This study is a real-world case-control study conducted, with 120 CHB patients who received continuous treatment with PEG-IFN-α for more than 24 weeks as study subjects. Among them, the clinical cure group obtained through PEG-IFN-α treatment is the case group; The group that did not achieve clinical cure after PEG-IFN-α treatment was used as the control group, and the case group and control group were allocated cases in a 2:1 ratio. Collect blood samples from subjects as sequencing samples for candidate genes, use high-throughput sequencing technology to detect the whole genome of subjects, identify relevant genetic polymorphism that have predictive value for clinical cure of chronic hepatitis B treated with PEG-IFN-α, and establish a predictive model and calculation formula between gene polymorphism and the efficacy of PEG-IFN-α antiviral therapy.
This study is a real-world case-control study conducted on 120 patients with chronic hepatitis B (CHB) who were continuously treated with pegylated interferon-α (PEG-IFN-α) for more than 24 weeks. Among them, the clinical cure group obtained through PEG-IFN-α treatment is the case group; The group that did not achieve clinical cure after PEG-IFN-α treatment was used as the control group, and the case group and control group were allocated cases in a 2:1 ratio. Collect blood samples as candidate gene sequencing samples, use high-throughput sequencing technology to detect the whole genome of the subjects, identify relevant genetic polymorphism that have predictive value for clinical cure of chronic hepatitis B with PEG-IFN-α therapy, and establish a predictive model and calculation formula between gene polymorphism and the efficacy of PEG-IFN-α antiviral therapy.
Study Type
OBSERVATIONAL
Enrollment
120
chronic hepatitis B (CHB) who were continuously treated with pegylated interferon (PEG-IFN - α) for more than 24 weeks
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGClinical cure
HBsAg negative, with or without the presence of anti HBs, HBV DNA below the lower limit of detection, ALT\<lower limit of normal value
Time frame: 96 weeks
Non clinical cure
Non clinical cure (partially effective and ineffective): HBsAg has not turned negative Partially effective: HBV DNA is below the lower limit of detection, ALT is below the lower limit of normal. Invalid: Not partially valid.
Time frame: 96 weeks
HBV DNA turns negative
HBV DNA suppression (HBV DNA below the detection limit or not detected);
Time frame: 96 weeks
HBeAg conversion to negative
HBeAg conversion to negative (disappearance of HBeAg in patients with previous HBeAg positivity).
Time frame: 96 weeks
HBsAg re positivity rate
Hepatitis B surface antigen re positive rate after PEG-IFN-α withdrawal
Time frame: 96 weeks
Improvement in liver function
Liver function status after PEG-IFN-α treatment
Time frame: 96 weeks
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