All enrolled patients must meet the European Guidelines for the Prevention and Treatment of Chronic Hepatitis B (EASL, 2017) recommended discontinuation criteria, that is, HBeAg-negative chronic hepatitis B patients without fibrosis or cirrhosis who have undetectable HBV DNA for more than 3 years after receiving NUC treatment can attempt to discontinue the drug. At the same time, the patient's HBsAg level will not be higher than 1000 IU/mL. The study will set up three groups, group A directly stopped nucleoside analogues, follow-up to 96 weeks; Group B received PegIFNα-2b monotherapy for 48 weeks, group C received PegIFNα-2b combined with NUC treatment for 48 weeks, group B and group C stopped all antiviral drugs after completing 48 weeks of treatment, and then followed up for 96 weeks, a total of 144 weeks of follow-up. This study aims to further optimize the design on the basis of previous clinical studies to observe whether sequential interferon or combined with NUC therapy can reduce the virological relapse rate of HBeAg-negative chronic hepatitis B patients with low HBsAg level after 96 weeks of discontinuation, and to observe the impact on the functional cure rate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
360
180 μg/ 0.5 ml ,hypodermic injection once a week
180 μg/ 0.5 ml ,hypodermic injection once a week, NUC drugs should be used according to the instructions of each drug
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Number of participants who relapse
the cumulative virological relapse rate (HBV DNA\>2000 IU/ml on 2 separate occasions 1 months apart) during the research period.
Time frame: 96 weeks after stopping NAs
Number of participants who relapse
The total number of relapse (HBV DNA\>2000 IU/ml on 2 separate occasions 1 months apart) during the research period.
Time frame: 72 weeks after stopping all antivirals
Number of participants who relapse Clinically
Time frame: 72 weeks and 96 weeks after stopping all antivirals
Number of participants who achieve HBsAg clearance and HBsAg seroconversion
Time frame: 96 weeks after stopping all antivirals
Number of participants who restart treatment
Patients with virological relapse may be retreated according to the following criteria: 1) ALT \>10×ULN, 2)ALT \>5×ULN and total bilirubin \>2 mg/dl, 3)ALT \>3×ULN and HBV DNA \>100,000 IU/ml, 4) ALT \>ULN and HBV DNA \>2,000 IU/ml for more than 3 months; 5) PT increases by more than 2s, while ALT \>5×ULN.
Time frame: 96 weeks after stopping all antivirals
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