geneOmbio’s Molecular diagnostic services has initiated a promotional drive for its Hepatitis C Virus genotyping assay due to growing importance of this test. Hepatitis C virus (HCV) is an important and widely transmitted virus in the world. Estimates from the World Health Organization report that 3.3% (200 million) of the world population is infected with HCV. HCV is a highly infectious, blood-borne agent that causes liver related ailments, and a significant cause of morbidity and mortality in the human population.

Hepatitis C virus (HCV) shows considerable genetic heterogeneity among isolates from all over the world. Seven main groups of sequence variants are recognized. Genotype 1, 2 and 3 are most common in North America and Europe, genotype 4 is most common in Middle East, genotype 5 and 6 are common in South East Asia. In India, genotype 3 is most common and genotype 2 is least common. The knowledge about the genotype distribution of HCV in a geographical area may help for treatment plan and also provide clues about the outcome of HCV related liver disease in that area.

Identification of HCV genotype/subtype is important for therapy and patient management. Recent studies revealed that there are the 7 major HCV genotypes and 67 subtypes (Smith et al., 2014).During the last decade, the standard therapy for chronic hepatitis C infection is treatment with pegylated interferon- that is administrated as a monotherapy or in combination with ribavirin. The response rate to this therapy differs among patients as the HCV genotype is a strong prognostic factor for sustained virological response. It is observed that patients with genotype 2 and 3 have a two- to three-fold higher response rate than patients infected with genotype 1. The new management approach has shown an increased response rate from 35% to 70% and the duration of therapy is reduced from 12 to 6 months. However, the drugs have side effects, require effective drug treatment regimens by health professionals are extremely expensive and are not equally available worldwide, which limit their use to a great extent. Therefore, in most parts of the world particularly in the developing countries, peg-interferon and ribavirin still remains the therapy of choice. In such scenario a rapid, accurate, and affordable HCV genotyping assay for treatment management and patient care is necessary. Currently, sequence analysis of specific regions (NS5, core, E1and 5’UTR) is considered to be the gold standard for genotyping (Ohno and Lau, 1996).

Considering the increasing demand of HCV genotyping assay geneOmbio Technologies have developed its own indigenous method that determines the genotype of Hepatitis C virus in an infected patient. We also conducted a to genotype and subtype HCV isolates in patients from Pune, Mumbai and Nashik districts of Maharashtra, determine association of HCV genotypes between both sexes and different age groups and perform phylogenetic analysis of the study isolates. Eighty HCV RNA positive patients were genotyped and subtyped in the study.  Primers targeting 5’untranslated region (UTR) were designed for both amplification and sequencing of all isolates. All HCV isolates were characterized by direct sequencing of 5’ UTR followed by analysis with NCBI genotyping tool and in-silico BLAST analysis. The results were correlated with the Los Alamos Hepatitis C sequence and immunology database’s sequence alignment tool HCVAlign and phylogenetic analysis. Most of HCV isolates in this study belonged to genotype 3(56.25%) followed by genotype 1(35%) and genotype 4(7.5%). A rare genotype 5(1.25%) was identified in one of the patients. Prevalent subtypes were: subtype 3a (42.5%), subtype 1a (21.25%) and subtype 1b (13.75%). No notable association of age and gender with respect to genotypes was observed except for genotype 1a which showed an overrepresentation in males. Compared with phylogenetic analysis, NCBI genotyping tool was simpler for genotyping and subtyping HCV isolates. The study revealed that HCV genotypes 3 and 1 were prevalent in Pune, Mumbai and Nashik districts of Maharashtra. With rare genotype (genotype 5) being identified and due to very few genotyping studies carried out in this region, this study aimed at contributing towards monitoring the distribution of HCV genotypes among studied regions of Maharashtra. This article is available online at DOI: http://dx.doi.org/10.21746/ijbio.2015.12.005.

geneOmbio technologies is currently providing HCV genotyping test to many specialists treating patients infected with Hepatitis C virus. Our Molecular diagnostics business development has been directed to spread awareness about this test to Gastro specialists.

– Sharad Pawar

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