HBV diagnostic, prognostic, and therapeutic methods and products
AssigneeAbbott Laboratories
InventorsRene Geissler, Megha Patel, Xiaoxing Qiu, Gavin Cloherty
Life of this patent
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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.
Claims16
A method of treating chronic HBV in a subject, the method comprising the steps of:
- a) administering a treatment for chronic HBV to a subject diagnosed with chronic HBV;
- b) performing an assay to detect the presence or level of Hepatitis B core antigen (HBcAg) and phosphorylated Hepatitis B core antigen (P-HBcAg) in at least one sample obtained from the subject, wherein the assay comprises contacting the at least one sample with an antibody that specifically binds to HBcAg and an antibody that specifically binds to P-HBcAg;
- and
- c) assessing and monitoring the response to the treatment for chronic HBV based on the presence or level of HBcAg and P-HBcAg in the at least one sample.
A method of treating chronic Hepatitis B (HBV) infection in a subject, the method comprising the steps of:
- a) performing an assay to detect the presence or level of Hepatitis B core antigen (HBcAg) in at least one sample obtained from a subject diagnosed with chronic HBV, wherein the assay comprises contacting the at least one sample with an antibody that specifically binds to HBcAg;
- b) determining the amount of infectious HBV particles in the at least one sample based upon the presence or level of HBcAg in the at least one sample,
- c) identifying the subject as having an amount of infectious HBV particles in the at least one sample equal to or above a threshold value;
- and
- d) providing a treatment for chronic HBV to the subject identified as having an amount of infectious HBV particles in the at least one sample equal to or above a threshold value.
A method of treating chronic Hepatitis B (HBV) infection in a subject, the method comprising the steps of:
- a) administering a treatment for chronic HBV to a subject diagnosed with chronic HBV;
- b) performing an assay to detect the presence or level of Hepatitis B core antigen (HBcAg) in at least one sample obtained from a subject receiving a treatment for chronic HBV, wherein the assay comprises contacting the at least one sample with an antibody that specifically binds to HBcAg;
- c) determining the amount of infectious HBV particles in the at least one sample based upon the presence or level of HBcAg in the at least one sample;
- and
- d) determining that the treatment is efficacious when the amount of infectious HBV particles in the at least one sample is less than a reference level;
- or
- determining that the treatment is not efficacious when the amount of infectious HBV particles in the at least one sample is greater than or equal to a reference level.
A method of treating chronic Hepatitis B (HBV) infection in a subject, the method comprising the steps of:
- a) administering a treatment for chronic HBV to a subject diagnosed with chronic HBV;
- b) performing an assay to detect the presence or level of Hepatitis B core antigen (HBcAg) and phosphorylated Hepatitis B core antigen (P-HBcAg) in at least one sample obtained from a subject receiving a treatment for chronic HBV, wherein the assay comprises contacting the at least one sample with an antibody that specifically binds to HBcAg and an antibody that specifically binds to P-HBcAg;
- c) determining the amount of infectious HBV particles in the at least one sample based upon the presence or level of HBcAg in the at least one sample;
- d) determining the amount of non-infectious HBV particles in the at least one sample based upon the presence or level of P-HBcAg in the at least one sample;
- and
- e) determining response to the treatment for chronic HBV based upon the amount of infectious and/or non-infectious HBV particles in the at least one sample.
A method of treating chronic Hepatitis B (HBV) infection in a subject, the method comprising the steps of:
- a) administering a treatment for chronic HBV to a subject diagnosed with chronic HBV;
- b) performing an assay to detect the presence or level of Hepatitis B core antigen (HBcAg) and phosphorylated Hepatitis B core antigen (P-HBcAg) in at least two samples obtained from a subject receiving a treatment for chronic HBV, wherein the at least two samples comprise a first sample obtained from the subject at a first time point before or after receiving the treatment for chronic HBV and a second sample obtained from the subject at a second time point after the first time point, and wherein the assay comprises contacting the at least two samples with an antibody that specifically binds to HBcAg and an antibody that specifically binds to P-HBcAg;
- c) determining the amount of infectious HBV particles in the at least two samples based upon the presence or level of HBcAg and/or determining the amount of non-infectious HBV particles in the at least two samples based upon the presence or level of P-HBcAg;
- and
- d) determining response to the treatment for chronic HBV based upon the amount of infectious and/or non-infectious HBV particles in the at least two samples.
Dependencies are inferred from the claim text.