Prevalence and Genetic Polymorphism of HLA-B*15 in the North Indian Population: Insights into SJS/TEN Prevention, Vaccines and Clinical Trials

Since HLA-B*15:02 is a biomarker for carbamazepine-induced Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in certain Asian populations, the United States food and drug administration (USFDA) recommends HLA-B*15:02 screening before carbamazepine administration in Asian and other communities. Several published reports across the globe suggested a strong association of HLA-B*15 with carbamazepine-induced hypersensitivity reactions.

This study was conducted to estimate the prevalence and the genetic polymorphism of HLA-B*15 in the North Indian population (N=5469) by PCR  sequence-specific oligonucleotide probe (SSOP) genotyping of the HLA-B locus.

The total allelic variants of HLA-B*15 identified amongst the studied samples were 17. The most frequent among these was HLA-B*15:17 (2.030%). Subsequently, HLA -B* 15:01 (1.463%) and B*15:02 (1.225%) were more frequent. Further, 185 HLA-B*15 genotypes were seen among the studied population with which the most frequent were HLA-B*15:17-40:06(0.402%), HLA-B*15:17-35:03 (0.366%) and HLA-B*15:02-40:06 (0.347%).

This information highlights the prevalence and diversity of HLA-B*15 genotyping and its importance in the screening of carbamazepine-induced SJS/TEN in the North Indian population where the prevalence of HLA-B*15 allelic variants was on the higher side. Further, this baseline information could be further explored in the understanding of the pathogenesis of the disease and may contribute valuable information for designing effective vaccines and clinical trials.