The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss in subjects who stop nucles(t)ide analogues (NAs) (Stop arm) compared to subjects who continue (Continue arm) Only subjects who already are on treatment with ETV, TDF or TAF monotherapy, and have achieved sustained virologic suppression (\<20 IU/mL), HBeAg negativity, normal ALT for more than 1 year (pretreatment HBeAg + pts) or 3 years (pretreatment HBeAg - pts), plus qHBsAg \<200 IU/mL, and HBV RNA or HBcrAg negativity will be included in this study. One treatment arm will stop the NAs therapy while the other treatment arm will continue the NAs therapy. Participants in the Stop arm will be monitored very closely with special focus on clinical relapse. If any participant in the Stop NAs arm exceeds one or more predefined limits for such flares or relapses, NAs treatment will be reinstituted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
195
Stop NAs therapy
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGPeking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGNo. 1 Hospital affiliated to Jilin University
Changchun, Jilin, China
RECRUITINGShengjing Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGRuijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGProportion of Participants With HBsAg Loss at Week 72 in Both Study Arms
HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Time frame: Week 72
Proportion of Participants With Sustained Disease Remission at Week 72 in Both Study Arms
Sustained Disease Remission is defined as HBeAg negativity, HBV DNA \<2000 IU/mL and ALT normalization at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Time frame: Week 72
Proportion of Participants With Clinical Relapse at Week 72 in Both Study Arms
Clinical Relapse is defined as HBV DNA \>2000 IU/mL and ALT \>2 ULN at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Time frame: Week 72
Proportion of Participants With Virologic Relapse at Week 72 in Both Study Arms
Virologic Relapse is defined as HBV DNA \>2000 IU/mL at two consecutive timepoints \[at least 14 days apart\] at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Time frame: Week 72
Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms
The analyses were summarized by 3 treatment subgroups: Stop NAs (NAs-Free), Restart NAs, and Continue NAs When participant randomized in the Stop NAs group restarted NAs therapy, that participant was considered part of the Restart NAs group from that point forward. For Restart NAs group, baseline is defined as the last available record on or prior to the restart date of NAs.
Time frame: Week 72
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