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Hepatitis B virus (HBV) infection is a major global health issue with 257 million chronically infected individuals. Of note, China has the largest population accounting for one third of the world's infected population. Approximately, about 300 000 people die each year due to the consequences of HBV. In 2016, the World Health Organization (WHO) proposed the goal for elimination of hepatitis B as public health threat by 2030 and China will be a major contributor towards this global goal. Currently, two approved therapeutic strategies are available including pegylated interferon (IFN) or nucleos (t) ide analogues (NA), which could suppress HBV replication and slow disease progression. Here, investigators hope to launch a cohort study to reveal the clinical features relating to therapeutic efficacy of antiviral therapy and the prognosis of patients with differential therapeutic strategies.
Patients with chronic HBV infection were recruited in the current study and divided in to peg-IFN-alpha alone group, NAs alone group and the combination therapy group. The serum HBV DNA level, HBV serological test and biochemical examination including serum transaminase level and AFP were recorded every three or six months. The serum, feces, urine and liver (if necessary) samples were collected during follow-up. And the clinical outcomes of patients were evaluated. The clinical and biological features of patients with different clinical outcomes will be compared to explore the factors affecting the antiviral therapeutic efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| peg-IFN-alpha alone | Patients with chronic HBV infection only treated with peg-IFN-alpha |
| |
| nucleos(t)ide analogues alone | Patients with chronic HBV infection only treated with nucleos(t)ide analogues |
| |
| combination | Patients with chronic HBV infection treated with nucleos(t)ide analogues and peg-IFN-alpha |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard antiviral therapy | Other | pegylated interferon or/and nucleos(t)ide analogues |
|
| Measure | Description | Time Frame |
|---|---|---|
| virological response | serum HBV DNA level below the detection limit | 3 years |
| HBeAg seroconversion | Loss of HBeAg and presence of anti-hepatitis B e antibody (anti-HBe) in a person who was previously HBeAg-positive and anti-HBe-negative | 3 years |
| Clinical cure | Sustained virological response and HBsAg clearance or with anti-HBs seroconversion, alanine aminotransferase (ALT) within the normal range, and mild or no lesions in the liver | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| HBV DNA | The serum HBV DNA level will be detected and reported every 3 to 6 months | 3 years |
| HBV serological test | HBV serological markers include HBsAg, anti-HBs, HBeAg, anti-HBe, hepatitis B core antibody (anti-HBc) were detected and reported every 3 months |
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Inclusion Criteria:
patients with evidence of chronic HBV infection
Exclusion Criteria:
chronic liver injury mainly caused by other reasons, such as autoimmune diseases, alcohol, drugs and so on.
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The chronic HBV-infected patients with differential antiviral strategies were recruited and separated to peg-IFN-alpha alone, NAs alone or combination treatment groups according to their antiviral therapies. The clinical outcomes of patients with differential treatments were compared during the follow-up management.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Huang | Contact | +86 13874854142 | ganrankedrhyan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Huang | Xiangya Hospital of Central South University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Infectious Disease, Xiangya Hospital, Central South University | Recruiting | Changsha | Hunan | 410008 | China |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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whole blood including blood cells, serum and plasma, urine, faeces and liver tissue
| 3 years |
| liver function | The serum levels of transaminase including ALT and aspartate aminotransferase (AST) will be collected and reported every 3 months | 3 years |
| Alpha-fetoprotein (AFP) | The serum AFP level will be detected and reported every 3 to 6 months | 3 years |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |