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

Capital Medical University

Status: Unknown

Conditions: Liver Cirrhosis; Hepatitis B

Treatments: Drug: Lamivudine plus Adefovir Dipivoxil; Drug: Entecavir

Study type: Observational

Funder types: Other

Identifiers

NCT01720238

D1211000039120003

Details and patient eligibility

About

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.

Enrollment: 621 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

621 participants in 2 patient groups

Group 1

Description:

Entecavir Therapy

Treatment:

Drug: Entecavir

Group 2

Description:

Lamivudine plus Adefovir Dipivoxil Therapy

Treatment:

Drug: Lamivudine plus Adefovir Dipivoxil