Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant

Phase 4

• Conditions: POST LIVER TRANSPLANT; HBV
• Interventions: Drug: Tenofovir Alafenamide 25 MG

• Registration Number: NCT05063071
• Lead Sponsor: Fudan University

Brief Summary

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.

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 Timeline

• Status Verified: 2021-07
• Study Start: 2021-07-29
• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-09-22
• Last Update Submitted: 2021-09-22
• Study First Posted: 2021-09-30
• Last Update Posted: 2021-09-30
• Primary Completion: 2022-07-29
• Study Completion: 2022-12-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAF monotherapy without HBIG	Tenofovir Alafenamide 25 MG	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.

Primary Outcome Measures

Name	Time	Method
HBV DNA undetectable rate at week 48.	48 weeks	evaluate the HBV DNA undetectable rate (defined as HBV DNA \< 20 IU/mL) at week 48 after liver transplant.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China