Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load

The University of Hong Kong50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis B, Chronic

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Determine the efficacy of lamivudine therapy in patients with prior entecavir treatment with undetectable viral load

Time frame: 96 weeks

Secondary Outcomes

Determine the chance of lamivudine resistance in patients with prior entecavir treatment with undetectable viral load