The Value of Fibroscan® in Assessing the Liver Status and Presence of MASLD/MASH in Patients With Chronic Hepatitis B and Monitoring Changes by Antiviral Therapy: Faraday Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Histological activity index (HAI) evaluatin by liver biopsy in patients with chronic hepatitis B before initiating antiviral therapy.
研究概览
简要总结
The aim of the study was to evaluate the consistency between liver biopsy and Liver Stiffness Measurement (LSM) for fibrosis and controlled attenuation parameter (CAP) for steatosis in FibroScan® in patients with chronic hepatitis B. The secondary aim of the study was to demonstrate the efficacy of FibroScan® for following the CHB patients at 12th month of antiviral therapy.
The study was prospectively planned in four different centers. Patients with HBsAg positivity for more than six months and HBV-DNA>2,000 IU/mL, underwent liver biopsy and FibroScan® together within two week. FibroScan® was performed twice, before the antiviral therapy and one year later.
详细描述
Patients aged 18 years and older with HBsAg positivity for more than six months and HBV-DNA level >2,000 IU/ml were included in the study. The exclusion criteria were established as presence of cirrhosis, alcohol consumption >140 g/week for women and 210 g/week for men, hepatitis C, hepatitis D and/or HIV coinfections.
The baseline characteristics including patient demographics, BMI, comorbidities, LSM and CAP via transient elastography (FibroScan®), liver ultrasound, HBV serology, platelet count, ALT, HBV viral load.
All patients underwent liver biopsy before initiating antiviral therapy, with a maximum interval of two week between liver biopsy and the FibroScan®.
Transient elastography was performed by a certified operator, using the M probe for patients with skin to capsule distance < 2.5 cm or an XL probe for patients with skin to capsule distance > 2.5 cm. Patients were fasted for > 2 h before FibroScan®. At least 10 successful measurements were performed and recorded.
Fibrosis stage by Liver Stiffness Measurement (LSM) and steatosis by Controlled Attenuation Parameter (CAP) were investigated on FibroScan® for MASLD and MASH. Obese or diabetic patients with a CAP value >240 dB/m were considered MASLD. Patients with normal BMI and nondiabetic patients had at least two risk factors for metabolic dysfunction were also considered to have MASLD. Patients with MASLD and concomitant necroinflammation in the liver were considered as MASH. Necroinflammation was considered as LSM ≥7.2 kPa in patients with MASLD or LSM >5.5 kPa in patients with liver injury (histologic and/or ALT>NSU).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older with HBsAg positivity for more than six months
- •Patients have HBV-DNA level >2,000 IU/ml for more than six months
排除标准
- •Presence of cirrhosis
- •Alcohol consumption >140 g/week in women and 210 g/week in men
- •Hepatitis C coinfection
- •Hepatitis D and/or HIV coinfections
研究组 & 干预措施
Chronic hepatitis B patients
Patients aged 18 years and older with HBsAg positivity for more than six months and HBV-DNA level >2,000 IU/ml
干预措施: Transient elastography (Diagnostic Test)
Chronic hepatitis B patients
Patients aged 18 years and older with HBsAg positivity for more than six months and HBV-DNA level >2,000 IU/ml
干预措施: Tenofovir Disoproxil Fumarate (Drug)
结局指标
主要结局
Histological activity index (HAI) evaluatin by liver biopsy in patients with chronic hepatitis B before initiating antiviral therapy.
时间窗: 23.01.2023-25.04.2023
All patients underwent liver biopsy before initiating antiviral therapy, for evaluating histological activity index (HAI). According to modified HAI system (Ishak), HAI scores ranging from 0 to 18 were used.
Fibrosis score evaluation by liver biopsy in patients with chronic hepatitis B before initiating antiviral therapy.
时间窗: 23.01.2023-25.04.2023
All patients underwent liver biopsy before initiating antiviral therapy, for evaluating fibrosis score. According to modified HAI system (Ishak), seven point scale ranging from 0 to 6 for fibrosis stage.
Hepatic steatosis evaluation by Controlled Attenuation Parameter (CAP) on FibroScan® in patients with chronic hepatitis B before initiating antiviral therapy.
时间窗: 23.01.2023-25.04.2023
FibroScan® measurements were perfomred at most two weeks apart from biopsy. Hepatic steatosis by Controlled Attenuation Parameter (CAP) were investigated on FibroScan® for MASLD and MASH. Obese or diabetic patients with a CAP value \>240 dB/m were considered MASLD. Patients with normal BMI and nondiabetic patients had at least two risk factors for metabolic dysfunction were also considered to have MASLD.
Fibrosis stage by Liver Stiffness Measurement (LSM) on FibroScan® in patients with chronic hepatitis B before initiating antiviral therapy.
时间窗: 23.01.2023-25.04.2023
FibroScan® measurements were perfomred at most two weeks apart from biopsy. Fibrosis stage by Liver Stiffness Measurement (LSM) was investigated on FibroScan®. Necroinflammation was considered as LSM ≥7.2 kPa in patients with MASLD. Patients with MASLD and concomitant necroinflammation in the liver were considered as MASH.
次要结局
- Fibrosis stage by Liver Stiffness Measurement (LSM) on FibroScan® in patients with chronic hepatitis B.(23.01.2024-25.04.2024)
- Hepatic steatosis evaluation by Controlled Attenuation Parameter (CAP) on FibroScan® in patients with chronic hepatitis B at 12th month of antiviral therapy.(23.01.2024-25.04.2024)
研究者
Yaşar Bayındır, MD
Chief Physician, Prof. Dr., M.D.
Guven Health Group