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Hepatitis B virus (HBV) infection is prevalent across the world. Functional cure is the optimal endpoint of antiviral therapy for chronic hepatitis B virus (HBV) infection. Currently available anti-HBV therapy includes nucleoside analogs (NAs) and peginterferon-α (Peg-IFNα). Combination of Peg-IFNα and NAs, each with different mechanisms of action, is an attractive approach for treating chronic HBV infection. In this study, we aim to establish logistic regression models to predict durable functional cure in patients with CHB treated by combination of Peg-IFNα and NAs, which might be useful for clinical physicians to make personalized treatment decisions. These models will be constructed using baseline routine clinical laboratory indicators with high diagnostic accuracy. These models might be widely applicable to almost all medical institutions and will effectively promote the application of Peg IFN α plus NAs therapy in clinical work. The findings in this study might greatly improve the functional cure rate of CHB and reducing the incidence rate and mortality of HBV related end-stage liver diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "de novo" strategy-HBeAg positive | HBeAg positive patients treated with simultaneous administration of NA and Peg-IFN |
| |
| "de novo" strategy-HBeAg negative | HBeAg positive patients treated with simultaneous administration of NA and Peg-IFN |
| |
| "add-on" strategy-HBeAg positive | HBeAg positive patients treated with NA followed by addition of Peg-IFN. |
| |
| "add-on" strategy-HBeAg negative | HBeAg negative patients treated with NA followed by addition of Peg-IFN. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon-α; Nucleoside analogs | Drug | Patients with chronic hepatitis B were treated with the combination of peginterferon-α and nucleoside analogs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional cure of chronic hepatit B | The level of hepatitis B surface antigen (HBsAg) is below 0.05IU/ml. | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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The participants were retrospectively enrolled from more than 10 hospitals in China.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuai Gao, MD;PhD | Contact | +86-18560088213 | qilugaoshuai@sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41229921 | Derived | Liu HH, Jiang XM, Cui C, Zhao J, Xu J, Wang SK, Hu LH, Yin YP, Wang X, Yu LJ, Xu C, Zhao ZH, Xing YQ, Liu Y, Wang K, Gao S. Development and Validation of a Predictive Model for HBsAg Seroclearance After Peg-IFN-Based Therapy: A Multicentre Study. Drug Des Devel Ther. 2025 Nov 7;19:9973-9982. doi: 10.2147/DDDT.S545700. eCollection 2025. |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D009705 | Nucleosides |
| ID | Term |
|---|---|
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |