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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis B, Chronic Lipid Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group A

normal blood lipid level at baseline

Group Type OTHER

oral Tenofovir Amibufenamide 25mg each day

Intervention Type DRUG

patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day

group B1

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

Group Type OTHER

oral Tenofovir Amibufenamide 25mg each day

Intervention Type DRUG

patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day

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

Intervention Type DRUG

lipid lowering drugs, , patients in group B1 continue take lipid lowering drugs

group B2

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

Group Type OTHER

oral Tenofovir Amibufenamide 25mg each day

Intervention Type DRUG

patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day

Interventions

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oral Tenofovir Amibufenamide 25mg each day

patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day

Intervention Type DRUG

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

lipid lowering drugs, , patients in group B1 continue take lipid lowering drugs

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No