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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Liver Transplant Disorder; HBV

Treatments: Drug: Tenofovir Alafenamide 25 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04703465

In the application

Details and patient eligibility

About

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.

Full description

We intent to enroll 30 patients who are HBV negative but received HBcAb+ liver. Antiviral treatment with TAF(25mg/d,oral) will be started on the first day after liver transplantation. Post-operative HBV infection is defined with positive HBV marker (HBsAg) and/or positive HBV DNA after liver transplantation. Primary outcome will be evaluated at 48 weeks. All the patients will be followed up for another at least 1 year to evaluate the long term efficacy and safety of TAF.

The primary endpoint is to calculate de novo HBV infection after liver transplantation when treating with TAF. Secondary endpoint is to evaluate the renal safety of TAF after liver transplantation.

Enrollment: 30 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

tenofovir alafenamide

Experimental group

Description:

tenofovir alafenamide 25mg daily for 48 weeks

Treatment:

Drug: Tenofovir Alafenamide 25 MG