This study evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B in 96 weeks after nucleoside analogue (NUC) withdrawal. The HBV HBeAg-Negative patients who received NUC anti-virus treatment for 2.5 years and reached stopping rule in 《Chinese chronic hepatitis B prevention and treatment guidelines》(2010) were randomly assigned into three groups: One group discontinue the NUC treatment and follow up for 96 weeks,One discontinue the NUC treatment ,receive Peg-IFN alfa-2a 180 μg by week for 24 weeks and follow up for 72 weeks,The other discontinue the NUC treatment ,receive Peg-IFN alfa-2a 180 μg by week for 48 weeks and follow up for 48 weeks.
NUC is a potent inhibitor of hepatitis B viral(HBV) replication, but long-term therapy may be required. Therefore, NUC resistance is an important clinical risk resulting from long-term therapy in chronic hepatitis B (CHB) management. Discontinuation of NUC is a feasible strategy to reduce resistance. However, the high rate of relapse after cessation of NUC treatment in CHB patients remains a big problem. NUC treatment of how to safely stop drug needs to be solved. Peg-IFN can clear HBV by direct anti-viral and immune regulation mechanisms including enhancing natural killer cell response, increased cluster of differentiation 8(CD8 +) T lymphocytes and other mechanisms to restore and enhance the immune response in patients with CHB. Response to PEG-IFN is frequently sustained after a finite treatment course due to its immune modulating capacity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
180
180 μg/ 0.5 ml ,hypodermic injection once a week
Wuhan Seventh People's Hospital
Wuhan, Hubei, China
Changzhou Third People's Hospital
Changzhou, Jiangsu, China
First Affiliated Hospital of Zhejiang University
Hangzhou, Jiangsu, China
People's Hospital of Jiangsu Province
Nanjing, Jiangsu, China
Nantong Third People's Hospital
Nantong, Jiangsu, China
Suzhou Fifth People's Hospital
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Taicang People's Hospital
Taicang, Jiangsu, China
Wuxi Infectious Disease Hospital
Wuxi, Jiangsu, China
Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
...and 9 more locations
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: 96 weeks
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: 48 weeks
Number of participants who achieve HBsAg seroconversion
To investigate whether Peg-IFN alfa-2a can improve the HBsAg seroconversion in CHB patients at the point of discontinuation of PegIFN therapy compared to the control group ,which will be measured by the number of participants who achieve HBsAg seroconversion. Pegasys 24 weeks Group:24 weeks and Pegasys 48 weeks Group:48 weeks
Time frame: At the point of discontinuation of PegIFN therapy
Number of participants who achieve HBsAg seroconversion
To investigate whether Peg-IFN alfa-2a can improve the HBsAg seroconversion in CHB patients at 24,48 or 72 weeks post-discontinuation of PegIFN therapy compared to the control group ,which will be measured by the number of participants who achieve HBsAg seroconversion. Pegasys 24 weeks Group:48,72,96 weeks and Pegasys 48 weeks Group:72,96 weeks
Time frame: 24,48,72 weeks post-discontinuation of PegIFN therapy
HBsAg changes from Baseline
Pegasys 24 weeks Group:12,24 weeks and Pegasys 48 weeks Group:12,24,48 weeks
Time frame: 12,24 and 48 weeks
Predictive value of other markers for recurrence after NUC withdrawal
To investigate whether the other markers including HBcAb quantification and so on can predict the recurrence of hepatitis B.
Time frame: 48 weeks and 96 weeks
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