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
Conditions: Chronic Hepatitis B, Hepatic Steatosis
Sponsor: Yaşar Bayındır, MD

Document Date: January 02, 2023  
 
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 
Study Protocol 
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. Written informed consent was obtained 
from all participants. 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). 
The study protocol was approved by the Ethics Committee of Dicle University (Protocol 
number: 2022/261).  
Statistical Analysis 
The IBM SPSS 21.0 statistical software for Windows was used for the statistical evaluation of 
the research data. The measurable variables were presented as the mean ± standard deviation 
(SD), while the categorical variables were presented as the number and percentage (%). 
Spearman's rho correlation analysis was performed to determine the relationship between the 
variables. The hypotheses were bidirectional, and p ≤0.05 was considered statistically 
significant.