Establish a study cohort of adult chronic hepatitis B antiviral treatment based on the principle of responseguidedtreatment (RGT) corresponding to the child cohort, analyze the clinical cure factors of IC and IT stage adults chronic hepatitis B, and optimize the antiviral treatment plan. To determine the safety and efficacy of PD-1 antibody combined with Peg-FNa-2b in the treatment of adult NAs patients with CHB advantage.
This research group established an adult randomized controlled study cohort corresponding to the children cohort: 1 immunetolerance (IT) and 1 immuneclearance (IC) antiviral treatment cohort, respectively according to 1: 1 Randomly divided into two intervention groups: nucleoside (acid) analogues (NAs) and NAs combined with pegylated interferon α-2b (PegIFNα-2b). 1 NAs treatment-advantaged population antiviral combined with novel immunotherapy cohort: PD-1 antibody, PegIFNα-2b and combination group were randomly enrolled 1:1:1, and the response guidance treatment plan was adjusted according to the response of patients during treatment, the HBsAg clearance rate at 24 weeks and 48 weeks of different optimal treatment groups was evaluated, the clinical curative characteristics and differences between children and adults were compared, and the key factors affecting clinical cure were screened. To determine the safety and efficacy of PD-1 antibody combined with Peg-FNa-2b in the treatment of adult NAs patients with CHB advantage.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
NA combined with Peg interferon alfa-2b
Beijing Ditan hospital
Beijing, China
HBsAg clearance at 48 weeks.
HBsAg clearance in enrolled patients at week 48.（The detection of serum HBV markers is carried out using a HBsAg quantitative Elecsys （Roche Diagnostics GmbH, German）, with a HBsAg quantitative detection limit of 0.05IU/mL.）
Time frame: 48weeks
Serum HBsAg clearance or conversion rates at week 24, week 72, and week 24 after drug withdrawal
Serum HBsAg clearance or conversion rates.（The detection of serum HBV markers is carried out using a HBsAg quantitative Elecsys （Roche Diagnostics GmbH, German）, with a HBsAg quantitative detection limit of 0.05IU/mL.）
Time frame: 24 weeks,72 weeks
HBeAg conversion rate at week 24, 48, 72 and 24 weeks after drug withdrawal
HBeAg conversion rate.（The detection of serum HBV markers is carried out using a HBsAg quantitative Elecsys （Roche Diagnostics GmbH, German）, with a HBsAg quantitative detection limit of 0.05IU/mL.）
Time frame: 24 weeks,48 weeks,72 weeks
The degree of serum HBsAg and HBeAg reduction from baseline at week 24, 48, 72 and 24 weeks after drug withdrawal
The degree of serum HBsAg and HBeAg reduction from baseline.（The detection of serum HBV markers is carried out using a HBsAg quantitative Elecsys （Roche Diagnostics GmbH, German）, with a HBsAg quantitative detection limit of 0.05IU/mL.）
Time frame: 24 weeks,48 weeks,72 weeks
The proportion of serum HBVDNA lower than the lower limit of detection at week 24, 48, 72 and 24 weeks after drug withdrawal
The proportion of serum HBVDNA lower than the lower limit of detection.（HBV DNA detection: Real time fluorescent quantitative PCR system is used for detection, with a detection limit of 10 IU/ml.）
Time frame: 24 weeks,48 weeks,72 weeks
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Evaluation of drug safety during treatment
Evaluation of drug safety during treatment.(The rate of adverse reactions experienced by patients during medication use.)
Time frame: 36 months