Virus related biomarkers to improve management of chronic conditions

The unifying aim of VIROMARKERS is to define virus related biomarkers to improve management of chronic diseases, including biomarkers of response to antiviral treatment of persistent viral infections and virome features as indicators of disease progression in immunosuppressed people.

The project has the following objectives:1.To demonstrate a novel bioinformatics method for prediction of HIV-1 susceptibility to broadly neutralising antibodies based on the HIV-1 gp120 sequence.2.To demonstrate novel HDV biomarkers (HDV-RNA, HBsAg isoforms and HDV genotype) to predict treatment response to the recently approved anti-HDV bulevirtide.3.To validate serum CMV-RNA as a biomarker of CMV infection/reactivation to optimise the correct timing for preventive strategies in patients undergoing hematopoietic stem cell transplantation. 4.To validate the torque teno virus DNA as a prognostic biomarker for CMV disease in immunocompromised patients. 5.To validate total and intact cellular HIV DNA as a biomarker of HIV infection status to guide novel antiviral strategies.Validation or demonstration of several technologies required to measure the candidate biomarkers is an integral part of the project objectives.

In particular, this refers to the following diagnostic tools:•dPCR as a tool for HDV quantification •NGS platform for HDV sequencing •qPCR diagnostics for CMV-RNA quantification •IPDA suitable for detection of intact HIV-DNA in any viral subtype •qPCR diagnostics for TTV-DNA Leveraging on the regulatory expertise present in the consortium, VIROMARKERS will define the regulatory pathway for each of its outcomes and will generate the experimental data necessary to move prototype methods and tools to regulatory approval.Overall, VIROMARKERS, with its public private partnership nature, will make available for healthcare providers and for researchers robust and fit-for-purpose biomarkers and linked technologies enabling their clinical use in response to important unmet clinical needs with, in the end, an important impact also for patients.VIROMARKERS is supported by the Innovative Health Initiative Joint Undertaking (IHI JU).

The JU receives support from the European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bío, MedTech Europe, and Vaccines Europe