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.

Conditions

• Chronic Hepatitis B

Interventions

OTHER

Facilitate 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.

OTHER

Assessment 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.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University

  lead OTHER

Principal Investigators

• Liang Peng · Third Affiliated Hospital, Sun Yat-Sen University

• Zhongsi Hong · Fifth Affiliated Hospital, Sun Yat-Sen University

• Fangfang Wei · Sixth Affiliated Hospital, Sun Yat-sen University

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-03

Primary Completion

2027-06-30

Completion

2027-12-31

Countries

• China

Study Locations