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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adefovir dipivoxil or Entecavir | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the rates of serum HBVDNA undetectable and Renal dysfunction | 3years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ying-Jie Ji, MD. | Beijing 302 Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 302 military hospital of China | Beijing | Beijing Municipality | 100039 | China |
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| Label | URL |
|---|---|
| Click here for more recruit information about this study | View source |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C106812 | adefovir dipivoxil |
| C413685 | entecavir |
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|
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| at week 24、48、72、96、120、144 |
| the rate of HBeAg negative | at week 24、48、72、96、120、144 |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |