Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients

Study Overview
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Brief Summary
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Some patients with low-level viremia (LLV) are also likely to develop hepatocellular carcinoma (HCC) or other liver diseases. The relationship between HBV RNA levels and fibrosis in patients with HBV DNA negative or LLV is still lacking evidence. The purpose of this study is to observe the differences in HBV RNA levels and their association with efficacy in HBV DNA negative or LLV patients. Investigators conduct the prospective, single-center, non-randomized, observational clinical study. A total of 100 chronic hepatitis B (CHB) patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years will be enrolled. The enrolled patients will be followed up five times to collect clinical data and record adverse events (at baseline, week 12, week 24, week 36 and week 48, respectively).

Official Title
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Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients With Low Level HBV DNA Treated With Nucleoside (Acid) Analogues

Conditions
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Chronic Hepatitis B Patients

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.18 years old or above and the gender is not limited; 2. Patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years ; 3. Patients with HBV DNA negative (HBV DNA<20 IU/ml) or LLV（HBV DNA 20-2000 IU/mL） 4. Good compliance and voluntary signing of informed consent. Exclusion Criteria: 1. Patients with decompensated cirrhosis; 2. Patients co-infection with other viruses, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV virus, etc.; 3. Patients with significant renal, cardiovascular, pulmonary, or neurological disease; 4. Patients have active or suspected malignancy or history of malignancy; 5. Patients who were identified not appropriate for the study by investigators.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decrease of HBV RNA from baseline to 48 weeks | The investigators detect the dynamic change of HBV RNA and the decline from baseline to 48 weeks; | 2023.8-2025.8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV RNA undetectable rate at 48 weeks; | After 48 weeks of treatment after enrollment, the investigators detect the HBV RNA undetectable rate 48 weeks; | 2023.8-2025.8 | 
| The association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels; | During 48 weeks of treatment, the investigators detect the association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels; | 2023.8-2025.8 | 
| The association of HBV RNA changes with the liver stiffness; | During 48 weeks of treatment, the investigators detect the association of HBV RNA changes with the liver stiffness; | 2023.8-2025.8 |