Union-FAST: An Intelligent-Agent Intervention to Increase Antiviral Treatment Uptake in Diagnosed-but-Untreated Hepatitis B Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Agent Intelligence education: Patients, while receiving usual care, will also receive four services from Union-Agent: (i) guideline-based educational modules tailored to patients' baseline knowledge of hepatitis B; (ii) personalized medication reminders with real-time adherence records; (iii) semantic follow-up that converts patient-reported symptoms into structured data and generates early risk alerts; and (iv) algorithm-driven referral suggestions aligned with China's three-tiered healthcare referral system.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Proportion of DBU patients initiating antiviral treatment — from enrollment to six months post-enrollment
  6-month antiviral treatment initiation rate in DBU patients meeting 2022 Chinese CHB guideline indications: * Absolute increase: ≥10 percentage points from baseline. * Relative increase: 50% from baseline.

Trial sites (1)

More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China

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