Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, Treg cells Regulatory T cells played a negative role in immune. This study was aimed at investigating the changes of Treg cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α suppressed the virus, which led to the decline of Treg cells frequency and function;negative regulation of Tregs for immune cells diminished, hence, the function of immune cells recovered.
Pegylated interferon α-2a(Peg-IFN-α)and Nucleoside analog(ue) drugs can inhibit viral replication , but Peg-IFN-α also play an important role in immune regulation . In hepatitis B infection, Treg cells play an important role in immune regulation.Peg-IFN-α recommended as the first-line treatment has a higher chance to achieve HBeAg seroconversion and even HBsAg disappearance than nucleoside analog(ue) drugs, which may be related to the functional activation of Treg cells in the case of hepatitis and the function enhancement of Treg cells during Peg-IFN-α therapy. This study was aimed at investigating the changes of Treg cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α suppressed the virus, which led to the decline of Treg cells frequency and function;negative regulation of Tregs for immune cells diminished, hence, the function of immune cells recovered.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
patients untreated in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly in experiment group
Beijing Ditan hospital,Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGthe changes of Treg Cells
Treg Cells will be measured by flow cytometry after Pegylated Interferon α-2a and entecavir(ETV) Treatment 24weeks.
Time frame: after treatment 24 weeks.
the change of HBVDNA levels (IU/ML)
the curative effect of antiviral therapy will be evaluated by HBV DNA levels
Time frame: afte treatment 48 weeks
the change of ALT levels(U/L)
the curative effect of antiviral therapy will be evaluated by ALT levels
Time frame: afte treatment 48 weeks
the change of AST levels(U/L)
the curative effect of antiviral therapy will be evaluated by AST levels
Time frame: afte treatment 48 weeks
the change of HBsAg levels (IU/ML)
the curative effect of antiviral therapy will be evaluated by HBsAg levels
Time frame: afte treatment 48 weeks
the change of HBeAg levels (IU/ML)
the curative effect of antiviral therapy will be evaluated by HBeAg levels
Time frame: afte treatment 48 weeks
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