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

The University of Hong Kong (HKU)

Status: Completed

Conditions: Hepatitis B, Chronic

Treatments: Drug: Lamivudine; Drug: Entecavir

Study type: Interventional

Funder types: Other

Identifiers

NCT01013272

HKUHEP-01

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Entecavir

Active Comparator group

Description:

Ongoing entecavir 0.5mg daily

Treatment:

Drug: Entecavir

Lamivudine

Active Comparator group

Description:

Switch to lamivudine 100mg daily

Treatment:

Drug: Lamivudine