SD prepared at the New York Blood Center by an FDA-licensed procedure. ALT levels and HIV antibody have been monitored bi-weekly for two months and monthly until the end of six months. Seven patients who have received 475 -20,000 units of AHF(total units 38,255, median dose ∽3400 units) have been followed for at least three months. There has been no indication in these patients ofinfection with either NANBHV or HIV. An eighth patient who had an elevatedALT level prior to enrollment was followed for HIV antibody only. He remains HIV antibody negative through fivemonths of follow-up. Six additional patients have entered the study, but have not yet required treatment or have been followed for only a short time. These results suggest that the risk of virus infection associated with the use of AHF concentrates is significantly diminished by solvent/detergenttreatment.