COIN-B: COntrolled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Infections

Antwerp University Hospital (UZA)

Status: Active, not recruiting

Conditions: Chronic Hepatitis B

Treatments: Other: Cessation of ongoing treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04779970

1.0

Details and patient eligibility

About

In this study we will prospectively stop NA in both Caucasian and non-Caucasian patients matched for gender and age, to validate the observed host and viral parameters for future roll-out of this treatment strategy.

Full description

An estimated 290 million people worldwide are chronically infected with the Hepatitis B Virus (HBV). One fourth of untreated patients develop progressive liver damage and are at risk of liver-related death, which can be prevented by treatment with Nucleos(t)ide Analogues (NA). These drugs efficiently suppress viral replication, but seroclearance of the virus, defined as loss of Hepatitis B surface Antigen (HBsAg), is predicted to require an average of 36 to 52 years of treatment. Cessation of NA after long-term viral suppression in patients without HBV seroclearance might reduce costs and may even increase the chance of subsequent HBsAg loss. We have recently shown in a retrospective multicentric international study, that Caucasian ethnicity and off-treatment viral control are associated with HBsAg loss after NA cessation. In this study we will prospectively stop NA in both Caucasian and non-Caucasian patients matched for gender and age, to validate the observed host and viral parameters for future roll-out of this treatment strategy.

Enrollment: 156 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis B
• Under continuous NA treatment
• >= 18 years old and <= 75 years
• HBeAg negative at start of treatment
• HBV DNA undetectable >36 months or <100 IU/mL >48 months
• ALT <= 80 U/L

Exclusion criteria

• Fibrosis >F2
• Active coinfection with HCV, HDV or HIV
• Pregnancy or lactation
• Immunocompromised patients
• Ever HCC or family history of HCC
• Ever participated in HBV siRNA therapeutic trials

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 3 patient groups

STOP: Caucasian patients

Experimental group

Description:

Cessation of treatment

Treatment:

Other: Cessation of ongoing treatment

STOP: non-Caucasian patients

Experimental group

Description:

Cessation of treatment

Treatment:

Other: Cessation of ongoing treatment

Control group

No Intervention group

Description:

Standard of care follow-up