Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic HBV Infection

• Status: Recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

Summary

tenofovir alafenamide (TAF) has been approved to be highly effective and safe in patients with chronic hepatitis B (CHB), therefore TAF may be a good option in kidney or liver transplant patients with chronic HBV infection. The aim of this prospective cohort study is to assess the safety, efficacy, and drug adherence improvement of TAF switching therapy in kidney or liver transplant patients with HBV infection.

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

Details

• Lead Sponsor: Taichung Veterans General Hospital
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

1. At least 20 years of age

2. Chronic HBV infection under NA therapy other than TAF

3. Underwent kidney and/ or liver transplantation

4. Without clinical or pathologic evidence of moderate or severe rejection

5. Patients who are indicated for TAF switching therapy, such as concerns in virological response, biochemical response, drug compliance, or safety issues to other NAs.

Exclusion Criteria:

1. End stage renal disease (eGFR < 15 mL/min/1.73m2)

2. Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)

3. Any active malignancies

4. Pregnant or breast-feeding women

5. Known allergy to tenofovir-contained regimens