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

Not Applicable

Completed

• Conditions: Antiviral Drugs
• Interventions: Drug: Entecavir; Drug: tenofovir alafenamide

• Registration Number: NCT05453448
• Lead Sponsor: Xiangya Hospital of Central South University

Brief 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) .

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30
• Status Verified: 2022-06
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-07-10
• Last Update Submitted: 2022-07-10
• Study First Posted: 2022-07-12
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

• the presence of hepatitis B surface antigen (HBsAg) in the serum for at least 6 months.
• evidence of active viral replication as documented by measurable HBV DNA in the serum (≥2000IU/mL).

Exclusion Criteria

• Less than 18 years old.
• history of ESKD or kidney transplantation.
• unknown baseline estimated glomerular filtration rate (eGFR).
• coexistence with other liver diseases such as alcoholic liver disease, autoimmune hepatitis, drug-induced liver injury, or other viral infections(hepatitis A, C, and E virus or HIV infection).
• concomitant with malignant tumor or other serious diseases affecting survival time.
• patients with missing data. follow-up period of <48 weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
entecavir	Entecavir	entecavir,Fujian cosunter pharmaceutical co.LTD,capsule,0.5mg,once a day,Continuous use for 48 weeks.
tenofovir alafenamide	tenofovir alafenamide	tenofovir alafenamide,Gilead Sciences,capsule,25 mg,once a day,Continuous use for 48 weeks.

Primary Outcome Measures

Name	Time	Method
the survival rates without transplantation	48 weeks	the survival rates without transplantation

Trial Locations

Locations (1)

Wenting Peng; 🇨🇳 Changsha, China