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

Not Applicable

• Conditions: Lipid Disorder; Hepatitis B, Chronic
• Interventions: Drug: oral Tenofovir Amibufenamide 25mg each day; Drug: lipid lowering drugs (e.g. Atorvastatin and amlodipine.)

• Registration Number: NCT05398393
• Lead Sponsor: Wuhan Union Hospital, China

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-03-10
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-25
• Last Update Submitted: 2022-05-25
• Study First Posted: 2022-06-01
• Last Update Posted: 2022-06-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group A	oral Tenofovir Amibufenamide 25mg each day	normal blood lipid level at baseline
group B1	oral Tenofovir Amibufenamide 25mg each day	baseline blood lipid is elevated and treat with lipid-lowering drugs
group B1	lipid lowering drugs (e.g. Atorvastatin and amlodipine.)	baseline blood lipid is elevated and treat with lipid-lowering drugs
group B2	oral Tenofovir Amibufenamide 25mg each day	baseline blood lipid is elevated and without lipid-lowering drugs treatment

Primary Outcome Measures

Name	Time	Method
change from baseline HBV-DNA at 1/3/6/12month	baseline, follow up of 1,3,6,12month	test virological response rate
change from baseline level of blood lipid at 1/3/6/12month	baseline, follow up of 1,3,6,12month	test blood lipid level

Secondary Outcome Measures

Name	Time	Method
change from baseline serum calcium at 6/12month	baseline, follow up of 6,12month	test blood serum calcium
change from baseline serum phosphorus at 6/12month	baseline, follow up of 6,12month	test blood serum phosphorus

Trial Locations

Locations (1)

Wuhan Union hosipital; 🇨🇳 Wuhan, Hubei, China