Clinical trial NCT04501224: The Efficacy and Safety of TAF vs Other NAs in Patients With LVL
Official title: The Efficacy and Safety of Tenofovir Alafenamide Fumarate Compared With Other Nucleoside Analogues (Acid) to Treat Patients With Low-level Viremia of HBV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis b
Cirrhosis Due to Hepatitis B
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Ratio of patients with undetectable hepatitis b virus DNA after treatment
timeFrame: 24 week
measure: The changes of glomerular filtration rate
timeFrame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
measure: The changes of bone mineral density in lumbar spine and hip
timeFrame: 0 week, 48 week, 96 week, 144 week.
Secondary outcomes:
measure: Ratio of patients with undetectable hepatitis b virus DNA after treatment
timeFrame: 12 week, 48 week, 72 week, 96 week, 120 week, 144 week
measure: The changes of HBsAg
timeFrame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
measure: The changes of the degree of liver fibrosis
timeFrame: 0 week, 48 week, 96 week, 144 week.
measure: Differences in symptoms
timeFrame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
measure: The changes of HBeAg
timeFrame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
measure: The changes of alanine aminotransferase
timeFrame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
measure: Differences in body weight
timeFrame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
measure: Differences in proteinuria, albuminuria and urinary β2-microglobulin
timeFrame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
measure: Differences in osmotic pressure
timeFrame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
measure: Differences in blood calcium and phosphorus
timeFrame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
measure: Differences in blood lipid
timeFrame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
measure: Differences in serum creatine kinase
timeFrame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Yuehua Huang, doctorate
role: PRINCIPAL_INVESTIGATOR
References: