Clinical trial NCT05708560: Relationship Between MAFLD and Liver Fibrosis Progression in Patients With Chronic Hepatitis B: a Multicenter Retrospective Cohort Study
Official title: Relationship Between Metabolic Dysfunction Associated Fatty Liver Disease and Liver Fibrosis Progression in Patients With Chronic Hepatitis B: a Multicenter Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B, Chronic
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic hepatitis B patients

Brief summary: This multicenter retrospective study aims to study the association between the presence of MAFLD and change in liver stiffness over time in untreated and treated patients with chronic hepatitis B

Detailed description: This project is a multicenter retrospective cohort study. All CHB patients who underwent at least 2 liver stiffness assessments with a Fibroscan device at least 6 months apart are eligible for enrolment. At baseline (defined as the first liver stiffness assessment) patients will be allocated to one of 4 groups (figure) based on use of antiviral therapy and presence of MAFLD. MAFLD is defined as presence of steatosis (based on ultrasound, histology or controlled attenuation parameter) in the presence of overweight (BMI \>23 for Asians or \>25 for Caucasians), diabetes mellitus, or at least 2 minor metabolic dysfunction criteria.(9) Baseline and follow-up data on biochemistry, virology, liver stiffness and clinical outcomes will be collected for all eligible patients. In case of initiation of antiviral therapy or development of MAFLD during follow-up, patients will transition to the appropriate cohort from that time-point onwards.

To ascertain the influence of the presence of MAFLD on liver stiffness progression, changes in liver stiffness will be compared within study groups (ie. cohort A vs B and cohort C vs D). To study the influence of antiviral therapy on liver stiffness progression in relation to presence of MAFLD, liver stiffness dynamics will be compared in cohort B vs cohort D (figure). The latter analysis will also be performed in the subgroup of patients with low levels of viremia (HBV DNA \<2,000 IU/mL) and/or low levels of ALT (\< 2 times the upper limit of normal).

Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis B monoinfection
* At least two liver stiffness measurements more than 6 months apart
* Availability of data on hepatic steatosis (ultrasound, controlled attenuation parameter or histology) within 1 year of baseline

Exclusion Criteria:

* antiviral therapy with drugs other than entecavir, tenofovir disoproxil fumarate or tenofovir alafenamide (for group 2 only)
* Presence of concomitant liver disease such as Wilson's disease, autoimmune hepatitis, hemochromatosis or alcohol abuse (\>21 alcoholic drinks/week, female's \>14/week)
* Presence of secondary causes of hepatic steatosis (medication, alcohol abuse)
* Coinfection with HCV, HIV, HEV

Primary outcomes:
measure: Study the association between presence of MAFLD and change in liver stiffness over time in untreated patients with chronic hepatitis B
timeFrame: 12 months
measure: Study the association between presence of MAFLD and change in liver stiffness over time in patients with chronic hepatitis B who initiate antiviral therapy
timeFrame: 12 months
measure: Assess the influence of antiviral therapy on liver stiffness changes over time in CHB patients with and without MAFLD
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
Study officials:
References: