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This is a prospective, multicenter, open-label, non-randomized controlled real-world study to explore the efficacy and safety and to accumulate more evidence-based medical data of an antiviral treatment programme for chronic viral hepatitis B with nonalcoholic fatty liver disease.
A total of 1500 patients with chronic hepatitis B complicated with nonalcoholic fatty liver disease are divided into test group (1000 patients receiving PEG-IFNα-based antiviral therapy (combined NAs or Peg-IFNα monotherapy) and control group(500 patients receiving NAs monotherapy) according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events and drug combinations are recorded detailly.
The primary efficacy indicator is HBsAg clearance at 48 weeks of treatment, and the secondary indicators included: (1) HBsAg clearance at 96 weeks of treatment, (2) Cumulative HBsAg clearance at week 24、120、144、168、192、216 and 240; (3) The improvement of liver function level(ALT, AST, TBIL, etc.), blood lipid (TC, TG, LDL-C, HDL-C, etc.), fasting blood glucose, insulin resistance index (HOMA-IR), controlled attenuation parameter, body mass index , liver stiffness measurement, liver histological fibrosis, FIB-4 index from baseline; (4)Incidence of liver cirrhosis and hepatocellular carcinoma during follow-up.
The security assessment includes adverse events, vital signs, and imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | Treatment Group [PEG-IFNα-based antiviral therapy (combined with NAs or PEG-IFNα monotherapy)]: PEG IFNα injection 180 μg is administrated subcutaneously on the first day of the first week, weekly; If HBsAg is negative within 48 weeks of treatment, Peg IFNα combined with NAs or PEG-IFNα monotherapy was continued for 12 weeks, with a maximum of 96 weeks, and the patients are followed up to 240 weeks after the end of treatment. If the patient doesn't achieve HBsAg negative conversion within 48 weeks of treatment, the maximum duration of Peg-IFNα treatment is 96 weeks, and the NAs treatment can be continued until the time of discontinuation where combined treatment programme is used (if HBsAg negative, the consolidation treatment for not less than 24 weeks, and if HBsAg positive still, the treatment with NAs continue). The total of duration of treatment or follow-up is 240 weeks after the end of treatment. |
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| Control Group | No Intervention | Control group (receiving NAs monotherapy) : on the first day of the first week, daily, according to the standard dosage of each drug, until the time when the drug can be stopped (if HBsAg negative conversion is achieved, NAs should be ended after consolidation treatment for not less than 24 weeks; if HBsAg negative conversion is not achieved, NAs therapy should be continued), and follow-up up to 240 weeks after the end of treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peg-Interferon α | Drug | Peg IFN-α injection was subcutaneously injected 180 μg weekly on the first day of the first week, and NAs was administered daily according to the standard dosage of each drug. For example, HBsAg sero-conversion is achieved within 48 weeks of treatment, Peg IFNα combined with NAs or PEG-IFNα monotherapy was continued for 12 weeks, with a maximum of 96 weeks, and follow-up up to 240 weeks after treatment. If HBsAg negative sero-conversion is not achieved within 48 weeks of treatment, the maximum duration of PEG-IFNα is not more than 96 weeks. If Peg IFNα combined NAs regimen is used, NAs can be continued until the drug can be ended (if HBsAg negative conversion is achieved, NAs should be ended after consolidation therapy not less than 24 weeks; if HBsAg negative conversion is not achieved, NAS should be continued), followed up to 240 weeks after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| HBsAg clearance | HBsAg clearance at 48 weeks of treatment | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HBsAg clearance at 96 weeks | HBsAg clearance at 96 weeks of treatment | 96 weeks |
| Cumulative HBsAg clearance rate | The cumulative clearance rate of HBsAg in chronic hepatitis B patients with different degrees of hepatic steatosis at different treatment nodes; Stratified analysis was performed according to the CAP baseline at enrollment (mild, moderate and severe fatty liver) to explore the correlation between hepatic steatosis and HBsAg clearance rate under different antiviral treatment regimens. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongping Chen, Professor | Contact | 13505777281 | 13505777281@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningbo No.2 Hospital | Recruiting | Ningbo | China |
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| week 24、72、120、144、168、192、216、240 |
| Liver Function Tests | the level of ALT and AST | week 24、48、72、96、120、144、168、192、216、240 |
| The incidence of liver cirrhosis and liver cancer | The incidence of liver cirrhosis and liver cancer | week 24、48、72、96、120、144、168、192、216、240 |
| Ruian People's Hospital | Recruiting | Rui’an | China |
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| The Second Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | China |
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| Wenzhou People's Hospital | Recruiting | Wenzhou | China |
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| Yueqing People's Hospital | Recruiting | Yueqing | China |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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