Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection

Summary

Since 2022, the Third Affiliated Hospital of Sun Yat-sen University has initiated the "Hot Wave Project", a comprehensive hepatitis B infection prevention and management system encompassing patient education, screening, referral, treatment, and follow-up. In 2024, this system was expanded to the Sixth Affiliated Hospital and the Fifth Affiliated Hospital of Sun Yat-sen University, transitioning into a multicenter, hospital-based cohort study on hepatitis B management.The primary objective of this study is to increase the referral rate of HBsAg-positive patients in non-hepatology/non-infectious disease departments to 50%. The secondary objective is to improve the treatment rate of hepatitis B infected patients in non-hepatology/non-infectious disease departments, particularly focusing on the diagnosed but untreated (DBU) population. Furthermore, this study aims to analyze the cost-effectiveness and clinical benefits of in-hospital hepatitis B screening and management strategies.In 2025, a Patient-Reported Outcomes (PRO) sub-study was added to the project to evaluate the impact of antiviral therapy on the Health-Related Quality of Life among a cohort of treatment-naïve patients with chronic hepatitis B.

Eligibility

Inclusion Criteria:

* HBsAg-positive patients attending non-infectious disease/hepatology departments at three study centers.

Additional inclusion criteria for the PRO sub-study:

* Age ≥ 18 years;
* Treatment-naïve HBV-infected patients;
* Meet the treatment criteria according to the "Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B" (2022 version);
* Be able to understand the study content, willing to participate, and sign the informed consent;
* Have the ability to complete questionnaires independently or with assistance.

Exclusion Criteria:

* HBsAg-positive patients already under regular follow-up in infectious disease/hepatology clinics.
* Chronic HBV patients on regular antiviral treatment.

Additional exclusion criteria for the PRO sub-study:

* History of chronic liver diseases other than chronic HBV infection, including but not limited to: alcoholic liver disease, autoimmune liver disease, hereditary metabolic liver disease, etc. Co-infection with HCV, HDV, or HIV. Presence of other severe conditions that may affect HRQoL (such as severe cardiovascular and cerebrovascular diseases, uncontrolled mental illnesses, malignant tumors, etc.);
* Pregnant or lactating women;
* Use of pegylated interferon during the study;
* Failure to complete all follow-up visits;
* Other conditions that the investigator deems inappropriate for participation.

Conditions2

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