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. 2024 Jul 6;8(3):179-187.
doi: 10.1016/j.livres.2024.07.001. eCollection 2024 Sep.

Long-term hepatitis B surface antigen kinetics after nucleos(t)ide analog discontinuation in patients with noncirrhotic chronic hepatitis B

Lina Wu  1   2 , Jiadi Lai  1   2 , Qiumin Luo  1   2 , Yeqiong Zhang  1   2 , Chaoshuang Lin  1   2 , Dongying Xie  1   2 , Youming Chen  1   2 , Hong Deng  1   2 , Zhiliang Gao  1   2   3 , Liang Peng  1   2   3 , Wenxiong Xu  1   2
Affiliations

Long-term hepatitis B surface antigen kinetics after nucleos(t)ide analog discontinuation in patients with noncirrhotic chronic hepatitis B

Lina Wu et al. Liver Res. .

Abstract

Background and aim: Few studies have reported hepatitis B surface antigen (HBsAg) kinetics after nucleos(t)ide analog (NA) discontinuation in patients with noncirrhotic chronic hepatitis B (CHB). The study specifically investigated long-term HBsAg kinetics after NA discontinuation.

Methods: Between January 2014 to January 2024, this study prospectively enrolled 106 outpatients with noncirrhotic CHB who met the discontinuation criteria after NA consolidation treatment. Demographic, clinical, and laboratory data were collected and analyzed after NA discontinuation.

Results: Ninety-six patients who finished 5 years of follow-up were included. HBsAg remained undetectable in 29 patients with end of treatment (EOT) HBsAg negativity. Among 67 patients with EOT HBsAg positivity, HBsAg seroclearance occurred in 12 (17.9%) patients with an estimated annual incidence of HBsAg seroclearance of 3.6%. Patients with EOT HBsAg levels of ≤1000 IU/mL had a higher HBsAg seroclearance rate than those with EOT HBsAg levels of >1000 IU/mL (33.3% vs. 5.4%). The proportion of patients with HBsAg ≤1000 IU/mL increased during follow-up. Logistic regression analysis indicated that the EOT HBsAg level was an independent factor for HBsAg seroclearance and an HBsAg level decline exceeding 1 log10 IU/mL. The optimal EOT HBsAg cutoff for both HBsAg seroclearance and an HBsAg level decline exceeding 1 log10 IU/mL was 359 IU/mL.

Conclusions: Patients with EOT HBsAg negativity experienced no relapse and maintained HBsAg seroclearance during 5 years of follow-up after NA discontinuation. A higher HBsAg seroclearance rate can be obtained in patients with EOT HBsAg levels of ≤1000 IU/mL during 5 years of follow-up after NA discontinuation. Close monitoring and proper NA retreatment are recommended to guarantee the safety of NA discontinuation.

Clinical trial number: Clinicaltrials.gov number NCT02883647.

Keywords: Chronic hepatitis B (CHB); Hepatitis B surface antigen (HBsAg); Hepatitis B virus (HBV); Kinetics; Nucleos(t)ide analogs (NAs); Quantitative HBsAg.

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Conflict of interest statement

Zhiliang Gao is an associate editor for Liver Research and was not involved in the editorial review or the decision to publish this article. The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Patient enrollment and HBsAg seroclearance achievement during follow-up. Abbreviations: CHB, chronic hepatitis B; EOT, end of treatment; HBsAg, hepatitis B surface antigen; NA, nucleos(t)ide analog.
Fig. 2
Fig. 2
Cumulative virological (A) and clinical relapse rates (B) of the 96 patients during 5 years of follow-up. Abbreviations: HBsAg, hepatitis B surface antigen; NA, nucleos(t)ide analog.
Fig. 3
Fig. 3
HBsAg kinetics of the 96 patients during the 5-year follow-up period. The dots and lines represent the median and interquartile range, respectively. Abbreviations: EOT, end of treatment; HBsAg, hepatitis B surface antigen; NA, nucleos(t)ide analog.
Fig. 4
Fig. 4
ROC analysis of the end of treatment (EOT) HBsAg levels with HBsAg seroclearance (A) and HBsAg decreases of more than 1 log10 IU/mL (B) in EOT HBsAg-positive patients. Abbreviations: AUC, area under the curve; ROC, receiver operating characteristic; HBsAg, hepatitis B surface antigen.
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