Evaluation of the effect of betapropiolactone/ultraviolet irradiation (BPL/UV) treatment of source plasma on hepatitis transmission by factor IX complex in chimpanzees.
To evaluate the safety of a beta-Propiolactone/Ultraviolet (BPL/UV), irradiated Factor IX complex preparation we inoculated 8 chimpanzees with 25 units Factor IX/Kilo from a pool of 5 production lots which had been treated in this manner. These lots were derived from approximately 1,000 donors. Animals were followed with weekly tests for hepatitis B serologic markers and transaminases, and biweekly liver biopsies, for 6 months. No evidence of transmission of hepatitis B, or non-A, non-B viruses was observed. To further evaluate the BPL/UV procedure a plasma pool was intentionally contaminated with hepatitis B virus and one half of the pool treated with BPL/UV. Factor IX complex was isolated from the treated and untreated pools and each was inoculated into 4 chimpanzees. The Factor IX derived from untreated plasma infected all four animals with an average incubation period of 10.5 weeks, whereas that prepared from PBL/UV treated plasma infected only one of four animals with an incubation period of 21 weeks. These results were interpreted as suggesting that BPL/UV can inactivate approximately 99.9% of hepatitis B virus infectivity.
D000818:Animals; D000998:Antiviral Agents; D005164:Factor IX / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006509:Hepatitis B / Q000382:microbiology / Q000517:prevention & control / Q000635:transmission*; D006515:Hepatitis B virus / Q000472:pathogenicity*; D007783:Lactones / Q000627:therapeutic use*; D008297:Male; D002679:Pan troglodytes; D011420:Propiolactone / Q000627:therapeutic use*; D013242:Sterilization; D014467:Ultraviolet Therapy
D000998:Antiviral Agents; D007783:Lactones; D011420:Propiolactone; D005164:Factor IX