HBV diagnostic, prognostic, and therapeutic methods and products
Inventors
Cloherty, Gavin A. • Kuhns, Mary • Luk, Ka-Cheung • Karabatsos, Peter J.
Assignees
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Publication Number
US-12235273-B2
Publication Date
2025-02-25
Expiration Date
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).
Core Innovation
The invention relates to receiving an indication of presence, level, or status of markers obtained from an assay using a test sample from a subject who is administered a treatment for Hepatitis B Virus (HBV) or diagnosed with HBV. At least two markers are used to assess and monitor disease stage or phase and monitor response to HBV therapy, and one or more markers are selected from Hepatitis B core-related antigen (HBcrAg) and aspartate aminotransferase (AST).
The invention further relates to identifying a treatment for HBV based on the presence, level, or status of the markers, including selecting a treatment from interferon, nucleoside analogue, nucleotide analogue, nucleic acid, immunodulator, core protein assembly inhibitor, HBsAg release inhibitor, entry inhibitor, interfering RNA, or a combination thereof. The treatment is administered when it is determined that the subject will benefit if the marker level is favorable compared to a predetermined or reference level, and not administered when the marker level is unfavorable compared to the predetermined or reference level.
The invention includes a kit or system comprising reagents for detection of the presence, level, or status of at least two markers, wherein the at least two markers are HBcrAg and AST. The marker-based decision supports monitoring and treatment decisions, including individualized treatment regimens designed or developed for the subject by a clinician and treatments administered as part of one or more clinical trials.
Claims Coverage
The independent claims cover three main areas: marker-based methods using at least two markers including AST to assess and monitor disease stage or phase or response to HBV therapy and decide whether to administer an HBV therapeutic; marker-based methods using HBcrAg and/or AST for the same decision framework; and a kit/system containing reagents to detect HBcrAg and AST.
Marker-based HBV treatment selection using AST and at least two markers
Receiving an indication of presence, level, or status of at least two markers obtained from an assay using a test sample from a subject being administered a treatment for HBV or diagnosed with HBV, wherein the at least two markers include aspartate aminotransferase (AST); assessing and monitoring disease stage or phase or monitoring response to HBV therapy based on the presence, level, or status of the at least two markers; and administering the treatment if the level of the at least two markers is favorable compared to a predetermined or reference level or not administering if unfavorable compared to the predetermined or reference level.
Marker-based HBV treatment selection using HBcrAg and AST
Receiving an indication of presence, level, or status of one or more markers obtained from an assay using a test sample from a subject being administered a treatment for HBV or diagnosed with HBV, wherein the one or more markers are selected from Hepatitis B core-related antigen (HBcrAg) and aspartate aminotransferase (AST); assessing and monitoring disease stage or phase or monitoring response to HBV therapy based on the presence, level, or status of said one or more markers; and administering the treatment if the level of the one or more markers is favorable compared to a predetermined or reference level or not administering if unfavorable compared to the predetermined or reference level.
Kit or system for detection of HBcrAg and AST
A kit or system comprising reagents for detection of the presence, level, or status of at least two markers, wherein the at least two markers are Hepatitis B core-related antigen (HBcrAg) and aspartate aminotransferase (AST).
The claim set centers on assay-based indications of HBV-related markers that include AST, and in particular HBcrAg and AST, to assess and monitor disease stage or phase or therapy response and to select and administer, or not administer, an HBV therapeutic based on whether the marker level is favorable or unfavorable relative to a predetermined or reference level. A kit/system is also claimed for detecting HBcrAg and AST.
Stated Advantages
Enables assessing and monitoring disease stage or phase and monitoring response to a HBV therapy based on presence, level, or status of HBV markers including AST.
Enables identifying a HBV treatment based on presence, level, or status of HBV markers including AST.
Enables administering an HBV therapeutic when it is determined the subject will benefit if the marker level is favorable compared to a predetermined or reference level.
Enables not administering an HBV therapeutic when it is determined the subject will not benefit if the marker level is unfavorable compared to the predetermined or reference level.
Documented Applications
Monitoring disease stage or phase and monitoring response to a HBV therapy in a subject being administered HBV treatment or diagnosed with HBV using assay-based indications of marker presence, level, or status.
Identifying and selecting an HBV therapeutic for a subject based on assay-based presence, level, or status of HBV markers (AST and/or HBcrAg), including use of predetermined or reference levels to determine whether to administer or not administer treatment.
Use with individualized treatment regimens designed or developed for the subject by a clinician based on clinical parameters, cutoffs, publications or a combination thereof.
Use with treatments administered as part of one or more clinical trials comprising a treatment regimen designed or developed for one or more subjects based on clinical parameters, cutoffs, patient profiles, publications or a combination thereof.
Providing a kit or system comprising reagents for detecting HBcrAg and AST as markers used in the described HBV decision framework.
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