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

Study Overview
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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.

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.

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

Conditions
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Hepatitis B, Chronic, Lipid Disorder

Intervention / Treatment
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* Drug: oral Tenofovir Amibufenamide 25mg each day
* Drug: lipid lowering drugs (e.g. Atorvastatin and amlodipine.)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70 years old; Chronic hepatitis B patients who meet the CHB diagnostic criteria of Guidelines for the Prevention and Treatment of Chronic Hepatitis B (Chinese 2019 version); HBV-DNA can be detected (≥20IU/mL); With or without liver cirrhosis caused by hepatitis B; The treatment plan is TMF antiviral therapy, and no other antiviral drugs are used for at least 1 year before; The clinical data are relatively complete, and the follow-up time reaches 24 weeks (6 months). Exclusion Criteria: Patients with primary liver cancer or liver metastases; Combined with hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus and human immunodeficiency virus infection; Combined with alcoholic liver disease, drug-induced liver disease, autoimmune liver disease and liver disease caused by other factors; History of treatment of dysglycemia and dyslipidemia; Patients with lactose intolerance; Pregnant women and lactating women; Patients with other serious systemic diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: group A<br>normal blood lipid level at baseline | Drug: oral Tenofovir Amibufenamide 25mg each day<br>* patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day<br>|
| Other: group B1<br>baseline blood lipid is elevated and treat with lipid-lowering drugs | Drug: oral Tenofovir Amibufenamide 25mg each day<br>* patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day<br>Drug: lipid lowering drugs (e.g. Atorvastatin and amlodipine.)<br>* lipid lowering drugs, , patients in group B1 continue take lipid lowering drugs<br>|
| Other: group B2<br>baseline blood lipid is elevated and without lipid-lowering drugs treatment | Drug: oral Tenofovir Amibufenamide 25mg each day<br>* patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline HBV-DNA at 1/3/6/12month | test virological response rate | baseline, follow up of 1,3,6,12month | 
| change from baseline level of blood lipid at 1/3/6/12month | test blood lipid level | baseline, follow up of 1,3,6,12month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline serum calcium at 6/12month | test blood serum calcium | baseline, follow up of 6,12month | 
| change from baseline serum phosphorus at 6/12month | test blood serum phosphorus | baseline, follow up of 6,12month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tenofovir Amibufenamide