Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HBV, POST LIVER TRANSPLANT

Intervention / Treatment
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* Drug: Tenofovir Alafenamide 25 MG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAF monotherapy without HBIG<br>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<br>* After orthotopic liver transplant, all patients will receive Tenofovir Alafenamide monotherapy without HBIG for HBV Prophylaxis.<br>|

What is the study measuring?
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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 |