HBV/4DR 9G test and its comparison with INNO-LiPA HBV multi-DR test for the detection of drug-resistant Hepatitis B virus

Abstract

A significant proportion of patients with chronic Hepatitis B infection require antiviral therapy during their life time. The Antiviral therapy with lamivudine or adefovir or telbivudine has shown to be a major risk factor for selection of resistance. Eighty percent of patients showed a development of lamivudine-resistant strains after five years of treatment with lamivudine alone. Adefovir and telbivudine inhibit HBV with very high efficacy and have moderate incidences of drug resistance. Entecavir and tenofovir have been shown to have a higher barrier to resistance with rates of less than 1.5% after five years of treatment. The rtA181V, rtM204V/I, rtN236T and, rtM250V are high prevalent mutations found in the drug-resistant HBV strains. Therefore, for accurate treatment of HBV-infected patients, it is important to discriminate the drug-resistant HBV strains by using simple and accurate detection method.In this study, we describe the HBV/4DR 9G test and its evaluation by using clinical samples and plasmid DNA standards with a range of HBV mutation sites. In tests with 384 plasmid DNA standards, the HBV/4DR 9G test showed higher than 95% sensitivity and 98% specificity. The HBV/4DR 9G test was compared with the INNO-LiPA HBV Multi DR test for detection of drug-resistant HBV strains only in clinical samples. The plasma samples were collected from patients suspected with HBV drug-resistant strain infection. The results of both tests were cross-checked with the HBV DNA sequence analysis. The HBV/4DR 9G test demonstrated a good agreement with the sequencing results as compared to the INNO-LiPA HBV Multi-DR test. These results indicate that the HBV/4DR 9G test can be a reliable, sensitive, and accurate diagnostic tool for the detection of drug-resistant genotypes of HBV in clinical specimens. HBV/4DR 9G test can genotype 4 drug resistant HBV strains in 1 PCR. The HBV/4DR 9G test will help to minimize the risk of HBV patients from liver cancer.