Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable Hepatitis B Virus DNA

Study Overview
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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 0.5mg QD from lamivudine versus maintaining lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.

Detailed Description
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Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than those of Lamivudine in nucleoside-naïve CHB patients. The switch from Lamivudine to Entecavir in patients who have undetectable hepatitis B virus DNA (HBV DNA < 60 IU/mL) may lead to more prolonged viral suppression to undetectable level by PCR method, compared to patients with continuous lamivudine treatment. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.

Official Title
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Randomized, Open-Labeled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B Who Achieved Undetectable HBV DNA

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: Entecavir
* Drug: Lamivudine


Participation Criteria
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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 status. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>entecavir 0.5 mg QD | Drug: Entecavir<br>* entecavir 0.5 mg QD<br>* Other names: Baraclude 0.5mg;|
| Active Comparator: B<br>lamivudine 100 mg QD | Drug: Lamivudine<br>* lamivudine 100 mg QD<br>* Other names: Zeffix 100mg QD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy |  | at Week 96 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy |  | at Week 48 | 
| Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion |  | at Week 48 and 96 | 
| Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough, Safety assessment |  | Follow up period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis B, Lamivudine, Entecavir