Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection

Study Overview
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Brief Summary
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Influence of antiviral treatment to the long term prognosis of patients with chronic HBV infection. The aim of antiviral treatment for HBV is to reduce the long term severe complications. In this study, the investigators divided patients with chronic HBV infection into two groups, which start early antiviral treatment and conventional antiviral treatment respectively. All the patients will be followed for ten years. From this study, the investigators want to find out the optimal time for patients with chronic HBV infection to start antiviral treatment.

Official Title
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Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection.

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: lamivudine
* Drug: Telbivudine
* Drug: Enticavir
* Drug: Adefovir Dipivoxil Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HBsAg positive for more than 6 months. HBeAg positive. HBV DNA over 10E5 copies/ml. Exclusion Criteria: Previous antiviral treatment for HBV. Co infection of HIV, HCV, HEV, HAV, or HAV. Evidence of hepatic carcinoma. Evidence of autoimmune disease. Evidence of thyroid disease. History of mental sickness.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>120 subjects (have family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is lower than 80u/L (early antiviral treatment). | Drug: lamivudine<br>* 100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.<br>Drug: Telbivudine<br>* 600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.<br>Drug: Enticavir<br>* 0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.<br>Drug: Adefovir Dipivoxil Tablets<br>* 10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.<br>|
| Active Comparator: B<br>120 subjects (have family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is higher than 80u/L (regular antiviral treatment). | Drug: lamivudine<br>* 100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.<br>Drug: Telbivudine<br>* 600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.<br>Drug: Enticavir<br>* 0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.<br>Drug: Adefovir Dipivoxil Tablets<br>* 10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.<br>|
| Experimental: C<br>180 subjects (have no family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is lower than 80u/L (early antiviral treatment). | Drug: lamivudine<br>* 100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.<br>Drug: Telbivudine<br>* 600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.<br>Drug: Enticavir<br>* 0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.<br>Drug: Adefovir Dipivoxil Tablets<br>* 10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.<br>|
| Active Comparator: D<br>180 subjects (have no family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is higher than 80u/L (regular antiviral treatment). | Drug: lamivudine<br>* 100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.<br>Drug: Telbivudine<br>* 600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.<br>Drug: Enticavir<br>* 0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.<br>Drug: Adefovir Dipivoxil Tablets<br>* 10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence rate of hepatic carcinoma |  | 10 years after treatment | 
| incidence rate of liver cirrhosis |  | 10 years after treatment | 
| incidence rate of fulminant hepatitis |  | 10 years after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis B, antiviral treatment, long term prognosis