drugset / Trial / NCT05398393
An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment
Unknown
150 enrolled
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-01-01
- Primary completion
- 2023-06-30
- Completion
- 2023-06-30
Publications
- Results 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 Study Group. Tenofovir-disoproxil-fumarate modulates lipid metabolism via hepatic CD36/PPAR-alpha activation in hepatitis B virus infection. J Gastroenterol. 2021 Feb;56(2):168-180. doi: 10.1007/s00535-020-01750-3. Epub 2020 Nov 19.
- Results 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 HIV. AIDS. 2020 Jul 1;34(8):1161-1170. doi: 10.1097/QAD.0000000000002541.
- Results 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 prospective observational study. AIDS Res Ther. 2021 May 27;18(1):30. doi: 10.1186/s12981-021-00354-y.
- Results 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.antiviral.2020.104948. Epub 2020 Sep 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenofovir Amibufenamide | Unknown | 25 mg | Oral |
| Background | Amlodipine | Other / unclassified | — | — |
| Background | Atorvastatin | Small molecule | — | — |