Liver Status and Presence of MASLD/MASH in Patients With Chronic Hepatitis B
NCT Number: NCT06573190
Acronym: Faraday
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Chronic Hepatitis B|Hepatic Steatosis
Interventions: DIAGNOSTIC_TEST: Transient elastography|DRUG: Tenofovir Disoproxil Fumarate
Sponsor: Yaşar Bayındır, MD
Collaborators: Nobel Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-02
Completion Date: 2024-05-15
Locations: Guven Hospital, Ankara, TR-06540, Turkey

Summary:
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.

Primary Outcome Measures: Histological activity index (HAI) evaluatin by liver biopsy in patients with chronic hepatitis B before initiating antiviral therapy., 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., 23.01.2023-25.04.2023|Fibrosis score evaluation by liver biopsy in patients with chronic hepatitis B before initiating antiviral therapy., 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., 23.01.2023-25.04.2023|Hepatic steatosis evaluation by Controlled Attenuation Parameter (CAP) on FibroScan® in patients with chronic hepatitis B before initiating antiviral therapy., 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., 23.01.2023-25.04.2023|Fibrosis stage by Liver Stiffness Measurement (LSM) on FibroScan® in patients with chronic hepatitis B before initiating antiviral therapy., 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., 23.01.2023-25.04.2023
Secondary Outcome Measures: Hepatic steatosis evaluation by Controlled Attenuation Parameter (CAP) on FibroScan® in patients with chronic hepatitis B at 12th month of antiviral therapy., 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., 23.01.2024-25.04.2024|Fibrosis stage by Liver Stiffness Measurement (LSM) on FibroScan® in patients with chronic hepatitis B., FibroScan® measurements were performed 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., 23.01.2024-25.04.2024