None listed
Conditions
Brief summary
The current internationally accepted endpoint for chronic hepatitis B (CHB) treatment is loss of hepatitis B surface antigen (HBsAg), but this is rarely achieved. Recent studies have shown that stopping antiviral treatment in a highly selected group of patients ie non cirrhotic patients who have had undetectable HBV DNA on treatment for at least 1-2 years with low baseline HBsAg level can increase the chance of HBsAg loss ie functional cure, and a large proportion (50%) also had sustained virological response off treatment and not required retreatment. We aim to perform a randomized pilot study of 40 non cirrhotic patients at Middlemore Hospital with low baseline HBsAg <100IU/mL to determine whether it is safe to stop antiviral treatment and whether this will help improve the chance of functional cure from hepatitis B.
Interventions
Group 1: patients will stop antiviral treatment and have close observation (monthly blood tests for the first 12 months, then 3 monthly thereafter for up to 5 years)
Group 2: standard of care patients to continue antiviral treatment as usual (3 monthly blood tests)
Strategies used to monitor adherence to intervention- direct questioning by study personnel at each clinic visit
We would do interim analysis at 12 months and based on the results at this point determine whether we would continue or
Group 1: patients will stop antiviral treatment and have close observation (monthly blood tests for the first 12 months, then 3 monthly thereafter for up to 5 years) Group 2: standard of care patients to continue antiviral treatment as usual (3 monthly blood tests) Strategies used to monitor adherence to intervention- direct questioning by study personnel at each clinic visit We would do interim analysis at 12 months and based on the results at this point determine whether we would continue or terminate the study.
Sponsors
Dr Tien Huey Lim
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
- Non-cirrhotic patients with chronic hepatitis B (CHB), on nucleos(t)ide analogue (NA) therapy for at least 2 years - Age 18-60 years - Normal ALT level at screening - HBV DNA undetectable levels x3 (>6 months apart) - HBsAg levels <100 IU/mL within the last 3 months
Exclusion criteria
- Patients with cirrhosis/severe fibrosis (Fibroscan >9kpa), hepatocellular carcinoma - Other significant medical co-morbidities - Patients who have history of significant non compliance - Significant alcohol consumption (>30g/day for women and >50g/day for men) - Poor venous access
Outcome results
None listed