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

Overview

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.

Detailed description

The "Hot wave Project" aims to establish a multicenter management cohort for HBsAg-positive patients within hospitals. Led by infectious disease specialists, the program conducts regular hepatitis B training sessions for hospital staff to enhance their understanding of HBV prevention and control. This initiative seeks to increase HBsAg screening rates overall and encourage patients from non-infectious disease departments to seek referrals to specialized care.

For all paper reports containing HBsAg test results, a remark is added stating: "HBsAg (+) - Recommended to visit the Hepatitis B Health Clinic in the Infectious Disease Department." Positive HBsAg results are automatically extracted by the information system and sent to a dedicated computer in the Hepatitis B Health Clinic, enabling centralized digital patient management.

Additionally, the Infectious Disease Department appoints a "Hepatitis B Specialist Assistant" responsible for reviewing HBsAg screening results, notifying HBsAg-positive patients or their attending physicians, and establishing follow-up records for all patients. A "Hepatitis B Health Clinic" is also set up within the department, managed by a specialized medical team that handles the diagnosis, treatment, and education for referred chronic hepatitis B patients.

Building upon this comprehensive management cohort, the project was expanded in 2025 to include a prospective Patient-Reported Outcomes (PRO) sub-study. This sub-study is designed to evaluate the longitudinal impact of antiviral therapy on the Health-Related Quality of Life among treatment-naïve patients with chronic hepatitis B. Utilizing the validated, localized Chronic Hepatitis B Quality of Life Scale (CHBQOL), the study assesses patients across four key dimensions-physical symptoms, emotional symptoms, beliefs, and social stigma-at baseline, 24 weeks, and 48 weeks post-treatment. By integrating PROs into clinical practice, the Hot wave Project goes beyond traditional biological endpoints to understand the challenges and benefits of HBV treatment from the patient's perspective, ultimately fostering a more patient-centered approach to chronic disease management.

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 re
• 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 wil

Primary outcome measures

• Referral Rate [Time frame: 2 weeks]
• Changes in Health-Related Quality of Life assessed by the CHBQOL Scale [Time frame: Baseline (Week 0), week 24, and week 48]

Secondary outcome measures (4)

• Antiviral Treatment Rate [Time frame: 2 weeks]
• Incremental Cost-Effectiveness Ratio [Time frame: 3 years]
• Correlation Between HRQoL Changes and Clinical Responses [Time frame: Baseline (Week 0), Week 24, and Week 48]
• Predictive Factors Affecting HRQoL Changes [Time frame: Baseline (Week 0), Week 24, and Week 48]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 3 centers

• The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou
• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou
• The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai

Identifiers

NCT: NCT06966908 · PL19

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗