cirB-RNA

Quantification de l'ARN viral circulant comme nouveau biomarqueur de guérison de l’hépatite B

Identity card

Global budget: 22083000 k€

Public funding: 5910000 k€

Public funders: ANR, Agence Nationale de la Recherche (In-Kind contribution from F. Hoffmann La Roche Ldt)

Call for projects: RHU

Year start: 2017

Completed project (2023-12)



Strategic business area: Human Medicines, In vitro Diagnostic, Hepatitis B; HBV cure; Antivirals; Treatment monitoring; Biomarkers; Circulating RNA; Diagnostics

Application fields: Infectious diseases, Hepatitis B

Technological approaches / Keywords: Biobank, Biologics, Cell model / Animal model

Stage of development at the beginning of the project: Basic research

Abstract

The 240 million chronic HBV infections remain a major health burden worldwide. Current treatments for CHB included interferon and nucleos(t)ide analogues. Only a limited number of treated patients achieve the loss of HBsAg allowing treatment cessation(functional cure). A challenge for new drug development is to target the pool of cccDNA, the nuclear replicative intermediate that act as template for the transcription of all viral mRNAs. Several new agents have reached preclinical and/or early clinical evaluation with the aim of silencing cccDNA and/or reducing the size of the cccDNA pool to achieve a cure with finite treatment duration. Our hypothesis is that circulating HBV RNAs reflects the transcriptional activity of cccDNA in the liver and would be the best biomarker for the reduction of the cccDNA pool and/or its inactivation. The aim will be to validate cir-HBV RNAs as a clinically relevant, early and non-invasive biomarker to predict HBV cure and develop the related assay.


Objectives

The goals of the cirB-RNA Project are the validation of circulating hepatitis B virus (HBV) RNAs (cirHBV RNA) as an innovative, clinically relevant, non-invasive biomarker for patients with chronic hepatitis B (CHB) to predict a functional cure, and the development of the related diagnostic test up to a Clinical Trial Assay(CTA).


Innovative assets
Highlights
Perspectives

Innovative assets

The working hypothesis is that cir-HBV RNA reflects the transcriptional activity of the cccDNA in the liver and would be the best biomarker for the reduction of the cccDNA pool and its functional inactivation. The cirB-RNA assay will significantly impact on HBV cure by providing a new virological endpoint and fastening the clinic development of NMEs.

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