Gut. 2020 Mar 24. pii: gutjnl-2019-320015. doi: 10.1136/gutjnl-2019-320015. [Epub ahead of print]
Discontinuation of nucleos(t)ide analogues is not associated with a higher risk of HBsAg seroreversion after antiviral-induced HBsAg seroclearance: a nationwide multicentre study.
Kim MA1, Kim SU2, Sinn DH3, Jang JW4, Lim YS5, Ahn SH2, Shim JJ6, Seo YS7, Baek YH8, Kim SG9, Kim YS9, Kim JH10, Choe WH11, Yim HJ12, Lee HW13, Kwon JH14, Lee SW15, Jang JY16, Kim HY17, Park Y3, Kim GA6, Yang H4, Lee HA7, Koh M8, Lee YS10, Kim M12, Chang Y16, Kim YJ1, Yoon JH1, Zoulim F18, Lee JH19.
Author information
1
Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.
2
Department of Internal Medicine and Yonsei Liver Center, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
3
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
4
Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
5
Department of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
6
Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, South Korea.
7
Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, South Korea.
8
Department of Internal Medicine, Dong-A University College of Medicine, Busan, South Korea.
9
Department of Internal Medicine, Bucheon Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Bucheon, South Korea.
10
Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, South Korea.
11
Department of Internal Medicine, Konkuk University Hospital, Konkuk University School of Medicine, Seoul, South Korea.
12
Department of Internal Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, South Korea.
13
Department of Internal Medicine and Yonsei Liver Center, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
14
Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, Catholic University of Korea, Incheon, South Korea.
15
Department of Internal Medicine, Bucheon St. Mary's hospital, College of Medicine, Catholic University of Korea, Bucheon, South Korea.
16
Department of Internal Medicine, Seoul Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Seoul, South Korea.
17
Department of Inernal Medicine, Ewha Women's University College of Medicine, Seoul, South Korea.
18
Cancer Research Centre of Lyon, INSERM U1052, Lyon University, Hospices Civils de Lyon, Lyon, France.
19
Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea [email protected].
Abstract
OBJECTIVE:
Direct comparison of the clinical outcomes between nucleos(t)ide analogue (NA) discontinuation versus NA continuation has not been performed in patients with chronic hepatitis B who achieved HBsAg-seroclearance. Whether NA discontinuation was as safe as NA continuation after NA-induced surface antigen of HBV (HBsAg) seroclearance was investigated in the present study.
DESIGNS:
This multicentre study included 276 patients from 16 hospitals in Korea who achieved NA-induced HBsAg seroclearance: 131 (47.5%) discontinued NA treatment within 6 months after HBsAg seroclearance (NA discontinuation group) and 145 (52.5%) continued NA treatment (NA continuation group). Primary endpoint was HBsAg reversion and secondary endpoints included serum HBV DNA redetection and development of hepatocellular carcinoma (HCC).
RESULTS:
During follow-up (median=26.9 months, IQR=12.2-49.2 months), 10 patients (3.6%) experienced HBsAg reversion, 6 (2.2%) showed HBV DNA redetection and 8 (2.9%) developed HCC. Compared with NA continuation, NA discontinuation was not associated with HBsAg reversion in both univariable (HR=0.45, 95% CI=0.12 to 1.76, log-rank p=0.24) and multivariable analyses (adjusted HR=0.65, 95% CI=0.16 to 2.59, p=0.54). The cumulative probabilities of HBsAg reversion at 1, 3 and 5 years were 0.8%, 2.3% and 5.0% in the NA discontinuation group, and 1.5%, 6.3% and 8.4% in the NA continuation group, respectively. NA discontinuation was not associated with higher risk of either HBV redetection (HR=0.83, 95% CI=0.16 to 4.16, log-rank p=0.82) or HCC development (HR=0.53, 95% CI=0.12 to 2.23, log-rank p=0.38).
CONCLUSION:
The discontinuation of NA was not associated with a higher risk of either HBsAg reversion, serum HBV DNA redetection or HCC development compared with NA continuation among patients who achieved HBsAg seroclearance with NA.
