Evaluation of human viral disease transmission through plasma products.
Alpha's Wet Heat-Treatment process is being applied to both Factor VIII (AHF) and Factor IX Complex (PTC). Twelve hemophilia A, five hemophilia B, and one von Willebrands patient have been followed for at least 6 months for evidence of non-A, non-B hepatitis. No ALT elevations were seen in the hemophilia B patients. There have been four cases of ALT elevation, three in hemophilia A patients and one in the von Willebrand's patient. A subset of these patients have been followed for over one year for anti-HTLV-III status. No patient, either hemophilia A, hemophilia B, or von Willebrand's seroconverted to anti-HTLV-III positive status. Intravenous gamma globulin was studied in 11 normal patients given a single infusion and in 23 immune deficient patients with multiple infusions and evaluations of liver enzymes over a two year period. No elevated ALT or AST values were seen in either group.
D005164:Factor IX / Q000592:standards* / Q000627:therapeutic use; D005169:Factor VIII / Q000592:standards* / Q000627:therapeutic use; D006467:Hemophilia A / Q000628:therapy*; D006801:Humans; D007116:Immunization, Passive / Q000592:standards; D007153:Immunologic Deficiency Syndromes / Q000628:therapy*; D008111:Liver Function Tests; D014777:Virus Diseases / Q000517:prevention & control / Q000635:transmission*; D005719:gamma-Globulins / Q000008:administration & dosage*; D014842:von Willebrand Diseases / Q000628:therapy*
D005719:gamma-Globulins; D005169:Factor VIII; D005164:Factor IX