Stopping Antiviral Treatment in Chronic Hepatitis B

NCT04431245 | Active Not Recruiting

• 1 other identifier: HKUUW20-425
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic hepatitis B (CHB) infection affected 292 million individuals in the world, translating to about 3.9% of global prevalence. Up to 40% of patients with CHB will develop liver-related complications. Many patients require long-term oral antiviral therapy since off-treatment sustained virological control can only be achieved in a minority of patients. It is uncommon for patients taking long-term antivirals to be able to stop the treatment if favorable factors are not present. Those include low viral load, long enough duration of treatment, and absence of cirrhosis. Some studies have found that inducing a mild flare is beneficial for achieving functional cure in chronic hepatitis B infection. There is lack of data in the immunological and virological profile in patients who stop their long-term antiviral therapy, and in those who developed flare after treatment cessation.

Conditions

Chronic Hepatitis b

Keywords

functional cure; antiviral therapy; nucleoside analogue

Outcome Measures

Primary Outcomes (2)

• The immunological profile in CHB patients who stopped antiviral therapy

  The investigators will perform analysis for the immunological aspects for these patients

  24 months

• The virological profile in CHB patients who stopped antiviral therapy

  The investigators will perform analysis for the virological aspects for these patients

  24 months

Study Arms (1)

Stop antiviral

HBeAg-negative non-cirrhotic CHB patients on long-term NA ≥3 years will be identified. Only those who have undetectable serum HBV DNA by the conventional assay (Cobas Taqman, Roche Diagnostics, Branchburg, NJ) which has a lower limit of detection (LLOD) of 10 IU/mL will be recruited. CHB patients were treated with potent oral NA (i.e. tenofovir or entecavir). All recruited patients will have written informed consent for participation of study. Patients with HCC, cirrhosis, history of liver transplantation, or on immunosuppressants, will be excluded.

Drug: Entecavir

Interventions

Entecavir DRUG

Study subjects will stop the antiviral therapy. Patients will be closely monitored every 6-8 weeks for virological flare and/or biochemical flare.

Also known as: oral nucleoside analogue

Stop antiviral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HBeAg-negative non-cirrhotic CHB patients on long-term NA ≥3 years will be identified. Only those who have undetectable serum HBV DNA by the conventional assay (Cobas Taqman, Roche Diagnostics, Branchburg, NJ) which has a lower limit of detection (LLOD) of 10 IU/mL will be recruited. CHB patients were treated with potent oral NA (i.e. tenofovir or entecavir). All recruited patients will have written informed consent for participation of study. Patients with HCC, cirrhosis, history of liver transplantation, or on immunosuppressants, will be excluded.

You may qualify if:

• HBeAg-negative
• non-cirrhotic
• on long-term NA ≥3 years (entecavir or tenofovir)
• undetectable serum HBV DNA

You may not qualify if:

• HCC, cirrhosis, history of liver transplantation, or on immunosuppressants,

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Man Fung Yuen

Hong Kong, Please Select One ..., Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir; Nucleosides

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosides; Carbohydrates; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Man-Fung Yuen, DSc, MD, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Study Record Dates

• First Submitted: May 31, 2020
• First Posted: June 16, 2020
• Study Start: June 1, 2021
• Primary Completion: August 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)