Multidisciplinary Research to Accelerate Hepatitis B Cure in Persons Living with HIV and HBV (U19 Clinical Trial Not Allowed)

Background
The purpose of this Notice of Funding Opportunity (NOFO) is to support research to better understand the impact of host and viral heterogeneity on pathogenesis of disease, viral persistence, and immunopathology of Hepatitis B (HBV) and inform cure strategies for HBV in people living with HIV (PLWH). Applicants will establish multidisciplinary teams that span the clinical and basic/translational research arenas and establish an observational cohort to accelerate discovery and increase clinical impact.

Grant Details
Each application will include a cross-disciplinary team of investigators that engages preclinical and clinical researchers in HBV and in HIV as expertise requires. Research applications are strongly encouraged to focus on the study of primary viral isolates from different genotypes and include objectives that address multiple stages of the natural life cycle of HBV in PLWH. Investigators are encouraged to develop multi-omics strategies to identify novel host and viral factors that underly disease mechanisms with an emphasis on identifying drug targets and biomarkers for HBV cure. Applications will combine at least one clinical research project and one basic or translational research project to accelerate discovery and increase clinical impact.

Examples of research areas of interest include, but are not limited to: Determine the impact of host and viral heterogeneity on disease progression, persistence, immunopathology, and the impact on therapeutic outcomes including HBV and/or HIV drug resistance.

Elucidate the liver microenvironment in distinct stages of chronic HBV and the impact of HBV viral infection on the immunological response.

Measure the size of the latent HBV reservoir and design targeted approaches to eradicate the persistent reservoir (e.g., cccDNA, iDNA)

Evaluate the impact of HIV and HIV treatment on cccDNA and iDNA.

Determine the clinical impact of HBV iDNA on the immune response.

Discover and develop new surrogate markers that predict progression through the different stages of chronic HBV, including the immune response, inflammation (e.g., hepatic flares), liver injury and indicators and predictors of treatment response.

Develop non-invasive diagnostic tools to assess stages of HBV disease progression, liver injury, and hepatic flares.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, state governments, county governments, city or township governments, special district governments, Indian/Native American Tribal Governments (Federally Recognized), U.S. Territory or Possession, foreign institutions, as well as foreign components of U.S. Organizations. Individuals from diverse backgrounds are encouraged to apply for NIH support.

Period of Performance
The period of performance should reflect the scope of the proposed project with a maximum project period of 5 years.

Grant Value
NIAID intends to commit $6 million in FY 2025 to fund 1-3 awards.