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Abstract Details
Hbsag Levels Can Be Used to Rule Out Cirrhosis in Hbeag Positive Chronic Hepatitis B: Results From the Sonic-B Study
Milan J Sonneveld1, Bettina E Hansen23, Willem P Brouwer1, Henry L-Y Chan4, Teerha Piratvisuth5, Ji-Dong Jia6, Stefan Zeuzem7, R N Chien8, R J de Knegt1, Cynthia Wat9, Vedran Pavlovic9, Anuj Gaggar10, Qing Xie11, Maria Buti12, R A de Man1, Harry L A Janssen12, SONIC-B Study group
Author information
1Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
2Department of Toronto Centre for Liver Disease, University Health Network, Toronto, Canada.
3Department of IHPME, University of Toronto, Toronto, Canada.
4Department of Medicine and Therapeutics and Institute of Digestive Disease, the Chinese University of Hong Kong, Hong Kong SAR, China.
5NKC Institute of Gastroenterology and Hepatology, Songklanagarind Hospital, Prince of Songkla University, Hat Yai, Thailand.
6Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
7Medical Clinic 1, Johann Wolfgang Goethe University Medical Center, Frankfurt, Germany.
8Liver Research Unit, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan.
9Roche Product Ltd, Welwyn Garden City, UK.
10Gilead Sciences, Foster City, CA, USA.
11Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
12Unit, Hospital Universitari Vall d'Hebron and CIBEHED del Instituto Carlos III, Barcelona, Spain.
Abstract
Background & aims: Serum HBsAg levels correlate with the duration of chronic HBV infection and may predict the extent of hepatic fibrosis.
Methods: We analysed data from the SONIC-B database, which contains data from 8 global randomized trials and two large hepatology centers. Relationship between HBsAg levels and presence of significant fibrosis (Ishak 3-4) or cirrhosis (Ishak 5-6) were explored and clinically relevant cut-offs were identified to rule out cirrhosis.
Results: The dataset included 2779 patients; 1866 HBeAg-positive; 322 with cirrhosis. Among HBeAg-positive patients, lower HBsAg levels were associated with higher rates of significant fibrosis (Odds Ratio [OR] 0.419, P<0.001) and cirrhosis (OR 0.435, p<0.001). No relationship was observed among HBeAg-negative patients. Among HBeAg-positive patients, genotype specific HBsAg cut-offs had excellent NPVs (>97%) and low misclassification rates (≤7.1%) and may therefore have utility in ruling out cirrhosis. Diagnostic performance of the HBsAg cut-offs was comparable among patients in whom cirrhosis could not be ruled out with FIB-4.
Conclusions: HBV genotype specific HBsAg cut-offs may have utility in ruling out presence of cirrhosis in HBeAg-positive patients with genotypes B, C and D and can be an adjunct to FIB-4 to reduce the need for further testing.