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.

The prevalence of factor VIII and IX inhibitors among Saudi patients with hemophilia

“…A large Indian study of 1285 patients with hemophilia A found that only 6.07% of the patients had inhibitors, although there were remarkable regional variations (the highest prevalence was 20.99%). [35] We also found a higher prevalence of inhibitors among patients who were receiving recombinant factors, and this result agrees with the findings from our previous studies. [36–38] …”

Prevalence of inhibitors and clinical characteristics in patients with haemophilia in a middle‐income Latin American country

“…In a previous study conducted in India, researchers found that 6.07% of patients exhibited inhibitors. However, the authors found significant variations among the various regions studied, with one region featuring a prevalence of 20.99% …”

Prevalence of FVIII inhibitors in severe haemophilia A patients: Effect of treatment and genetic factors in an Indian population

“…There is a paucity of data regarding the prevalence of inhibitors in severe haemophilia A from low and middle income countries (LMIC) and from different races and ethnicities. A previous study that published data in this regard from India showed an overall prevalence of 6.07% with a varying distribution of 4.17%, 4.89%, 5.45% and 13.04% of inhibitors from Western, Eastern, Northern and Southern regions . Several of these studies were not comprehensively designed and have a tertiary centre referral bias.…”

“…A previous study that published data in this regard from India showed an overall prevalence of 6.07% with a varying distribution of 4.17%, 4.89%, 5.45% and 13.04% of inhibitors from Western, Eastern, Northern and Southern regions. 17 Several of these studies were not comprehensively designed and have a tertiary centre referral bias. In this study, we undertook a comprehensive community-based evaluation of severe haemophilia A patients to study the prevalence of inhibitors and its predisposing factors.…”