Investigation of porcine parvovirus among persons with hemophilia receiving Hyate:C porcine factor VIII concentrate.
BACKGROUND
Porcine clotting factor has been used for more than 15 years to treat severe bleeding episodes in persons with hemophilia who have antibodies to human clotting factor. In 1996, QC procedures revealed for the first time the presence of porcine parvovirus (PPV) in the product. This report describes an investigation to determine the extent of product contamination and to evaluate past recipients of porcine clotting factor (Hyate:C, Speywood Biopharm) for evidence of PPV infection.


METHODS
Stored specimens from 22 lots of previously released Hyate:C were tested for the presence of PPV DNA by PCR and nested PCR assays. Serum specimens from 98 recipients of Hyate:C and 24 controls who did not receive Hyate:C were tested for PPV antibodies by an immunofluorescence assay.


RESULTS
PPV DNA was detected in product from 21 of the 22 lots of Hyate:C, primarily by nested PCR testing. In contrast, none of the serum specimens from the 98 Hyate:C recipients tested positive for PPV IgG antibodies.


CONCLUSIONS
The risk of human disease from percutaneous exposure to low levels of PPV seems to be low. Nevertheless, the theoretical risk of human infection with PPV has led to manufacturing changes, including PCR screening of all porcine plasma, which are designed to eliminate this risk.
Soucie
J M
JM
Division of AIDS, STD, and TB Laboratory Research, and the Respiratory and Enterovirus Branch, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30033, USA. jps9@cdc.gov
Erdman
D D
DD
Evatt
B L
BL
Anderson
L J
LJ
Török
T J
TJ
El-Jamil
M
M
Barnhart
E
E
Tepper
M
M
Burrill
H N
HN
Pickett
A M
AM
Mengeling
W L
WL
D000328:Adult; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood*; D002170:Canada / Q000453:epidemiology; D004279:DNA, Viral / Q000097:blood*; D004340:Drug Contamination; D005169:Factor VIII / Q000009:adverse effects*; D006467:Hemophilia A / Q000150:complications* / Q000628:therapy; D006801:Humans; D008297:Male; D010321:Parvoviridae / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D010322:Parvoviridae Infections / Q000453:epidemiology / Q000635:transmission / Q000662:veterinary*; D016133:Polymerase Chain Reaction; D012189:Retrospective Studies; D016036:Seroepidemiologic Studies; D016037:Single-Blind Method; D013552:Swine / Q000097:blood / Q000821:virology*; D013553:Swine Diseases / Q000635:transmission*; D014481:United States / Q000453:epidemiology; D014766:Viremia / Q000662:veterinary; D015047:Zoonoses
D000914:Antibodies, Viral; D004279:DNA, Viral; D005169:Factor VIII