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This is a prospective observational study of CHB patients who have not received antiviral treatment but HBV DNA are positive.Investigators aim to explore the antiviral effect and influencing factors of patients over 30 years old with normal ALT level after receiving antiviral treatment.
In the past, clinicians thought that patients with chronic hepatitis B with normal ALT should be followed up regularly and not be treated with antiviral therapy for the time being, but more and more studies show that if antiviral therapy is not started in time, these patients still have a relatively high risk of cirrhosis and HCC. Therefore, the current Chinese guideline recommends that patients over the age of 30 with HBV DNA positive need antiviral treatment even if their ALT levels are normal. In this study, investigators aim to observe the antiviral effect of CHB patients above 30 years old and normal liver function. CHB patients were divided into NAs (TMF, ETV, or TAF) treatment and untreated groups for follow-up. Then, participants who achieved HBV DNA negative and HBsAg <3000 IU/ml after 12 weeks of NAs therapy could choose either NAs combined with 48 weeks of pegylated interferon α-2b(Peg-IFNα-2b) therapy or continue NAs monotherapy. Follow-ups were conducted every 12-24 weeks for a total duration of 96 weeks. Dynamic observations included monitoring virological markers,biochemical indicators,liver stiffness measurement(LSM),and controlled attenuation parameter(CAP) throughout the study period. After obtaining the informed consent of participants, the serum of participants and PBMC of some participants were collected for further study,so that investigators are able to explore the serological indexes related to curative effect and the immune function of participants before and after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NA treatment | NA treated with TDF,ETV OR TMF | ||
| Control group without antiviral treatment | Control group without antiviral treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| 48-week HBV DNA negativity rate(%) | HBV DNA negative rate(%) at 48 weeks | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 48-week ALT normalization rate(%) | ALT normalization rate(%) at 48 weeks | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of improvement in liver fibrosis | Changes in liver stiffness measurement (LSM) by FibroScan were used to describe changes in patients' liver fibrosis | 48 weeks |
Inclusion Criteria:
Exclusion Criteria:
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The research population is CHB patients who have never received antiviral treatment and come to Tongji hospital for consultation and reexamination.
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| Name | Affiliation | Role |
|---|---|---|
| Meifang Han, Doctor | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital,Wuhan,Hubei | Wuhan | Hubei | 430000 | China |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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serum and PBMCs
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |