Hepatitis B, Chronic
Conditions
Keywords
entecavir, lamivudine, sequential therapy
Brief summary
Patients with chronic hepatitis B and treated with entecavir for over 6 months (with no previous other antiviral treatment) will be invited to participate in this study. They will be eligible if their liver tests are normal and their viral load is undetectable. Patients will be switched to lamivudine treatment to assess whether lamivudine can maintain adequate suppression of the hepatitis B virus after successful treatment with entecavir. Patients will be monitored closely after switching treatment at 1 months and then every 3 monthly. If there is any evidence of increase in viral load then patients will be given the option of changing back to entecavir.
Interventions
DRUGEntecavir
Entecavir 0.5mg orally daily
DRUGLamivudine
Lamivudine 100mg orally, daily
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with chronic hepatitis B treated with entecavir for 6 months or more * Normal ALT * Undetectable HBV DNA by Roche Taqman PCR Assay * No other previous therapy with nucleoside/nucleotide analogues
Exclusion criteria
* Presence of other liver diseases including hepatitis C co-infection, autoimmune hepatitis , primary biliary cirrhosis, primary sclerosing cholangitis, alcoholic liver disease, and Wilson's disease * History of hepatocellular carcinoma * History of decompensated liver disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the efficacy of lamivudine therapy in patients with prior entecavir treatment with undetectable viral load | 96 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Determine the chance of lamivudine resistance in patients with prior entecavir treatment with undetectable viral load | 96 weeks |
Countries
China
Outcome results
None listed