Clinical trial NCT06573190: Liver Status and Presence of MASLD/MASH in Patients With Chronic Hepatitis B
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis B
Hepatic Steatosis
Keywords: Chronic hepatitis B
Metabolic syndrome
Hepatic fibrosis
Hepatic steatosis
Lead sponsor: Guven Health Group
Sponsor class: OTHER
Collaborators: name: Nobel Pharmaceuticals
First posted: 2024-08-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Histological activity index (HAI) evaluatin by liver biopsy in patients with chronic hepatitis B before initiating antiviral therapy.
timeFrame: 23.01.2023-25.04.2023
measure: Fibrosis score evaluation by liver biopsy in patients with chronic hepatitis B before initiating antiviral therapy.
timeFrame: 23.01.2023-25.04.2023
measure: Hepatic steatosis evaluation by Controlled Attenuation Parameter (CAP) on FibroScan® in patients with chronic hepatitis B before initiating antiviral therapy.
timeFrame: 23.01.2023-25.04.2023
measure: Fibrosis stage by Liver Stiffness Measurement (LSM) on FibroScan® in patients with chronic hepatitis B before initiating antiviral therapy.
timeFrame: 23.01.2023-25.04.2023
Secondary outcomes:
measure: Hepatic steatosis evaluation by Controlled Attenuation Parameter (CAP) on FibroScan® in patients with chronic hepatitis B at 12th month of antiviral therapy.
timeFrame: 23.01.2024-25.04.2024
measure: Fibrosis stage by Liver Stiffness Measurement (LSM) on FibroScan® in patients with chronic hepatitis B.
timeFrame: 23.01.2024-25.04.2024
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Guven Hospital
Study officials:
affiliation: Dicle University, Medical Faculty, Department of Infectious Diseases
name: Mustafa Kemal Çelen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vittal A, Ghany MG. WHO Guidelines for Prevention, Care and Treatment of Individuals Infected with HBV: A US Perspective. Clin Liver Dis. 2019 Aug;23(3):417-432. doi: 10.1016/j.cld.2019.04.008.
citation: European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.
citation: Wang L, Wang Y, Liu S, Zhai X, Zhou G, Lu F, Zhao J. Nonalcoholic fatty liver disease is associated with lower hepatitis B viral load and antiviral response in pediatric population. J Gastroenterol. 2019 Dec;54(12):1096-1105. doi: 10.1007/s00535-019-01594-6. Epub 2019 May 27.
citation: Jiang K, Zhang L, Li J, Hu H, Huang Q, Qiu T, Mo X, Ren J, Guo W, Tao Y, Cui H, Zuo Y, Chen X, Xie Y, Li Y, Liang H, Liu Z, Xie L, Mao R, Jiang Q, Huang K. Diagnostic efficacy of FibroScan for liver inflammation in patients with chronic hepatitis B: a single-center study with 1185 liver biopsies as controls. BMC Gastroenterol. 2022 Jan 29;22(1):37. doi: 10.1186/s12876-022-02108-0.