Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis

Study Overview
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Brief Summary
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Though newly reported HBV infection and HBsAg prevalence in China have greatly decreased, patients who had been chronically infected with HBV, especially those with liver cirrhosis cause great burden on public health care. In view of economic development level, drug availability and lack of independent health economics evidence, the investigators are still unable to give specific guidelines for HBV related compensated liver cirrhosis in China. Therefore, the investigators aim to investigate clinical effects and cost-effectiveness of two early anti-viral therapy strategies on HBV related compensated liver cirrhosis through this prospective, open-label, multicenter and nonrandomized study.

Official Title
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Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis

Conditions
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Liver Cirrhosis, Hepatitis B

Intervention / Treatment
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* Drug: Entecavir
* Drug: Lamivudine plus Adefovir Dipivoxil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consent aged 18-70 years clinical diagnosis of compensated liver cirrhosis liver biopsy showing cirrhosis endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension if no biopsy or endoscopy ，should meet two of the four: Imaging(US, CT or MRI, et al) showing Surface nodularity： Echogenecity （spleen pachydiameter > 4.0cm or> 5 costal region） PLT < 100×10 < 9 >/L，no other interpretation ALB < 35.0 g/L, or INR > 1.3, or CHE < 5.0KU/L Liver stiffness measurement value > 12.4 kpa HBeAg(+)with HBVDNA > 10 < 3 > IU/mL or HBeAg(-) wtih HBVDNA > 102 IU/mL Exclusion Criteria: patient with decompensated liver cirrhosis:presence of ascites, variceal hemorrhage,hepatic encephalopathy allergic to any ingredients of the drugs patient complicated with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease. AFP > 100ng/ml or Cr > 1.5×ULN pregnant woman patient with severe disease or other organ failure patient with any tumors patient with sever mental disease. patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Group 1<br>Entecavir Therapy | Drug: Entecavir<br>* 0.5mg qd<br>* Other names: other manufacturers;|
| Group 2<br>Lamivudine plus Adefovir Dipivoxil Therapy | Drug: Lamivudine plus Adefovir Dipivoxil<br>* Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd<br>* Other names: other manufactures;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decompensation rate of liver cirrhosis | presence of ascites, variceal hemorrhage, hepatic encephalopathy and HCC | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| child-pugh score |  | 1,2 and 3 years | 
| HBVDNA undetected |  | 1,2 and 3 years | 
| liver elasticity |  | 1, 2, and 3 years | 
| life quality score |  | 1, 2 and 3 years | 
| cost-effectiveness |  | 1, 2 and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compensated Liver Cirrhosis, Early Antiviral Therapy, Cost Effectiveness