Maintaining Antiviral Efficacy After Switching to Generic Entecavir 1 mg for Chronic Hepatitis B

Study Overview
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Brief Summary
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Entecavir 1 mg is commonly used in patients with chronic hepatitis B (CHB) patients with previous antiviral resistance. This study evaluates the efficacy and safety of switching to generic entecavir 1 mg (Baracle®, Dong-A Science Technology) in CHB patients taking brand name entecavir 1 mg (Baraclude®, Bristol-Myers Squibb) alone or in combination with other nucleos(t)ide analogues after the development of antiviral resistance. The primary aim is virological response (<20 IU/mL) at 12 months

Detailed Description
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This study is a prospective single-arm open-label trial. The primary endpoint is virological response (<20 IU/mL) at 12 months after switching treatment. Patients who satisfy the inclusion and exclusion criteria will switch from Baraclude® 1 mg to Baracle®. Assessment of treatment response at 12 months is performed by comparing undetectable HBV DNA rates between baseline and 12 months after switching therapy.

Official Title
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Maintaining Antiviral Efficacy After Switching to Generic Entecavir, Baracle® in Patients Taking Baraclude® 1 mg for Antiviral Resistant Chronic Hepatitis B; A Noninferiority Study Assessing Non-detection Rate of Hepatitis B Virus DNA

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Switching to Generic Entecavir (Baracle®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >19 years old CHB patients Confirmed antiviral resistance Taking brand entecavir 1 mg for more than 1 year HBV DNA < 20 IU/mL Compensated liver cirrhosis Willing to participate Exclusion Criteria: Failure to meet the inclusion criteria Cr>1.5 mg/dL Postive HCV Ab Decompensated cirrhosis Pregnant women HCC Alcoholics

Ages Eligible for Study
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Minimum Age: 19 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
Intervention Model: Single Group Assignment
Interventional Model Description: CHB patients receiving treatment with Baraclude® 1 mg alone or in combination with other nucleos(t)ide analogues for 12 months or longer after the development of antiviral resistance.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baracle<br>Chronic hepatitis B patients who swiched to Baracle® 1 mg from Baraclude® 1 mg treatment as mono- or combination therapy after the development of antiviral resistance to nucleos(t)ide analogues | Drug: Switching to Generic Entecavir (Baracle®)<br>* switching to Baracle® 1 mg (generic drug) in chronic hepatitis B patients taking Baraclude® 1 mg (brand drug)<br>* Other names: Antiviral therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-detection rate of hepatitis B virus DNA | undetectable HBV DNA (<20 IU/mL) at 12 months after switching treatment. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of liver enzyme | ALT < 40 IU/L | 12 months | 
| Loss of serological markers of hepatitis B e antigen | Loss of HBeAg | 12 months | 
| Signs of newly developing antiviral resistance | Elevation of hepatitis B virus DNA by 10 fold assessed by real time PCR | 12 months |