Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-11-30

Brief Summary

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This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine monotherapy.

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Detailed Description

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Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than Lamivudine in nucleoside-naïve CHB patients. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL by PCR) may lead to full viral suppression to undetectable level by PCR method. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL) may preclude development of drug resistance. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.

Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

entecavir 1.0 mg QD

Group Type EXPERIMENTAL

Entecavir

Intervention Type DRUG

entecavir 1.0 mg QD

B

lamivudine 100 mg QD

Group Type ACTIVE_COMPARATOR

Lamivudine

Intervention Type DRUG

lamivudine 100 mg QD

Interventions

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Entecavir

entecavir 1.0 mg QD

Intervention Type DRUG

Lamivudine

lamivudine 100 mg QD

Intervention Type DRUG

Other Intervention Names

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Baraclude 1.0mg Zeffix 100mg

Eligibility Criteria

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Inclusion Criteria

* Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic HBV infection for at least 6 months with ≥ HBV DNA 60 IU/mL level and HBeAg positive at baseline.

Exclusion Criteria

* All subjects will be tested for presence of M204V/I mutations in the YMDD motif at baseline. Subjects with M204V/I mutations in the YMDD motif at baseline are not eligible for the study.
* Subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study.
* Subjects should have ALT \< 10 x ULN, and no evidence of hepatocellular carcinoma.
* Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.
* Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No