This non-interventional clinical study will be conducted to prospectively collect serial plasma samples from subjects with chronic HBV infection who are initiating antiviral therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HBV Quant assay, which is used as an aid in the management of HBV-infected patients undergoing HBV antiviral therapy.
Study Type
OBSERVATIONAL
Enrollment
331
Association between virologic response at Week 12 (assessed using the Aptima HBV Quant assay) and virologic response at Week 48 (assessed using an FDA-approved HBV quant assay).
Virologic response is defined as HBV DNA levels less than the lower limit of quantitation at the assessed time point. Association will be measured as an odds ratio.
Time frame: Week 48 (from start of therapy)
Association between virologic response at Week 24 (assessed using the Aptima HBV Quant assay) and virologic response at Week 48 (assessed using an FDA-approved HBV quant assay).
Virologic response is defined as HBV DNA levels less than the lower limit of quantitation at the assessed time point. Association will be measured as an odds ratio.
Time frame: Week 48 (from start of therapy)
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