Effect of Fatty Liver on Antiviral Treatment in Patients With Hepatitis B
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 主要终点
- Comparison of virological levels in serum
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 and ≤75 years old, regardless of gender;
- •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);
- •Liver pathology indicated fatty liver (hepatitis B combined with fatty liver group);
- •All patients have complete medical history, B-ultrasound, FibroSan, hepatitis B five items, liver function and other laboratory test data.
排除标准
- •Aged <18 or >75 years old;
- •Patients diagnosed with or previously diagnosed with HCC;
- •Those who are co-infected with other hepatitis viruses (HAV, HCV, HDV, HEV) or HIV or syphilis;
- •The follow-up data of patients are seriously missing.
研究组 & 干预措施
Fatty Liver
Hepatitis B patients with fatty liver
干预措施: Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；Interferons (Drug)
Non-Fatty Liver
Hepatitis B patients without fatty liver
干预措施: Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；Interferons (Drug)
结局指标
主要结局
Comparison of virological levels in serum
时间窗: 5 years
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.
Comparison of liver function improvement
时间窗: 5 years
Liver function was assessed by measuring serum ALT, AST, and GGT levels during treatment.
次要结局
- Impact of Fatty Liver on the Incidence of Adverse Outcomes in CHB Patients(5 years)
- Factors affecting adverse outcomes in patients with chronic hepatitis B(5 years)