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ARS Home » Midwest Area » Ames, Iowa » National Animal Disease Center » Virus and Prion Research » Research » Publications at this Location » Publication #102347
Title: INVESTIGATION OF PORCINE PARVOVIRUS AMONG PERSONS WITH HEMOPHILIA RECEIVING HYATE:C PORCINE FACTOR VIII CONCENTRATE

Author
item SOUCIE, J. - CENTERS FOR DISEASE CNTRL
item ERDMAN, DEAN - CENTERS FOR DISEASE CNTRL
item EVATT, BRUCE - CENTERS FOR DISEASE CNTRL
item ANDERSON, LARRY - CENTERS FOR DISEASE CNTRL
item TOROK, THOMAS - CENTERS FOR DISEASE CNTRL
item EL-JAMIL, MUHYDINE - CENTERS FOR DISEASE CNTRL
item BARNHART, ELIZABETH - CENTERS FOR DISEASE CNTRL
item TEPPER, MARTIN - CTR DISEASE CNTRL, CANADA
item BURRILL/PICKETT, HUGH/A.M. - IPSEN/CAMR, ENGLAND
item Mengeling, William

Submitted to: Lancet
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 1/1/2000
Publication Date: N/A
Citation: N/A

Interpretive Summary: Porcine clotting factor [Hyate:C (registered trademark)] 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 porcine parvovirus (PPV), a reproductive pathogen of pigs, was identified as a contaminant in a commercial preparation of porcine clotting factor. This finding raised questions as to the prevalence of PPV in porcine clotting factor and the consequences of direct exposure of people to PPV. To address these questions, commercial lots of porcine clotting factor were tested for PPV and sera collected from people who were likely to have been exposed to PPV through a contaminated product were tested for antibody for PPV. These tests indicated a high prevalence of contamination in the commercial product, but no evidence that people had become infected. However, despite indications that infection of people with PPV is unlikely, ,all preparations of porcine clotting factor are now tested for PPV and onl those deemed free of PPV are used for treatment.

Technical Abstract: Background: Porcine clotting factor [Hyate:C (registered trademark)] 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, quality control 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 Hyate:C 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 polymerase chain reaction (PCR) and nested PCR assays. Serum specimens from 98 recipients of Hyate:C and 24 non-infused controls were tested for anti-PPV antibodies by an immunofluorescence assay. Findings: PPV DNA was detected in product from 21 of the 22 lots of Hyate:C, primarily by nested PCR testing. On the other hand, none of the serum specimens from the 98 Hyate:C recipients tested positive for anti-PPV IgG antibodies. Interpretation: These findings suggest that the risk of human disease from percutaneous exposure to low-levels of PPV is low. Nevertheless, the theoretical risk of human infection with PPV has led to manufacturing changes, including PCR screening of all porcine plasma, designed to eliminate this risk. Key Words: Hemophilia, Haemophilia, Factor VIII, Inhibitors, Swine, Parvovirus, Infectious disease, Blood safety.