Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

1. Adefovir add-on therapy is superior to switching to adefovir monotherapy or entecavir 1mg monotherapy for chronic hepatitis B (CHB) patients with lamivudine resistance (LAM-R)

2. Long-term adefovir add-on therapy was effective for viral suppression. However, the economic burden for such dual antiviral therapy is heavy because of infinite treatment.

3. Tenofovir disoproxil fumarate (TDF) is a potent antiviral agent. TDF demonstrated potent antiviral efficacy in a subset of lamivudine experienced HBeAg-positive patients. TDF is also superior to ADV in HBeAg-negative and HBeAg-positive treatment-naive patients.

4. Theoretically, TDF can replace LAM/ADV when viral suppression has been achieved by LAM/ADV combination treatment in LAM-R CHB patients.

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

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: Chi Mei Medical Hospital; Chia-Yi Christian Hospital; Chiayi Christian Hospital; China Medical University Hospital; Kaohsiung Medical University Chung-Ho Memorial Hospital
• Treatments: Adefovir; Adefovir dipivoxil; Lamivudine; Tenofovir

Criteria

Inclusion Criteria:

• HBsAg-positive for more than 6 months (HBeAg-positive or HBeAg-negative).

• Age > 20 y/o.

• Under lamivudine/adefovir treatment for more than 1 year due to previous lamivudine resistance (LAM-R), current HBV DNA is undetectable (< 20 IU/ml) during enrollment.

Exclusion Criteria:

• HCV, HIV, HDV coinfection.

• Uncontrolled HCC, malignancy or decompensated liver cirrhosis (CTP score ≥ 7).

• Uremia patients or Creatinine ≥ 2 mg/dl.