Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant

Fudan University

Status and phase: Unknown; Phase 4

Conditions: POST LIVER TRANSPLANT; HBV

Treatments: Drug: Tenofovir Alafenamide 25 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05063071

TAF-Prophylaxis-Post Liver Tx

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

TAF monotherapy without HBIG

Experimental group

Description:

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.

Treatment:

Drug: Tenofovir Alafenamide 25 MG