The World Health Organization (WHO) has set a target to eliminate viral hepatitis by 2030, aiming for a 90% diagnosis rate and an 80% treatment rate for chronic hepatitis B (CHB). However, as of 2024, only 26.1% of CHB infections globally have been diagnosed, and only 14.6% have received treatment, with treatment coverage falling far short of the target. A large number of patients are in a "Diagnosed-but-Untreated (DBU)" state, with major barriers including: low disease awareness, concerns about medication side effects, fragmented healthcare pathways, and poor physician-patient communication. Traditional hospital-based follow-up models are constrained by human resources and the capacity for health information system integration, making them difficult to scale widely in primary care settings. Supported by the National Key R\&D Program of China, our team has successfully developed the world's first infectious disease agent (Union-Agent) after more than two years of research. This study aims to conduct a multicenter, prospective, two-cohort observational and interventional investigation to identify the reasons why DBU patients fail to initiate treatment and to explore whether an intervention using the Union-Agent can significantly increase the rate of antiviral treatment initiation within six months among DBU patients who meet the antiviral indications according to the 2022 Chinese guidelines for the prevention and treatment of chronic hepatitis B. The study hypothesizes that, compared to baseline, the Union-Agent can enable 50%-60% of treatment-eligible DBU patients to initiate antiviral therapy within six months.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Proportion of DBU patients initiating antiviral treatment
Timeframe: from enrollment to six months post-enrollment