The Relationship Between Long-term Oral Anti Hepatitis B Nucleoside Analogs and Hepatic Steatosis

NCT ID: NCT05416008

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2025-12-31

Brief Summary

This study aims to investigate whether long-term use of nucleotide analogues could promote hepatic steatosis in patients with chronic hepatitis B. The degree of hepatic steatosis was observed after 3 years of antiviral treatment with nucleoside (acid) analogues for the first time to determine whether the long-term use of anti hepatitis B nucleoside (acid) analogues could promote hepatic steatosis. To explore the anti hepatitis B nucleotide analogues that can promote liver steatosis, so as to provide evidence-based medical evidence for the selection or adjustment of anti hepatitis B virus drugs in patients with chronic hepatitis B.

Detailed Description

This is a single-center, prospective, observational study involving chronic hepatitis B patients from the Second Affiliated Hospital of Chongqing Medical University.

Research implementation process and route

Recruitment object: Patients with chronic hepatitis B, defined as persistent hepatitis B surface antigen positive for ≥ 6 months, (aged ≥ 18, treatment-naive ) were consecutively recruited for outpatient routine examination between July 2021 and December 2022. We excluded patients with prior history of hepatocellular carcinoma, concomitant hepatitis C virus or human immunodeficiency virus infection, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis, significant alcohol intake (≥ 30 g per day for male, or ≥ 20 g per day for female), on steatogenic medications, prior liver transplantation. The basic information and various examination indexes of the patients were collected, and the patients were informed that they needed to go to the outpatient clinic of our hospital for follow-up examination every 1 year, with a total follow-up of 3 years.

Data to be collected: general medical history characteristics: medical record number, name, gender, age, , enrollment time, contact information, and name of anti hepatitis B drugs. Examination and inspection indicators: liver function, renal function, blood chart analysis, blood lipid, hepatitis B two half and half, anti hepatitis C virus, anti hepatitis D virus, AIDS syphilis screening, high precision hepatitis B virus-DNA quantification, abdominal color Doppler ultrasound (if necessary CT or MR), transient elastography of the liver.

Follow up: after enrollment, the relevant examination indexes were rechecked every 1 year. The follow-up period was 3 years.

Statistical analysis: after a three-year follow-up, the data collected were tested by t-test and multivariate Cox analysis to analyze whether the long-term use of anti hepatitis B nucleoside (acid) analogues could promote hepatic steatosis.

Conditions

Hepatic Steatosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1: treatment with ETV

The patients in this group were composed of patients with chronic hepatitis B who firstly take entecavir for the treatment of chronic hepatitis B.

Take Entecavir capsule orally for a long time, once a day, 0.5mg each time.

No interventions assigned to this group

Group 2: treatment with TAF

The patients in this group were composed of patients with chronic hepatitis B who firstly take Tenofovir alafenamide Fumarate for the treatment of chronic hepatitis B.

Take Tenofovir alafenamide Fumarate tablets orally for a long time, 25mg once a day.

No interventions assigned to this group

Group 3: treatment with TDF

The patients in this group were composed of patients with chronic hepatitis B who firstly take Tenofovir disoproxil Fumarate for the treatment of chronic hepatitis B.

Tenofovir disoproxil fumarate was orally administered for a long time, once a day, 300mg each time.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Willing and able to sign informed consent.
• Male or female.
• 18 ≤ age≤ 80.
• Clinical diagnosis of chronic hepatitis B.
• Has not received anti HBV treatment.

Exclusion Criteria

• With prior history of HCC
• Concomitant HCV or HIV
• Primary biliary cholangitis
• Wilson's disease
• Autoimmune hepatitis
• Significant alcohol intake (≥ 30 g per day for male, or ≥ 20 g per day for female)
• Taking steatogenic medications
• Prior liver transplantation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dazhi Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Chongqing Medical University

Locations

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

Zhangdz2021

Identifier Type: -

Identifier Source: org_study_id