Document 0312
 DOCN  M9460312
 TI    Viral safety of solvent-detergent treated blood products.
 DT    9408
 AU    Horowitz B; Prince AM; Horowitz MS; Watklevicz C; New York Blood Center,
       NY 10021.
 SO    Dev Biol Stand. 1993;81:147-61. Unique Identifier : AIDSLINE
       MED/94229368
 AB    Laboratory research commencing in 1982 led to licensing in the United
       States in 1985 of a solvent/detergent (SD)-treated anti-haemophilic
       factor (AHF) concentrate. Licensing was based on (a) studies
       demonstrating the inactivation of several marker viruses [vesicular
       stomatitis virus (VSV), Sindbis virus, Sendai virus], human
       immunodeficiency virus (HIV), hepatitis B virus (HBV), and non-A, non-B
       hepatitis virus [NANBHV; now known to be principally hepatitis C virus
       (HCV)] added to AHF just before treatment, (b) the realization that the
       principal viruses of concern in a transfusion setting (e.g. HIV, HBV,
       NANBHV) were all lipid-enveloped, and (c) laboratory, preclinical and
       clinical evidence indicating that AHF and other proteins present in the
       preparation were unaffected. The applicability of the SD method to a
       wide range of products and preparations, high process recoveries, and a
       growing body of viral safety information linked with the failure of
       several other virus inactivation methods to eliminate hepatitis
       transmission fostered the adoption of SD technology by more than 50
       organizations world-wide. SD mixtures are now used in the preparation of
       products as diverse as intermediate purity and monoclonal antibody
       purified AHF and other coagulation factor concentrates, fibrin glue,
       normal and hyperimmune IgG and IgM preparations including those derived
       from tissue culture, plasma for transfusion, and various diagnostic
       controls. Over four million doses of SD-treated products have been
       administered, and numerous laboratory and clinical studies designed to
       assess virus safety have been conducted. SD treatment has been shown to
       inactivate > or = 10(9.2) tissue culture infectious doses (TCID50) of
       VSV, > or = 10(8.8) TCID50 of Sindbis virus, > or = 10(6.0) TCID50 of
       Sendai virus, > or = 10(7.3) duck infectious doses of duck HBV, > or =
       10(11.0) degrees TCID50 of HIV-1, > or = 10(6.0) TCID50 of HIV-2, > or =
       10(6.0) chimpanzee infectious doses (CID50) of HBV, > or = 10(5.0) CID50
       of HCV, > or = 10(6.0) TCID50 of cytomegalovirus, > or = 10(5.8) TCID50
       of herpes simplex virus type 1, > or = 10(4.0) TCID50 of PI-1, > or =
       10(6.0) TCID50 of murine leukemia virus (Mov-3), > or = 10(4.0) TCID50
       of murine xenotropic virus, and > or = 10(2.0) TCID50 of Rauscher murine
       leukemia ecotropic virus. Moreover, in ten prospective clinical studies,
       0/53, 0/427, and 0/455 patients susceptible to HBV, NANBHV (HCV), and
       HIV became infected on follow-up.(ABSTRACT TRUNCATED AT 400 WORDS)
 DE    Biological Products/ADVERSE EFFECTS/*STANDARDS  Blood/DRUG
       EFFECTS/*MICROBIOLOGY  Blood Proteins/DRUG EFFECTS  Clinical Trials
       Detergents/*PHARMACOLOGY  Drug Contamination/PREVENTION & CONTROL
       Protein Denaturation  Safety  Solvents/*PHARMACOLOGY  Virus
       Diseases/*PREVENTION & CONTROL/TRANSMISSION  Viruses/*DRUG EFFECTS
       JOURNAL ARTICLE  REVIEW  REVIEW, TUTORIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).