Request for Information (RFI): Inviting Comments and Suggestions on a Framework for the Trans-NIH Strategic Plan to Cure Hepatitis B

Notice Number: NOT-AI-19-046

Key Dates
Release Date: February 28, 2019
Response Date: March 28, 2019

Related Announcements
None

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)
National Cancer Institute (NCI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Minority Health and Health Disparities (NIMHD)

Purpose

This notice is a time-sensitive Request for Information (RFI) inviting comments and suggestions on the framework for a Trans-NIH Strategic Plan to Cure Hepatitis B.

NOTE: It is important to read this entire RFI notice to ensure an adequate response is prepared and to have a full understanding of how your response will be utilized.

Background

NIH is developing a strategic plan to cure hepatitis B. The strategic plan aligns with NIH's ongoing efforts to intensify innovative hepatitis B research, and with the HHS-wide National Viral Hepatitis Action Plan.

The trans-NIH strategic plan will be structured around three areas of research vital to developing a cure for hepatitis B. A cure is defined as a sustained loss of hepatitis B surface (HBs) antigen, with or without the presence of antibodies against HBs, and undetectable hepatitis B virus (HBV) DNA in serum after completion of a finite course of treatment.

Strategic Priorities

Strategic Priority 1: Understand Hepatitis B Biology

  • Develop a comprehensive understanding of the virus and host factors underlying HBV pathogenesis, immunity, reactivation, and transmission
  • Characterize HBV infection, responses to treatment, reactivation, and disease progression to chronic hepatitis B, liver disease or liver cancer, taking into account: individuals with relevant co-infections (e.g. HIV and hepatitis D virus) or underlying immunosuppression (e.g. cancer treatment); various subpopulations such as people of Asian and Pacific Islander or Sub-Saharan African descent; and the influence of social, cultural, dietary and environmental factors

Strategic Priority 2: Develop Tools and Resources

  • Identify biomarker(s) for detection of early HBV infection, stages of liver injury, and viral replication, and for prediction of disease progression
  • Develop diagnostics, including those that accurately measure cccDNA
  • Develop cell culture and animal models that reflect human disease for preclinical use
  • Promote cross-disciplinary research and support early investigators to expand the cadre of innovative hepatitis B researchers
  • Leverage and expand clinical capacity to test therapeutic, diagnostic and vaccine candidates, particularly for high-risk and underserved populations

Strategic Priority 3: Develop Strategies to Cure Hepatitis B

  • Characterize immune profiles associated with viral clearance including in individuals functionally cured with existing treatments
  • Discover and develop strategies leading to the selective elimination or inactivation of HBV-infected cells using therapeutic vaccines, antivirals, and other approaches
  • Evaluate putative preventive and curative approaches on various patient subpopulations, including individuals with HIV infection, liver disease, liver cancer or other co-morbidities
  • Develop effective strategies to promote screening and vaccination of high-risk and underserved populations, and follow up and adherence to treatment for those with hepatitis B
  • Coordinate the development of guidelines for the implementation of a future cure regimen

Information Requested

This RFI seeks input from stakeholders throughout the scientific research community and the general public regarding the above proposed framework.

NIH seeks comments on any or all of, but not limited to, the following topics in hepatitis B cure research:

  • Significant research gaps and/or barriers not identified in the strategic priorities above
  • Necessary resources critical to advancing research in the three strategic areas
  • Emerging scientific advances or techniques that may accelerate research related to the three priorities

How to Submit a Response

All comments must be submitted electronically on the submission website.

Responses (no longer than 500 words in MS Word or pdf format) must be received by 11:59:59 pm (ET) on March 29, 2019 . You will see an electronic confirmation acknowledging receipt of your response

Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.

We look forward to your input and hope that you will share this RFI document with your colleagues.

Inquiries

Please direct all inquiries to:

hepBcureplan@nih.gov