The Efficacy and Safety of TAF vs Other NAs in Patients With LVL
Summary
Patients with chronic hepatitis B should maximize the inhibition of HBV replication, which could reduce the incidence of liver cancer and liver disease-related complications. However, after 96 weeks of treatment with the first-line drugs, entecavir or tenofovir disoproxil fumarate, a certain proportion of patients still had low levels of HBV replication. Tenofovir alafenamide fumarate is a newly marketed anti-hepatitis B drug that is currently considered to be non-inferior to tenofovir disoproxil fumarate and safer bone and renal effects. Therefore, this research was put forward to investigate whether tenofovir alafenamide fumarate replacement for hepatitis B had a higher virological response rate and safety in patients with low levels of virus after 48 weeks of treatment with entecavir and tenofovir disoproxil fumarate.
Timeline
- Start
- 2020-08-03
- Primary completion
- 2021-10-31
- Completion
- 2024-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Entecavir | Small molecule | 0.5 mg | — |
| Comparator | Tenofovir disoproxil fumarate | Small molecule | 300 mg | — |
| Subject | tenofovir alafenamide | Small molecule | 25 mg | — |