Optimization of Antiviral Therapy of Chronic HBV Infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Observation Study of Different Optimized Therapy Method of Patients With Chronic Hepatitis B

Conditions
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Australia Antigen Positive, Hepatitis B, Adverse Effects

Intervention / Treatment
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* Drug: Interferon Alfa-2a add on ADV


Participation Criteria
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Eligibility Criteria
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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: no decompensated cirrhosis, no hepatitis C, hepatitis D or human immunodeficiency virus (HIV) co-infection, no hepatocellular carcinoma and other tumors or history of severe hepatitis, no other systems diseases, such as a history of cardiopulmonary diseases, thyroid disorders, immune system disorders, epilepsy or mental illness (such as severe depression).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Add on ADV<br>Patients with inadequate response to interferon at 24 weeks received interferon add on ADV optimized therapy | Drug: Interferon Alfa-2a add on ADV<br>* Interferon add on ADV for 48 weeks<br>* Other names: Chronic HBV infection;|
| Switch to LDT<br>Patients with inadequate response to interferon at 24 weeks received switching to LDT therapy | Drug: Interferon Alfa-2a add on ADV<br>* Interferon add on ADV for 48 weeks<br>* Other names: Chronic HBV infection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBeAg seroconversion rate |  | 48weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA decline |  | 48weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBeAg seroconversion, Peginterferon alfa-2a, chronic hepatitis B(CHB, Optimal therapy, Response guild treatment(RGT);