Hepatitis B, Liver Cirrhosis
Conditions
Keywords
Compensated Liver Cirrhosis, Early Antiviral Therapy, Cost Effectiveness
Brief summary
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.
Interventions
DRUGEntecavir
0.5mg qd
DRUGLamivudine plus Adefovir Dipivoxil
Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd
Sponsors
Peking University First Hospital
Peking University People's Hospital
Beijing YouAn Hospital
Beijing Tiantan Hospital
Beijing Ditan Hospital
Peking Union Medical College Hospital
Beijing 302 Hospital
Beijing Friendship Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* written informed consent * aged 18-70 years * clinical diagnosis of compensated liver cirrhosis 1. liver biopsy showing cirrhosis 2. endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decompensation rate of liver cirrhosis | 3 years | presence of ascites, variceal hemorrhage, hepatic encephalopathy and HCC |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed