BACKGROUND: Double inactivation by solvent/detergent treatment plus heating at 100 degrees C for 30 minutes after lyophilization has been adopted to improve viral safety of factor VIII and factor IX concentrates, particularly with respect to non-lipid-enveloped viruses. The aim of this study was to evaluate the safety of concentrates exposed to these virucidal methods. STUDY DESIGN AND METHODS: Twenty-six previously untreated hemophiliacs, 19 with factor VIII deficiency and 7 with factor IX deficiency, were investigated in a prospective multicenter study over a 12-month follow-up period by the use of serologic and virologic markers for lipid- and non-lipid-enveloped viruses (human immunodeficiency virus types 1 and 2; hepatitis A, B, and C viruses; B19 parvovirus antibodies; and B19 DNA). Overall, 270,000 U of factor VIII and 102,000 U of factor IX concentrate were administered during the study period. RESULTS: None of the 26 patients seroconverted for human immunodeficiency virus or hepatitis C virus. Hepatitis B virus markers remained negative in the 10 unvaccinated hemophiliacs. No hepatitis A virus seroconversion occurred among 17 susceptible patients. B19 seroconversion (IgM) and B19 viremia were observed within 2 weeks of the first concentrate infusion in 8 of 15 susceptible patients, 5 of 11 treated with factor VIII and 3 of 4 with factor IX concentrate. CONCLUSION: This prospective study indicates that very high temperatures applied to lyophilized concentrates appear to prevent the transmission of hepatitis A virus to hemophiliacs. However, B19 parvovirus still contaminates concentrates despite the use of this robust virucidal method.
BACKGROUND: Double inactivation by solvent/detergent treatment plus heating at 100 degrees C for 30 minutes after lyophilization has been adopted to improve viral safety of factor VIII and factor IX concentrates, particularly with respect to non-lipid-enveloped viruses. The aim of this study was to evaluate the safety of concentrates exposed to these virucidal methods. STUDY DESIGN AND METHODS: Twenty-six previously untreated hemophiliacs, 19 with factor VIII deficiency and 7 with factor IX deficiency, were investigated in a prospective multicenter study over a 12-month follow-up period by the use of serologic and virologic markers for lipid- and non-lipid-enveloped viruses (human immunodeficiency virus types 1 and 2; hepatitis A, B, and C viruses; B19parvovirus antibodies; and B19 DNA). Overall, 270,000 U of factor VIII and 102,000 U of factor IX concentrate were administered during the study period. RESULTS: None of the 26 patients seroconverted for human immunodeficiency virus or hepatitis C virus. Hepatitis B virus markers remained negative in the 10 unvaccinated hemophiliacs. No hepatitis A virus seroconversion occurred among 17 susceptible patients. B19 seroconversion (IgM) and B19 viremia were observed within 2 weeks of the first concentrate infusion in 8 of 15 susceptible patients, 5 of 11 treated with factor VIII and 3 of 4 with factor IX concentrate. CONCLUSION: This prospective study indicates that very high temperatures applied to lyophilized concentrates appear to prevent the transmission of hepatitis A virus to hemophiliacs. However, B19parvovirus still contaminates concentrates despite the use of this robust virucidal method.
Authors: Johannes Blümel; Reinhard Burger; Christian Drosten; Albrecht Gröner; Lutz Gürtler; Margarethe Heiden; Martin Hildebrandt; Bernd Jansen; Thomas Montag-Lessing; Ruth Offergeld; Georg Pauli; Rainer Seitz; Uwe Schlenkrich; Volkmar Schottstedt; Johanna Strobel; Hannelore Willkommen; Carl-Heinz Wirsing von König Journal: Transfus Med Hemother Date: 2010-11-17 Impact factor: 3.747
Authors: J Michael Soucie; Christine De Staercke; Paul E Monahan; Michael Recht; Meera B Chitlur; Ralph Gruppo; W Craig Hooper; Craig Kessler; Roshni Kulkarni; Marilyn J Manco-Johnson; Jerry Powell; Meredith Pyle; Brenda Riske; Hernan Sabio; Sean Trimble Journal: Transfusion Date: 2012-09-24 Impact factor: 3.157
Authors: Mei-Ying W Yu; Harvey J Alter; Maria Luisa A Virata-Theimer; Yansheng Geng; Li Ma; Cathy A Schechterly; Camilla A Colvin; Naomi L C Luban Journal: Transfusion Date: 2010-02-12 Impact factor: 3.157
Authors: Steven H Kleinman; Simone A Glynn; Tzong-Hae Lee; Leslie H Tobler; Karen S Schlumpf; Deborah S Todd; Hannah Qiao; Mei-Ying W Yu; Michael P Busch Journal: Blood Date: 2009-08-17 Impact factor: 22.113
Authors: Rabab Hasanain Ahmed Hasanain; Rania M Saleh; Fadia M Attia; Hanaa H Gomaa Journal: Indian J Hematol Blood Transfus Date: 2020-09-22 Impact factor: 0.900