Hepatitis B, Chronic
Conditions
Keywords
Aged, Hepatitis B, Chronic, Antiviral Agents
Brief summary
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.
Interventions
DRUGAdefovir 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
Sponsors
Ying-Jie Ji
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rates of serum HBVDNA undetectable and Renal dysfunction | 3years |
Secondary
| 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 |
Countries
China
Outcome results
None listed