Study of the role of hepatitis B virus (HBV) genotypes on clinical outcome, severity of liver disease and response to treatment in chronic HBV infection

Abstract

Chronic infection with the hepatitis B virus (HBV) is common in Brazil. This disease admits serious forms of chronic hepatitis, and can lead to cirrhosis and hepatocellular carcinoma (HCC). Several factors influence the evolution of HBV infection, among them the patient's age and gender and the viral load of HBV. More recently, researches have been made about the influence of HBV genotypes and mutations in the development and response to treatment of hepatitis B. The objectives of this work are: to determine the HBV genotypes in included patients; to compare the frequency of genotypes in different subgroups of patients with chronic infection by HBV: HBeAg negative, HBeAg positive, inactive carriers, pre-core and core promoter mutants, patients with cirrhosis and HCC; to study the influence of genotype on the severity of liver disease and response to treatment of hepatitis B. Patients with chronic infection by HBV will be included. Following evaluations will be conducted: clinical through structured interviews; laboratorial by sorological tests and ALT; histological, which include the determination of necroinflammatory activity and the degree of fibrosis using the Knodell index modified by Desmet et al (1994); virological, by determination of viral load using branched DNA (bDNA) (340 System bDNA Analyzer, Bayer) and real-time PCR. The genotyping and the search for pre-core and core promoter mutations will be made by automatic sequencing. (AU)