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

Sun Yat-sen University

Status: Unknown

Conditions: Chronic Hepatitis b; Cirrhosis Due to Hepatitis B

Treatments: Drug: Tenofovir alafenamide fumarate; Drug: Entecavir or Tenofovir disoproxil fumarate

Study type: Interventional

Funder types: Other

Identifiers

NCT04501224

TAF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

switch to tenofovir alafenamide fumarate

Experimental group

Description:

Patients will switch to tenofovir alafenamide fumarate treatment, 25mg，once a day

Treatment:

Drug: Tenofovir alafenamide fumarate

Continue with the original regimen

Active Comparator group

Description:

Patients will continue with the original regimen treatment, entecavir, 0.5mg once a day, or tenofovir disoproxil fumarate 300mg once a day

Treatment:

Drug: Entecavir or Tenofovir disoproxil fumarate