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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: Adefovir dipivoxil or Entecavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 years HBsAg positive for more than 6 months before enrollment Serum HBVDNA >2×104IU/ml and serum ALT >80U/L or TBIL < 34 umol/L for chronic hepatitis B Serum ALT < 80U/L, but hepatic inflammation scores ≥ G2 or hepatic fibrosis stage ≥ S2 for chronic hepatitis B Serum HBVDNA >40 IU/ml for cirrhosis regardless of ALT and TBIL Exclusion Criteria: Co-infected with HCV, HDV or HIV, or autoimmune liver diseases combined received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment Renal function: creatinine >1.5 ULN or eGFR< 50ml/min/1.73m2 before therapy Combined with hepatocarcinoma before therapy suspend therapy voluntarily use other nephrotoxic drugs

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| youth<br><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<br>* 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<br>* Other names: ETV, Baraclude;|
| middle age<br>≥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<br>* 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<br>* Other names: ETV, Baraclude;|
| elderly<br>≥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<br>* 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<br>* Other names: ETV, Baraclude;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aged, Hepatitis B, Chronic, Antiviral Agents