Human parvovirus B19 infection in hemophiliacs first infused with two high‐purity, virally attenuated factor Vlll concentrates

Abstract

Human parvovirus B19 can be transmitted by coagulation factor concentrates and is highly resistant to virucidal methods. To evaluate whether the additional removal of virus by chromatographic methods during the manufacture of high-purity concentrates reduces the risk of B19 transmission, we have prospectively evaluated the rate of anti-B19 seroconversion in two groups of susceptible (anti-B19 negative) hemophiliacs infused with high-purity, heated (pasteurized) or solvent-detergent-treated factor VIII concentrates. Both products infected a relatively high proportion of patients (nine of 20).

A linked donor-recipient study to evaluate parvovirus B19 transmission by blood component transfusion

“…[1][2][3][4][5] These cases, combined with the potential for very high B19V DNA concentrations (up to 10 12 IU/mL) in plasma donations 4 and the relative resistance of B19V to inactivation methods, 4,6 have led to B19V DNA testing of plasma donations to ensure that manufacturing plasma pools destined for plasma derivatives have a B19V DNA concentration less than or equal to 10 4 IU/mL, a limit proposed by the Food and Drug Administration (FDA). 7-9 The same limit for this so-called "in process testing" is a European regulatory requirement for anti-D immunoglobulin (Ig) preparations and plasma treated for virus inactivation.…”

The obstetric and gynaecological management of women with inherited bleeding disorders – review with guidelines produced by a taskforce of UK Haemophilia Centre Doctors’ Organization

“…Plasmaderived clotting factor concentrates, treated with the currently available virucidal method have no risk of transmitting the hepatitis B and C virus and human immunodeficiency virus [30]. However, they have the potential to transmit hepatitis A and parvovirus B19 [31,32]. While not normally a serious infection in non-immunocompromised adults, parvovirus infection of the fetus may result in hydrops fetalis and fetal death.…”

Human Parvovirus B19 Antibodies Are Less Frequent among Patients Treated with Factor IX Concentrate Inactivated by Ultrafiltration: A Report from a Single Spanish Institution

“…The human parvovirus B19 (B19), a thermoresistant non-lipid enveloped virus, can be transmitted by coagulation factor concentrates despite the virucidal methods [1,2]. Therefore, in patients with congenital bleeding disorders infused with plasma-derived factor VIII or factor IX concentrates, the prevalence of antibodies against B19 is higher than among the general population [3,4].…”

“…Transmission of B19 has been reported after infusion of heated (dry-heated, steamheated and pasteurized) or solvent-detergent concentrates [1,2,5]. Furthermore, B19 can be transmitted by concentrates with double viral inactivation: solvent-detergent and heat for 30 min in a lyophilized state at 100 C [6].…”