Hepatitis B, Chronic, Lipid Disorder
Conditions
Keywords
Tenofovir Amibufenamide
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.
Interventions
DRUGoral Tenofovir Amibufenamide 25mg each day
patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day
DRUGlipid lowering drugs (e.g. Atorvastatin and amlodipine.)
lipid lowering drugs, , patients in group B1 continue take lipid lowering drugs
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| change from baseline liver stiffness measurement at 6/12month | baseline, follow up of 6,12month | test liver stiffness measurement and controlled attenuation parament through transient elastography(FibroTouch) |
| ultrasonography | baseline, follow up of 6,12month | liver ultrasonography |
Countries
China
Outcome results
None listed