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

Effectiveness and Safety of Tenofovir Alafenamide for HBV Prophylaxis in HBV Negative Recipients Received Orthotopic Liver Transplant With HBcAb+ Donors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HBV; Liver Transplant Disorder
• Intervention / Treatment: Drug: Tenofovir Alafenamide 25 MG

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qiang Xia, MD., Ph.D.; Phone Number: +8602168383775; Email: xiaqiang@shsmu.edu.cn
• Study Contact Backup: Name: Zhifeng Xi, MD.; Phone Number: +8602168383715; Email: xizhifeng@renji.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tenofovir alafenamide; tenofovir alafenamide 25mg daily for 48 weeks	Drug: Tenofovir Alafenamide 25 MG; Tenofovir Alafenamide 25mg for 48 weeks will be delivered; Other Names: Vemlidy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Chair: Qiang Xia, MD., Ph.D., RenJi Hospital; Principal Investigator: Zhifeng Xi, MD., RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: In the application

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No