Abstract
Background and Aims
Although chronic hepatitis C virus (HCV) infection affects millions of people in India, few studies have assessed host, viral, and disease characteristics of chronically infected patients at national and regional levels. Such information is critical to support large scale screening and treatment initiatives for chronic HCV infection in India.
Methods
Patients with known chronic HCV infection making routine or for-cause visits to the participating study centers were enrolled in this observational study. Patients attended a single outpatient visit during which demographics and medical history were collected, a physical examination was performed, and blood and urine samples were collected for laboratory assessments. Samples were analyzed to determine HCV genotypes and subtypes, and genotypes of interferon lambda 3 (IFNL3) single nucleotide polymorphism. No therapeutic interventions were administered.
Results
We enrolled 500 patients at 19 centers, categorized into four geographic regions (North, South, East, and West). All patients self-identified as Indian, and most (66 %) were male. Genotype 3 was the most common genotype overall (54 %); however, its prevalence varied greatly by region, ranging from 34 % in the South to 69 % in the East. Genotypes 1 (24 %) and 4 (6 %) were the next most common, and HCV genotype could not be determined for 16 % of patients.
Conclusions
This prospective survey suggests that demographics, viral, and host factors in patients with chronic HCV infection are highly variable in India and pose significant challenges for the implementation of broad-scale screening and treatment initiatives.
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Acknowledgments
This study was sponsored by the Gilead Sciences, Inc.
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Conflicts of Interest
Samir R Shah has served on advisory boards for Myland, Emcure, Alkem, Gilead Sciences, and Biocon. P N Rao has served on advisory boards and as a speaker for Roche, Abbott, BMS, and Dr. Reddy’s Laboratories. Dharmesh Kapoor has served on advisory boards for Dr. Reddy’s Laboratories, Emcure Pharma, and Alkem Pharma, and has served as a speaker for Roche, Novartis, Sanofi, Astra Zeneca, and Biocon. Shivaram Prasad Singh owns stock for Sun Pharmaceutical Industries Ltd., Torrent Pharmaceuticals Ltd., Dr. Reddy’s Laboratories, and Panacea Biotec. Sandra Chen, Anuj Gaggar, Steven J Knox, G Mani Subramanian are employees and/or own stock for Gilead Sciences. SKS, AC, SB, RD, BDG, RL, RM, SM, VGMP, RRR, SS, DS, NT, AS, JV, and RVV declare no conflicts of interest.
Ethical Statement
This study was approved by the institutional review board or independent ethics committee at each participating site and was conducted in compliance with Good Clinical Practice Guidelines and Declaration of Helsinki and local regulatory requirements. This study was designed and conducted according to protocol in collaboration with the principal investigators. All patients provided written informed consent.
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Shah, S.R., Rao, P.N., Sarin, S.K. et al. Chronic hepatitis C virus infection in India: Regional demographics and distribution of viral genotypes. Indian J Gastroenterol 35, 469–477 (2016). https://doi.org/10.1007/s12664-016-0709-1
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DOI: https://doi.org/10.1007/s12664-016-0709-1