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87 results
  • Value of prophylaxis vs on-demand treatment: Application of a value framework in hemophilia. [Journal Article]
  • HHaemophilia 2018; 24(5):755-765
  • Nugent D, O'Mahony B, … International Haemophilia Access Strategy Council
  • CONCLUSIONS: The hemophilia value framework affirmed value of primary and secondary prophylaxis vs on-demand therapy, with clinical benefit demonstrated in all three tiers. This analysis also demonstrates clinical utility of the value framework process in the determination of optimal and cost-effective hemophilia care for all stakeholders.
  • Drugs and Lactation Database (LactMed) [BOOK]
  • BOOKNational Library of Medicine (US): Bethesda (MD)
  • No information is available on the clinical use of antihemophilic factor (coagulation factor VIII) during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be ver...
  • Factor VIII products and inhibitor development in previously treated patients with severe or moderately severe hemophilia A: a systematic review. [Journal Article]
  • JTJ Thromb Haemost 2018; 16(6):1055-1068
  • Hassan S, Cannavò A, … van der Bom JG
  • CONCLUSIONS: Background Patients with severe hemophilia A who have been treated extensively with factor VIII products have a low but potentially serious risk of inhibitor development. It is unknown why these patients develop inhibitors, and data on product-related immunogenicity are scarce. Aims To summarize the currently available evidence on the relationship between inhibitor development and recombinant FVIII product type in previously treated patients (PTPs) with severe hemophilia A. Methods Longitudinal studies were included that reported on de novo inhibitor formation in patients with baseline FVIII activity levels of < 0.02 IU mL-1 who had been treated with FVIII for at least 50 days. Pooled incidence rates of inhibitor development according to product types were calculated with a random intercept Poisson regression model. Results Forty-one independent cohorts were included; 39 patients developed de novo inhibitors during 19 157 person-years of observation. The overall incidence rate was 2.06 per 1000 person-years, with a 95% confidence interval (CI) of 1.06-4.01. According to product type, the pooled incidence rates were 0.99 (95% CI 0.37-2.70) per 1000 person-years for patients treated with Advate, 5.86 (95% CI 0.25-134.92) per 1000 person-years for those treated with Kogenate/Helixate, 1.35 (95% CI 0.66-2.77) per 1000 person-years for those treated with Kogenate FS/Helixate NexGen, 12.05 (95% CI 1.53-94.78) per 1000 person-years for those treated with Refacto, and 4.64 (95% CI 0.82-26.43) per 1000 person-years for those treated with Refacto AF. Conclusion These results suggest that some products may be associated with increased immunogenicity. However, the low incidence of inhibitors in PTPs and the differences in study design may cause significant variation in estimates of risk.
  • International comparative field study evaluating the assay performance of AFSTYLA in plasma samples at clinical hemostasis laboratories. [Journal Article]
  • JTJ Thromb Haemost 2018; 16(3):555-564
  • St Ledger K, Feussner A, … Friedman KD
  • CONCLUSIONS: Introduction AFSTYLA (antihemophilic factor [recombinant] single chain) is a novel B-domain truncated recombinant factor VIII (rFVIII). For AFSTYLA, an approximate 50% discrepancy was observed between results of the one-stage (OS) and chromogenic substrate (ChS) FVIII activity assays. An investigation was undertaken to test whether there is a linear relationship between ChS and OS assay results that would allow reliable clinical interpretation of results independent of the assay method used. Aims To provide confidence in future clinical monitoring, this field study investigated the performance of AFSTYLA and a full-length rFVIII (Advate® ) in FVIII activity assays routinely performed in clinical laboratories. Methods The comparison of AFSTYLA and Advate was performed in an international, multicenter and blinded field study of simulated post-infusion samples. The study documented the extent of variability between methods and laboratories and characterized the relationship between the ChS and OS assays. Results Results from 23 laboratories demonstrate that intra and interlaboratory variability in OS assays were similar for both products. When comparing within the OS assay format, there was a similar and reagent-correlated variability in response to different activators for both AFSTYLA and Advate. The OS underestimation was highly predictable and consistent across the complete range of FVIII plasma concentrations. Conclusion Post-infusion plasma AFSTYLA levels can be monitored in patients by the OS and ChS assays. The consistent and predictable difference between the two assay formats provides clinicians with adequate guidance on how to interpret the results of the OS assay using a single conversion factor.
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