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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis; Hepatitis B
• Intervention / Treatment: Drug: Entecavir; Drug: Lamivudine plus Adefovir Dipivoxil

• Study Type: Observational
• Enrollment (Actual): 621

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Ditan Hospital
    • Beijing, Beijing, China
      • Beijing YouAn Hospital
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital
    • Beijing, Beijing, China
      • Beijing 302 Hospital
    • Beijing, Beijing, China
      • Beijing Tiantan Hospital
    • Beijing, Beijing, China
      • PeKing University People's Hopital
    • Beijing, Beijing, China
      • The First Hospital of Peking University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

compensated HBV Related liver cirrhosis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Entecavir Therapy	Drug: Entecavir; 0.5mg qd; Other Names: Baraclude; other manufacturers
Group 2; Lamivudine plus Adefovir Dipivoxil Therapy	Drug: Lamivudine plus Adefovir Dipivoxil; Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd; Other Names: Heptodin; other manufactures

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Peking University First Hospital; Peking University People's Hospital; Beijing YouAn Hospital; Beijing Ditan Hospital; Peking Union Medical College Hospital; Beijing Tiantan Hospital; Beijing 302 Hospital
• Investigators: Principal Investigator: Dong Ji Jia, Doctor, Beijing Friendship Hospital

Publications and helpful links

General Publications

• Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J. Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy. Hepatol Int. 2021 Feb;15(1):82-92. doi: 10.1007/s12072-020-10114-1. Epub 2021 Jan 18.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: October 31, 2012
• First Submitted That Met QC Criteria: November 1, 2012
• First Posted (Estimate): November 2, 2012

Study Record Updates

• Last Update Posted (Estimate): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Cost Effectiveness; Compensated Liver Cirrhosis; Early Antiviral Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis; Fibrosis; Hepatitis B; Liver Cirrhosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Entecavir; Lamivudine; Adefovir; Adefovir dipivoxil
• Other Study ID Numbers: D1211000039120003