Hepatitis C virus transmission by monoclonal antibody purified factor VIII concentrate

Berntorp, Erik; Nilsson, Inga Marie; Ljung, Rolf; Widell, Anders

doi:10.1016/0140-6736(90)93075-z

Cited by 35 publications

(13 citation statements)

References 3 publications

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“…Nearly 90% of the patients in this study had received more than 20 exposures to previous FVIII products, and 39.6% of the patients were seropositive for HCV and 10.4% were seropositive for HBsAg at the start of the treatment period. Despite improved methods of viral attenuation of pdFVIII preparations, the transmission of certain blood-borne viruses, such as hepatitis C [19], hepatitis A [20], parvovirus B19 [21] and HIV [22] has occasionally been associated with the use of such concentrates, undermining confidence in their safety. Recombinant FVIII products greatly reduce the risk of infusion-related disease transmission, and since they became available in many countries in the 1990s, there have been no confirmed cases of pathogen transmission with rFVIII use.…”

Section: Discussionmentioning

confidence: 99%

“…We have previously reported that among patients with haemophilia in a single centre in China, 19.2% were hepatitis B surface antigen (HBsAg) positive and 60% were hepatitis C virus-antibody (HCV Ab) positive [3]. Although most are now treated to inactivate lipid-enveloped virus types, the concentrates used in China remain predominantly plasma derived.…”

Section: Introductionmentioning

confidence: 99%

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Safety and efficacy of a sucrose‐formulated recombinant factor VIII product for the treatment of previously treated patients with haemophilia A in China

Shi

Zhao

et al. 2007

Haemophilia

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The use of plasma-derived products has contributed to a high rate of blood-borne infections among haemophilia patients in China. Recombinant factor VIII (rFVIII) products that are manufactured without human or bovine albumin and include dedicated viral inactivation steps, hold a significant safety advantage over plasma products. However, there is little information published on the use of rFVIII products in non-caucasian populations. This is the first reported evaluation of the efficacy and safety of a rFVIII product in Chinese haemophiliacs. An open-label, non-randomized, prospective, multicentre trial enroled previously treated Chinese patients with haemophilia A. All treatments were administered using a sucrose-formulated rFVIII-FS (Kogenate((R))). Forty-nine patients received totals of 291 infusions (mean, 5.94/patient) and 742 140 IU rFVIII-FS (mean, 2550.3 IU/infusion). Of the 60 acute bleeding episodes that were treated, 90% were successfully managed with only one (81.7%) infusion or two (8.3%) infusions. Physicians reported haemostasis control for acute bleeds to be 'Excellent' or 'Improved' with rFVIII-FS therapy. No FVIII inhibitors were detected in any patient. Only one treatment-related adverse event was reported, which was mild dizziness that resolved spontaneously. rFVIII-FS was efficacious, safe and well tolerated in the treatment of previously treated patients with haemophilia A in China.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Safety and efficacy of a sucrose‐formulated recombinant factor VIII product for the treatment of previously treated patients with haemophilia A in China

Shi

Zhao

et al. 2007

Haemophilia

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“…Effective elimination of HCV from coagulation concentrates has been achieved by virusinactivation steps in the manufacturing process which were introduced in the mid-1980s. Even in recent years, however, there have been occasional reports of possible HCV transmission by concentrates, and there is clearly a need for continued close surveillance (Berntorp et al, 1990;Schulman et al, 1992).…”

Section: Discussionmentioning

confidence: 99%

Investigation of chronic hepatitis C infection in individuals with haemophilia: assessment of invasive and non‐invasive methods

Hanley

Jarvis²,

Andrews

et al. 1996

Br J Haematol

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Hepatitis C virus (HCV) infection is the major cause of chronic liver disease in individuals with haemophilia. A wide spectrum of disease severity is found in this group, ranging from mild hepatitis to cirrhosis. We have studied a cohort of 87 anti-HCV positive haemophiliacs who have been infected with HCV for 10-25 years and assessed the relative value of invasive and non-invasive methods of evaluating liver disease. The severity of liver disease was assessed using ultrasound scan (n = 77), upper GI endoscopy (n = 50), laparoscopic liver inspection (n = 33) and liver biopsy (n = 22). Invasive investigations were performed without any significant bleeding complications. Evidence of severe liver disease was found in approximately 25% of patients. There was agreement between the severity of liver histology and the information derived from the laparoscopic liver inspection, endoscopy and ultrasound in 86%. Co-infection with HIV was significantly associated with more severe liver disease (P = 0.006). This study provides further evidence that liver disease is emerging as a major complication in haemophiliacs and severe liver disease is more common in those co-infected with HIV. We have shown the potential value of laparoscopic liver inspection, in combination with endoscopy and ultrasound, in staging the extent of liver disease, and suggest that most patients may be managed without resorting to liver biopsy.

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“…Nevertheless, continued surveillance of recipients of all plasma‐derived products is essential, as inadvertent viral transmission could still occur. Incidents of transmission of hepatitis C and hepatitis B viruses by heat‐treated PCC and factor VIII concentrates have been reported in this decade [29–31]. Parvovirus B19 is a nonlipid enveloped virus that is resistant to chemical and physical inactivation.…”

Section: Safetymentioning

confidence: 99%

Recombinant factor VIIa versus aPCCs in haemophiliacs with inhibitors: treatment and cost considerations

Teitel

1999

Haemophilia

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For haemophiliacs with factor VIII inhibitor titres greater than approximately 5 Bethesda Units, haemostasis is best achieved with activated prothrombin complex concentrates (aPCCs, AUTOPLEX®T and FEIBA®) and the recently approved recombinant factor VIIa (rFVIIa). The optimal treatment should be determined by consideration of efficacy, safety, availability, cost and convenience. The current evidence does not allow definitive conclusions to be drawn regarding the relative efficacy of aPCCs and rFVIIa. The principal safety concerns are transmission of viral or other pathogens, thrombogenicity and immunogenicity. The two aPCCs are derived from human plasma and therefore carry the potential for transmitting viruses. This risk is negligible for rFVIIa, although this product could theoretically transmit animal pathogens. The aPCCs are clinically safe in most applications. Likewise, rFVIIa should be considered potentially thrombogenic, though with a low risk. The aPCCs contain detectable factor VIII and can therefore be immunogenic, but in practice this rarely affects their efficacy. The costs of single doses of aPCCs and rFVIIa are similar, but a treatment course of rFVIIa typically requires more doses. Treatment with rFVIIa may be more cumbersome owing to the requirement for more frequent administration. In addition, as for any product for which there is only a single supplier, availability could be vulnerable in some circumstances.

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Hepatitis C virus transmission by monoclonal antibody purified factor VIII concentrate

Cited by 35 publications

References 3 publications

Safety and efficacy of a sucrose‐formulated recombinant factor VIII product for the treatment of previously treated patients with haemophilia A in China

Safety and efficacy of a sucrose‐formulated recombinant factor VIII product for the treatment of previously treated patients with haemophilia A in China

Investigation of chronic hepatitis C infection in individuals with haemophilia: assessment of invasive and non‐invasive methods

Recombinant factor VIIa versus aPCCs in haemophiliacs with inhibitors: treatment and cost considerations

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