Efficacy and Safety Study of Adefovir and Entecavir for Elderly With Chronic Hepatitis B

It is estimated that 350-400 million people have chronic infection with hepatitis B virus (HBV) all over the world. In china, 93 million individuals suffer from this chronic condition. Currently, seven medications are approved for the treatment of hepatitis B: two formulations of interferon and four nucleos(t)ide analogues. The Chinese population has one of the longer average life spans, and the size of the aged population has been increasing rapidly. As a result, the prevalence of elderly patients with HBV has increased, and the potential for development of cirrhosis or hepatocellular carcinoma in such patients is real. Hence, treatment of elderly patients with HBV is an important issue. However, ADV or ETV has become first choice due to the more side effect of INF and the resistant of LAM and LdT. But treatment outcomes with ADV and ETV in elderly are not known yet. In this study, we will evaluate and compare the efficacy and tolerability of ADV and ETV between younger and older patients with HBV. The aims of the present study are (1)to assess the benefits of ADV or ETV therapy for elderly patients with chronic hepatitis B, and (2)to determine differences in the emergence rate of side effect.

Study Overview

• Status: Completed
• Conditions: Hepatitis B, Chronic
• Intervention / Treatment: Drug: Adefovir dipivoxil or Entecavir

• Study Type: Observational
• Enrollment (Actual): 242

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • 302 Military Hospital of China

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

We retrospectively analyzed a consecutive cohort of chronic hepatitis B patients treated with ADV, 10mg, daily, or with ETV，0.5mg，daily between January 2010 and December 2013 in a single tererral referral hospital in Beijing. Data were retrieved from a prospectively maintined database.

Description

Inclusion Criteria:

1. Age≥18 years
2. HBsAg positive for more than 6 months before enrollment
3. Serum HBVDNA >2×104IU/ml and serum ALT >80U/L or TBIL < 34 umol/L for chronic hepatitis B
4. Serum ALT < 80U/L, but hepatic inflammation scores ≥ G2 or hepatic fibrosis stage ≥ S2 for chronic hepatitis B
5. Serum HBVDNA >40 IU/ml for cirrhosis regardless of ALT and TBIL

Exclusion Criteria:

1. Co-infected with HCV, HDV or HIV, or autoimmune liver diseases combined
2. received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment
3. Renal function: creatinine >1.5 ULN or eGFR< 50ml/min/1.73m2 before therapy
4. Combined with hepatocarcinoma before therapy
5. suspend therapy voluntarily
6. use other nephrotoxic drugs

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
youth; <45years Adefovir dipivoxil or Entecavir Participants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited. Participants who received 0.5mg ETV more than 3 years will be recruited.	Drug: Adefovir dipivoxil or Entecavir; Adefovir tablet, 10mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines. Entecavir tablet, 0.5mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines; Other Names: ADV, Hepsera,; ETV, Baraclude
middle age; ≥45years and<65years Adefovir dipivoxil or Entecavir Participants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited. Participants who received 0.5mg ETV more than 3 years will be recruited.	Drug: Adefovir dipivoxil or Entecavir; Adefovir tablet, 10mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines. Entecavir tablet, 0.5mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines; Other Names: ADV, Hepsera,; ETV, Baraclude
elderly; ≥65 years Adefovir dipivoxil or Entecavir Participants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited. Participants who received 0.5mg ETV more than 3 years will be recruited.	Drug: Adefovir dipivoxil or Entecavir; Adefovir tablet, 10mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines. Entecavir tablet, 0.5mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines; Other Names: ADV, Hepsera,; ETV, Baraclude

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the rates of serum HBVDNA undetectable and Renal dysfunction	3years

Secondary Outcome Measures

Outcome Measure	Time Frame
the rate of normalisation of ALT	at week 2、4、12、24、36、48、60、72、84、96
the rate of HBsAg negative	at week48、96、144
the rate of HBeAg seroconversion	at week 24、48、72、96、120、144
the rate of HBeAg negative	at week 24、48、72、96、120、144

Collaborators and Investigators

• Sponsor: Ying-Jie Ji
• Investigators: Principal Investigator: Ying-Jie Ji, MD., Beijing 302 Hospital

Publications and helpful links

Helpful Links

• The introduction of the investigator affiliation

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: February 27, 2014
• First Submitted That Met QC Criteria: February 27, 2014
• First Posted (Estimate): March 3, 2014

Study Record Updates

• Last Update Posted (Estimate): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 26, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Antiviral Agents; Aged; Hepatitis B, Chronic
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Entecavir; Adefovir; Adefovir dipivoxil
• Other Study ID Numbers: YNKT201313