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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05398393
• Other study ID #: UHCT21612
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2022
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis B
• Hepatitis B, Chronic
• Lipid Disorder
• Lipid Metabolism Disorders

Intervention

Drug:
• oral Tenofovir Amibufenamide 25mg each day
patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day
• lipid lowering drugs (e.g. Atorvastatin and amlodipine.)
lipid lowering drugs, , patients in group B1 continue take lipid lowering drugs

Locations

Country	Name	City	State
China	Wuhan Union hosipital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (4)

Ikeda M, Wakabayashi Y, Okamoto K, Yanagimoto S, Okugawa S, Moriya K. Changing trends in lipid profile and biomarkers of renal function and bone metabolism before and after switching from tenofovir disoproxil fumarate to tenofovir alafenamide: a prospecti — View Citation

Lacey A, Savinelli S, Barco EA, Macken A, Cotter AG, Sheehan G, Lambert JS, Muldoon E, Feeney E, Mallon PW, Tinago W; UCD ID Cohort Study. Investigating the effect of antiretroviral switch to tenofovir alafenamide on lipid profiles in people living with H — View Citation

Li M, Zhou L, Dorsey HG, Musoff C, Jnr DA, Schoen N, Djan K, Paintsil E. Tenofovir alafenamide does not inhibit mitochondrial function and cholesterol biosynthesis in human T lymphoblastoid cell line. Antiviral Res. 2020 Nov;183:104948. doi: 10.1016/j.ant — View Citation

Suzuki K, Suda G, Yamamoto Y, Furuya K, Baba M, Nakamura A, Miyoshi H, Kimura M, Maehara O, Yamada R, Kitagataya T, Yamamoto K, Shigesawa T, Nakamura A, Ohara M, Kawagishi N, Nakai M, Sho T, Natsuizaka M, Morikawa K, Ogawa K, Ohnishi S, Sakamoto N; NORTE — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change from baseline liver stiffness measurement at 6/12month	test liver stiffness measurement and controlled attenuation parament through transient elastography(FibroTouch)	baseline, follow up of 6,12month
Other	ultrasonography	liver ultrasonography	baseline, follow up of 6,12month
Primary	change from baseline HBV-DNA at 1/3/6/12month	test virological response rate	baseline, follow up of 1,3,6,12month
Primary	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	change from baseline serum calcium at 6/12month	test blood serum calcium	baseline, follow up of 6,12month
Secondary	change from baseline serum phosphorus at 6/12month	test blood serum phosphorus	baseline, follow up of 6,12month