title: The Epidemiology of FVIII Inhibitors in Indian Haemophilia A Patients.
abstract: A serious complication of replacement therapy in patients with bleeding disorders is the development of 'inhibitors', particularly FVIII inhibitors in haemophilia A patients. This leads to an increase in the management cost, morbidity and mortality, especially post-operatively. The mechanism of FVIII inhibitor development is quite complex and it is difficult to predict inhibitor development, but a prompt and accurate diagnosis is critical as early therapy can save lives. The aim of this study was to screen patients with bleeding disorders in India for inhibitors, and to analyse and compare the prevalence of inhibitors in different regions in India. Patient details were recorded and blood samples were collected in sodium citrate vacutainers from 1,505 patients with bleeding disorders, in different cities in India. Coagulation and inhibitor screening assays were performed, followed by the Bethesda assay in inhibitor positive samples to quantify the FVIII inhibitor titre. Out of the 1,505 samples analysed, 1,285 were Haemophilia A patients, out of which 78 (6.07 %) were positive for 'FVIII Inhibitors'. The highest incidence of FVIII Inhibitors was seen in South India (13.04 %). The highest incidence of 20.99 % was observed in Chennai, followed by Hyderabad (13.33 %), Jammu (9.90 %) and Guwahati (8.51 %), respectively, with respect to the samples analysed. The other regions showed an inhibitor incidence <8 %. The incidence of inhibitors in haemophilia A patients is different in different regions of India; this may be due to the intensity of treatment, type of product or the genetic characteristics of these patients.
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Patricia
authors.initials: P
authors.lastname: Pinto
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Tejashree
authors.initials: T
authors.lastname: Shelar
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Vidhya
authors.initials: V
authors.lastname: Nawadkar
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Darshana
authors.initials: D
authors.lastname: Mirgal
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Alfiya
authors.initials: A
authors.lastname: Mukaddam
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Preethi
authors.initials: P
authors.lastname: Nair
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Priyanka
authors.initials: P
authors.lastname: Kasatkar
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Tejasvita
authors.initials: T
authors.lastname: Gaikwad
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Shahnaz
authors.initials: S
authors.lastname: Ali
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Anshul
authors.initials: A
authors.lastname: Jadli
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Rucha
authors.initials: R
authors.lastname: Patil
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Anita
authors.initials: A
authors.lastname: Parihar
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Sharda
authors.initials: S
authors.lastname: Shanbhag
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Bipin
authors.initials: B
authors.lastname: Kulkarni
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Kanjaksha
authors.initials: K
authors.lastname: Ghosh
authors.affiliation: Department of Haemostasis & Thrombosis, National Institute of Immunohaematology, Indian Council of Medical Research, 13th Floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, 400 012 India.
authors.forename: Shrimati
authors.initials: S
authors.lastname: Shetty
keywords: Epidemiology; Haemophilia A; Inhibitors