Chromatographic removal of hepatitis B virus from a factor IX concentrate. Experimental studies in chimpanzees

Non-A, non-B hepatitis virus can be removed from a factor IX concentrate by a hydrophobic chromatographic step added to the ordinary fractionation process. The efficacy of this procedure for removal of hepatitis B virus (HBV) was evaluated in chimpanzees. A well-defined hepatitis B virus (HBV) inoculum was added to a factor IX preparation and this preparation was subjected to chromatography with octanohydrazide-Sepharose 4B at a high salt concentration and then injected intravenously into two chimpanzees. A control chimpanzee was inoculated with the part of the factor IX/HBV preparation that had not been chromatographed. The two chimpanzees that received the treated material remained free of any serologic or biochemical evidence of hepatitis B infection during a 12-month follow-up, whereas the control chimpanzee had hepatitis B. After a later HBV challenge, the two healthy animals also had hepatitis B. The hydrophobic binding procedure seems to be useful for the adsorption of viral agents in blood components.