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

Korea University40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

Switching to Generic Entecavir (Baracle®)DRUG

switching to Baracle® 1 mg (generic drug) in chronic hepatitis B patients taking Baraclude® 1 mg (brand drug)

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Korea University Ansan Hospital

Ansan, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Non-detection rate of hepatitis B virus DNA

undetectable HBV DNA (\<20 IU/mL) at 12 months after switching treatment.

Time frame: 12 months

Secondary Outcomes

Normalization of liver enzyme

ALT \< 40 IU/L

Time frame: 12 months

Loss of serological markers of hepatitis B e antigen

Loss of HBeAg

Time frame: 12 months

Signs of newly developing antiviral resistance

Elevation of hepatitis B virus DNA by 10 fold assessed by real time PCR

Time frame: 12 months

Data from ClinicalTrials.gov

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