Impact of Fatty Liver on Hepatitis B Therapy

NCT ID: NCT06535048

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2024-08-31

Brief Summary

The primary goal of treating chronic hepatitis B(CHB) is to achieve maximal suppression of HBV replication, thereby reducing hepatocyte inflammation, necrosis, and liver fibrosis. Among various treatment strategies, antiviral therapy plays a crucial role. The prevalence of fatty liver disease (FLD) has continued to increase in recent decades. This study aims to accurately diagnose the pathological state of patients through liver biopsy and conduct a five-year follow-up to explore the impact of FLD on the efficacy of CHB treatment and to identify factors influencing adverse outcomes.

Detailed Description

Chronic hepatitis B (CHB) remains a serious threat to people's health. As of 2019, approximately 296 million people (3.9% of the world's population) were infected with the HBV virus. In the treatment of CHB, Antiviral drugs can not only achieve long-term viral suppression for most CHB patients, but also have a positive impact on other CHB treatment goals and improvement of prognosis, but can not eliminate the risk of adverse clinical outcomes completely, which are partly attributed to concomitant diseases such as fatty liver disease (FLD). Both diseases can cause chronic liver injure and increase the risk of cirrhosis and HCC.All patients included in this study underwent liver biopsy to determine their pathological status, ensuring the reliability and accuracy of disease diagnosis. And based on biopsy results, patients were categorized into two groups:fatty liver combined with hepatitis B and hepatitis B alone. The main antiviral treatments used in the study include first-line NAs, such as entecavir, tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), and interferons (IFN-α and Peg-IFN-α). They were followed for five years to thoroughly assess the long-term efficacy of antiviral treatment. Additionally, complications and liver fibrosis were evaluated using ultrasound and FibroScan to monitor the advancement of liver disease.

Conditions

Fatty Liver Disease; Chronic Hepatitis B; Antiviral Treatment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Fatty Liver

Hepatitis B patients with fatty liver

Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；Interferons

Intervention Type: DRUG

Entecavir: Participants will receive Entecavir 0.5 mg orally once daily for the duration of the study.

Tenofovir Disoproxil Fumarate (TDF): Participants will receive TDF 300 mg orally once daily for the duration of the study.

Tenofovir alafenamide fumarate (TAF): Participants will receive TAF 25 mg orally once daily for the duration of the study.

Interferon (IFN): Participants will receive IFN 180 µg subcutaneously once weekly for at least 12 weeks.

Non-Fatty Liver

Hepatitis B patients without fatty liver

Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；Interferons

Intervention Type: DRUG

Entecavir: Participants will receive Entecavir 0.5 mg orally once daily for the duration of the study.

Tenofovir Disoproxil Fumarate (TDF): Participants will receive TDF 300 mg orally once daily for the duration of the study.

Tenofovir alafenamide fumarate (TAF): Participants will receive TAF 25 mg orally once daily for the duration of the study.

Interferon (IFN): Participants will receive IFN 180 µg subcutaneously once weekly for at least 12 weeks.

Interventions

Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；Interferons

Entecavir: Participants will receive Entecavir 0.5 mg orally once daily for the duration of the study.

Tenofovir Disoproxil Fumarate (TDF): Participants will receive TDF 300 mg orally once daily for the duration of the study.

Tenofovir alafenamide fumarate (TAF): Participants will receive TAF 25 mg orally once daily for the duration of the study.

Interferon (IFN): Participants will receive IFN 180 µg subcutaneously once weekly for at least 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Entecavir: Baraclude; Tenofovir Disoproxil Fumarate (TDF): Viread; Tenofovir Alafenamide Fumarate (TAF): Vemlidy; Pegylated Interferon Alpha (Peg-IFN-α): Pegasys

Eligibility Criteria

Inclusion Criteria

1. Aged ≥18 and ≤75 years old, regardless of gender;

2. The patient had a positive hepatitis B marker and met the criteria for current hepatitis B virus infection (hepatitis B combined with fatty liver group);

3. Liver pathology indicated fatty liver (hepatitis B combined with fatty liver group);

4. All patients have complete medical history, B-ultrasound, FibroSan, hepatitis B five items, liver function and other laboratory test data.

Exclusion Criteria

1. Aged <18 or >75 years old;

2. Patients diagnosed with or previously diagnosed with HCC;

3. Those who are co-infected with other hepatitis viruses (HAV, HCV, HDV, HEV) or HIV or syphilis;

4. The follow-up data of patients are seriously missing.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Second People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TJWJ2022XK034

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TJYXZDXK-059B

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AV-FLCHB

Identifier Type: -

Identifier Source: org_study_id