Guidelines for the prevention and treatment of chronic hepatitis B

Chronic hepatitis B virus (HBV) infection remains a significant global public health challenge, particularly in China and other Asia-Pacific regions. Over the past few decades, China has made substantial efforts to combat HBV through universal infant vaccination, reducing medication costs, exploring "functional cure" strategies with approved drugs, and promoting Chronic Hepatitis B (CHB) guidelines in primary healthcare. The first edition of the Guideline of Prevention and Treatment for Chronic Hepatitis B was published in 2005 by the Chinese Society of Hepatology and the Chinese Society of Infectious Diseases, both under the Chinese Medical Association. These guidelines have been updated periodically, with revisions in 2010, 2015, and 2019, reflecting research and clinical practice advancements.

To align with the World Health Organization's goal of eliminating viral hepatitis as a public health threat by 2030, the 2022 update of the guidelines aims to significantly improve the diagnosis and treatment rates of CHB in China, which currently stand at only 22% and 15%, respectively. The revision process followed internationally recognized standards for developing clinical recommendations, incorporating the best available clinical evidence (including recent studies and Phase III trials of newly approved medications), public health needs (such as disease burden and health threats), and health economics considerations (e.g., cost-effectiveness of diagnostic and treatment methods).

The guidelines employ a structured approach to evaluating the quality of evidence and the strength of recommendations. Evidence quality is categorized into levels A, B, and C. At the same time, the strength of recommendations is graded as 1 or 2 based on the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) classification system. This ensures that the recommendations are both evidence-based and practical for clinical implementation.

The 2022 update emphasizes three key areas to reduce the HBV-related disease burden:

1. Active Prevention: Strengthening vaccination programs and other preventive measures to reduce new infections.
2. Large-Scale Testing: Expanding screening efforts to improve early diagnosis and linkage to care.
3. Expansion of Therapeutic Indications: Broadening the criteria for treatment eligibility to ensure more patients receive timely and effective therapy.

By focusing on these strategies, the updated guidelines aim to enhance the overall management of CHB in China, contributing to the global effort to eliminate viral hepatitis as a public health threat by 2030. The collaboration between the Chinese Society of Hepatology and the Chinese Society of Infectious Diseases, along with the support of expert panels, ensures that the guidelines are both scientifically rigorous and aligned with the needs of public health systems.

The following are clinical imperatives that necessitate further investigation and resolution:

1. Investigate and identify novel biomarkers capable of precisely delineating the chronic HBV infection trajectory and the phases of disease advancement.
2. Assess the influence of comorbid conditions, such as metabolic dysfunction-associated fatty liver disease and diabetes, on the effectiveness of antiviral treatments and the risk of hepatocellular carcinoma in individuals with HBV.
3. Examine potential strategies and frameworks for the widespread dissemination and execution of mass HBV screening programs to facilitate early detection and intervention.
4. Evaluate the practicality and economic viability of extensive treatment programs, including the potential adoption of a universal treatment policy, to inform public health policy formulation.
5. Investigate cutting-edge technological solutions for enhancing disease management within healthcare systems, aiming to optimize therapeutic outcomes, adherence, surveillance of disease evolution, and early hepatocellular carcinoma detection.
6. Leverage real-world clinical datasets to appraise the enduring safety, effectiveness, and economic impact of sanctioned pharmaceuticals.
7. Determine the therapeutic and economic outcomes of utilizing approved medications to attain a clinical cure in suitable cohorts, particularly those already undergoing treatment.
8. Delve into the novel virological and immunological pathways of HBV infection to uncover fresh therapeutic targets for clinical intervention.
9. Develop innovative clinical trial methodologies and organizational structures to facilitate the execution of high-caliber research for emerging therapeutics, accelerating the regulatory endorsement of treatments aimed at achieving a clinical cure in HBV management.

The outlined clinical imperatives underscore the need for comprehensive research to advance the understanding, management, and treatment of chronic HBV infection, focusing on novel biomarkers, comorbid impacts, mass screening, treatment scalability, technological innovation, real-world data utilization, therapeutic efficacy, mechanistic insights, and innovative trial designs to expedite clinical cure and improve public health outcomes.

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https://www.xiahepublishing.com/2310-8819/JCTH-2023-00320

The study was recently published in the Journal of Clinical and Translational Hepatology.

The Journal of Clinical and Translational Hepatology (JCTH) is owned by the Second Affiliated Hospital of Chongqing Medical University and published by XIA & HE Publishing Inc. JCTH publishes high quality, peer reviewed studies in the translational and clinical human health sciences of liver diseases. JCTH has established high standards for publication of original research, which are characterized by a study’s novelty, quality, and ethical conduct in the scientific process as well as in the communication of the research findings. Each issue includes articles by leading authorities on topics in hepatology that are germane to the most current challenges in the field. Special features include reports on the latest advances in drug development and technology that are relevant to liver diseases. Regular features of JCTH also include editorials, correspondences and invited commentaries on rapidly progressing areas in hepatology. All articles published by JCTH, both solicited and unsolicited, must pass our rigorous peer review process.

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