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Time-varying serum gradient of hepatitis B surface antigen predicts risk of relapses after off-NA therapy.

Time-varying serum gradient of hepatitis B surface antigen predicts risk of relapses after off-NA therapy.
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Chien NH, Huang YT, Wu CY, Chang CY, Wu MS, Kao JH, Mo LR, Tai CM, Lin CW, Yang TH, Lin JT, Hsu YC,


Chien NH, Huang YT, Wu CY, Chang CY, Wu MS, Kao JH, Mo LR, Tai CM, Lin CW, Yang TH, Lin JT, Hsu YC, (click to view)

Chien NH, Huang YT, Wu CY, Chang CY, Wu MS, Kao JH, Mo LR, Tai CM, Lin CW, Yang TH, Lin JT, Hsu YC,

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BMC gastroenterology 2017 12 0817(1) 154 doi 10.1186/s12876-017-0697-3
Abstract
BACKGROUND
The serum gradient of hepatitis B surface antigen (HBsAg) varies over time after cessation of nucleos(t)ide analog (NA) treatment in patients with chronic hepatitis B (CHB). The association between the time-varying HBsAg serum gradient and risk of relapse has not been elucidated.

METHODS
This multicenter cohort study prospectively enrolled CHB patients who discontinued 3 year-NA treatment. Eligible patients were serologically negative for HBeAg and viral DNA at NA cessation. The participants (n = 140) were followed every 3 months through HBsAg quantification. Virological and clinical relapses were defined as viral DNA levels >2000 IU/mL and alanine aminotransferase (ALT) levels >80 U/mL, respectively. The association of time-varying HBsAg levels with relapses was assessed through a time-dependent Cox analysis.

RESULTS
During a median follow-up of 19.9 (interquartile range [IQR], 10.6-25.3) months, virological and clinical relapses occurred in 94 and 49 patients, with a 2-year cumulative incidence of 79.2% (95% confidence interval [CI], 70.9%-86.4%) and 42.9% (95% CI, 34.1%-52.8%), respectively. The serum level of HBsAg was associated with virological (P < 0.001) and clinical (P = 0.01) relapses in a dose-response manner, with adjusted hazard ratios of 2.10 (95% CI, 1.45-3.04) and 2.32 (95% CI, 1.28-4.21). Among the patients (n = 19) whose HBsAg levels ever dropped below 10 IU/mL, only one and three patients subsequently developed clinical and virological relapses. CONCLUSION
The serum gradient of HBsAg measured throughout the off-therapy observation is associated with the subsequent occurrence of virological and clinical relapses in CHB patients who discontinue NA treatment.

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