Optimization of Antiviral Therapy of Chronic HBV Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

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.

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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.

Conditions

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Australia Antigen Positive Hepatitis B Adverse Effects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Add on ADV

Patients with inadequate response to interferon at 24 weeks received interferon add on ADV optimized therapy

Interferon Alfa-2a add on ADV

Intervention Type DRUG

Interferon add on ADV for 48 weeks

Switch to LDT

Patients with inadequate response to interferon at 24 weeks received switching to LDT therapy

Interferon Alfa-2a add on ADV

Intervention Type DRUG

Interferon add on ADV for 48 weeks

Interventions

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Interferon Alfa-2a add on ADV

Interferon add on ADV for 48 weeks

Intervention Type DRUG

Other Intervention Names

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Response guild treatment optimized therapy Chronic HBV infection

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).

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No