SPEARHEAD RFP Program

Spearhead RFP Program

Screening imPlEmentation and linkage to cARe in HEpAtitis Delta

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

The American Association for the Study of Liver Diseases (AASLD) recommends HDV testing for HBsAg-positive persons at risk.7 The European Association for the Study of the Liver (EASL) recommends HDV screening for all people infected 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 has launched the SPEARHEAD RFP program. The program will support individual projects up to USD 300,000. Projects greater than USD 300,000 will require discussion with Gilead before submission.

Applications should propose 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
  • Include plans for the data to be submitted to relevant congresses and journals
  • The proposed study must be conducted within the United States

Gilead will not consider proposals that solely request support for HDV screening costs (including test kits). Proposals may request funds for screening costs 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 that will:
    • 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 primary care settings
    • 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
  • The sponsoring institution must be in the United States.
  • The sponsoring institution must not be currently receiving support from Gilead's FOCUS program for HBV or HDV Pilot Program.
  • Both investigator-sponsored research study proposals and collaborative research study proposals (developed in conjunction with Gilead) will be considered.
  • Proposed budget must be under USD 300,000; advance discussion with Gilead is required prior to submission for proposal with a budget over USD 300,000.
    • The budget should include overhead costs and applicable taxes.
    • Proposed overhead costs should not exceed 30% of the total budget.
  • The proposed study design must not take longer than 18 months to complete.
  • Funding requests for the sole purpose of screening costs will not be considered.
  • Funding for or contribution of study drug will not be provided.
  • There must be no more than one sponsor for contract negotiations and/or Institutional Review Board (IRB) review.

Application Process

  • May 9, 2022 at 12 a.m. PT: Submission window opens
  • June 30, 2022 at 11:59 p.m. PT: Submission window closes
  • Applicants should submit the Letter of Intent (LOI) application in the Gilead OPTICS portal.
  • After June 30, 2022, 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’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 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 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.

References

  1. Romeo R, Petruzziello A, Pecheur EI, et al. Hepatitis delta virus and hepatocellular carcinoma: an update. Epidemiol Infect. 2018;146(13):1612-1618. doi:10.1017/S0950268818001942.
  2. Fattovich G, Giustina G, Christensen E, et al. Influence of hepatitis delta virus infection on morbidity and mortality in compensated cirrhosis type B. The European Concerted Action on Viral Hepatitis (Eurohep). Gut. 2000;46(3):420-426. doi:10.1136/gut.46.3.420.
  3. Höner Zu Siederdissen C, Cornberg M. Management of HBV and HBV/HDV-Associated Liver Cirrhosis. Visc Med. 2016;32(2):86-94. doi:10.1159/000445518.
  4. Miao Z, Zhang S, Ou X, et al. Estimating the Global Prevalence, Disease Progression, and Clinical Outcome of Hepatitis Delta Virus Infection. J Infect Dis. 2020;221(10):1677-1687. doi:10.1093/infdis/jiz633.
  5. World Health Organization. Hepatitis D. July 28, 2020. Accessed June 30, 2021. https://www.who.int/news-room/fact-sheets/detail/hepatitis-d.
  6. Rizzetto M, Hamid S, Negro F. The changing context of hepatitis D. J Hepatol. 2021;74(5):1200-1211. doi:10.1016/j.jhep.2021.01.014.
  7. Terrault NA, Bzowej NH, Chang KM, et al. AASLD guidelines for treatment of chronic hepatitis B. Hepatology. 2016;63(1):261-283. doi:10.1002/hep.28156.
  8. European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017;67(2):370-398. doi:10.1016/j.jhep.2017.03.021
  9. Trimoulet P, Foucher J, Tumiotto C, Hermabessière P, Delamarre A , Irlès-Depé M, Lafon ME, De Ledinghen V. On the way to HDV elimination. A call for reflex testing in the large program “Bordeaux metropolis without viral hepatitis”. AASLD 2021. Poster #720
  10. Palom A, Rando-Segura A, Barciela MR, Barreira-Diaz A, Rodriguez-Frías F, Esteban-Mur R, Buti M. Low adherence to guidelines recommendation for testing hepatitis D in HBsAg positive patients leads to a high rate of undiagnosis. AASLD 2021. Oral #224
  11. Kushner T, Serper M, Kaplan DE. Delta hepatitis within the Veterans Affairs medical system in the United States: Prevalence, risk factors, and outcomes. J Hepatol 2015;63:586-92.
  12. Safaie P, Razeghi S, Rouster SD, Privitera I, Sherman KE. Hepatitis D diagnostics:Utilization and testing in the United States. Virus Res 2018;2:114-117.