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

NCT05453448 | Completed

• 1 other identifier: 202012708
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

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) .

Conditions

Antiviral Drugs

Outcome Measures

Primary Outcomes (1)

• the survival rates without transplantation

  the survival rates without transplantation

  48 weeks

Study Arms (2)

tenofovir alafenamide

EXPERIMENTAL

tenofovir alafenamide,Gilead Sciences,capsule,25 mg,once a day,Continuous use for 48 weeks.

Drug: tenofovir alafenamide

entecavir

EXPERIMENTAL

entecavir,Fujian cosunter pharmaceutical co.LTD,capsule,0.5mg,once a day,Continuous use for 48 weeks.

Drug: Entecavir

Interventions

tenofovir alafenamide DRUG

Antiviral therapy

tenofovir alafenamide

Entecavir DRUG

entecavir

entecavir

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Wenting Peng

Changsha, China

Location

Related Publications (1)

• Peng W, Gu H, Cheng D, Chen K, Wu C, Jiang C, Liu J, Peng S, Fu L. Tenofovir alafenamide versus entecavir for treating hepatitis B virus-related acute-on-chronic liver failure: real-world study. Front Microbiol. 2023 May 25;14:1185492. doi: 10.3389/fmicb.2023.1185492. eCollection 2023.

  PMID: 37303805 DERIVED

MeSH Terms

Interventions

tenofovir alafenamide; entecavir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 12, 2022
• Study Start: May 1, 2022
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)