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Clin Gastroenterol Hepatol. 2016 Mar 24. pii: S1542-3565(16)00330-X. doi: 10.1016/j.cgh.2016.03.024. [Epub ahead of print]
Association Between Serum Level of Hepatitis B Surface Antigen at End of Entecavir Therapy and Risk of Relapse in e Antigen-negative Patients.Hsu YC1, Mo LR2, Chang CY3, Wu MS4, Kao JH5, Wang WL3, Yang TH6, Wang CS6, Chiang MF6, Chen CC4, Fang YJ7, Hung HW8, Wu CY9, Lin JT10.
Author information
- 1Center for Database Research, E-Da Hospital, Kaohsiung City; Division of Gastroenterology, E-Da Hospital, Kaohsiung City; School of Medicine for International Students, I-Shou University, Kaohsiung City; Graduate Institute of Clinical Medicine, China Medical University, Taichung City. Electronic address: [email protected].
- 2Superintendent Office, Tainan Municipal Hospital, Tainan City.
- 3Division of Gastroenterology, E-Da Hospital, Kaohsiung City.
- 4Department of Internal Medicine, National Taiwan University Hospital, Taipei City.
- 5Graduate Institute of Clinical Medicine, National Taiwan University, Taipei City.
- 6Department of Internal Medicine, Lotung Poh-Ai Hospital, Yilan County.
- 7Department of Medicine, National Taiwan University Hospital Yun-Lin Branch, Yunlin County.
- 8Taipei Institute of Pathology, Taipei City.
- 9Graduate Institute of Clinical Medicine, China Medical University, Taichung City; Division of Gastroenterology, Taichung Veterans General Hospital, Taichung City; Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei City. Electronic address: [email protected].
- 10School of Medicine, Fu Jen Catholic University, New Taipei City; all institutions in Taiwan.
AbstractBACKGROUND & AIMS: We investigated whether serum levels of hepatitis B surface antigen (HBsAg) level at the end of entecavir treatment was associated with risk of relapse.
METHODS: We performed a prospective multi-center study of 161 consecutive patients with chronic hepatitis B in whom the hepatitis B virus (HBV) was no longer detected after 3 years or more of entecavir therapy. Treatment ended between July 1, 2011 and July 1, 2015. Patients were monitored for clinical relapse (HBV DNA>2000 IU/mL and level of alanine aminotransferase more than 2-fold the upper limit of normal) and virologic relapse (HBV DNA>2000 IU/mL). Outcomes were calculated using the Kaplan Meier method and risk factors were identified by the Cox proportional hazard modeling.
RESULTS: Two years after therapy ended, 49.2% of patients in the entire cohort had a clinical relapse (95% confidence interval [CI], 40.9%-58.1%) and 81.7% had a virologic relapse (95% CI, 74.3%-88.0%). Among patients who were hepatitis B e antigen (HBeAg) negative at the end of therapy, 39.2% had a clinical relapse (95% CI, 30.3-49.6%) and 77.4% had a virologic relapse (95% CI, 68.6-85.2%). Serum level of HBsAg was associated with relapse in the HBeAg-negative patients (Ptrend=.006 for clinical relapse, Ptrend=.0001 for virologic relapse). In multivariate Cox regression analysis, the hazard ratio (per log IU/mL increment) for clinical relapse was 2.47 (95% CI, 1.45-4.23) and for virologic relapse was 1.80 (95% CI, 1.33-2.45). The 11 (9%) patients with levels of HBsAg <10 IU/mL did not relapse.
CONCLUSIONS: Serum level of HBsAg is associated with risk of relapse in patients who are HBeAg negative after treatment with entecavir. A low titer of HBsAg might be used to identify patients at low risk for relapse after treatment.
Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.
KEYWORDS: ALT; liver disease; prognostic factor; response to therapy
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