HDV DESCRIBE RFP Program

HDV DESCRIBE RFP Program

(HDV Epidemiology, Screening and Barriers to Linkage to Care)

Hepatitis delta virus (HDV) infection is recognized as the most severe form of viral hepatitis. HDV is a defective RNA virus that requires the presence of the hepatitis B virus (HBV) to replicate and infect liver cells.¹ HDV is an important public health issue due to the aggressive nature of the disease. Compared to HBV mono-infection, HDV/HBV co-infection increases the risk of liver cirrhosis by two- to threefold, increases risk of hepatocellular carcinoma three- to sixfold and doubles the risk of death.² HDV also increases the rate of disease progression with 30% of people living with HDV progressing to liver cirrhosis within five years.³ Given the rates of disease progression and a lack of widely available therapy, HDV remains an area of high unmet need.

Of the approximately 257 million people globally who are chronically infected with HBV,⁴ between 9 and 60 million individuals are estimated to be living with HDV, based on meta-analysis data from recent publications.^3,5 However, the true prevalence of HDV is not fully understood due to insufficient data and likely underdiagnosis. The distribution of people with HDV varies around the world, and not all countries and geographies have consistent screening guidelines or equal availability of diagnostic tests. These challenges result in large gaps in the understanding of the epidemiology of the disease. Therefore, there is a significant need to 1) identify the true epidemiology of HDV and regional screening practices, and 2) understand the barriers to optimal care among both patients and healthcare providers.

To further understand this patient population, Gilead has launched the HDV Epidemiology, Screening and Barriers to Linkage to Care (HDV DESCRIBE) RFP Program. The program will support individual projects up to $150,000 USD or equivalent sum. Projects greater than $150,000 will require approval by Gilead prior to submission.

Successful applications should include projects that are able to be completed within 12 months and demonstrate clear objectives, include defined timelines, offer a comprehensive operational planand propose data that has relevance to the medical community and policymakers. Priority will be given to studies exploring regional data.

Gilead will not consider proposals that solely request HDV screening costs (including test kits) or proposals that request HDV study drug. Proposals should be drug-agnostic.

Application Criteria

Gilead will consider support for research proposals that address the following:

• Generation of systematic epidemiology data of HDV
  • Priority given to country and cross-country data collection versus single-center data collection
• Identification of current screening practices, including but not limited to:
  • Which HDV screening tests are used?
  • Which types of providers are ordering the screening tests?
  • What are the clinical profiles of those being selected for screening?
  • Turnaround time to obtain test results
  • Reimbursement criteria for screening
• Characterization of barriers in the cascade of care, including but not limited to:
  • Screening
  • Linkage to care
  • Treatment

Letters of intent (LOIs) should adhere to the following:

• Proposed budget is <$150,000 USD or equivalent sum; Gilead approval will be required prior to submission for proposal with a budget of >$150,000.
  • Budget should include overhead costs and applicable taxes.
  • Proposed overhead costs should not exceed 30% of the total budget.
• The proposed study design will not take longer than 12 months to complete.
• Funding requests for the sole purpose of screening costs will not be considered for HDV DESCRIBE.
• Funding for or contribution of study drug will not be provided through HDV DESCRIBE.
• Priority will be given for proposals exploring regional data.
• There must be no more than one sponsor for contract negotiations and/or Institutional Review Board (IRB)/Ethics Committee (EC) review.
• LOI details should be submitted into Gilead’s Gilead OPTICS portal.

The Letter of Intent submission is not binding on either party. The purpose of the LOI is to provide a brief summary of the proposed study to enable Gilead to determine on a preliminary basis whether the proposed study and related budget are aligned with the criteria, timeline and scope of this RFP.

Submission Deadlines and Application Process

Submission Window

• May 3, 2021: Submission window opens
• June 4, 2021: Submission window closes

How to Apply

• Applicants should complete the LOI application in the Gilead OPTICS portal.
• After June 4, 2021, Gilead will evaluate and rank all LOIs received. Top-ranked LOIs will be invited to submit a full application and additional instructions will be provided to the submitter.

Gilead approval of awards will depend on availability of funds and receipt of meritorious and complete proposals. Awards shall be granted solely on the merit of the research and alignment with the criteria of this program.

Note: Gilead approval of awards does not take into account the past, present, or future volume or value of any business or referrals between the parties, and awards are not being given, directly or indirectly, as an inducement or reward with respect to the purchase, utilization, recommendation or formulary placement of any Gilead product. Further, the awardee is not required to purchase, order, recommend or prescribe to any patients any products manufactured or available through Gilead.

Questions about the HDV DESCRIBE announcement or application process should be directed to your local Gilead Medical Scientist or DESCRIBE@gilead.com. Applications are reviewed by an internal review committee, and Gilead reserves the right to approve or decline any application.