Chronic HBV With Severe Exacerbation
Conditions
Keywords
tenofovir, lamivudine, hepatitis B, acute exacerbation
Brief summary
In Taiwan, 15% of general population had hepatitis B virus (HBV) infection, HBV is the leading cause of liver cirrhosis and hepatocellular carcinoma in Taiwan. After entering immune clearance, 10-30% of patients of chronic HBV develop acute exacerbation (AE) , some are mild but some developed hepatic decompensation or even death. Previous study found that early use of lamivudine before bilirubin level is above 20 mg/dl can improve survival in chornic HBV with severe AE. From the study from Hongkong, lamivudine was found to have better survival than entecavir in chronic HBV with severe AE. Recent study from India found that tenofovir is able to improve survival in chronic HBV with severe AE. The aim of this study is to compare the effect of lamivudine and tenofovir for chronic HBV with severe AE. The study aims to enroll 120 patients with chronic HBV defined as persistence of HBsAg for more than 6 months. Severe AE was defined as ALT \> 400 U/L, prolongation of prothrombin time \> 3 seconds, bilirubin \> 2 mg/dl. Patients with hepatitis A, C, D or HIV infection, drug or alcoholic liver disease, hepatocellular carcinoma, under immuno-suppressive agents use, or previous use of anti-HBV agents are excluded. All enrolled patients are randomized into group A who received tenofovir 300 mg qd for 3 years and group B who received lamivuidne 100 mg qd for 6 months, followed by tenofovir 300mg qd for 30 months. Mortality rate and virological, biochemical and serological response were evaluated at 1,2,4,48,96 and 144 weeks. The values are expressed as mean + SD. Categorical variables were analyzed with Chi-square test or Fisher's exact test as appropriate and continuous variables were analyzed by Mann-Whitney test. Logistic regression test was applied to analyze the independent association of various variables with outcome. A p value \< 0.05 was regarded as significant.
Interventions
DRUGTenofovir
DRUGlamivudine
Sponsors
Kaohsiung Veterans General Hospital.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* HBsAg (+) \> 6 months * ALT \> 5X ULN * Prolongation of prothrombin time \> 3 seconds and bilirubin level \> 2 mg/dl * 20-75 years old
Exclusion criteria
* HAV, HCV, HDV and HIV co-infection * Concurrent hepatocellular carcinoma * Drug, metabolic or alcohol as cause of hepatitis * Anti-viral treatment in recent 6 mnths * Pregnant woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 months survival | 6 months after treatment begins | 6 months survival after treatment begins |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rapid virological response | 1,2 and 4 weeks after treatment | Evaluate the relationship of rapid virological response ( at 1,2 and 4 weeks) and survival |
| HBeAg seroconversion and virological response 1, 2, and 3 years after treatment | 1,2 and 3 years after treatment | To evaluate the rate of HBeAg seroconversion and virological response 1, 2, and 3 years after treatment in the two arms |
| Safety profile | during and 6 months after treatment | Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
Countries
Taiwan
Contacts
Primary ContactWei-Lun Tsai, M.D.
Backup ContactHoi-Hung Chnan, M.D., PhD
Outcome results
None listed