China has made significant strides in controlling hepatitis B virus (HBV) infection over the past three decades, reducing the prevalence of hepatitis B surface antigen (HBsAg) from 9.72% in 1992 to 5.86% in 2020. Despite these achievements, an estimated 75 million individuals in China still live with chronic HBV infection, with only 59.78% aware of their status and 17.33% receiving treatment. To meet the World Health Organization (WHO) 2030 elimination targets—a 95% reduction in new infections and a 65% decline in HBV-related mortality—China has adopted a multifaceted approach combining public health interventions, clinical guideline updates, and pharmaceutical innovation. This review outlines China's progress, identifies persistent gaps, and highlights strategies for achieving HBV elimination.
Epidemiological Shifts and Vaccination Success
Universal infant hepatitis B vaccination, introduced in 1992, has been the cornerstone of China's HBV control strategy. By 2020, HBsAg prevalence among children under five plummeted from 9.67% to 0.30%, surpassing the WHO's 1% target. Key policies, such as free vaccination under the Expanded Program on Immunization (2002) and the "Triple Elimination" initiative (2011) targeting mother-to-child transmission (MTCT), have averted over 40 million infections and seven million deaths. The SHIELD program further reduced MTCT rates to 0.23% through standardized protocols and digital health tools. However, challenges persist in rural areas due to healthcare disparities and logistical barriers.
Gaps in Diagnosis and Treatment
While vaccination has curtailed new infections, the burden among older, unvaccinated cohorts remains high. Only 24% of chronic HBV cases are diagnosed, and 15% receive treatment. Barriers include fragmented healthcare systems, stigma, and financial constraints. Men and rural populations are disproportionately affected, with regional prevalence ranging from 15.9% to 25.3%. High-risk groups, such as hemodialysis and HIV-positive patients, face elevated HBV rates (up to 17.6%), underscoring the need for targeted micro-elimination strategies.
Expanding Treatment Eligibility
China's 2022 clinical guidelines expanded treatment criteria to include all HBV DNA-positive individuals at risk of progression, aligning with WHO's "treat all" approach. Modeling suggests that lowering ALT thresholds (30 U/L for men, 19 U/L for women) could reduce mortality by 65% by 2043. Early intervention in children and HBeAg-positive patients shows promise, but cost and adherence hurdles remain. Digital health tools and patient-centered education are critical to improving compliance.
Innovative Therapies for Functional Cure
Research focuses on achieving a functional cure (sustained HBsAg loss) through novel agents:
Antivirals: Small interfering RNAs (e.g., VIR-2218) and antisense oligonucleotides (e.g., bepirovirsen) reduce HBsAg levels.
Immunomodulators: Toll-like receptor agonists (GS-9688) and therapeutic vaccines (TG1050) aim to restore immune control.
Chinese-developed therapies, such as AHB-137 (62% HBsAg clearance in Phase II) and HH-003 for HBV/HDV coinfection, highlight the country's role in global HBV research. However, optimizing combination therapies and ensuring affordability are ongoing challenges.
Conclusion
China's integrated strategy—combining vaccination, MTCT prevention, expanded treatment, and innovation—has positioned it as a leader in HBV elimination. Key priorities include scaling up testing, addressing healthcare inequities, and advancing affordable curative therapies. These efforts offer a blueprint for global HBV control, demonstrating that elimination is achievable with sustained investment and collaboration.
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The study was recently published in the Journal of Clinical and Translational Hepatology .
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