The Relationship Between Novel Virological Indicators and Treatment With Different Nucleotide Analogues and the Prognosis of HBV-ACLF Patients

Tongji Hospital235 enrolled

Overview

This is an observational study. This study mainly explores the dynamic changes of HBV RNA and HBcrAg during the treatment of HBV-ACLF, as well as the safety of entecavir (ETV), tenofovir alafenamide (TAF) and tenofovir amibufenamide (TMF) during the treatment process, and evaluates the differences in patient prognosis among the three drugs.

NAs drugs play an important role in the treatment of HBV-ACLF. Currently, multiple research results indicate that the use of NAs can significantly improve the prognosis of HBV-ACLF patients, and the rapid decrease in early viral load is closely related to better prognosis. Compared to ETV and TDF, two early marketed NAs drugs, there is limited research on the prognosis and safety of TAF and TMF in HBV-ACLF patients, and head to head studies on the treatment of HBV-ACLF with various commonly used NAs drugs are even rarer. In addition, how novel virological markers change in HBV-ACLF patients after NAs treatment and whether there is a correlation with patient prognosis is also an unexplored topic. Therefore, this study aims to analyze the changes in clinical indicators and viral markers in HBV-ACLF patients during hospitalization, combined with the patient's prognosis, to explore the dynamic changes of novel virological markers during HBV-ACLF treatment, as well as the safety and impact of different NAs drugs on the prognosis of HBV-ACLF treatment.

Study Type

OBSERVATIONAL

Enrollment

235

Conditions

Acute-on-Chronic Liver Failure (ACLF)hepatitisB Treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18-70; 2. Hepatitis B surface antigen positive ≥ 6 months; 3. TBil\>5mg/dl or 85 μ mol/L; INR ≥ 1.5 or PTA \< 40%; Clinical manifestation of ascites and/or hepatic encephalopathy within four weeks of onset (According to the diagnostic criteria recommended by the Asian Pacific association for the study of the liver (APASL)) Exclusion Criteria: 1. Patients with malignant liver tumors and other tumors; 2. Pregnant or lactating women; 3. Patients with liver diseases caused by combined hepatitis C virus infection, hepatitis E virus infection, autoimmune hepatitis, poisoning, drug-induced liver damage, acute variceal bleeding, alcoholic liver disease, and genetic metabolic liver disease; 4. Patients with human immunodeficiency virus infection or other immunodeficiency diseases; 5. Patients with other organ dysfunction or failure; 6. Combined using more than one NAs drug

Locations (1)

Tongji Hospital

Wuhan, Hubei, China

Outcomes

Primary Outcomes

60-day survival rate of patients (%)

Survival status of patients 60 days after admission

Time frame: 60 days

Secondary Outcomes

24-week HBV DNA negativity rate (%)

HBV DNA negative rate(%) at 24 weeks

Time frame: 24 weeks

Data from ClinicalTrials.gov

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