Incidence, Factors, and Patient-Level Data for Spontaneous HBsAg Seroclearance: A Cohort Study of 11,264 Patients

INTRODUCTION: Spontaneous hepatitis B surface antigen (HBsAg) seroclearance, the functional cure of hepatitis B infection, occurs rarely. Prior original studies are limited by insufficient sample size and/or follow-up, and recent meta-analyses are limited by inclusion of only study-level data and la...

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Veröffentlicht in:Clinical and translational gastroenterology 2020-09, Vol.11 (9), p.e00196-e00196, Article 00196
Hauptverfasser: Yeo, Yee Hui, Tseng, Tai-Chung, Hosaka, Tetsuya, Cunningham, Chris, Fung, James Yan Yue, Ho, Hsiu J., Kwak, Min-Sun, Trinh, Huy N., Ungtrakul, Teerapat, Yu, Ming-Lung, Kobayashi, Mariko, Le, An K., Henry, Linda, Li, Jiayi, Zhang, Jian, Sriprayoon, Tassanee, Jeong, Donghak, Tanwandee, Tawesak, Gane, Ed, Cheung, Ramsey C., Wu, Chun-Ying, Lok, Anna S., Lee, Hyo-Suk, Suzuki, Fumitaka, Yuen, Man-Fung, Kao, Jia-Horng, Yang, Hwai-I, Nguyen, Mindie H.
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Zusammenfassung:INTRODUCTION: Spontaneous hepatitis B surface antigen (HBsAg) seroclearance, the functional cure of hepatitis B infection, occurs rarely. Prior original studies are limited by insufficient sample size and/or follow-up, and recent meta-analyses are limited by inclusion of only study-level data and lack of adjustment for confounders to investigate HBsAg seroclearance rates in most relevant subgroups. Using a cohort with detailed individual patient data, we estimated spontaneous HBsAg seroclearance rates through patient and virologic characteristics. METHODS: We analyzed 11,264 untreated patients with chronic hepatitis B with serial HBsAg data from 4 North American and 8 Asian Pacific centers, with 1,393 patients with HBsAg seroclearance (>= 2 undetectable HBsAg >= 6 months apart) during 106,192 person-years. The annual seroclearance rate with detailed categorization by infection phase, further stratified by hepatitis B e antigen (HBeAg) status, sex, age, and quantitative HBsAg (qHBsAg), was performed. RESULTS: The annual seroclearance rate was 1.31% (95% confidence interval: 1.25-1.38) and over 7% in immune inactive patients aged >= 55 years and with qHBsAg 55 years: aHR = 1.21), negative HBeAg (aHR = 6.34), and genotype C (aHR = 1.82) predicted higher seroclearance rates, as did lower hepatitis B virus DNA and lower qHBsAg (P< 0.05 for all), and inactive carrier state. DISCUSSION: The spontaneous annual HBsAg seroclearance rate was 1.31%, but varied from close to zero to about 5% among most chronic hepatitis B subgroups, with older, male, HBeAg-negative, and genotype C patients with lower alanine aminotransferase and hepatitis B virus DNA, and qHBsAg independently associated with higher rates (see Visual Abstract, Supplementary Digital Content 2, http://links.lww.com/CTG/A367).
ISSN:2155-384X
2155-384X
DOI:10.14309/ctg.0000000000000196