Discontinuation of Antiviral Therapy as a Strategy to Cure Hepatitis B

NCT05328427 | Active Not Recruiting

• 1 other identifier: STOP-B
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Cirrhosis or cancer of the liver caused by hepatitis B virus (HBV) are major global health problems. Chronic HBV infection has become more common in Sweden with immigration. The risk of cancer and the availability of effective antivirals has led to more and more people receiving long-term treatment with antiviral drugs. The disadvantages of this treatment are that it does not have a defined duration and that it very rarely leads to the cure. Several published studies suggest that a large proportion of patients who discontinue antiviral therapy after at least three years may achieve lasting cure of the infection or at least do not need to resume treatment. The mechanism of this effect is not known, but it is thought to be due to the fact that the immune response, which is activated when the amount of virus increases after the end of treatment, becomes more effective in eradicating infected liver cells than it was before starting treatment. As a consequence of these findings updated guidelines for treatment of hepatitis B state that for patients that have received nucleoside analogue treatment for \> 3 years, discontinuation is an accepted therapeutic alternative. The purpose of the planned study is to investigate the results of discontinued treatment, in terms of clinical outcome as well as immunological and virological mechanisms. The aim is to include 120 patients at four regional infectious diseases clinics (in Gothenburg, Borås, Skövde and Trollhättan), of which 90 will be randomized to discontinue and 30 to continue antiviral treatment. Blood samples will be taken regularly to monitor the outcome and for detailed studies of viral antigens and nucleic acid in the blood and for specific analyzes of the cells of the immune system. The goal is to understand why the discontinued treatment in some patients activates an effective immune response and how such an effect can be predicted even before or early after the treatment is stopped.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (5)

• HBsAg seronegativisation

  Serum HBsAg becoming negative

  1 year

• HBsAg seronegativisation

  Serum HBsAg becoming negative

  2 years

• HBsAg reduction

  HBsAg reduction by \> 1 log IU/mL

  1 year

• HBsAg reduction

  HBsAg reduction by \> 1 log IU/mL

  2 years

• Clinical responder

  Sustained HBV DNA \< 2000 IU/mL and normal ALT

  2 years

Secondary Outcomes (1)

• HBV-specific T cell activation

  After 16 weeks

Study Arms (2)

Stopping

ACTIVE COMPARATOR

Discontinuation of nucleoside analogue treatment

Other: Stopping

Continue

NO INTERVENTION

Treatment with nucleoside analogue continued

Interventions

Stopping OTHER

Discontinuation of nucleoside analogue

Stopping

Eligibility Criteria

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

You may qualify if:

• Nucleoside analogue treatment for HBeAg-negative chronic hepatitis B for at least 36 months.

You may not qualify if:

• Liver cirrhosis or liver cancer.
• Co-infection with HCV, HDV or HIV.
• Inability to understand study information and give informed consent

Sponsors & Collaborators

• Göteborg University: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Infectious Diseases Clinic, Sahlgrenska University Hospital

Gothenburg, VGR, 41650, Sweden

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tin Fluorides

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)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Tin Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 14, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)