Viral safety of solvent/detergent-treated blood products

Horowitz, Bernard; Prince, A. M.; Hamman, J. P.; Watklevicz, C

doi:10.1097/00001721-199412003-00006

Cited by 75 publications

(57 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Furthermore, formulation as a 10% liquid preparation offers the advantage of easier use by physicians, pharmacists, nurses and patients, and allows for smaller volumes of product to be infused (compared to 5% formulations). In the past, various state-of-the-art methods for virus reduction were developed and described in publications [8][9][10][11][12][13][14][15][16][17][18][19]. IGIV 10% is processed using 3 independent validated viral inactivation or removal steps: solvent/detergent (S/D) treatment, nanofiltration (35 nm), and low-pH incubation with elevated temperature.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of the New Intravenous Immunoglobulin IGIV 10% in Adults with Chronic Idiopathic Thrombocytopenic Purpura

Varga

Volková

Leibl

et al. 2006

Transfus Med Hemother

View full text Add to dashboard Cite

Background: Intravenous immunoglobulin (IGIV) 10% is a newly developed 10% liquid immunoglobulin preparation for intravenous use where 3 dedicated virus reduction steps have been integrated into the manufacturing process. The efficacy and safety of this product were assessed in a prospective multicenter study in chronic ITP (idiopathic thrombocytopenic purpura) patients with platelet counts of =20 × 109/l. Patients and Methods: 23 adult ITP patients received the product at a total dose of 2 g/kg body weight administered over 2-5 days, and were followed for 4 weeks. Results: Of the 21 subjects included in the Per-Protocol Analysis Data Set, 15 responded successfully to treatment (71.4%). Eleven subjects in this group attained a platelet count increase to >100 × 109/l, and 8 reached a platelet count of >200 × 109/l. All 15 responders achieved a platelet count of =50 × 109/l by day 8, and 14 of them reached this level by day 5. The median duration of platelet response was 25 days, and the highest median platelet count in the responders was 182 × 109/l. A total of 81 infusions were administered to the 23 subjects in the Safety Analysis Data Set over the course of the study. There were 40 non-serious adverse events related to the use of the study drug - 35 mild, 3 moderate, and 2 severe. The most frequent related adverse events were headache and pyrexia. Conclusion: The results obtained in this study demonstrate that IGIV 10% is effective in the treatment of adult subjects with chronic ITP and indicate a good safety profile.

show abstract

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of the New Intravenous Immunoglobulin IGIV 10% in Adults with Chronic Idiopathic Thrombocytopenic Purpura

Varga

Volková

Leibl

et al. 2006

Transfus Med Hemother

View full text Add to dashboard Cite

show abstract

“…This SD treatment is known to be highly virucidal on plasma-borne lipid-enveloped viruses [24,25] such as hepatitis B virus, hepatitis C virus and HIV. This result suggests that a large plasma pool of SD-treated fibrin glue combined with a synthetic antifibrinolytic could be a safe alternative to autologous or single-donor fibrinogen adhesive.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of a Fibrin Sealant Free of Bovine-Derived Components in an Experimental Vas Anastomosis Study

et al. 2000

View full text Add to dashboard Cite

Objectives: The risk of transmission of bovine spongiform encephalopathy cannot be excluded from the use of bovine-derived products. The present study was undertaken to evaluate the performance of a new fibrin glue free of bovine-derived components in vas anastomosis and to compare this product to conventional vas anastomosis with fibrin glue. Methods: Bilateral delayed vas anastomosis was performed in 40 Sprague-Dawley rats. All animals underwent a fibrin glue-assisted vas anastomosis with three transmural sutures tied prior to fibrin glue application. The composition and preparation of fibrin glue was similar for all vas anastomoses except the fibrinolysis inhibitor component which was aprotinin (3,000 KUI/ml) in group 1 and tranexamic acid (10 mg/ml) in group 2. The animals (20 rats in both groups) were sacrificed 7 weeks postoperatively and evaluated for gross patency, presence of sperm granuloma and tensile strength measurements at the anastomosis site. Results: No difference was found between the 2 groups for all parameters evaluated whether a bovine-derived or a synthetic fibrinolysis inhibitor component was used. Conclusion: This study showed that tranexamic acid, a fibrinolysis inhibitor, can be substituted for conventional fibrin glue thereby avoiding the risks of bovine products.

show abstract

“…S/D is used for the inactivation of lipid-enveloped viruses such as HIV, hepatitis B virus, and hepatitis C virus [19]. S/D requires removal from the IVIG after viral inactivation.…”

Section: Specific Ivig Productsmentioning

confidence: 99%

Immunoglobulin Replacement Therapy: A Twenty-Year Review and Current Update

Saeedian

Randhawa

2014

Int Arch Allergy Immunol

View full text Add to dashboard Cite

Objective: The expansion of immunoglobulin replacement to multiple disease entities marks a decade-long advancement in immune therapy. Parallel to its extension, the characteristics and composition of immunoglobulin products have diversified. The aim of this study was to summarize a 20-year comprehensive literature review of currently commercially available immunoglobulin products, particularly examining individual product properties in a comparative format. Data Sources/Study Selections: The literature review was performed using PubMed and Ovid, screening a time span of 2 decades. Both authors reviewed the obtained articles for acceptable quality, and the selection was narrowed down based on criteria for randomized clinical and therapeutic trials. Results: Product-specific characteristics in terms of purification strategy, stabilizers, composition, and viral inactivation were found among the immunoglobulin products investigated. Such differing characteristics manifest in their variable clinical safety and efficacy as assessed by the comparative product analysis. In subgroups of patients, subcutaneous immunoglobulin therapy may be an alternative to intravenous immunoglobulin (IVIG) therapy with an equal efficacy and a lower number of systemic adverse events. Conclusion: Only few comprehensive clinical synopses are available to clearly demonstrate the differences in IVIG products despite the widespread clinical use of the therapy. This review defines significant characteristics of individual immunoglobulin products, noting important differences in product development and application and allowing informed clinical decisions to match a product with patients' risk factors and comorbidity. This balanced approach to gammaglobulin replacement therapy is imperative to produce the highest clinical efficacy and lowest number of adverse events.

show abstract

Viral safety of solvent/detergent-treated blood products

Cited by 75 publications

References 0 publications

Efficacy and Safety of the New Intravenous Immunoglobulin IGIV 10% in Adults with Chronic Idiopathic Thrombocytopenic Purpura

Efficacy and Safety of the New Intravenous Immunoglobulin IGIV 10% in Adults with Chronic Idiopathic Thrombocytopenic Purpura

Evaluation of a Fibrin Sealant Free of Bovine-Derived Components in an Experimental Vas Anastomosis Study

Immunoglobulin Replacement Therapy: A Twenty-Year Review and Current Update

Contact Info

Product

Resources

About