Detection of HBsAg mutants in a population with a low prevalence of hepatitis B virus infection

Two independent studies were conducted to evaluate performance of two HBsAg immunoassay products performed on the Abbott ARCHITECT and Bayer ADVIA Centaur immunoassay analyzers. One was a retrospective study of 484 stored samples and the second was a prospective study of 349 samples from random population. In the process of the evaluation, a number of discordant samples from HBsAg-positive patients were found which led to the discovery of a number of HBsAg mutants in the general Australian population. Following viral DNA sequencing, these were identified as HBsAg escape mutants. Whilst the existence of HBsAg mutants has been well documented in various regions of the world, this is surprising in an area of low endemicity and demonstrates the necessity of an HBsAg assay to detect mutants reliably in a diagnostic situation where HBsAg is used as the only marker to detect an HBV infection. These studies demonstrate the ability of the Abbott ARCHITECT and AxSYM HBsAg immunoassays to detect these HBsAg mutations which were not detected by the Bayer ADVIA Centaur. © 2007 Wiley-Liss, Inc

The impact of chronic hepatitis B on quality of life: a multinational study of utilities from infected and uninfected persons

<b>Objectives</b>: Chronic hepatitis B (CHB) is a condition that results in substantial morbidity and mortality worldwide because of progressive liver damage. Investigators undertaking economic evaluations of new therapeutic agents require estimates of health-related quality of life (HRQOL). Recently, evidence has begun to accumulate that differences in cultural backgrounds have a quantifiable impact on perceptions of health. The objective was to elicit utilities for six health states that occur after infection with the hepatitis B virus from infected and uninfected respondents living in jurisdictions with low and with high CHB endemicity. <b>Methods</b>: Standard gamble utilities were elicited from hepatitis patients and uninfected respondents using an interviewer-administered survey in the United States, Canada, United Kingdom, Spain, Hong Kong, and mainland China. Generalized linear models were used to the effect on utilities of current health, age and sex, jurisdiction and, for infected respondents, current disease state. <b>Results</b>: The sample included 534 CHB-infected patients and 600 uninfected respondents. CHB and compensated cirrhosis had a moderate impact on HRQOL with utilities ranging from 0.68 to 0.80. Decompensated cirrhosis and hepatocellular carcinoma had a stronger impact with utilities ranging from 0.35 to 0.41. Significant variation was observed between countries, with both types of respondents in mainland China and Hong Kong reporting systematically lower utilities. <b>Conclusions</b>: Health states related to CHB infection have substantial reductions in HRQOL and the utilities reported in this study provide valuable information for comparing new treatment options. The observed intercountry differences suggest that economic evaluations may benefit from country-specific utility estimates. The extent that systematic intercountry differences in utilities hold true for other infectious and chronic diseases remains an open question and has considerable implications for the proper conduct and interpretation of economic evaluations