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

• Status: Active, not recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea University
• Treatments: Antiviral Agents; Entecavir

Criteria

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