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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05453448

Enrollment

272

Registered

2022-07-12

Start date

2022-05-01

Completion date

2022-05-30

Last updated

2022-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiviral Drugs

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) .

Interventions

DRUGtenofovir alafenamide

Antiviral therapy

DRUGEntecavir

entecavir

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
the survival rates without transplantation	48 weeks	the survival rates without transplantation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026