HBV diagnostic, prognostic, and therapeutic methods and products
Inventors
Geißler, Rene • Patel, Megha • Qiu, Xiaoxing • Cloherty, Gavin
Assignees
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Publication Number
US-12754185-B2
Publication Date
2026-10-06
Expiration Date
Abstract
Provided herein are compositions, systems, and methods for assessing and monitoring disease stage and phases, predicting likelihood of disease progression, and predicting and monitoring responses to hepatitis B virus infection.
Core Innovation
The invention describes antibody-based methods for treating chronic HBV, assessing viral status, and monitoring treatment response through the detection of HBcAg and phosphorylated HBcAg (P-HBcAg). HBcAg levels serve as a proxy for infectious, DNA-containing HBV particles, whereas P-HBcAg indicates non-infectious particles. Longitudinal measurements during antiviral therapy demonstrate positive correlations with viral nucleic acids, supporting the estimation of viral burden and treatment monitoring.
The methods evaluate treatment response using threshold values, reference levels, or changes in antigen-associated particle amounts across samples collected at different time points. The claims cover assessments based on HBcAg alone or in combination with P-HBcAg to determine treatment efficacy and guide therapy adjustments. This antigen-based approach supports HBV treatment-response monitoring and treatment selection or modification while potentially reducing or avoiding the need for separate nucleic-acid tests.
Claims Coverage
The five independent claims cover five inventive features concerning chronic HBV treatment, antigen measurement, particle assessment, and treatment-response evaluation.
Monitoring treatment response using HBcAg and P-HBcAg
The method administers chronic HBV treatment, detects HBcAg and P-HBcAg in a subject sample using specifically binding antibodies, and assesses and monitors treatment response based on the presence or level of those antigens.
Treating based on infectious HBV particle amount
The method detects HBcAg in a sample from a subject diagnosed with chronic HBV, determines the amount of infectious HBV particles based on the presence or level of HBcAg, and provides treatment when that amount is equal to or above a threshold value.
Assessing treatment efficacy using HBcAg
The method administers chronic HBV treatment and uses the presence or level of HBcAg in a sample to determine the amount of infectious HBV particles, determining treatment to be efficacious when that amount is below a reference level and not efficacious when it is at or above the reference level.
Assessing response using infectious and non-infectious HBV particles
The method detects HBcAg and P-HBcAg in a sample obtained during chronic HBV treatment, determines the amount of infectious HBV particles based on HBcAg and non-infectious HBV particles based on P-HBcAg, and determines treatment response based on those amounts.
Assessing treatment response across time points
The method detects HBcAg and P-HBcAg across samples obtained at different time points, determines amounts of infectious and/or non-infectious HBV particles based on antigen presence or levels, and determines treatment response based on those amounts.
Together, the independent claims cover antigen-based chronic HBV treatment decisions, efficacy determinations, and response monitoring using threshold values, reference levels, and multi-timepoint sampling.
Stated Advantages
HBcAg and P-HBcAg measurements support estimating viral burden and monitoring response to antiviral therapy.
The described methods may reduce or avoid the need for separate nucleic-acid tests.
Documented Applications
Monitoring response to treatment for chronic HBV using HBcAg and P-HBcAg measurements.
Assessing chronic HBV treatment efficacy by estimating infectious HBV particle amounts from HBcAg measurements and comparing them with a threshold or reference level.
Assessing treatment response using measurements of infectious and non-infectious HBV particles, including measurements from samples collected at different time points.
Treatment selection, modification, or guiding therapy adjustment based on HBV antigen measurements and treatment-response assessment.
HBV diagnostic kits and assay formats for detecting HBcAg and P-HBcAg.
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