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Competing Interests: DTYL reports support from ICE HBV for travel to present this work at COLDA 2023. AK reports grants from CANSA Cancer Association of South Africa, consulting fees from Roche Diagnostics, and support for attending meetings from Virology Education, University of Witwatersrand, and WHO. MLem reports consulting fees from Abbott and honoraria from Cepheid for lectures and presentations. GM reports grants from ViiV and Jannsen. CSC reports grants from GSK, Gilead Sciences, Janssen, and Roche Pharmaceuticals, and has participated in a data safety monitoring board for GSK. MH reports grants from Gilead Sciences and AbbVie. DAA reports being an inventor on Burnet Institute patents for alanine aminotransferase point of care tests for liver disease (PCT/IB2017/055943) and for dimeric IgA point of care tests for liver cirrhosis (PCT/AU2021/050037), and stock in Nanjing DeShi Diagnostic Technology Co. Ltd, which has licensed the alanine aminotransferase point-of-care test patents from Burnet Institute for manufacture and sale in China. PAR reports grants from NHMRC and a patent pending for CRISPR Cas13b guides targeting HBV (2023901165). CWS reports support by Gilead Sciences to attend AASLD. MLev reports honoraria from AbbVie and Gilead for lectures and presentations and support for attending meetings from AbbVie, Madrigal, and Gilead. ME-S reports support by Gilead Sciences. All other authors declared no competing interests.

Globally, 296 million people are infected with hepatitis B virus (HBV), and approximately one million people die annually from HBV-related causes, including liver cancer. Although there is a preventative vaccine and antiviral therapies suppressing HBV replication, there is no cure. Intensive efforts are under way to develop curative HBV therapies. Currently, only a few biomarkers are available for monitoring or predicting HBV disease progression and treatment response. As new therapies become available, new biomarkers to monitor viral and host responses are urgently needed. In October 2020, the International Coalition to Eliminate Hepatitis B Virus (ICE-HBV) held a virtual and interactive workshop on HBV biomarkers endorsed by the International HBV Meeting. Various stakeholders from academia, clinical practice and the pharmaceutical industry, with complementary expertise, presented and participated in panel discussions. The clinical utility of both classic and emerging viral and immunological serum biomarkers with respect to the course of infection, disease progression, and response to current and emerging treatments was appraised. The latest advances were discussed, and knowledge gaps in understanding and interpretation of HBV biomarkers were identified. This Roadmap summarizes the strengths, weaknesses, opportunities and challenges of HBV biomarkers., (© 2022. Springer Nature Limited.)

Over 257 million people live with chronic hepatitis B virus (HBV) infection and there is no known cure. The effective preventative vaccine has no impact on existing infection. Despite the existence of drugs which efficiently suppress viral replication, treatment is usually life-long and finite therapies that cure HBV infection are urgently required. However, even if such therapies were available today, it is unlikely they would reach all of those who need it most, due to chronic hepatitis B (CHB) being largely undiagnosed across the globe and to the dire need for health systems promoting access to therapy. Considerable challenges to developing and implementing an effective HBV cure remain. Nonetheless, important advances towards a cure are being made, both in the development of a multitude of new therapeutic agents currently undergoing clinical trials, and through the establishment of a new global initiative dedicated to an HBV cure, ICE-HBV, that is working together with existing organisations to fast-track an HBV cure available to all., Competing Interests: The authors declare no conflict of interest.