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

Third Affiliated Hospital, Sun Yat-Sen University16,300 enrolled

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.

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

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

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.

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

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Referral Rate

Referral rate of HBsAg-positive patients in non-infectious disease departments = Number of HBsAg-positive patients referred to infectious disease departments / Total number of HBsAg-positive patients in non-infectious disease departments.

Time frame: 2 weeks

Changes in Health-Related Quality of Life assessed by the CHBQOL Scale

Patient-Reported Outcomes (PROs) and HRQoL are evaluated using the validated, localized Chronic Hepatitis B Quality of Life Scale (CHBQOL). The CHBQOL comprises 23 items categorized into four dimensions: physical symptoms, emotional symptoms, beliefs, and social stigma. This measure will calculate the longitudinal changes in both the total CHBQOL score and its dimension-specific sub-scores before and after initiating standard antiviral therapy. The objective is to quantify the impact of antiviral treatment on the quality of life in treatment-naïve CHB patients.

Time frame: Baseline (Week 0), week 24, and week 48

Secondary Outcomes

Antiviral Treatment Rate

Antiviral treatment rate of HBsAg-positive patients in non-infectious disease departments = Number of patients from non-infectious disease departments starting antiviral treatment / Total number of HBsAg-positive patients in non-infectious disease departments.

Time frame: 2 weeks

Incremental Cost-Effectiveness Ratio

This measure evaluates the long-term cost-effectiveness and cost-utility of the "Hot wave" in-hospital management strategy. Real-world data collected from this study-specifically the observed HBV linkage-to-care and treatment initiation rates-will be integrated into a validated decision-analytic Markov model. The model will be parameterized with localized epidemiological and demographic data from Guangzhou . By simulating different policy scenarios over a lifetime horizon, the model will predict cumulative costs and health outcomes, including Quality-Adjusted Life Years (QALYs) and the number of averted HBV-related complications . The final outcome will be expressed as the Incremental Cost-Effectiveness Ratio, representing the cost per additional QALY gained compared to the status quo.

Time frame: 3 years

Correlation Between HRQoL Changes and Clinical Responses

To evaluate the relationship between the longitudinal changes in CHBQOL scores (Patient-Reported Outcomes) and key clinical efficacy indicators. Specifically, this measure will analyze how achieving virological suppression (undetectable HBV DNA) and biochemical response (ALT normalization) correlates with improvements or declines in patients' Health-Related Quality of Life during the antiviral treatment period.

Time frame: Baseline (Week 0), Week 24, and Week 48

Predictive Factors Affecting HRQoL Changes

To analyze the sociodemographic and clinical factors that significantly influence the trajectory of PRO changes in CHB patients undergoing antiviral therapy. Evaluated factors will include, but are not limited to, patient age, gender, baseline liver fibrosis stage (assessed via FibroScan scores or imaging), and the presence of comorbidities. This analysis aims to identify specific patient subgroups that may require additional clinical attention or distinct management strategies to improve their quality of life.