Low risk of viral infection after administration of vapor‐heated factor VIII concentrate

Mannucci, Pier Mannuccio; Schimpf, K.; Abe, Takaya; Aledort, Louis M.; Anderle, K; Brettler, Doreen B.; Hilgartner, Margaret W.; Kernoff, P. B. A.; Kunschak, M; McMillan, Clifford

doi:10.1046/j.1537-2995.1992.32292180141.x

Cited by 54 publications

(17 citation statements)

References 16 publications

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“…However, a subsequent multicenter international study of this concentrate carried out in 35 pa tients reported no case of HCV transmission [22], probably as a consequence of improved donor selection and screen ing. In the case observed in Bari the possibility of intrafami liar transmission of HCV cannot be exluded, because two close relatives of the patient were anti-HCV positive when the patient was first diagnosed.…”

Section: Discussionmentioning

confidence: 96%

Prevalence of Infection with the Hepatitis C Virus among Italian Hemophiliacs before and after the Introduction of Virally Inactivated Clotting Factor Concentrates: A Retrospective Evaluation

Mannucci¹,

Ciavarella²,

Schiavoni³

et al. 1994

Vox Sanguinis

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In July 1985, all coagulation factor concentrates were withdrawn from the market in Italy and replaced with virally inactivated concentrates. A retrospective survey comparing the prevalence of the antibody to the hepatitis C virus (anti-HCV) in hemophiliacs multitransfused with nonvirally inactivated concentrates until 1985 with that in previously untreated hemophiliacs transfused exclusively with virally inactivated concentrates since 1985 has been conducted in 9 Italian hemophilia centers. The centers, which follow about one-fourth of all the Italian hemophiliacs, provided information about 708 patients infused for the first time before 1985 (group A) and 80 patients infused for the first time between 1985 and 1991 (group B). The prevalence of anti-HCV was 83% (591/708) in group A and 6% (5/80) in group B. For the 5 anti-HCV-seropositive patients from group B, dry heating, hydrophobic interaction chromatography plus dry heating (2 patients), hot vapor and pasteurization were the virucidal methods used for the concentrates implicated in HCV transmission. In the case associated with pasteurization, there is the possibility of intrafamilial transmission of HCV It appears from this retrospective analysis that there has been a substantial reduction in the risk of HCV transmission since the adoption of virucidal methods. However, these methods do not eliminate completely the risk, which might be further reduced by the recent adoption of anti-HCV screening for plasma donations used to manufacture concentrates.

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Section: Discussionmentioning

confidence: 96%

Prevalence of Infection with the Hepatitis C Virus among Italian Hemophiliacs before and after the Introduction of Virally Inactivated Clotting Factor Concentrates: A Retrospective Evaluation

Mannucci¹,

Ciavarella²,

Schiavoni³

et al. 1994

Vox Sanguinis

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“…There have been no reported cases of HIV transmission after the introduction of concentrates that have been dry heated at 80°C for 72 hours, pasteurized at 60°C for 10 hours, vapor heated or solvent/detergent treated. [2][3][4] These methods have also drastically reduced the risk of transmission of HBV and hepatitis C virus, [1,2,14] which have a lipid envelope but are more heat-resistant than HIV. HAV is resistant to solvent/detergent treatment because it is not enveloped; it was responsible for outbreaks of hepatitis A among patients with hemophilia in the early 1990s.…”

Section: Viral Safety Issuesmentioning

confidence: 99%

“…The robust virucidal methods currently applied to concentrates have drastically reduced the risk of viral transmission. [1][2][3][4] Further important improvement in safety has been achieved by the availability of recombinant FVIII and FIX products.…”

mentioning

confidence: 99%

State of Care for Hemophilia in Pediatric Patients

2002

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On demand treatment of bleeding episodes is still the main approach to hemophilia care of patients of any age. Prompt infusion of coagulation factor concentrate in the home setting allows treatment of hemorrhages at early onset, reducing the incidence of complications and improving the quality of life. Nevertheless, the technological evolution and progressive improvement in the safety of therapeutic products have changed the management of the disease, particularly in children. The current availability of safer concentrates has drastically reduced the risk of transmission of blood-borne infections. Innovative approaches, such as early primary prophylaxis and immune tolerance induction, have become feasible and their introduction represents a major advance in the achievement of the main therapeutic goals: control of the bleeding diathesis and elimination of inhibitors. Prophylactic regimens have been shown to be effective in preventing the occurrence not only of joint bleeding but also of arthropathy when started early in children with severe hemophilia. Inhibitor development still represents the main complication of hemophilia treatment, making concentrate administration ineffective. Immune tolerance induction by daily infusion of coagulation factor concentrate was shown to eradicate the inhibitors in 63 to 83% of patients. These intensive treatment regimens are administered at home to very young children and create the problem of adequate venous access. Subcutaneous venous ports have been used in patients with hemophilia if peripheral veins could not be frequently accessed; however, the risk of infection is an important limit to their use.

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“…Viral inactivation techniques such as solvent/detergent (S/D) treatment and vapor heat treatment are accepted as effective in inactivating lipid-enveloped viruses and nonenveloped viruses, respectively [5,6,7,8,9,10]. …”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics, Efficacy and Safety of IMMUNATE® Solvent/Detergent (IMMUNATE® S/D) in Previously Treated Patients with Severe Hemophilia A: Results of a Prospective, Multicenter, Open-Label Phase III Study

Nemes¹,

Lissitchkov²,

Dobaczewski³

et al. 2008

Acta Haematol

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Low risk of viral infection after administration of vapor‐heated factor VIII concentrate

Cited by 54 publications

References 16 publications

Prevalence of Infection with the Hepatitis C Virus among Italian Hemophiliacs before and after the Introduction of Virally Inactivated Clotting Factor Concentrates: A Retrospective Evaluation

Prevalence of Infection with the Hepatitis C Virus among Italian Hemophiliacs before and after the Introduction of Virally Inactivated Clotting Factor Concentrates: A Retrospective Evaluation

State of Care for Hemophilia in Pediatric Patients

Pharmacokinetics, Efficacy and Safety of IMMUNATE® Solvent/Detergent (IMMUNATE® S/D) in Previously Treated Patients with Severe Hemophilia A: Results of a Prospective, Multicenter, Open-Label Phase III Study

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