Gholamreza Toogeh; Hassan Abolghasemi; Peyman Eshghi; Mohammadreza Managhchi; Mohammadreza Shaverdi-niasari; Katayoon Karimi; Samin Roostaei; Neda Emran; Alireza Abdollahi
Volume 11, Issue 3 , July 2016, , Pages 204-209
Abstract
Background: Recombinant activated factor VII induces hemostasis in patients with coagulopathy disorders. AryoSeven™ as a safe Iranian Recombinant activated factor VII has been available on our market. This study was performed to establish the safety of AryoSeven on patients with coagulopathy disorder. ...
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Background: Recombinant activated factor VII induces hemostasis in patients with coagulopathy disorders. AryoSeven™ as a safe Iranian Recombinant activated factor VII has been available on our market. This study was performed to establish the safety of AryoSeven on patients with coagulopathy disorder. Methods: This single-center, descriptive, cross sectional study was carried out in Thrombus and Homeostasis Research Center ValiAsr Hospital during 2013-2014. Fifty one patients with bleeding disorders who received at least one dose of Aryoseven were enrolled. Patients’ demographic data and adverse effect of drug and reaction related to Aryoseven or previous usage of Recombinant activated FVII were recorded in questionnaires. Finally data were analyzed to compare side effects of Aryoseven and other Recombinant activated FVII brands. Results: Aryoseven was prescribed for 51 Patients. Of all participants with mean age 57.18+21.38 yr, 31 cases were male and 26 subjects had past history of recombinant activated FVII usage. Glanzman was the most frequent disorder followed by congenital FVII deficiency, hemophilia with inhibitors, factor 5 deficiency, acquired hemophilia, hemophilia A with inhibitor, and hemophilia A or B with inhibitor. The majority of bleeding episodes had occurred in joints. Three patients (5.9%) complained about adverse effects of Aryoseven vs. 11.5 % about adverse effects of other brands. However this difference was not significant, statistically. Conclusion: Based on monitor patients closely for any adverse events, we concluded that Aryoseven administration under careful weighing of benefit versus potential harm may comparable with other counterpart drugs. How to cite this article: Toogeh G, Abolghasemi H, Eshghi P, Managhchi M, Shaverdi-niasari M, Karimi K, et al. Evaluation of Aryoseven Safety (recombinant activated factor VII) in patients with bleeding disorders (An observational post-marketing surveillance, study). Iran J Pathol. 2016; 11(3):204-9.
Alireza Abdollahi; Reza Shahsiah; Mohssen Nassiri Toosi; Manije Lak; Katayoun Karimi; Mohammadreza Managhchi; Katayoun Samimi-rad
Volume 3, Issue 3 , June 2008, , Pages 119-124
Abstract
Background and Objective: Although transfusion therapy has lead to great improvement in longevity for hemophiliacs, but there have been tragic setbacks especially from transmission of human immunodeficiency virus (HIV) and hepatitis C virus (HCV) .HIV was reported to increase the rate of HCV-related ...
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Background and Objective: Although transfusion therapy has lead to great improvement in longevity for hemophiliacs, but there have been tragic setbacks especially from transmission of human immunodeficiency virus (HIV) and hepatitis C virus (HCV) .HIV was reported to increase the rate of HCV-related liver failure by 4.2 times. In this study, we aimed to determine the seroprevalence of HIV and HCV, the association of HCV with abnormal liver tests, impact of HIV on HCV-related abnormalities and the distribution of HCV genotypes in Iranian hemophiliacs. Patients and Methods: In a cross-sectional study, we determined virological, clinical and epidemiological characteristics for HIV and HCV infection of 236 hemophiliacs attending our center. Data were analyzed using Chi-square test. Results: Ten (4.7%) out of 211 patients tested were HIV seropositive and 145 (83.3%) were HCV seropositive. All tested positive HIV patients also had HCV. HCV seroprevalence was significantly higher in patients with hemophilia A and B as compared to other congenital coagulopathies and it was directly related to coagulation severity. HCV seroprevalence was lower in hemophiliacs with positive HBsAg (p = 0.03) but it did not differ by HBcAb or HBsAb results. HCV genotype 1a (48.5%) was predominant type and genotype 3a (33.3%) was also common. Frequency of abnormal aspartate aminotransferase and alanine aminotransferase liver enzymes was significantly higher in the HCV positive group (p = 0.006). Conclusion: This study provides evidence that hepatitis c virus infection is a major problem for Iranian hemophiliacs and it has higher prevalence in hemophiliacs with higher age, more severe coagulopathies, abnormal alanine aminotransferase level, and human immunodeficiency virus co-infection.
