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

• Status: Recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Treatments: Entecavir; Tenofovir

Criteria

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.