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Clinical outcomes after interruption of entecavir therapy in HBeAg-negative chronic hepatitis B patients with compensated cirrhosis
Y. C. Chen1, C. Y. Peng2, W. J. Jeng1, R. N. Chien3 andY. F. Liaw1,*
Article first published online: 18 SEP 2015
DOI: 10.1111/apt.13409
© 2015 John Wiley & Sons Ltd
Issue
Cover image for Vol. 42 Issue 9
Alimentary Pharmacology & Therapeutics
Early View (Online Version of Record published before inclusion in an issue)
Article has an altmetric score of 1
1 Liver Research Unit, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan
2 School of Medicine, Division of Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan
3 Liver Research Unit, Chang Gung Memorial Hospital and University, Keelung, Taiwan
* Correspondence to:
Prof. Y. F. Liaw, Liver Research Unit, Chang Gung Memorial Hospital, 199, Tung Hwa North Road, Taipei 105, Taiwan.
E-mail: [email protected]
This article was accepted for publication after full peer-review.
Background
Long-term nucleos(t)ide analogues therapy may reduce hepatocellular carcinoma (HCC) in chronic hepatitis B patients with advanced fibrosis or cirrhosis.
Aim
To investigate in a retrospective–prospective study whether this beneficial effect would be reduced in cirrhotic patients who discontinued a successful course of entecavir (ETV) therapy.
Methods
The study included 586 hepatitis B e antigen (HBeAg)-negative patients with compensated cirrhosis, mean age of 53.8 ± 10 years and 81% males, treated with ETV for at least 12 months. After ETV therapy for 46.5 ± 22.9 months, 205 patients who achieved hepatitis B virus (HBV) DNA suppression discontinued therapy. The clinical outcomes were assessed and HCC incidence was compared between propensity score (PS)-matched patients who continued and patients who discontinued ETV therapy by Asian Pacific Association for the Study of Liver stopping rule.
Results
During a mean duration of 59.3 ± 19 months after start of ETV therapy, nine and six HCC developed in an estimated annual incidence of 2.3% and 1.6% in 154 PS-matched patients who continued and who discontinued ETV therapy, respectively (P = 0.587). Multivariate Cox proportional hazards regression analyses showed that age (HR 1.065, P < 0.001) and HBV DNA (HR 1.216, P = 0.048) were the significant factors for HCC development. The rates of adverse clinical outcomes were comparable.
Conclusions
The clinical outcomes, including HCC, after cessation of a successful course of entecavir therapy in patients with compensated cirrhosis were comparable to those who continued therapy. The results suggest that this strategy of finite therapy is safe and a feasible alternative to indefinite therapy, especially in a low resources setting.
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