Absence of Hepatitis after Treatment with a Pasteurized Factor VIII Concentrate in Patients with Hemophilia and No Previous Transfusions

Schimpf, Kl.; Pm, Mannucci; Kreutz, W; Brackmann, H.-H.; Auerswald, Günter; Ciavarella, N.; Mösseler, J; DeRosa,; Kraus, Brigitte; Brueckmann, C

doi:10.1056/nejm198704093161505

Cited by 162 publications

(69 citation statements)

References 11 publications

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“…The mean age of patients differed according to severity of haemophilia and HCV status; patients with severe haemophilia, who were never infected, were younger [mean age 23 years, 95% confidence interval (CI) [19][20][21][22][23][24][25][26][27][28] …”

Section: Hepatitis Cmentioning

confidence: 99%

Hepatitis C infection among Dutch haemophilia patients: a nationwide cross‐sectional study of prevalence and antiviral treatment

et al. 2005

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Summary. Hepatitis C is a major co‐morbidity among patients with haemophilia who received inadequately or non‐virus‐inactivated clotting factor concentrates before 1992. The objectives of this study were to investigate the prevalence of hepatitis C and the use of antiviral therapies during the last decade among patients with haemophilia in the Netherlands. We performed a cross‐sectional study and a questionnaire was sent to all 1519 patients known with haemophilia in the Netherlands between 2001 and 2002. The study population for the present study consisted of 771 patients who had received clotting factor products before 1992 of whom 638 reported their hepatitis C status. In total, 441 of the 638 (68%) patients ever had a positive test for hepatitis C virus (HCV); 344 patients (54%) had a current infection, and 97 (15%) had cleared the virus. Among 344 patients currently HCV infected, 111 (32%) had received treatment for hepatitis C, while 34% (33/97) of patients with an infection in the past had been treated for hepatitis C. In 2002 the prevalence of hepatitis C among patients with haemophilia who received clotting factor products before 1992 was 54%. The majority of patients with a current HCV infection had not been treated with antiviral therapy.

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Section: Hepatitis Cmentioning

confidence: 99%

Hepatitis C infection among Dutch haemophilia patients: a nationwide cross‐sectional study of prevalence and antiviral treatment

et al. 2005

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“…[6][7][8] Haemate ® P has also had an excellent safety record with regards to blood-borne infections over the past 25 years of clinical use. [9][10][11][12] Clinical efficacy data were collected for Haemate ® P through a large retrospective study organized by the Canadian Hemophilia Centers. 13 Other published studies include a retrospective analysis of the efficacy and safety of Haemate ® P in preventing bleeding during surgery or invasive procedures in 26 Italian VWD patients, 14 as well as two prospective, multicenter, open-label, non-randomized studies conducted in the USA on Humate ® -P used in urgent bleeding and urgent surgical events.…”

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confidence: 99%

Clinical use of Haemate(R) P in inherited von Willebrand's disease: a cohort study on 100 Italian patients

Federici¹,

Castaman²,

Franchini³

et al. 2007

Haematologica

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“…9 Haemate P has demonstrated a good safety record in clinical practice. [10][11][12] The Importance of Pharmacokinetics…”

Section: Managing Von Willebrand Diseasementioning

confidence: 99%

“…Although rare, thrombotic complications may arise from repeated administrations of concentrate during vWF replacement therapy, especially in a post-operative setting. [6][7][8][9][10][11][12][13] Due to the different ratios of vWF:RCo/FVIII:c, the various available concentrates sustain FVII levels at different rates.…”

Section: Managing Von Willebrand Diseasementioning

confidence: 99%

“…9 Haemate P has demonstrated a good safety record in clinical practice. [10][11][12] The Importance of PharmacokineticsThe pharmacokinetic profiles of the various concentrates are important considerations in the treatment of vWD. Although they are all considered members of the same drug class, it is important to note that they are not equivalent products for the treatment of vWD.…”

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Importance of Pharmacokinetics in the Treatment of von Willebrand Disease

Kessler¹

2007

European Oncology &Amp; Haematology

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von Willebrand disease (vWD) and haemophilia A are the most frequent bleeding disorders in the general population, occurring in 66-100 people per million worldwide. 1 vWD is caused by both qualitative and quantitative defects in von Willebrand factor (vWF) resulting in a dual defect in haemostasis, i.e. the abnormal platelet adhesion due to reduced and/or dysfunctional vWF (primary haemostasis) and the abnormal coagulation due to low levels of factor VIII (FVIII) (secondary haemostasis).vWF serves as a bridge between platelets and subendothelium and is essential for the cohesion of platelets. Thus, vWF has a primary function in the formation of thrombi in blood coagulation. In addition, vWF binds to circulating FVIII and acts as a chaperone, protecting FVIII from proteolytic degradation. In the absence of or after a decrease in vWF, the half-life of FVIII in the circulation is reduced significantly. 2 However, the absence of vWF does not affect FVIII synthesis. Classification of von Willebrand DiseaseSince vWD is caused by both qualitative and quantitative mutations in vWF, the disease is classified according to the degree of qualitative and quantitative involvement (see Table 1). 3 Patients with type 1 vWD present with a decrease in the production of vWF and most remain mildly symptomatic. Type 2 vWD is the result of a vWF-dependent platelet function. 4,5 Type 3 vWD is the least common subtype and results from absent or profound reductions in plasma vWF and the absence of vWF in platelets and endothelial cells. In general, type 3 vWD is diagnosed in the first year of life due to severe and sometimes life-threatening bleeds. Managing von Willebrand DiseaseThe treatment options for vWD are dependent on the subtype of the disease.The main goal of treatment is to normalise the levels of both vWF and FVIII to achieve haemostasis. 6 Demopressin (DDAVP) is the gold standard for the treatment of type 1 vWD. DDAVP induces the release of endogenous vWF and helps to correct vWF/FVIII levels in the majority of these patients.However, DDAVP is not effective in type 3 vWD or in severe forms of types 1 and 2 vWD. Also, DDAVP is not recommended in patients with type 2A vWD because any increase in vWF is dysfunctional. 7 In patients with type 2B vWD, DDAVP can induce transient thrombocytopenia, thus it is generally contraindicated. 8 In patients in whom DDAVP either is not effective or is contraindicated, the current treatment option of choice is transfusional therapy with virally inactivated plasma-derived FVIII/vWF concentrates. Since the 1980s, plasma-derived FVIII/vWF concentrates have been used successfully to treat types 3 and 2B vWD patients and types 1 and 2 patients who are unresponsive to DDAVP. 9 Currently, recombinant-concentratecontaining vWF is unavailable, and the majority of products are intermediatepurity plasma-derived FVIII concentrates containing vWF. Approved in 1981, Haemate P has become the most widely used concentrate in vWD. 9 Haemate P has demonstrated a good safety record in clinical practice. [10][11...

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Absence of Hepatitis after Treatment with a Pasteurized Factor VIII Concentrate in Patients with Hemophilia and No Previous Transfusions

Cited by 162 publications

References 11 publications

Hepatitis C infection among Dutch haemophilia patients: a nationwide cross‐sectional study of prevalence and antiviral treatment

Hepatitis C infection among Dutch haemophilia patients: a nationwide cross‐sectional study of prevalence and antiviral treatment

Clinical use of Haemate(R) P in inherited von Willebrand's disease: a cohort study on 100 Italian patients

Importance of Pharmacokinetics in the Treatment of von Willebrand Disease

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