A Randomized, open-label, multicenter study. The patients after 1-3 years NAs treatment and having achieved HBeAg loss and HBV DNA \<200IU/ml will be switched to Pegasys for 48 or 96 weeks (with a 12 weeks period of overlap with the NA for safety reasons). The subjects will be randomized into 2 groups: Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180µg/week. All the patients will be followed up for 48 weeks after discontinuation of the study medication. Note: NAs will be stratified LAM, ETV and ADV, with the ratio 1:1:1.
eligibility criteria: Men and women old of 18 to 65 years with chronic hepatitis B HBeAg positive treated with nucleoside and/or nucleotide analogues for 1-2 years and with partial response (HBeAg loss and HBV DNA \<1000copies/ml).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180µg/week.
The 2nd affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
determine the response rate (HBsAg clearance at Week 48 and 96)
To determine the response rate (HBsAg clearance at Week 48 and 96) in subjects who are being treated by NAs and achieved a combined response which consists of both HBeAg loss and HBV DNA \<1000 copies/ml
Time frame: 1 year
HBsAg/HBeAg/HBV DNA changes/ALT normalization /HBsAg seroconversion at EOT and EOF
1. HBsAg loss at EOF 2. Quantitative HBe/sAg reduction at every check point. 3. HBeAg seroconversion at EOT and EOF 4. HBV DNA changes over 48 or 96 weeks at every check points 5. ALT normalization at EOT and EOF 6. HBsAg seroconversion at EOT and EOF
Time frame: 1 year
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