Biomarkers and uses thereof in the treatment of chronic hbv infection
AssigneeJanssen Sciences Ireland Unlimited Company
InventorsMarianne Isabelle TUEFFERD, Marjolein CRABBE, Jacques Armand Henri BOLLEKENS, Jeroen Marcel Maria Roger AERSSENS, Alessandro DI CARA
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Abstract
Immunogenetic biomarkers of viral control of chronic hepatitis B (CHB) infection that are indicative of relapse after a viral suppression treatment, such as a NUC treatment, in CHB infected subject are described. Also described are methods and compositions of using the immunogenetic biomarkers in predicting the relapse in the viral suppression treatment of CHB infection.
Claims27
An in vitro method of determining whether a subject having a chronic hepatitis B (CHB) infection has a high or low probability of relapse after discontinuation of a viral suppression treatment, comprising:
- a. detecting in a biological sample obtained from the subject the presence of one or more immunogenetic biomarkers of viral control of the CHB infection, wherein the one or more immunogenetic biomarkers are selected from the group consisting of:
- i. a human leukocyte antigen (HLA) allele;
- ii. one or more HLA-C single nucleotide polymorphisms (SNPs);
- iii. a HLA evolutionary diversity (HED) score;
- and
- iv. leucocyte receptor complex (LCR) SNPs;
- b. determining that the probability of relapse is low for the subject if the one or more immunogenetic biomarkers are detected in the biological sample, or determining that the probability of relapse is high for the subject if none of the immunogenetic biomarkers is detected in the biological sample.
A method of treating a chronic hepatitis B (CHB) infection in a subject in need thereof, comprising:
- a. administering to the subject a viral suppression treatment to treat the CHB infection;
- b. detecting in a biological sample obtained from the subject the presence of one or more immunogenetic biomarkers of viral control of the CHB infection, wherein the one or more immunogenetic biomarkers are selected from the group consisting of:
- i. a human leukocyte antigen (HLA) allele;
- ii. one or more HLA-C single nucleotide polymorphisms (SNPs);
- iii. a HLA evolutionary diversity (HED) score;
- and
- iv. leucocyte receptor complex (LCR) SNPs;
- c. if the one or more immunogenetic biomarkers of step b are detected in the biological sample, discontinuing the viral suppression treatment once viral suppression is achieved;
- or if none of the immunogenetic biomarkers of step b is detected in the biological sample, continuing the viral suppression treatment even after viral suppression is achieved, and/or administering to the subject a further or different viral suppression treatment.
A method of treating a chronic hepatitis B (CHB) infection in a subject in need thereof, the method comprising:
- a. administering to the subject a viral suppression treatment to treat the CHB infection;
- b. detecting in a biological sample obtained from the subject the presence of one or more immunogenetic biomarkers of viral control of the CHB infection, wherein the one or more immunogenetic biomarkers are selected from the group consisting of:
- i. a human leukocyte antigen (HLA) allele;
- ii. one or more HLA-C single nucleotide polymorphisms (SNPs);
- iii. a HLA evolutionary diversity (HED) score;
- and
- iv. leucocyte receptor complex (LCR) SNPs;
- c. discontinuing the viral suppression treatment when the CHB infection is suppressed in the subject, and
- d. administering to the subject the viral suppression treatment or another viral suppression treatment less than two years after the discontinuation if none of the immunogenetic biomarkers is detected in the biological sample.
A kit for serological HLA typing, or a kit for genetic HLA typing, for use in predicting efficacy of a viral suppression agent in treating a chronic hepatitis B (CHB) infection in a subject in need thereof.
(canceled)
Dependencies are inferred from the claim text.