Real World Assessment of People Living With Chronic Hepatitis B in Australia

Study Overview
=================
Brief Summary
-----------------
The REACH-B study establishes an observational cohort study of people living with chronic hepatitis B from a national network, including a diverse range of services, to characterise and monitor hepatitis B linkage to care and treatment requirements amongst this population.

Detailed Description
-----------------
Participants presenting to participating clinics for HBV care within the previous 12 months will be identified and enrolment data will be collected including demographics, laboratory parameters, liver disease assessment, treatment history and clinical management. Follow-up data on HBV treatment and clinical management, liver disease stage and laboratory parameters will be collected at each subsequent visit or at minimum every 12 months.

Official Title
-----------------
Real World Assessment of People Living With Chronic Hepatitis B in Australia

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All individuals diagnosed with chronic hepatitis B in the participating study sites are eligible to be included (both newly diagnosed cases and those diagnosed in the past). 16 years of age or older. Attended the health service for HBV care within the prior 12 months from study commencement (retrospective recruitment) OR Attending the health service for HBV care from study commencement (prospective recruitment) Exclusion Criteria: 1. Nil

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HBsAg Positive<br>Patients with chronic hepatitis B infection as defined by HBV surface antigen positive | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterisation of HBV | To characterise and monitor hepatitis B linkage to care and treatment requirements amongst people living with chronic hepatitis B | July 2027 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Socio-demographics of HBV infected population | To characterise the socio-demographic spectrum of people living with chronic HBV | July 2027 | 
| HBV Disease staging | To assess the proportion of individuals in each phase of the disease, based on the natural history of hepatitis B infection | July 2027 | 
| HBV Care Cascade | To assess the proportion of individuals who are eligible for each recommended hepatitis B clinical care level | July 2027 | 
| HBV Treatment and Care | To monitor the uptake of recommended hepatitis B clinical care, including antiviral treatment | July 2027 | 
| HBV Care and treatment adherence | To monitor the adherence to recommended hepatitis B care, including the patterns of antiviral use and cessation | July 2027 | 
| HCC Surveillance | To assess the rate of surveillance for hepatocellular carcinoma | July 2027 | 
| HBV Disease Progression | To assess the rate of progression from each phase to the subsequent phase of hepatitis B | July 2027 | 
| Liver fibrosis progression | To assess the rate of liver fibrosis progression, including the development of cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma | July 2027 |