The Efficacy and Safety of TAF vs Other NAs in Patients With LVL

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    200
  • sponsor
    Third Affiliated Hospital, Sun Yat-Sen University
Updated on 25 January 2021
liver cancer
cancer
tenofovir
hepatitis
fumarate
liver disease
entecavir
hepatitis b antigen
chronic hepatitis

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.

Description

Patients who meet the inclusion and exclusion criteria will be enrolled into the research. The participants will voluntarily choose to enter the experimental group or the control group with full informed consent. The control group will continue with the original regimen, while the study group will switch to tenofovir alafenamide fumarate antiviral therapy. Each group will enroll 100 participants.

Details
Condition Hepatitis B, Hepatitis B, chronic hepatitis b, Cirrhosis Due to Hepatitis B
Treatment Tenofovir alafenamide Fumarate, Entecavir or Tenofovir disoproxil fumarate
Clinical Study IdentifierNCT04501224
SponsorThird Affiliated Hospital, Sun Yat-Sen University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

HBsAg positive for over half a year
Age from 18 to 80 years old
Entecavir (0.5mg qd) or Tenofovir disoproxil fumarate (300mg qd) for 48 weeks or more
HBV DNA level was between 20IU/ ml-2000 IU /mL (COBAS, Taqman)

Exclusion Criteria

Low-level viremia of HBV caused by non-standard medication
serum total bilirubin is more than 2 times the upper limit of normal (ULN), or ALT or AST is more than 5ULN, or serum albumin is less than 30g/L
Overlap with HAV, HCV, HDV, HEV or HIV infection
Other liver disease: drug liver disease, alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease, etc
Decompensated cirrhosis or liver cancer
Kidney damage, or autoimmune disease, or other organ failure
Combination of Entecavir or Tenofovir disoproxil fumarate
Interferon therapy within half a year
Entecavir (0.5mg qd) or Tenofovir disoproxil fumarate
Investigator considering inappropriate
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