Linking Diagnosed but Untreated HBV Patients to Care RFP Grant

Linking Diagnosed but Untreated HBV Patients to Care RFP Grant

Status: ACTIVE
Funder: Gilead Sciences, Inc.
Amount: More than US $150,000
Last Updated: September 15, 2025

Summary

Gilead Sciences is seeking proposals to improve the management of Chronic Hepatitis B (CHB) patients who are diagnosed but untreated. This initiative aims to address the significant gap in treatment, as millions remain untreated despite being eligible. The project emphasizes the need to connect these patients to appropriate care, reducing the risks of severe complications such as cirrhosis and liver cancer, ultimately enhancing public health outcomes.

Overview

Note: Gilead will evaluate all LOIs received on a rolling basis until funds are exhausted. After an initial LOI review, invitations will be issued for selected applicants to submit a full application with a detailed budget. It is recommended to submit as soon as possible to increase the likelihood that funding is available for your proposal. Gilead Sciences Medical Affairs Request for Proposal (RFP) LINK-DBU 2.0 (Linking Diagnosed but Untreated HBV Patients to Care) Chronic hepatitis B (CHB) can be a life-threatening liver infection caused by the hepatitis B virus (HBV). CHB continues to be a major public health issue despite the availability of an effective vaccine and potent antiviral therapies. Untreated individuals with CHB have an estimated 30%- 40% lifetime risk of cirrhosis or hepatocellular carcinoma (HCC). Therapy for HBV has greatly improved, with the availability of effective and safe oral antivirals with high barriers to resistance. Additionally, treatment has been shown to decrease the occurrence of complications such as liver decompensation and hepatocellular carcinoma. Globally, it is estimated that over 250 million individuals are Hepatitis-B surface antigen (HBsAg)-positive, of which 36 million patients are diagnosed as of 2022. Among 83.3 million estimated to be treatment eligible based on 2022 criteria, only 6.8 million are actually being treated. Additionally, an estimated 1.1 million deaths were due to HBV, mostly due from cirrhosis and HCC. For example, in the United States, it is estimated that among 1.6 million infections, 323,000 are diagnosed and 499,000 qualify for treatment; yet, only 144,000 are estimated to receive treatment. Similar trends with diagnosed but untreated (DBU) patients have also been observed in other parts of the world, despite variations in practice guidance on the regional and country-levels. These DBU patients—particularly those who are diagnosed, qualify for treatment, and remain untreated— represent an important patient segment. By definition, clinical guidelines on both the regional society level (e.g. EASL, APASL, AASLD) as well as the country-level (e.g. China, Taiwan, Korea, Japan) have identified patients who fit these profiles as benefiting from treatment. Therefore, these patients represent an important missed opportunity to mitigate the risks of HBV-related morbidity and mortality. Collectively, these data suggest that regardless of treatment guideline, there remains a gap between recommended clinical guidance and actual practice. The underlying cause(s) of the gap is not understood.

Eligibility

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