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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| switch to tenofovir alafenamide fumarate | Experimental | Patients will switch to tenofovir alafenamide fumarate treatment, 25mg，once a day |
|
| Continue with the original regimen | Active Comparator | Patients will continue with the original regimen treatment, entecavir, 0.5mg once a day, or tenofovir disoproxil fumarate 300mg once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir alafenamide fumarate | Drug | Patients would take tenofovir alafenamide fumarate, 25mg，once per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of patients with undetectable hepatitis b virus DNA after treatment | Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 24 week after treatment. | 24 week |
| The changes of glomerular filtration rate | Glomerular filtration rate will be tested to know the changes after treatment | 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week |
| The changes of bone mineral density in lumbar spine and hip | Bone mineral density in lumbar spine and hip were tested after treatment | 0 week, 48 week, 96 week, 144 week. |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of patients with undetectable hepatitis b virus DNA after treatment | Hepatitis b virus DNA would be tested at 6 time points. | 12 week, 48 week, 72 week, 96 week, 120 week, 144 week |
| The changes of HBsAg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuehua Huang, doctorate | Contact | 0086-13822232795 | huangyh53@mail.sysu.edu.cn | |
| Guofen Zeng, masterate | Contact | 0086-13570305907 | zengguofen06@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuehua Huang, doctorate | Third Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510630 | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C442442 | tenofovir alafenamide |
| C413685 | entecavir |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| Entecavir or Tenofovir disoproxil fumarate | Drug | Patients would take entecavir 0.5 mg once per day, or tenofovir disoproxil fumarate 300 mg once per day |
|
|
The levels of HBsAg were tested at each time point.
| 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week |
| The changes of the degree of liver fibrosis | Fibroscan would be conducted once every 48 weeks | 0 week, 48 week, 96 week, 144 week. |
| Differences in symptoms | Symptoms would be evaluated at each time point | 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week |
| The changes of HBeAg | The levels of HBeAg were tested at each time point. | 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week |
| The changes of alanine aminotransferase | The levels of alanine aminotransferase were tested at each time point. | 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week |
| Differences in body weight | Body weight would be evaluated at each time point | 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week |
| Differences in proteinuria, albuminuria and urinary β2-microglobulin | Proteinuria, albuminuria and urinary β2-microglobulin would be evaluated at each time point | 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week |
| Differences in osmotic pressure | The levels of osmotic pressure would be evaluated at each time point | 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week |
| Differences in blood calcium and phosphorus | The levels of blood calcium and phosphorus would be evaluated at each time point | 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week |
| Differences in blood lipid | The levels of blood lipid would be evaluated at each time point | 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week |
| Differences in serum creatine kinase | The levels of creatine kinase would be evaluated at each time point | 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |