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

Not Applicable

• Conditions: HBV; Liver Transplant Disorder
• Interventions: Drug: Tenofovir Alafenamide 25 MG

• Registration Number: NCT04703465
• Lead Sponsor: RenJi Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-08
• Last Update Submitted: 2021-01-08
• Study First Posted: 2021-01-11
• Last Update Posted: 2021-01-11
• Study Start: 2021-04-01
• Primary Completion: 2022-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tenofovir alafenamide	Tenofovir Alafenamide 25 MG	tenofovir alafenamide 25mg daily for 48 weeks

Primary Outcome Measures

Name	Time	Method
De novo HBV infected rate after liver transplantation at 48 weeks	48 weeks	Primary outcome is to calculate de novo HBV infection after liver transplantation when treating with TAF.

Secondary Outcome Measures

Name	Time	Method
48 weeks Renal safety of TAF after liver transplantation.	48 weeks	Secondary outcome is to evaluate changes in renal function (Serum Creatinine, eGFR, β2-MG: Cr, RBP:Cr) at 48 weeks.
96 weeks Renal safety of TAF after liver transplantation.	96 weeks	Secondary outcome is to evaluate changes in renal function (Serum Creatinine, eGFR, β2-MG: Cr, RBP:Cr) at 96 weeks.