NCT05453448

The Renal Safety of Tenofovir Alafenamide in HBV-related Acute-on-chronic Liver Failure: Real-World Study

Higher Risk of Kidney Function Decline With Entecavir Than Tenofovir Alafenamide in Patients With HBV Related Acute-on-chronic Liver Failure: Real-World Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Tenofovir alafenamide (TAF) and entecavir (ETV) are the preferred agents in patients with predisposing factors for nephrotoxicity, but few studies to date have directly compared the renal safety of the two antiviral drugs in patients with acute-on-chronic liver failure (ACLF). Hence, the investigators compared the risk of kidney function decline among patients with HBV related acute-on-chronic liver failure (HBV-ACLF) treated with ETV or TAF.From April 2020 to June 2021, a total of 272 HBV-related ACLF hospitalized patients in the Xiangya Hospital of Central South University were enrolled in this prospective study. Chronic hepatitis B was diagnosed by hepatitis B surface antigen and/or hepatitis B virus deoxyribonucleic acid (HBV-DNA) positivity for ≥6 months. ACLF was diagnosed based on the criteria proposed by the APASL Working Party. All patients received antiviral therapy with TAF (25 mg QD, n=100) or ETV (0.5mg QD, n=172), and comprehensive medical treatments. Clinical and laboratory data were collected to evaluate the progression of chronic kidney disease (CKD) .

Conditions

• Antiviral Drugs

Interventions

Type	Name	Description
DRUG	tenofovir alafenamide	Antiviral therapy
DRUG	Entecavir	entecavir

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-05-30
• Completion: 2022-05-30
• First posted: 2022-07-12
• Last updated: 2022-07-12

Locations

1 site across 1 country: China