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Increasing blood component transfusion\u2010associated HEV infections highlight the need for reliable virus inactivation procedures for plasma derivatives from pooled plasma donations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>An animal infection study was conducted to evaluate the efficiency of HEV inactivation by pasteurization during the manufacturing process of the von Willebrand Factor\/Factor VIII (VWF\/FVIII) concentrate Haemate P\/Humate\u2010P (CSL Behring, Marburg, Germany). For this purpose, groups of pigs were inoculated with stabilized VWF\/FVIII intermediate spiked with HEV\u2010positive liver homogenate and exposed to increasing incubation times of 0, 3, 6, and 10 h at 60\u00b0C. Animals were evaluated for virus replication over 27\u2009days and in a subsequent trial over 92\u2009days.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Virus replication was detected in animals up to the 6\u2010h pasteurization group. In contrast, pasteurization for 10 h did not reveal virus detection when the observation period was 27\u2009days. In an additional experiment using the 10\u2010h pasteurized material, two individuals started virus excretion and seroconverted when the observation period was extended to 92\u2009days. Based on the total infection rate (2 of 12) of the animals inoculated with the sample pasteurized for 10 h, a virus reduction factor of at least 4.7 log<jats:sub>10<\/jats:sub> is calculated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study demonstrates that pasteurization at 60\u00b0C for 10 h of an HEV\u2010positive plasma derivative leads to the effective reduction of infectivity, resulting in a VWF\/FVIII product with an appropriate margin of safety for HEV.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.16298","type":"journal-article","created":{"date-parts":[[2021,2,20]],"date-time":"2021-02-20T23:18:51Z","timestamp":1613863131000},"page":"1266-1277","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Hepatitis <scp>E<\/scp> virus: Efficacy of pasteurization of plasma\u2010derived <scp>VWF<\/scp>\/<scp>FVIII<\/scp> concentrate determined by pig 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