HIV and Hepatitis B Co-Infection: Advancing HBV Functional Cure through Clinical Research (R01) | PA 17 279

Opportunity Information: Apply for PA 17 279

The grant opportunity titled "HIV and Hepatitis B Co-Infection: Advancing HBV Functional Cure through Clinical Research (R01)" is a National Institutes of Health (NIH) discretionary grant program (Funding Opportunity Number PA-17-279) focused on improving outcomes for people living with both HIV and hepatitis B virus (HBV). The central aim is to close key scientific and clinical knowledge gaps that are holding back progress toward an HBV functional cure specifically in the HIV/HBV co-infected population. In practical terms, the FOA is designed to support clinical research that both deepens understanding of how co-infection changes HBV biology, immune responses, and treatment dynamics, and accelerates the discovery and development of new HBV interventions that are safe, effective, and capable of achieving functional cure in this higher-complexity group.

A major emphasis of the FOA is the concept of an "HBV functional cure" in the setting of HIV co-infection. While the announcement text does not provide a formal definition, functional cure in HBV research commonly refers to durable control of the virus and loss of hepatitis B surface antigen (HBsAg), with or without seroconversion, after stopping therapy, rather than complete eradication of all viral genetic material. The FOA highlights that people with HIV/HBV co-infection face unique biological and clinical challenges, which can include altered immune function, different inflammatory environments, potential drug-drug interactions, overlapping toxicities, and distinct risks for liver disease progression. Because of these differences, findings from HBV-only populations may not translate cleanly to co-infected individuals, and the FOA explicitly seeks research that addresses that translational gap rather than assuming one-size-fits-all HBV cure strategies.

The opportunity supports projects intended to inform HBV functional cure strategies by expanding what is known about the co-infected host. This can reasonably include clinical investigations into mechanisms that shape HBV persistence under HIV infection, the impact of immune reconstitution on HBV control, the role of HIV-related immune dysfunction in maintaining HBV reservoirs, and biomarkers that predict treatment response or relapse. It also points toward studies that clarify why current HBV treatments may behave differently in co-infected patients, or why safety and efficacy profiles might diverge from HBV mono-infection. The overall intent is to generate clinically grounded evidence that can guide the design of cure-directed regimens and make them more likely to succeed in real-world HIV/HBV populations.

Alongside the knowledge-building component, the FOA also explicitly encourages work that advances novel HBV interventions toward functional cure in co-infected individuals. In other words, it is not limited to observational research; it is also aimed at moving new therapeutic approaches forward through clinical research pathways, with a strong emphasis on safety and achieving functional cure in the target population. This "advance the discovery and development" language signals interest in projects that bridge the gap between promising concepts and clinical testing in co-infected people, particularly where the co-infection context creates special considerations for dosing, regimen design, monitoring, endpoints, and adverse event management.

From an administrative standpoint, this is an R01 research project grant, meaning it is structured to support substantial, hypothesis-driven research programs rather than small pilots alone. The funding instrument type is listed as "Grant," and the activity categories associated with the opportunity are Education and Health. The CFDA numbers attached to the FOA include 93.273, 93.394, 93.395, 93.399, 93.855, and 93.856, reflecting NIH program linkages across related infectious disease, immunology, and clinical research portfolios. The original FOA creation date is May 12, 2017, and the original closing date shown is January 7, 2019. The source data provided does not specify an award ceiling or expected number of awards, indicating that applicants would typically need to consult the full FOA and NIH Institute/Center guidance for budget expectations, paylines, and funding levels.

Eligibility is broad and includes many types of domestic U.S. organizations and governmental entities, spanning state, county, city/township, and special district governments, as well as independent school districts. Higher education institutions are eligible across public/state-controlled and private categories. Tribal eligibility is also included through federally recognized Native American tribal governments and other Native American tribal organizations. The FOA allows applications from nonprofit organizations with or without 501(c)(3) status, public housing authorities/Indian housing authorities, for-profit organizations (other than small businesses), and small businesses, plus an "Others" category that NIH often uses to capture additional eligible entity types described in the announcement.

In addition to those standard categories, the FOA explicitly calls out a range of "other eligible applicants" to emphasize inclusion of institutions that serve historically underrepresented or priority communities and regions. These include Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, and Historically Black Colleges and Universities (HBCUs). It also includes Tribally Controlled Colleges and Universities (TCCUs), Indian/Native American Tribal Governments that are not federally recognized, faith-based or community-based organizations, regional organizations, eligible federal government agencies, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). The inclusion of foreign and regional organizations is especially relevant for HIV and HBV research because co-infection burdens and clinical cohorts are often concentrated in global regions where HBV is endemic and HIV prevalence is substantial, making international collaboration and recruitment essential for many clinically meaningful studies.

Overall, the opportunity is aimed at supporting rigorous clinical research that directly tackles the complexities of HIV/HBV co-infection, with the dual goal of improving the scientific foundation for HBV functional cure strategies and pushing new HBV cure-directed interventions closer to real clinical impact for co-infected individuals. The FOA frames co-infected people not as an afterthought to HBV cure research, but as a population requiring tailored strategies, dedicated safety evaluation, and evidence built specifically in the context of HIV.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HIV and Hepatitis B Co-Infection: Advancing HBV Functional Cure through Clinical Research (R01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273, 93.394, 93.395, 93.399, 93.855, 93.856.
• This funding opportunity was created on 2017-05-12.
• Applicants must submit their applications by 2019-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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