Combining hepatitis B core-related and surface antigens at end of nucleos(t)ide analogue treatment to predict off-therapy relapse risk
Journal
Alimentary Pharmacology and Therapeutics
Journal Volume
49
Journal Issue
1
Pages
107-115
Date Issued
2019
Author(s)
Hsu Y.-C.
Nguyen M.H.
Mo L.-R.
Yang T.-H.
Tseng C.-H.
Tai C.-M.
Wu C.-Y.
Lin J.-T.
Tanaka Y.
Chang C.-Y.
Abstract
Background: There remains an unmet need for convenient biomarkers to assess the risks of discontinuing nucleos(t)ide analogues (NAs) in chronic hepatitis B (CHB). Aim: To investigate if hepatitis B core-related antigen (HBcrAg) is an independent of surface antigen (HBsAg) for risk prediction of NA cessation. Methods: This prospective multicentre study enrolled 135 CHB patients who stopped entecavir or tenofovir after achieving viral remission for a median of 25.2?months. All patients stopped NA with negative HBeAg and undetectable viral DNA, and were then observed for clinical relapse and HBsAg loss. Predictors including HBsAg and HBcrAg levels were explored using Cox proportional hazard model and weighted to develop a risk score. Results: During a median follow-up of 25.9?months, clinical relapse and HBsAg loss occurred in 66 and eight patients, respectively, with a 5-year cumulative incidence of 56.1% (95% CI 46.7-66.0%) and 8.8% (95% CI 4.3-17.4%), respectively. HBcrAg was an independent relapse predictor, as well as HBsAg, age, ALT and tenofovir use. A score (SCALE-B) was calculated by the equation of 35*HBsAg (log?IU/mL)?+?20*HBcrAg (log U/mL)?+?2*age (year)?+?ALT (U/L)?+?40 for tenofovir use. The concordance rates for clinical relapse were 0.87, 0.88, 0.87, 0.85 and 0.90 at 1, 2, 3, 4 and 5?years, respectively. Moreover, HBsAg loss occurred exclusively in low-risk patients predicted by the score. Conclusions: Serum HBcrAg and HBsAg levels were independent predictors of off-NA relapse and can be factored into a risk score to guide treatment cessation in patients with CHB. ? 2018 John Wiley & Sons Ltd
SDGs
Other Subjects
alanine aminotransferase; entecavir; hepatitis B surface antigen; nucleoside analog; tenofovir; virus DNA; antivirus agent; biological marker; entecavir; guanine; hepatitis B core antigen; hepatitis B surface antigen; adult; Article; chronic hepatitis B; drug use; female; follow up; human; low risk patient; major clinical study; male; prediction; priority journal; prospective study; relapse; remission; risk factor; blood; chronic hepatitis B; clinical trial; incidence; metabolism; middle aged; multicenter study; recurrent disease; treatment withdrawal; Adult; Antiviral Agents; Biomarkers; DNA, Viral; Female; Guanine; Hepatitis B Core Antigens; Hepatitis B Surface Antigens; Hepatitis B, Chronic; Humans; Incidence; Male; Middle Aged; Prospective Studies; Recurrence; Tenofovir; Withholding Treatment
Publisher
Blackwell Publishing Ltd
Type
journal article