Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant

Effectiveness and Safety of Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant With HBV-related Disease

TAF treatment for HBV prophylaxis could lead to significant reduction in ALT and significant improvement in renal function. However, data are scarce regarding to TAF monotherapy without HBIG for HBV prophylaxis in post orthotopic liver transplant with HBV-related disease. This study is based on a real-world, multi-center, prospective study to assess the effectiveness and safety of TAF for HBV prophylaxis, which will fill in gaps with TAF monotherapy without HBIG in post liver transplant.

Study Overview

• Status: Active, not recruiting
• Conditions: HBV; POST LIVER TRANSPLANT
• Intervention / Treatment: Drug: Tenofovir Alafenamide 25 MG

Detailed Description

LT has evolved rapidly, becoming the standard therapy for acute and chronic liver failure of a variety of aetiologies, with more than 80,000 procedures performed to date [13]. HBV infection is a worldwide public health problem, especially in China. The need for an antiviral treatment with NAs for liver transplant recipients has two objectives: the improvement of liver function and to decrease the risk of HBV recurrence after transplant. TAF, TDF and ETV are currently the first-line therapy in patients with CHB in all CHB treatment guidelines, which have a greater potency and higher barriers to resistance. TAF treatment for HBV prophylaxis could lead to significant reduction in ALT and significant improvement in renal function. However, data are scarce regarding to TAF monotherapy without HBIG for HBV prophylaxis in post orthotopic liver transplant with HBV-related disease. This study is based on a real-world, multi-center, prospective study to assess the effectiveness and safety of TAF for HBV prophylaxis, which will fill in gaps with TAF monotherapy without HBIG in post liver transplant.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient must be capable of understanding and signing written informed consent; Before commencing the study procedure, participants must obtain informed consent. If the patient is hepatic Coma, the family member shall sign the written informed consent.
• ≥18 years old.
• Orthotopic liver transplant for HBV-related disease (such as HCC, DCC or liver failure). Patients were all positive for HBsAg for at least 6 months prior to liver transplantation.
• HBV DNA ≤ 2000 IU/mL before orthotopic liver transplant . (Including patients who received or did not receive oral antiviral therapy before liver transplantation)

Exclusion Criteria:

• Post OLT patients received HBIG
• Other solid organs transplant recipients
• HCV, HDV or HIV coinfection
• Other primary end-stage liver diseases (PBC, PSC, etc)
• Patients with underwent liver re-transplantation
• Liver grafts from HBsAg+ donors
• Graft dysfunction of any other causes
• HCC with primary portal vein thrombus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: TAF monotherapy without HBIG; The standard dose of TAF 25mg daily was used. TAF can be used on the first day after orthotopic liver transplantation. No HBIG was used before, during, or after transplantation; and therapeutic vaccination was not routinely used.	Drug: Tenofovir Alafenamide 25 MG; After orthotopic liver transplant, all patients will receive Tenofovir Alafenamide monotherapy without HBIG for HBV Prophylaxis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBV DNA undetectable rate at week 48.	evaluate the HBV DNA undetectable rate (defined as HBV DNA < 20 IU/mL) at week 48 after liver transplant.	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBV DNA undetectable rate at week 96	evaluate the HBV DNA undetectable rate (defined as HBV DNA < 20 IU/mL) at week 96 after liver transplant.	96 weeks
HBsAg negative rate at week 48	evaluate the HBsAg negative rate at week 48 after liver transplant.	48 weeks
HBsAg negative rate at week 96	evaluate the HBsAg negative rate at week 96 after liver transplant.	96 weeks
ALT normalization rate at week 48	evaluate the ALT normalization rate at week 48 after liver transplant.	48 weeks
ALT normalization rate at week 96	evaluate the ALT normalization rate at week 96 after liver transplant.	96 weeks
Changes in Serum Creatinine at week 48	evaluate the change of Serum Creatinine at week 48 after liver transplant.	48 weeks
Changes in Serum Creatinine at week 96	evaluate the change of Serum Creatinine at week 96 after liver transplant.	96 weeks
Changes in eGFR (MDRD) at week 48	evaluate the change of eGFR (MDRD) at week 48 after liver transplant.	48 weeks
Changes in eGFR (MDRD) at week 96	evaluate the change of eGFR (MDRD) at week 96 after liver transplant.	96 weeks
Changes in β2-MG:Cr at week 48	evaluate the change of β2-MG:Cr at week 48 after liver transplant.	48 weeks
Changes in β2-MG:Cr at week 96	evaluate the change of β2-MG:Cr at week 96 after liver transplant.	96 weeks

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Jian zhou, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2021
• Primary Completion (Anticipated): July 29, 2022
• Study Completion (Anticipated): December 29, 2022

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: July 1, 2021

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: TAF-Prophylaxis-Post Liver Tx

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
• product manufactured in and exported from the U.S.: No