RecruitingNCT06966908

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

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Enrollment

16,300 participants

Start Date

Jan 3, 2025

Study Type

OBSERVATIONAL

Conditions

Chronic Hepatitis B

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 Criteria6

HBsAg-positive patients attending non-infectious disease/hepatology departments at three study centers.
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 Criteria7

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

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Interventions

OTHERFacilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department.

After visiting the hospital, high-risk HBV patients are prescribed HBsAg testing by their primary physician. If HBsAg positivity is detected in patients from non-infectious disease departments, their lab reports will include a reminder to visit the Hepatitis B Health Clinic. Some primary physicians may also request an infectious disease consultation or recommend patient referral. Additionally, within two weeks, the Hepatitis B Specialist Assistant will contact the patients by phone to provide referral recommendations. Once referred to the Hepatitis B Health Clinic, physicians will conduct health education, complete liver function and virological assessments, and develop individualized treatment and follow-up plans.

OTHERAssessment of patient-reported outcomes (PROs) in patients with chronic hepatitis B.

Patients with chronic hepatitis B who meet treatment criteria and have not previously received treatment will undergo a routine clinical evaluation in a private setting under the guidance of trained staff and complete the Chronic Hepatitis B Quality of Life (CHBQOL) questionnaire prior to initiating standard antiviral therapy (baseline, Week 0). Subsequently, patients will return for scheduled follow-up visits at Weeks 24 and 48 after treatment initiation. During follow-up visits, physicians will assess liver function and virological suppression. Additionally, the CHBQOL questionnaire will be administered again to evaluate changes in patients' health-related quality of life over time, as well as to monitor medication adherence and adverse events.