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M9460693.TXT
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1994-06-25
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Document 0693
DOCN M9460693
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).