Viral Hepatitis

Entecavir Treatment for Up to 5 Years in Patients With Hepatitis B E Antigen–Positive Chronic Hepatitis B

Chang, Ting-Tsung1,*; Lai, Ching-Lung2; Yoon, Seung Kew3; Lee, Samuel S.4; Coelho, Henrique Sergio M.5; Carrilho, Flair Jose6; Poordad, Fred7; Halota, Waldemar8; Horsmans, Yves9; Tsai, Naoky10; Zhang, Hui11; Tenney, Daniel J.11; Tamez, Ricardo12; Iloeje, Uchenna11

Author Information
Hepatology 51(2):p 422-430, February 2010. | DOI: 10.1002/hep.23327

Abstract

 

Sustained virologic suppression is a primary goal of therapy for chronic hepatitis B (CHB). In study entecavir (ETV)-022, 48 weeks of entecavir 0.5 mg was superior to lamivudine for virologic suppression for hepatitis B e antigen (HBeAg)-positive CHB. A total of 183 entecavir-treated patients from ETV-022 subsequently enrolled in study ETV-901. We present the results after up to 5 years (240 weeks) of continuous entecavir therapy. The entecavir long-term cohort consists of patients who received ≥1 year of entecavir 0.5 mg in ETV-022 and then entered ETV-901 with a treatment gap ≤35 days. In ETV-901 the entecavir dose was 1.0 mg daily. For patients with samples available at Year 5, proportions with hepatitis B virus (HBV) DNA <300 copies/mL, normal alanine aminotransferase (ALT) levels, HBeAg loss, and HBeAg seroconversion were determined. In all, 146 patients met criteria for inclusion in the entecavir long-term cohort. At Year 5, 94% (88/94) had HBV DNA <300 copies/mL and 80% (78/98) had normal ALT levels. In addition to patients who achieved serologic responses during study ETV-022, 23% (33/141) achieved HBeAg seroconversion and 1.4% (2/145) lost hepatitis B surface antigen (HBsAg) during study ETV-901. Through 5 years, entecavir resistance emerged in one patient. The safety profile of entecavir was consistent with previous reports.Conclusion:Extended therapy with entecavir through 5 years maintained or increased rates of HBV DNA suppression and ALT normalization. Additional patients also achieved HBeAg loss and seroconversion. Entecavir provides sustained viral suppression with minimal resistance during long-term treatment of HBeAg-positive CHB. (Hepatology 2010.)

Copyright © 2010 American Association for the Study of Liver Diseases.

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