Overview

Tenofovir Alafenamide for HBV Prophylaxis in HBV(-) Liver Transplant Recipients With HBcAb+ Donors

Status:
Not yet recruiting

Trial end date:
2024-04-01

Target enrollment:
0

Participant gender:
All

Summary

Liver transplantation is currently the only effective way to treat end-stage liver disease.The shortage of donor liver is still the major problem. Incidence of HBcAb+ varies between different regions. The HBcAb positive rate could be as high as 52% in China.HBcAb positive donor liver may enlarge donor pool and thus save ESLD patients. However, the use of HBcAb positive donor liver may induce HBV infection in hepatitis B negative recipient after liver transplantation. Tenofovir alafenamide (TAF) has better stability in plasma and higher liver targeting property in comparison with tenofovir (TDF), with an extra amide bond, which allows strong antiviral effect with much less doses and reducing the renal and bone injury. Our study intends to evaluate the efficacy and safety of HBV prophylaxis treatment of TAF in HBV negative patients after receiving HBcAb positive donor livers.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

RenJi Hospital

Treatments:

Tenofovir

Criteria

Inclusion Criteria:

1. Patients with written informed consent.

2. Age ≥12 years old

3. HBV negative recipients (HBV DNA undetectable and HBsAg negative) receiving HBsAg-,
HBcAb+ donor liver

Exclusion Criteria:

1. Patients underwent liver re-transplantation

2. CKD (CrCl<30 ml/min by MDRD formula)

3. HBV/HCV-related OLT

4. Other solid organs transplant recipients

5. HIV coinfection