Chronic Hepatitis B Infection
Conditions
Keywords
chronic hepatitis B, hepatitis B virus, Pegylated Interferon α-2a, entecavir, Plasmacytoid Dendritic Cells
Brief summary
Pegylated interferon(IFN) α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while entecavir(ETV) drugs only inhibit viral replication. In hepatitis B infection, Plasmacytoid Dendritic Cells（pDCs） are the main effector cells in early antiviral innate immune response. This study was aimed at investigating the changes of pDCs frequency and function, and the expression of costimulatory molecules CD86(Cluster of Differentiation antigen 86) during Peg-IFN-αand entecavir(ETV) therapy.Meanwhile, investigators want to verify whether Peg-IFN-α suppressed the virus and the reduction of virus led to the recovery of pDCs function, or Peg-IFN-α enhanced pDCs function which gave rise to the decline of the virus.
Detailed description
Pegylated interferon α-2a(Peg-IFN-α)and entecavir(ETV) drugs can inhibit viral replication , but Peg-IFN-α also play an important role in immune regulation . In hepatitis B infection, Plasmacytoid Dendritic Cells (pDCs) are the main effector cells in early antiviral innate immune response.Peg-IFN-α recommended as the first-line treatment has a higher chance to achieve HBeAg seroconversion and even HBsAg disappearance than entecavir(ETV) drugs, which may be related to the functional activation of pDCs in the case of hepatitis and the function enhancement of pDCs during Peg-IFN-α therapy. This study was aimed at investigating the changes of pDCs frequency and function, and the expression of costimulatory molecules CD86 during Peg-IFN-αandentecavir(ETV) therapy.Meanwhile,investigators want to explore whether the decline of HBsAg and HBeAg resulted in recovery of CD86+pDC function, or recovery of CD86 + pDC function led to the decrease of HBsAg and HBeAg. Several studies demonstrated that HBsAg and HBeAg could damage pDC function, and the loss of HBsAg and HBeAg led to recovery of CD86+pDC function.
Interventions
None listed
Sponsors
Beijing Ditan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* HBsAg and HBeAg positive for more than 6 months, HBVDNA detectable with ALT(alanine aminotransferase) level abnormal lasted for three months and at least time190 IU/L or liver puncture biopsy demonstrated apparent inflammation, never treated before enrolled.
Exclusion criteria
* Active consumption of alcohol and/or drugs * Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus * History of autoimmune hepatitis * Psychiatric disease * Evidence of neoplastic diseases of the liver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change of pDC% | after treatment 24 weeks | The host immune function will be evaluated by pDC. pDC% will be measured by flow cytometry after Pegylated Interferon α-2a and entecavir(ETV) Treatment 24 weeks. |
| the change of CD86+pDC% | after treatment 24 weeks | CD86+pDC% will be measured by flow cytometry after Pegylated Interferon α-2a and entecavir(ETV) Treatment 24 weeks. |
| the change of mean fluorescence intensity of costimulatory molecules CD86(CD86-MFI) | after treatment 24 weeks | mean fluorescence intensity of costimulatory molecules CD86(CD86-MFI) will be measured by flow cytometry after Pegylated Interferon α-2a and entecavir(ETV) Treatment 24 weeks. |
| the change of absolute molecular counting of costimulatory molecules CD86 | after treatment 24 weeks | absolute molecular counting of costimulatory molecules CD86 (CD86-ABC) will be measured by flow cytometry after Pegylated Interferon α-2a and entecavir(ETV) Treatment 24 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the change of HBVDNA levels (IU/ML) | after treatment 48 weeks | the curative effect of antiviral therapy will be evaluated by HBV DNA levels |
| the change of HBeAg levels (IU/ML) | after treatment 48 weeks | the curative effect of antiviral therapy will be evaluated by HBeAg levels |
| the change of ALT levels(U/L) | after treatment 48 weeks | the curative effect of antiviral therapy will be evaluated by ALT levels |
| the change of AST levels(U/L) | after treatment 48 weeks | the curative effect of antiviral therapy will be evaluated by AST levels |
| the change of HBsAg levels (IU/ML) | after treatment 48 weeks | the curative effect of antiviral therapy will be evaluated by HBsAg levels |
Countries
China
Contacts
Primary ContactYao Xie, MD
Outcome results
None listed