This study evaluates whether PegIFN alfa-2a add on can improve CHB patients HBsAg clearance at the end of 48 weeks treatment. The CHB patients who received nucleot(s)ides anti-virus treatment and reached HBV DNA\<1000 copies/ml and HBsAg\<3000 IU/ml, were randomly assigned into two groups: One group continue the nucleot(s)ides treatment for 72 weeks, the other add on PegIFN alfa-2a on the basis of the original treatment for 48 weeks, and follow up for 24 weeks.
nucleot(s)ides is a potent inhibitor of hepatitis B viral(HBV) replication, but long-term therapy may be required, and it is difficult for CHB patients to achieve HBsAg clearance by using nucleot(s)ides. Therefore, it is need take long-term therapy if chronic hepatitis B (CHB) choose to use nucleot(s)ides, and in another way, nucleot(s)ides resistance is an important clinical risk. More and more young patients want to stop treating, and discontinuation of nucleot(s)ides is a feasible strategy to reduce resistance. However, it is really easy to relapse if patients did not arrive HBsAg clearance. PegIFN alfa-2a 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; and what's more, patients are safety after discontinuing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
chronic hepatitis B patients who treated with nucleot(s)ides (including lamivudine, adefovir, entecavir, tenofovir) arrived HBV DNA \<1000copies/ml, and HBsAg\<3000IU/ml, then change the treatment to original nucleot(s)ides add on PegIFN alfa-2a, the combined treatment is for 48 weeks, and follow up for 24 weeks
Number of participants who achieve HBsAg clearance
To investigate whether Peg-IFN alfa-2a add on treatment can improve the HBsAg clearance in CHB patients at the end of the treatment (48 week).
Time frame: treat for 48 weeks
Number of participants who achieve HBsAg seroconversion
To investigate whether Peg-IFN alfa-2a add on treatment can improve the HBsAg seroconversion in CHB patients at the end of the treatment (48 week).
Time frame: 48 weeks
Number of participants who achieve HBeAg clearance and seroconversion
To investigate whether Peg-IFN alfa-2a add on treatment can improve HBeAg clearance and seroconversion at the end of the treatment (48 week).
Time frame: 48 weeks
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
Number of participants who achieve HBV DNA<1000 copies/ml
To investigate whether Peg-IFN alfa-2a add on treatment can improve HBV DNA\<1000 copies/ml
Time frame: 12,24 and 48 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.