Treatment and Prognosis of Patients With Chronic HBV Infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study on the Antiviral Therapy and Prognosis of Patients With Chronic HBV Infection

Conditions
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Hepatitis B Virus Infection

Intervention / Treatment
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* Other: Standard antiviral therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| peg-IFN-alpha alone<br>Patients with chronic HBV infection only treated with peg-IFN-alpha | Other: Standard antiviral therapy<br>* pegylated interferon or/and nucleos(t)ide analogues<br>|
| nucleos(t)ide analogues alone<br>Patients with chronic HBV infection only treated with nucleos(t)ide analogues | Other: Standard antiviral therapy<br>* pegylated interferon or/and nucleos(t)ide analogues<br>|
| combination<br>Patients with chronic HBV infection treated with nucleos(t)ide analogues and peg-IFN-alpha | Other: Standard antiviral therapy<br>* pegylated interferon or/and nucleos(t)ide analogues<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B Virus Infection, antiviral therapy, prognosis