An observational study in Chronic Hepatitis B and Hepatic Steatosis, sponsored by Yaşar Bayındır, MD. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Yaşar Bayındır, MD · Observational
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.
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).
The study protocol was approved by the Ethics Committee of Dicle University (Protocol number: 2022/261) 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.
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This study's enrollment of 70 is below the median of 250 across 687 observational studies indexed under Hepatitis A.
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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.
Exclusion Criteria:
Patients aged 18 years and older with HBsAg positivity for more than six months and HBV-DNA level \>2,000 IU/ml
Diagnostic Test: Transient elastography · Drug: Tenofovir Disoproxil Fumarate
Liver Stiffness Measurement, Controlled Attenuation Parameter
Also known as: Fibroscan
Guided Therapy
Also known as: TDF
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 23.01.2023-25.04.2023
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.
Time frame: 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.
Time frame: 23.01.2024-25.04.2024
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Yaşar Bayındır, MD