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Removal of Hepatitis Virus Infectivity from Clotting Factor Concentrates
Author(s) -
Gerety R.
Publication year - 1984
Publication title -
scandinavian journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0036-553X
DOI - 10.1111/j.1600-0609.1984.tb02577.x
Subject(s) - hbsag , clotting factor , hepatitis b virus , virology , medicine , hepatitis b , neutralization , hepatitis b vaccine , antibody , hepatitis , virus , immunology
Viral hepatitis remains a serious problem following intravenous therapy with plasma derivatives such as clotting factor concentrates. The risk of hepatitis B has been reduced but not eliminated by screening plasma for hepatitis B surface antigen (HBsAg) by sensitive tests prior to its use in manufacturing plasma derivatives. The use of hepatitis B vaccine has the potential to eliminate completely the risk of hepatitis B transmission among hemophiliacs when administered prior to the initiation of clotting factor concentrate therapy. Non‐A, non‐B hepatitis remains a significant risk for hemophiliacs. Neither a screening test to detect transmitters of this disease nor a vaccine to prevent it appear likely to be developed in the near future. Methods to remove, immunologically neutralize, or inactivate viruses in clotting factor concentrates have been studied. Three methods to remove hepatitis B virus from clotting factor concentrates have been evaluated. Solid‐phase immunoadsorption, polyethylene glycol precipitation and hydrophobic interaction chromatography can each remove HBsAg and hepatitis B virus (HBV) from plasma and/or clotting factor concentrates but none appear adequate to assure consistent removal of all infectious HBV. Immunological neutralization of HBV in clotting factor concentrates by the addition of neutralizing antibodies (anti‐HBs) has been accomplished. This method is applied routinely in one country to all plasma derivatives with the potential to contain infectious HBV. Immunological neutralization can only be accomplished, however, for hepatitis B virus since neutralizing antibodies for non‐A, non‐B hepatitis virus(es) have not yet been identified. The differential stabilization of plasma clotting factors to heat by a variety of specific methods has permitted the heating of clotting factor concentrates to inactivate hepatitis viruses while retaining acceptable biological activity of the clotting factors. Available data indicate that heat inactivation of both HBV and non‐A, non‐B hepatitis agents in clotting factor concentrates can be accomplished.