SPEARHEAD Europe RFP Program

Screening imPlEmentation and linkage to cARe in HEpAtitis Delta (SPEARHEAD)

Chronic hepatitis delta virus (HDV) is the most severe form of viral hepatitis, occurring in some people who are living with hepatitis B virus (HBV). HDV leads to a rapid progression of liver disease, increasing the risk of cirrhosis, decompensated cirrhosis, liver transplant, hepatocellular carcinoma, and mortality compared to HBV alone.^1,2,3 The global prevalence of HDV is estimated to be between 5% to 13% in people with HBV, accounting for 12 to 60 million people living with HDV worldwide.^4,5 However, the prevalence of HDV is largely underestimated due to the lack of universal HDV testing among people living with HBV.⁶ Given the disease severity and general underdiagnosis of HDV, there is an unmet need for enhanced screening and linkage to care in those with HBV.

The European Association for the Study of the Liver (EASL) recommends HDV screening for all individuals living with HBV.⁸ Even with these guideline recommendations in place, recent data have demonstrated a large proportion of people living with HBV remain untested for HDV.^9,10 In the United States, HDV screening rates are as low as 8.5% to 12% of HBsAg-positive individuals.^11,12

To understand and address barriers to HDV screening and linkage to care, Gilead launched the SPEARHEAD RPF program in 2022 in the United States and is expanding the program to Europe in 2023. The program will support individual projects up to 200,000 USD. Projects greater than 200,000 USD will require discussion with Gilead before submission.

Applications should include projects that can be completed within 18 months and demonstrate clear objectives, include defined timelines, offer a comprehensive operational plan, propose data that has relevance to the medical community and policymakers, and includes plans for the data to be submitted to relevant congresses and journals. The proposed study must be conducted in Europe.

Gilead may provide research funds for screening and testing support only if it is an essential component of a valid study design to address the research needs outlined in the RFP. Gilead will not consider proposals that request HDV study drugs and is not seeking studies that focus on treatment outcomes. Proposals should be treatment/drug agnostic.

Application Criteria

Gilead will evaluate and support select programs designed to:

• Generate data to understand the impact of HDV screening implementation
  • Examples include but are not limited to:
    • Implementation of reflex testing to screen all positive HBV samples for HDV
    • Leveraging EMR and other digital platforms to enhance screening rates
    • Optimization of screening rates for appropriate patients in high prevalence settings
    • Enhancing screening awareness within varied populations and settings such as primary care, HIV clinics, safety-net clinics
  • Studies should aim to evaluate HDV screening practice before and after study implementation, including the proportion of people with HBV screened, number of HDV diagnoses, and HDV prevalence rates
• Generate data to assess current HDV linkage-to-care practice, identify barriers, develop and implement novel approaches to enhance linkage to care
  • Examples include but are not limited to:
    • Healthcare provider survey to understand current care approaches to generate insights on existing barriers
    • Chart analyses to identify patient or institutional factors associated with sub-optimal linkage to care and implement quality improvement measures
    • Implementation of case managers and other patient resources to decrease rates of patient disengagement
    • Novel approaches to engage and educate patients and caregivers

In addition, the following criteria apply:

• Both investigator-sponsored research study proposals and collaborative research study proposals (developed in conjunction with Gilead) will be considered
• The study sponsor must be based in Europe.
• The study sponsor may not currently receiving Gilead grants to conduct HDV screening.
• The same institution may receive multiple grants for HDV screening if they are mutually exclusive to the sponsoring department (i.e. Hepatology vs. ED).
• The proposed budget is under 200,000 USD. Advance discussion with Gilead is required prior to submission of proposal with a budget over 200,000 USD.
• The 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 18 months to complete.
• Funding for screening and& testing supplies may be provided as part of a valid study design to address the research needs outlined in the RFP
• Funding for or contribution of study drugs will not be provided.
• There must be no more than one sponsor for contract negotiations and/or Institutional Review Board (IRB) review.

Application Process

Applicants should submit applications in the Gilead OPTICS portal.

• Gilead will evaluate and rank all letters of intent (LOI) received on a rolling basis until funds are exhausted.
• It is recommended to submit earlier than later to ensure that funding is available for your proposal.
• Monday, April 3rd, 2023 at 00:00 AM GMT: Submission window opens.
• Wednesday, November 1st, 2023 6:59 AM GMT: Submission window closes.
• Top-ranked LOIs will be invited to submit a full application and additional instructions will be provided to the submitter.

Gilead’s approval of awards will depend on the 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 consider 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 concerning 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 SPEARHEAD RFP program or application process should be directed to your local Gilead Medical Scientist or SPEARHEAD@gilead.com.

Applications are reviewed by an internal review committee, and Gilead reserves the right to approve or decline any application.