Clinical trial NCT06535048: Impact of Fatty Liver on Hepatitis B Therapy
Official title: Effect of Fatty Liver on Antiviral Treatment in Patients With Hepatitis B
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fatty Liver Disease
Chronic Hepatitis B
Antiviral Treatment
Lead sponsor: Tianjin Second People's Hospital
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Comparison of virological levels in serum
timeFrame: 5 years
measure: Comparison of liver function improvement
timeFrame: 5 years
Secondary outcomes:
measure: Impact of Fatty Liver on the Incidence of Adverse Outcomes in CHB Patients
timeFrame: 5 years
measure: Factors affecting adverse outcomes in patients with chronic hepatitis B
timeFrame: 5 years
Other outcomes:
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