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

Huazhong University of Science and Technology

Status: Unknown

Conditions: Hepatitis B, Chronic; Lipid Disorder

Treatments: Drug: oral Tenofovir Amibufenamide 25mg each day; Drug: lipid lowering drugs (e.g. Atorvastatin and amlodipine.)

Study type: Interventional

Funder types: Other

Identifiers

NCT05398393

UHCT21612

Details and patient eligibility

About

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.

Full description

In June 2021, Chinese Food and Drug Administration approved the launch of the self-developed new drug Tenofovir Amibufenamide(TMF). TMF is the phosphoramidite precursor of Tenofovir, belonging to the nucleoside reverse transcriptase and owning higher cell membrane penetration rate, which make it easier to enter hepatocytes and achieve liver-targeted therapy. Meanwhile, TMF can effectively improve drug stability in plasma and reduce systemic tenofovir(TFV) exposure, and make long-term treatment safer.

Previous studies have shown that tenofovir disoproxil (TDF), the first generation of TFV, had the effect of lowering blood lipids. While patients who switched to tenofovir alafenamide (TAF), the second generation of TFV, had elevated blood lipids. TMF is a new second generation of 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

group A

Other group

Description:

normal blood lipid level at baseline

Treatment:

Drug: oral Tenofovir Amibufenamide 25mg each day

group B1

Other group

Description:

baseline blood lipid is elevated and treat with lipid-lowering drugs

Treatment:

Drug: lipid lowering drugs (e.g. Atorvastatin and amlodipine.)

Drug: oral Tenofovir Amibufenamide 25mg each day

group B2

Other group

Description:

baseline blood lipid is elevated and without lipid-lowering drugs treatment

Treatment:

Drug: oral Tenofovir Amibufenamide 25mg each day