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

Korea University

Status and phase: Unknown; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: Switching to Generic Entecavir (Baracle®)

Study type: Interventional

Funder types: Other

Identifiers

NCT04069858

2106AS0033

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Baracle

Experimental group

Description:

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

Treatment:

Drug: Switching to Generic Entecavir (Baracle®)