An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment

• Status: Enrolling by invitation
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

In June 2021, Chinese Food and Drug Administration approved the launch of the self-developed new drug Tenofovir Amibufenamide(TMF). TMF is a new second generation of tenofovir(TFV) and its effect on blood lipids is unclear. Our study aims to figure out the effect of TMF on serum lipid level in the process of antiviral therapy for chronic hepatitis B patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Amlodipine; Amlodipine, atorvastatin drug combination; Atorvastatin; Hypolipidemic Agents; Tenofovir

Criteria

Inclusion Criteria:

1. Age 18-70 years old;

2. Chronic hepatitis B patients who meet the CHB diagnostic criteria of "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (Chinese 2019 version)";

3. HBV-DNA can be detected (≥20IU/mL);

4. With or without liver cirrhosis caused by hepatitis B;

5. The treatment plan is TMF antiviral therapy, and no other antiviral drugs are used for at least 1 year before;

6. The clinical data are relatively complete, and the follow-up time reaches 24 weeks (6 months).

Exclusion Criteria:

1. Patients with primary liver cancer or liver metastases;

2. Combined with hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus and human immunodeficiency virus infection;

3. Combined with alcoholic liver disease, drug-induced liver disease, autoimmune liver disease and liver disease caused by other factors;

4. History of treatment of dysglycemia and dyslipidemia;

5. Patients with lactose intolerance;

6. Pregnant women and lactating women;

7. Patients with other serious systemic diseases.