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

NCT ID: NCT05453448

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-05-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tenofovir alafenamide

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

Group Type: EXPERIMENTAL

tenofovir alafenamide

Intervention Type: DRUG

Antiviral therapy

entecavir

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

Group Type: EXPERIMENTAL

Entecavir

Intervention Type: DRUG

entecavir

Interventions

tenofovir alafenamide

Antiviral therapy

Intervention Type: DRUG

Entecavir

entecavir

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wenting Peng

Changsha, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37303805 (View on PubMed)

Other Identifiers

202012708

Identifier Type: -

Identifier Source: org_study_id