Analysis of Renal Impairment Characteristics and High-Risk Factors in Chronic Hepatitis B Patients on Long-Term Oral Nucleos(t)Ide Analogues

Foshan Hospital of Traditional Chinese Medicine300 enrolled

Overview

This is a single-center retrospective observational study. A total of 300 patients with non-alcoholic fatty liver disease treated in our hospital will be included. We collect clinical data, laboratory indicators and imaging results, and analyze the correlation between long-term nucleoside antiviral drugs and renal function changes in patients. The study does not use any new intervention measures, and only conducts statistical analysis on existing medical record data.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Non-alcoholic Fatty Liver Disease, Renal Function Impairment

Interventions

Long-term oral nucleos(t)ide analogs antiviral therapyDRUG

Oral nucleos(t)ide analog antiviral drugs, including tenofovir alafenamide, tenofovir disoproxil fumarate, entecavir, used for long-term treatment of chronic hepatitis B virus infection. This is a retrospective observational study analyzing renal safety after long-term antiviral treatment.

Medical Language ↔ Plain English

Inclusion Criteria: 1. Meet the diagnostic criteria for chronic hepatitis B specified in the 2019 Chinese Society of Infectious Diseases guidelines. 2. Patients received continuous NAS antiviral treatment for at least 12 months. 3. Patients voluntarily participated in the study and signed informed consent. 4. Complete records of liver function, renal function, urinary indicators and HBV-DNA data are available. Exclusion Criteria: 1. Combined with chronic nephritis, nephrotic syndrome and other primary kidney diseases. 2. Co-infection with hepatitis C virus, hepatitis E virus and other hepatitis viruses. 3. Duration of antiviral treatment less than 12 months. 4. Patients with drug resistance during anti-HBV treatment who switched or combined other antiviral agents. 5. Autoimmune hepatitis, alcoholic liver disease, schistosomal liver disease and other liver diseases. 6. Malignant tumor, severe cardiovascular and other systemic serious diseases.

Outcomes

Primary Outcomes

Serum creatinine level

Serum creatinine levels will be obtained from medical records and compared among patients with chronic hepatitis B in the NA-untreated, entecavir-treated, and tenofovir disoproxil fumarate-treated groups. Serum creatinine will be reported in μmol/L.

Time frame: At baseline (the index assessment).

Estimated glomerular filtration rate

Estimated glomerular filtration rate will be determined from serum creatinine using the prespecified equation and compared among patients with chronic hepatitis B in the NA-untreated, entecavir-treated, and tenofovir disoproxil fumarate-treated groups. Values will be reported in mL/min/1.73 m².

Time frame: At baseline (the index assessment).

Blood urea nitrogen level

Blood urea nitrogen levels will be obtained from medical records and compared among patients with chronic hepatitis B in the NA-untreated, entecavir-treated, and tenofovir disoproxil fumarate-treated groups. Blood urea nitrogen will be reported in mmol/L.

Time frame: At baseline (the index assessment).

Analysis of Renal Impairment Characteristics and High-Risk Factors in Chronic Hepatitis B Patients on Long-Term Oral Nucleos(t)Ide Analogues

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes