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.
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);
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;
HBsAg-positive patients attending non-infectious disease/hepatology departments. PRO sub-study: Adult patients who have not previously received treatment and have been diagnosed with chronic hepatitis B
Cohort
Prospective
Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department.
Other interventionAfter 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 interventionPatients 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.
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.
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.
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.
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.
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.
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.
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