Impact of Fatty Liver on Hepatitis B Therapy (AV-FLCHB)

Tianjin Second People's Hospital

Status: Active, not recruiting

Conditions: Chronic Hepatitis B; Antiviral Treatment; Fatty Liver Disease

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

Study type: Observational

Funder types: Other

Identifiers

NCT06535048

TJYXZDXK-059B (Other Grant/Funding Number)

AV-FLCHB

TJWJ2022XK034 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

Fatty Liver

Description:

Hepatitis B patients with fatty liver

Treatment:

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

Non-Fatty Liver

Description:

Hepatitis B patients without fatty liver

Treatment:

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