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J Gastroenterol Hepatol. 2017 Jan 25. doi: 10.1111/jgh.13728. [Epub ahead of print]
Serum viral load at the virological relapse predicts subsequent clinical flares in chronic hepatitis B patients off entecavir therapy.Hsu YC1,2,3,4,5, Mo LR6, Chang CY2, Wu MS7, Yang TH8, Kao JH7, Chen CC7, Tseng CH2, Tai CM2, Lin CW2, Wu CY4,9,10,11, Lin JT2,12.
Author information
- 1Center for Database Research, E-Da Hospital, Kaohsiung, Taiwan.
- 2Department of Medicine, E-Da Hospital, Kaohsiung, Taiwan.
- 3School of Medicine for International Students, I-Shou University, Kaohsiung, Taiwan.
- 4Graduate Institute of Clinical Medical Science, China Medical University, Taichung, Taiwan.
- 5School of Public Health, Fu Jen Catholic University, New Taipei, Taiwan.
- 6Superintendent Office, Tainan Municipal Hospital, Tainan, Taiwan.
- 7Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
- 8Department of Medicine and Therapeutics, Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, China.
- 9Division of Gastroenterology, Taichung Veterans General Hospital, Taichung, Taiwan.
- 10Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.
- 11National Institute of Cancer Research, National Health Research Institutes, Miaoli, Taiwan.
- 12Big Data Research Center, Fu Jen Catholic University, New Taipei, Taiwan.
AbstractBACKGROUND: Therapeutic duration of nucleos(t)ide analogues for chronic hepatitis B (CHB) is not indefinite in many parts of the world. Viral reactivation is common off therapy but the risk of subsequent clinical outcome remains unclear and unpredictable.
AIM: We aimed to quantify the incidence of and explore the predictors for clinical flare following virological relapse in CHB patients who discontinue entecavir therapy.
METHODS: This multicenter cohort study prospectively monitored 133 CHB patients who were HBeAg-negative and viral DNA-undetectable when discontinuing entecavir after at least 3 years on therapy. Following virological relapse (viral DNA >2,000 IU/mL) that occurred in 92 patients, the incidences of subsequent clinical flare and persistent (unremittent for 3 months) or severe hepatitis (with jaundice or coagulopathy) were determined, and risk factors were explored. Patients did not resume antiviral therapy until occurrence of persistent or severe hepatitis.
RESULTS: The cumulative incidence of clinical hepatitis 2 years after virological relapse was 61.0% (95% CI, 49.9-72.3%) and that of persistent or severe hepatitis was 53.0% (95% CI, 40.9-66.2%). Serum viral load at the virological relapse was associated with both clinical hepatitis (adjusted hazard ratio [HR], 1.31 per log IU/mL; 95% CI, 1.07-1.60) and persistent or severe hepatitis (adjusted HR, 1.63 per log IU/mL; 95% CI, 1.27-2.10), after adjustment for serum aminotransferase and alfa-fetoprotein levels in the multivariate analysis. Viral DNA >100,000 IU/mL predicted a nearly inevitable occurrence of clinical flare (P < 0.0001).
CONCLUSIONS: A high viral load at the virological relapse predicts subsequent clinical hepatitis in CHB patients who discontinue entecavir.
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