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Along with the improvement of the accuracy of detection of HBV serological markers, the optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection becomes feasible. Currently, the recommendation of optimized treatment especially interferon therapy are mainly based on retrospective studies, it still lacks prospective evidence. This study is aimed to evaluate the efficacy, safety and pharmacoeconomics benefits of 48 weeks optimized interferon therapy (switch to telbivudine or plus adefovir dipivoxil) for HBeAg positive CHB with inadequate response to 24 weeks interferon treatment.
Patients with inadequate response to interferon therapy at 24 weeks were enrolled in this study and accepted the optimized therapy (add on ADV or switch to LDT) for 48weeks. All these patients were followed for 48 weeks and the HBeAg seroconversion and HBV DNA level were observed. Safety and the economic effect of the two optimized therapy methods also were observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Add on ADV | Patients with inadequate response to interferon at 24 weeks received interferon add on ADV optimized therapy |
| |
| Switch to LDT | Patients with inadequate response to interferon at 24 weeks received switching to LDT therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon Alfa-2a add on ADV | Drug | Interferon add on ADV for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| HBeAg seroconversion rate | 48weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HBV DNA decline | 48weeks |
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Inclusion Criteria:
patients receiving Peg interferon α-2a with inadequate response at 24 weeks (HBeAg titer ≥ 100Paul Ehrlich Institute Unit (PEIU)/ml and HBV DNA ≥ 5.0 Log copies/ml or HBV DNA titer decline <1 Log copies/ml) were enrolled into this study.
Exclusion Criteria:
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cases of HBeAg-positive CHB with inadequate response to 24 weeks Peg interferon alpha-2a were enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Wan Mo Bin, Dr | Changhai Hospital affiliated to the Second Military Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai hospital | Shanghai | Shanghai Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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Blood samples were retented at 12w,24w and 48w after optimized therapy
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |