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KMID : 1040620160220030382
Clinical and Molecular Hepatology
2016 Volume.22 No. 3 p.382 ~ p.389
Hepatitis B surface antigen titer is a good indicator of durable viral response after entecavir off-treatment for chronic hepatitis B
Lee Han-Ah

Seo Yeon-Seok
Park Seung-Woon
Kim Tae-Hyung
Suh Sang-Jun
Jung Young-Kul
Kim Ji-Hoon
An Hyung-Gin
Yim Hyung-Joon
Yeon Jong-Eun
Byun Kwan-Soo
Um Soon-Ho
Abstract
Background/Aims: Clear indicators for stopping antiviral therapy in chronic hepatitis B (CHB) patients are not yet available. Since the level of hepatitis B surface antigen (HBsAg) is correlated with covalently closed circular DNA, the HBsAg titer might be a good indicator of the off-treatment response. This study aimed to determine the relationship between the HBsAg titer and the entecavir (ETV) off-treatment response.

Methods: This study analyzed 44 consecutive CHB patients (age, 44.6¡¾11.4 years, mean¡¾SD; men, 63.6%; positive hepatitis B envelope antigen (HBeAg) at baseline, 56.8%; HBV DNA level, 6.8¡¾1.3 log10 IU/mL) treated with ETV for a sufficient duration and in whom treatment was discontinued after HBsAg levels were measured. A virological relapse was defined as an increase in serum HBV DNA level of >2000 IU/mL, and a clinical relapse was defined as a virological relapse with a biochemical flare, defined as an increase in the serum alanine aminotransferase level of >2 ¡¿ upper limit of normal.

Results: After stopping ETV, virological relapse and clinical relapse were observed in 32 and 24 patients, respectively, during 20.8¡¾19.9 months of follow-up. The cumulative incidence rates of virological relapse were 36.2% and 66.2%, respectively, at 6 and 12 months, and those of clinical relapse were 14.3% and 42.3%. The off-treatment HBsAg level was an independent factor associated with clinical relapse (hazard ratio, 2.251; 95% confidence interval, 1.076?4.706; P=0.031). When patients were grouped according to off-treatment HBsAg levels, clinical relapse did not occur in patients with an off-treatment HBsAg level of ¡Â2 log10 IU/mL (n=5), while the incidence rates of clinical relapse at 12 months after off-treatment were 28.4% and 55.7% in patients with off-treatment HBsAg levels of >2 and ¡Â3 log10 IU/mL (n=11) and >3 log10 IU/mL (n=28), respectively.

Conclusion: The off-treatment HBsAg level is closely related to clinical relapse after treatment cessation. A serum HBsAg level of <2 log10 IU/mL is an excellent predictor of a sustained off-treatment response in CHB patients who have received ETV for a sufficient duration.
KEYWORD
Hepatitis B virus, Hepatitis B surface antigen, Relapse, Off-treatment
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