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

Effect of Fatty Liver on Antiviral Treatment in Patients With Hepatitis B

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Hepatitis B; Fatty Liver Disease; Antiviral Treatment
• Intervention / Treatment: Drug: Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；Interferons

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.

• Study Type: Observational
• Enrollment (Actual): 500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study included patients between the ages of 18 and 75 who underwent liver biopsies and were diagnosed with chronic hepatitis B (CHB), all of whom received antiviral therapy for the first time. Patients were divided into two groups according to whether they had fatty liver. All patients had a complete history, including B-ultrasound, fiber scan, hepatitis B serology, liver function tests and other examination data.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fatty Liver; Hepatitis B patients with fatty liver	Drug: 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.; Other Names: Entecavir: Baraclude; Tenofovir Disoproxil Fumarate (TDF): Viread; Tenofovir Alafenamide Fumarate (TAF): Vemlidy; Pegylated Interferon Alpha (Peg-IFN-α): Pegasys
Non-Fatty Liver; Hepatitis B patients without fatty liver	Drug: 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.; Other Names: Entecavir: Baraclude; Tenofovir Disoproxil Fumarate (TDF): Viread; Tenofovir Alafenamide Fumarate (TAF): Vemlidy; Pegylated Interferon Alpha (Peg-IFN-α): Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of virological levels in serum	The incidence of negativity for HBV DNA, HBsAg, and HBeAg, defined as serum levels less than 20 IU/mL, 0.05 IU/mL, and 1.0 S/CO, respectively.	5 years
Comparison of liver function improvement	Liver function was assessed by measuring serum ALT, AST, and GGT levels during treatment.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of Fatty Liver on the Incidence of Adverse Outcomes in CHB Patients	Evaluation of the incidence of adverse outcomes such as liver cirrhosis, hepatocellular carcinoma (HCC) under ultrasound, and overall survival in CHB patients with fatty liver compared to those without fatty liver.	5 years
Factors affecting adverse outcomes in patients with chronic hepatitis B	Kaplan-Meier method was used for survival analysis, and the influencing factors of poor prognosis were analyzed.	5 years

Collaborators and Investigators

• Sponsor: Tianjin Second People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): June 30, 2019
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: July 27, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Chronic Disease; Liver Diseases; Hepatitis B; Hepatitis; Hepatitis A; Fatty Liver; Hepatitis B, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antineoplastic Agents; Immunologic Factors; Tenofovir; Interferons; Interferon-alpha; Entecavir
• Other Study ID Numbers: AV-FLCHB; TJWJ2022XK034 (Other Grant/Funding Number: Tianjin Health Science and Technology Project key discipline special); TJYXZDXK-059B (Other Grant/Funding Number: Tianjin Key Medical Discipline (Specialty) Construction Project)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to concerns about participant privacy, data security, and the administrative burden of managing data requests, individual participant data (IPD) will not be shared. Additionally, the current research agreement does not include a data sharing clause.