Investigation of porcine parvovirus among persons with hemophilia receiving Hyate:C porcine factor VIII concentrate.

Soucie, J M; Erdman, D D; Evatt, B L; Anderson, L J; Török, T J; El-Jamil, M; Barnhart, E; Tepper, M; Burrill, H N; Pickett, A M; Mengeling, W L

Soucie, J M; Erdman, D D; Evatt, B L; Anderson, L J; Török, T J; El-Jamil, M; Barnhart, E; Tepper, M; Burrill, H N; Pickett, A M; Mengeling, W L.

Afiliación

Soucie 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

Transfusion ; 40(6): 708-11, 2000 Jun.

Article en En | MEDLINE | ID: mdl-10864993

RESUMEN

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. STUDY DESIGN AND 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. CONCLUSION: 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.

Asunto(s)

Anticuerpos Antivirales/sangre; ADN Viral/sangre; Contaminación de Medicamentos; Factor VIII/efectos adversos; Hemofilia A/complicaciones; Infecciones por Parvoviridae/veterinaria; Parvoviridae/aislamiento & purificación; Enfermedades de los Porcinos/transmisión; Porcinos/virología; Adulto; Animales; Canadá/epidemiología; Hemofilia A/terapia; Humanos; Masculino; Parvoviridae/genética; Parvoviridae/inmunología; Infecciones por Parvoviridae/epidemiología; Infecciones por Parvoviridae/transmisión; Reacción en Cadena de la Polimerasa; Estudios Retrospectivos; Estudios Seroepidemiológicos; Método Simple Ciego; Porcinos/sangre; Estados Unidos/epidemiología; Viremia/veterinaria; Zoonosis

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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Parvoviridae / Porcinos / Enfermedades de los Porcinos / ADN Viral / Factor VIII / Contaminación de Medicamentos / Infecciones por Parvoviridae / Hemofilia A / Anticuerpos Antivirales Tipo de estudio: Observational_studies / Risk_factors_studies Límite: Adult / Animals / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: Transfusion Año: 2000 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

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