Hbv diagnostic, prognostic, and therapeutic methods and products
AssigneeAbbott Laboratories
InventorsGavin A. Cloherty, Mary Kuhns, Ka-Cheung Luk, Peter J. Karabatsos
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Abstract
Provided herein are compositions, systems, and methods for assessing and monitory disease stage and phases, predicting likelihood of disease progression, and predicting and monitoring responses to disease therapies (e.g., in HBV infection).
Claims41
A method of assessing and monitoring disease stage or phase, predicting likelihood of disease progression, or predicting or monitoring response to a Hepatitis B (HBV) therapy, the method comprising the steps of:
- (a) contacting a test sample obtained from a subject being administered a treatment for HBV or diagnosed with HBV with reagents for detection of the presence, level, or status of one or more markers selected from the group consisting of Hepatitis B e-antigen (HBeAg), Hepatitis B surface antigen (HBsAg), an isoform of HBsAg, Hepatitis B core antigen (I1BcAg), HBV DNA, one or more HBV splice variants HBV RNA, Hepatitis B core-related antigen (I1BcrAg), anti-Hepatitis B surface antigen antibody (anti-HBs), anti-Hepatitis B e-antigen antibody (anti-HBe), Hepatitis B surface antigen antibody (anti-HBs) complexes formed between HBsAg and anti-HBs, alanine aminotransferase (ALT), and aspartate aminotransferase (AST);
- and
- (b) assessing and monitoring disease stage or phase, predicting likelihood of disease progression, or predicting or monitoring response to a Hepatitis B (HBV) therapy based on the presence, level, or status of said one or more markers.
A method of detecting the presence, level, or status of one or more markers, comprising:
- (a) contacting a test sample obtained from a subject being administered a treatment for HBV or diagnosed with HBV with reagents for detection of the presence, level, or status of one or more markers selected from the group consisting of Hepatitis B e-antigen (HBeAg), Hepatitis B surface antigen (HBsAg), an isoform of HBsAg, Hepatitis B core antigen (HBcAg), HBV DNA, one or more HBV splice variants, HBV RNA, Hepatitis B core-related antigen (HBcrAg), anti-Hepatitis B surface antigen antibody (anti-HBs), anti-Hepatitis B e-antigen antibody (anti-HBe), Hepatitis B surface antigen antibody (anti-HBs) complexes formed between HBsAg and anti-HBs, alanine aminotransferase (ALT), and aspartate aminotransferase (AST);
- and
- (b) determining the presence, level, or status of said one or more markers.
A method of treating HBV, comprising:
- (a) contacting a test sample obtained from a subject diagnosed with HBV with reagents for detection of the presence, level, or status of one or more markers selected from the group consisting of Hepatitis B e-antigen (HBeAg), Hepatitis B surface antigen (HBsAg), an isoform of HBsAg, Hepatitis B core antigen (HBc Ag), HBV DNA, one or more HBV splice variants, HBV RNA, Hepatitis B core-related antigen (HBcrAg), anti-Hepatitis B surface antigen antibody (anti-HBs), anti-Hepatitis B e-antigen antibody (anti-HBe), anti-Hepatitis B surface antigen antibody (anti-HBs) complexes formed between HBsAg and anti-HBs, alanine aminotransferase (ALT), and aspartate aminotransferase (AST);
- (b) identifying a treatment for HBV based on said presence, level, or status of said one or more markers;
- and
- (c) administering said treatment.
A kit or system, comprising:
- reagents for detection of the presence, level, or status of one or more markers selected from the group consisting of Hepatitis B e-antigen (HBeAg), Hepatitis B surface antigen (HBsAg), an isoform of HBsAg, Hepatitis B core antigen (HBcAg), HBV DNA, one or more HBV DNA splice variants, HBV RNA, Hepatitis B core-related antigen (HBcrAg), anti-Hepatitis B surface antigen antibody (anti-HBs), anti-Hepatitis B e-antigen antibody (anti-HBe), anti-Hepatitis B core antigen antibody (anti-HBc), complexes formed between HBsAg and anti-HBs, alanine aminotransferase (ALT), and aspartate aminotransferase (AST).
The use of reagents for detection of the presence, level, or status of one or more markers selected from the group consisting of Hepatitis B c-antigen (HBeAg), Hepatitis B surface antigen (HBsAg), an isoform of HBsAg, Hepatitis B core antigen (HBcAg), HBV DNA, one or more HBV DNA splice variants, HBV RNA, Hepatitis B core-related antigen (HBcrAg), anti-Hepatitis B surface antigen antibody (anti-HBs), anti-Hepatitis B e-antigen antibody (anti-HBe), Hepatitis B surface antigen antibody (anti-HBs) complexes formed between HBsAg and anti-HBs, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) to provide an assessment of disease stage or phase, a prediction of likelihood of disease progression, or a prediction of a response to a Hepatitis B (HBV) therapy.
A method of assessing efficacy of treatment with a Hepatitis B virus (HBV) therapeutic in a subject suffering from a chronic HBV infection, the method comprising:
- (a) performing an assay on a sample obtained from the subject to detect or measure a level of at least one HBV antigen biomarker, at least one HBV genomic biomarker, or at least one HBV antigen marker and at least one HBV genomic biomarker;
- and
- (b) determining whether seroclearance has been achieved by comparing the level of the at least one HBV antigen biomarker, the at least one HBV genomic biomarker, or the at least one HBV antigen marker and the at least one HBV genomic biomarker to a reference level of the at least one HBV antigen biomarker, the at least one HBV genomic biomarker, or the at least one HBV antigen marker and the at least one HBV genomic biomarker;
- wherein:
- (i) the treatment is not efficacious if the level of the at least one HBV antigen biomarker, the at least one HBV genomic biomarker, or the at least one HBV antigen marker and the at least one HBV genomic biomarker is unfavorable when compared to the reference level of the at least one HBV antigen biomarker, the at least one HBV genomic biomarker, or the at least one HBV antigen marker and the at least one HBV genomic biomarker;
- or
- (ii) the treatment is efficacious if the level of the at least one HBV antigen biomarker, the at least one HBV genomic biomarker, or the at least one HBV antigen marker and the at least one HBV genomic biomarker is favorable when compared to the reference level of the at least one HBV antigen biomarker, the at least one HBV genomic biomarker, or the at least one HBV antigen marker and the at least one HBV genomic biomarker.
A method of determining whether a subject suffering from a chronic Hepatitis B virus (HBV) infection will benefit from receiving treatment with an HBV therapeutic, the method comprising:
- (a) performing an assay on a sample obtained from the subject to detect or measure a level of at least one HBV antigen biomarker, at least one HBV genomic biomarker, or at least one HBV antigen marker and at least one HBV genomic biomarker;
- and
- (b) comparing the level of the at least one HBV antigen biomarker, the at least one HBV genomic biomarker, or the at least one HBV antigen marker and the at least one HBV genomic biomarker to a predetermined level of the at least one HBV antigen biomarker, the at least one HBV genomic biomarker, or the at least one HBV antigen marker and the at least one HBV genomic biomarker;
- wherein it is determined that:
- (i) the subject will not benefit from an HBV therapeutic if the level of the at least one HBV antigen biomarker, the at least one HBV genomic biomarker, or the at least one HBV antigen marker and the at least one HBV genomic biomarker is unfavorable when compared to the reference level of the at least one HBV antigen biomarker, the at least one HBV genomic biomarker, or the at least one HIP/antigen marker and the at least one HBV genomic biomarker;
- or
- (ii) the subject will benefit from an HEX therapeutic if the level of the at least one HBV antigen biomarker, the at least one HBV genomic biomarker, or the at least one HBV antigen marker and the at least one HBV genomic biomarker is favorable than the reference level of the at least one HBV antigen biomarker, the at least one HBV genomic biomarker, or the at least one HBV antigen marker and the at least one HBV genomic biomarker.
Dependencies are inferred from the claim text.