title: A Comparison of Efficacy Between Recombinant Activated Factor VII (Aryoseven) and Novoseven in Patients With Hereditary FVIII Deficiency With Inhibitor.
abstract: BACKGROUND
  This study compared the efficacy of Aryoseven with Novoseven to control bleeding episodes in patients with hemophilia A with inhibitors.
  
  
  METHODS
  Sixty-six patients were randomized into 2 groups, with 4 consecutive block randomization. These groups received Aryoseven and Novoseven dosages of 90 to 120 μg/kg intravenously every 2 hours.
  
  
  RESULTS
  Median (interquartile range) level of factor VIII (FVIII) inhibitor in groups A and B was 15.0 and 19.0 Bethesda Unit (BU) preadministration. Bleeding onset in group A was 1246 ± 1104 minutes and in group B was 2301 ± 1693 minutes (P = .311). The Kavakli global response scores and treatment success rate was comparable in both the groups. The side effects in groups A (9.7%) and B (2.9%) were comparable.
  
  
  CONCLUSIONS
  Biosimilar recombinant activated FVII is found to be as effective as Novoseven in the treatment of acute joint bleeding in patients with hemophilia with inhibitors. Its usage will decrease the gaps in hemophilia.
authors.affiliation: Iran university of Medical Sciences, Rasool Akram Hospital, Tehran, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Faranoush
authors.affiliation: Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran h.abolghasemi@ibto.ir.
authors.forename: H
authors.initials: H
authors.lastname: Abolghasemi
authors.affiliation: Biotechnology Research Center, Pasteur Institute of Iran, Tehran Iran.
authors.forename: F
authors.initials: F
authors.lastname: Mahboudi
authors.affiliation: Thrombosis and Hemostasis Research Center, Tehran University of Medical Sciences, Imam Khomeini Hospital, Tehran, Iran.
authors.forename: Gh
authors.initials: G
authors.lastname: Toogeh
authors.affiliation: Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Karimi
authors.affiliation: Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: P
authors.initials: P
authors.lastname: Eshghi
authors.affiliation: Thrombosis and Hemostasis Research Center, Tehran University of Medical Sciences, Imam Khomeini Hospital, Tehran, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Managhchi
authors.affiliation: Isfahan University of Medical Sciences, Isfahan, Iran.
authors.forename: H
authors.initials: H
authors.lastname: Hoorfar
authors.affiliation: Ahwaz University of Medical Sciences, Ahwaz, Iran.
authors.forename: B Keikhaei
authors.initials: BK
authors.lastname: Dehdezi
authors.affiliation: MAHAK Children's Hospital, Tehran, Iran.
authors.forename: A
authors.initials: A
authors.lastname: Mehrvar
authors.affiliation: Aryogen Zist Darou Company, Karaj, Iran.
authors.forename: B
authors.initials: B
authors.lastname: Khoeiny
authors.affiliation: Biotechnology Research Center, Pasteur Institute of Iran, Tehran Iran.
authors.forename: B
authors.initials: B
authors.lastname: Vaziri
authors.affiliation: Aryogen Zist Darou Company, Karaj, Iran.
authors.forename: K
authors.initials: K
authors.lastname: Kamyar
authors.affiliation: Thrombosis and Hemostasis Research Center, Tehran University of Medical Sciences, Imam Khomeini Hospital, Tehran, Iran.
authors.forename: R
authors.initials: R
authors.lastname: Heshmat
authors.affiliation: Iranian Comprehensive Hemophilia Care Center, Tehran, Iran.
authors.forename: M R
authors.initials: MR
authors.lastname: Baghaeipour
authors.affiliation: Golestan University of Medical Sciences, Gorgan, Iran.
authors.forename: N B
authors.initials: NB
authors.lastname: Mirbehbahani
authors.affiliation: MD, Kerman University of Medical Sciences, Kerman, Iran.
authors.forename: R
authors.initials: R
authors.lastname: Fayazfar
authors.affiliation: High Institute of Research, Iranian Blood Transfusion Organization, Tehran, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Ahmadinejad
authors.affiliation: Zahedan University of Medical Sciences, Ahwaz, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Naderi
mesh_terms: D000293:Adolescent; D000328:Adult; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage*; D019774:Blood Coagulation Factor Inhibitors / Q000097:blood*; D002648:Child; D015942:Factor VIIa / Q000008:administration & dosage*; D005260:Female; D006467:Hemophilia A / Q000097:blood / Q000188:drug therapy*; D006470:Hemorrhage / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D008297:Male; D011994:Recombinant Proteins / Q000008:administration & dosage; D013997:Time Factors
chemical_list: D059451:Biosimilar Pharmaceuticals; D019774:Blood Coagulation Factor Inhibitors; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa
keywords: Aryoseven; Hemophilia A; Inhibitor; Novoseven; rFVIIa