Virus safety of pasteurized factor VIII and factor IX concentrates: study in virgin patients.
In a long term surveillance study hemophilia A and B patients were treated with a Factor VIII HS and Factor IX HS concentrate respectively, both pasteurized by heating in solution: 10 hours at 60 degrees C. None of 31 virgin hemophiliacs treated with Factor VIII HS Behringwerke developed hepatitis B during a follow up between 6 to 60 months. One patient who received 379.280 IU Factor VIII by 977 applications showed a seroconversion after 961 days of treatment. Passive/active immunisation is suggested. 4 patients had moderate elevations of transaminases (less than 120 U/l) without clinical signs of liver disease. 2 patients suffered a non-icteric NA NB-hepatitis two months after synovectomy in the same hospital. 6 virgin hemophilia B patients who had been treated with Factor IX concentrate HS Behringwerke remained serologically negative and did not develop any symptoms indicative of a hepatic disease during a follow up between 11-29 months. The HTLV-III safety of Factor VIII HS and Factor IX HS Behringwerke is presently under investigation by determination of the corresponding antibody.
D000293:Adolescent; D000914:Antibodies, Viral / Q000032:analysis; D002648:Child; D002675:Child, Preschool; D017977:Deltaretrovirus / Q000276:immunology; D005164:Factor IX / Q000592:standards* / Q000627:therapeutic use; D005169:Factor VIII / Q000592:standards* / Q000627:therapeutic use; D005500:Follow-Up Studies; D015483:HIV Antibodies; D006467:Hemophilia A / Q000628:therapy*; D006509:Hepatitis B / Q000209:etiology*; D006511:Hepatitis B Antigens / Q000032:analysis; D006526:Hepatitis C / Q000209:etiology*; D006525:Hepatitis, Viral, Human / Q000209:etiology*; D006801:Humans; D007223:Infant; D012449:Safety; D013242:Sterilization
D000914:Antibodies, Viral; D015483:HIV Antibodies; D006511:Hepatitis B Antigens; D005169:Factor VIII; D005164:Factor IX