Hepatitis A Virus Transmission
by Blood Products in the
United States

Mosley, James W.; Nowicki, Marek; Kasper, Carol K.; Donegan, Elizabeth; Aledort, Louis M.; Hilgartner, Margaret W.; Operskalski, Eva A.; Group, None The Transfusion Safety Study

doi:10.1159/000462666

Cited by 6 publications

(4 citation statements)

References 12 publications

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“…The level of protection that might be conferred by these antibodies is unknown. This finding is similar to that in substituted haemophiliacs where the detection of anti-HAV antibodies is also a frequent finding [25,26] . In hemophiliacs, the high concentration of antibodies in plasma preparations of multiple donors and the frequency of their administration facilitate the passive transmission of antibodies.…”

Section: Discussionsupporting

confidence: 89%

Prevalence of anti-HAV antibodies in multitransfused patients with beta-thalassemia

Siagris

Kouraklis-Symeonidis²,

Konstantinidou³

et al. 2008

WJG

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AIM:To detect the prevalence of anti-HAV IgG antibodies in adult multitransfused beta-thalassemic patients. METHODS:We studied 182 adult beta-thalassemic patients and 209 controls matched for age and sex from the same geographic area, at the same time. Anti-HAV IgG antibodies, viral markers of hepatitis B virus (HBV) and hepatitis C virus (HCV) infection were evaluated. RESULTS:Anti-HAV IgG antibodies were detected more frequently in thalassemic patients (133/182; 73.1%) than in healthy controls (38/209; 18.2%, P < 0.0005). When we retrospectively evaluated the prevalence of anti-HAV IgG antibodies in 176/182 (96.7%) thalassemic patients, whose medical history was available for the previous ten years, it was found that 83 (47.2%) of them were continuously anti-HAV IgG positive, 16 (9.1%) acquired anti-HAV IgG antibody during the previous ten years, 49 (27.8%) presented anti-HAV positivity intermittently and 28 (15.9%) were anti-HAV negative continuously. CONCLUSION:Multitransfused adult beta-thalassemic patients present higher frequency of anti-HAV IgG a n t i b o d i e s t h a n n o r m a l p o p u l a t i o n o f t h e s a m e geographic area. This difference is difficult to explain, but it can be attributed to the higher vulnerability of thalassemics to HAV infection and to passive transfer of anti-HAV antibodies by blood transfusions.

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Section: Discussionsupporting

confidence: 89%

Prevalence of anti-HAV antibodies in multitransfused patients with beta-thalassemia

Siagris

Kouraklis-Symeonidis²,

Konstantinidou³

et al. 2008

WJG

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“…Therefore the risk of transmission of non-enveloped viruses cannot be excluded completely [11]. Nowadays plasma pools are screened for HAV and Parvovirus B19 to reduce transmission risk.…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of a plasma‐derived monoclonal purified factor VIII concentrate during 10 years of follow‐up

Mauser‐Bunschoten¹,

Posthouwer²,

Fischer

et al. 2007

Haemophilia

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In 1995, AAFACT, a new monoclonal purified factor VIII concentrate (FVIII), derived from human plasma, was introduced in the Netherlands. The monoclonal purification based production process includes a viral inactivation step by solvent/detergent treatment. Products manufactured according to this procedure, for example Hemofil M are used worldwide. The aim of the present study was to assess inhibitor development in a large cohort of previously treated patients (PTPs) who were followed up for 10 years. In addition, efficacy, HIV and hepatitis C virus (HCV) transmission, and allergic reactions were monitored. All 165 patients with severe haemophilia A (FVIII<1%) known at the van Creveldkliniek who ever used AAFACT during the period from October 1995 to September 2005 were included. Two of them were previously untreated patients (PUPs) and two others had <50 exposure days. Data on FVIII consumption, number of exposures, bleedings and hospitalization days were collected from start of AAFACT until last clinical and laboratory evaluation while on this product. At the end of follow-up, 91 patients were still using this plasma-derived FVIII. Median age at start of follow-up was 26 years (range 1-52). None of the patients reported lack of efficacy. Median FVIII consumption per patient during follow-up was 2058 IU kg(-1) bodyweight per year, and median number of exposures was 148 per year. During 1029 patient-years of follow-up, one inhibitor was diagnosed in a previously treated patient PTP. This patient developed high titre inhibitor following surgery for which he, during 1 week, had been treated with continuous infusion with recombinant FVIII. No inhibitor occurred during 68 cases of surgery using continuous infusion with AAFACT. No viral transmissions or other adverse events occurred during 10 years of follow-up; AAFACT appeared to be an effective and safe FVIII product.

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“…The development of recombinant factor VIII (rFVIII) replacement therapy represents an important advance in infusion therapy for treatment of hemophilia. Use of early FVIII concentrates derived from plasma has been associated with the transmission of blood‐borne viruses such as hepatitis A, B, or C and human immunodeficiency virus (HIV) [1–5]. Concerns regarding the infectious disease risks of plasma‐derived concentrates, along with development and refinement of molecular biology techniques in the 1970s and 1980s, fueled development of rFVIII products [6,7].…”

Section: Introductionmentioning

confidence: 99%

Human recombinant DNA-derived antihemophilic factor in the treatment of previously untreated patients with hemophilia A: final report on a hallmark clinical investigation

Lusher

Abildgaard

Arkin

et al. 2004

Journal of Thrombosis and Haemostasis

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Summary. Background: Development of recombinant factor VIII (rFVIII) replacement therapy represents a milestone in the treatment of hemophilia A. Objective: The objective of this long‐term, multicenter study was to assess the safety, efficacy and rate of inhibitor formation of rFVIII (Kogenate®) in the treatment of hemophilia A in a group of previously untreated patients (PUPs). Patients and methods: Between January 1989 and October 1997, 102 evaluable patients (mean age 3.9 years) were treated with rFVIII as sole therapy for prophylaxis against bleeding or for hemorrhage. Patients with mild hemophilia were treated for ≥2 years, while those with moderate or severe hemophilia were treated for ≥5 years or 100 exposure days. Results: All patients responded well to therapy, so that 82% of bleeding episodes required a single infusion for treatment. Only four mild drug‐related adverse events were recorded during the study for an overall rate of 0.03% (4/13 464 infusions). No viral seroconversions were observed. The inhibitor incidence in PUPs with severe hemophilia was 29% (19/65). Overall, inhibitory antibodies developed in 21 patients (20.6%). Inhibitor titers were low (<10 Bethesda Units) in nine of the 21 patients despite continued episodic treatment with rFVIII and transient in eight patients receiving episodic treatment (seven low titer, one high titer). Eight high‐titer inhibitor patients were treated with immune‐tolerance induction therapy; five had successful outcomes. Conclusions: The observed incidence of inhibitor formation is similar to studies of PUPs receiving plasma‐derived FVIII. These results demonstrate the safety and efficacy of rFVIII in long‐term treatment of hemophilia A.

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Hepatitis A Virus Transmission by Blood Products in the United States

Cited by 6 publications

References 12 publications

Prevalence of anti-HAV antibodies in multitransfused patients with beta-thalassemia

Prevalence of anti-HAV antibodies in multitransfused patients with beta-thalassemia

Safety and efficacy of a plasma‐derived monoclonal purified factor VIII concentrate during 10 years of follow‐up

Human recombinant DNA-derived antihemophilic factor in the treatment of previously untreated patients with hemophilia A: final report on a hallmark clinical investigation

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