Human Immunoglobulins for intravenous use and hepatitis C viral transmission.
Abstract
Receive: RSS Feeds, eTOCs, free email alerts (when new articles cite this article), more» Information about commercial reprint orders: http://cvi.asm.org/site/misc/reprints.xhtml To subscribe to to another ASM Journal go to: http://journals.asm.org/site/subscriptions/ CLINICAL AND DIAGNOSTiC LABORATORY IMMUNOLOGY, Nov. 1994, 1071-412X/94/$04.00+0 p. 613-619 Vol. 1, No. 6 Human Immunoglobulins for Intravenous Use and Hepatitis C Viral Transmissiont HERBERT B. SLADE* Clinical Research and Development, Department of Allerg/Immunology/AIDS, Rhone-Poulenc Rorer, Collegeville, Pennsylvania INTRODUCTION On February 23, 1994, a U.S. Food and Drug Administration (FDA)-licensed immunoglobulin intravenous (IGIV) manufacturer initiated a worldwide withdrawal of two products following an accumulation of 14 reported cases of hepatitis in American and European patients receiving one of these products. By July 1994, this number had grown to 112 in the United States alone (5). A newly licensed version of the product in question has since been introduced following the incorporation of a solvent-detergent treatment in the manufacturing process. This most recent episode has brought to light some unresolved questions concerning the past and future safety of IGIV products with respect to viral transmission in general and hepatitis C virus (HCV) in particular. HCV HCV is a small enveloped virus containing -10 kb of single-stranded RNA, with a