HIV and Hepatitis B Co-Infection: Advancing HBV Functional Cure through Clinical Research (R21) | PA 17 278

Opportunity Information: Apply for PA 17 278

The grant opportunity titled "HIV and Hepatitis B Co-Infection: Advancing HBV Functional Cure through Clinical Research (R21)" (Funding Opportunity Number PA-17-278) is a National Institutes of Health (NIH) discretionary grant focused on early-stage, exploratory clinical research aimed at improving outcomes for people living with both HIV and hepatitis B virus (HBV). Its central goal is to close key scientific gaps that have slowed progress toward an HBV functional cure specifically in the context of HIV/HBV co-infection, where the biology, immune environment, and treatment constraints can be meaningfully different from HBV infection alone.

The FOA emphasizes two major priorities. First, it seeks studies that improve understanding of the unique challenges faced by HIV/HBV co-infected individuals in ways that directly inform functional cure strategies. In practical terms, this includes research that clarifies how HIV-related immune dysfunction, chronic inflammation, antiretroviral therapy (ART), and other host or viral factors influence HBV persistence, immune control, viral antigen production, and relapse risk after treatment changes. The intent is to generate clinically relevant knowledge about why co-infection may alter the trajectory of HBV disease or response to candidate cure approaches, and to identify measurable biomarkers, mechanisms, or patient subgroups that can guide smarter trial designs.

Second, the FOA supports advancing the discovery and development of novel HBV interventions that are both safe and capable of achieving a functional cure in people with HIV/HBV co-infection. A functional cure for HBV is generally understood as durable control of infection without ongoing therapy, commonly associated with sustained loss of hepatitis B surface antigen (HBsAg) with or without seroconversion, and long-term suppression of HBV replication and liver inflammation. Because HIV/HBV co-infected populations may have distinct safety considerations (for example, drug-drug interactions with ART, immune reconstitution effects, or risks linked to changing HBV-active components of HIV therapy), the opportunity is oriented toward clinical research that can responsibly evaluate new therapeutic strategies in this population or generate translational evidence that de-risks moving promising approaches forward.

The mechanism is an NIH R21, which typically supports exploratory and developmental projects designed to test innovative ideas, generate preliminary clinical data, or establish feasibility for larger future studies. The stated award ceiling is $200,000. This structure signals that applicants are expected to propose focused, high-impact projects rather than large-scale, definitive clinical trials. Projects might include early clinical studies, intensive sampling protocols, pilot interventional studies, or targeted investigations that yield clear go/no-go signals for subsequent development.

Eligibility is broad and includes a wide range of public and private entities. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations (other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other unspecified eligible organizations. The FOA also explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, Indian/Native American tribal governments that are not federally recognized, and non-domestic (non-U.S.) entities (foreign organizations). This wide eligibility reflects an interest in bringing in diverse scientific teams and community-relevant research infrastructure, including settings where HIV/HBV co-infection burdens may be substantial.

From an administrative standpoint, the opportunity is listed under multiple CFDA numbers (93.273, 93.394, 93.395, 93.399, 93.855, 93.856), indicating alignment with several NIH program areas spanning infectious diseases and related research portfolios. The FOA was created on 2017-05-12 and lists an original closing date of 2019-01-07, which is important for applicants to verify in current NIH systems whether the announcement remains active, has been reissued, or has transitioned to a newer version.

Overall, this FOA is designed to catalyze practical clinical research that both explains and addresses why HBV functional cure is especially challenging in HIV/HBV co-infected individuals. It encourages proposals that either deepen mechanistic and clinical understanding of co-infection in ways that directly shape cure strategy development, or that move new therapeutic concepts closer to a safe, effective, and durable functional cure specifically for co-infected patients.

• 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 (R21)" 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.)
• Each selected applicant is eligible to receive up to $200,000.00 in funding.
• 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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