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

A Prospective Observational Study on the Relationship Between Long-term Oral Anti Hepatitis B Nucleoside Analogs and Hepatic Steatosis

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hepatic Steatosis

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • The Second Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hepatitis B patients who meet the inclusion conditions and don't meet the exclusion conditions.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal color Doppler ultrasound (if necessary CT or MR)	Patients with fatty liver were evaluated by abdominal color Doppler ultrasound	once a year up to 3 years
Liver transient elastography	The CAP value was obtained from the liver transient elastography. According to the CAP value, steatosis is divided into mild (CAP 248-267 dB / m), moderate (CAP 268-279 dB / m) and severe (≥ 280 dB / m).	once a year up to 3 years
Lipid profiles	Lipid profiles, such as total cholesterol (TC), triglycerides(TG), high-density lipoprotein cholesterol(HDL-C), and low-density lipoprotein cholesterol(LDL-C).	once a year up to 3 years

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Principal Investigator: Dazhi Zhang, Doctor, The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis; Hepatitis B; Fatty Liver
• Other Study ID Numbers: Zhangdz2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no sharing plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No