Entecavir treatment for up to 5 years in patients with hepatitis b e antigen-positive chronic hepatitis B

Ting-Tsung Chang, Ching Lung Lai, Seung Kew Yoon, Samuel S. Lee, Henrique Sergio M. Coelho, Flair Jose Carrilho, Fred Poordad, Waldemar Halota, Yves Horsmans, Naoky Tsai, Hui Zhang, Daniel J. Tenney, Ricardo Tamez, Uchenna Iloeje

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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 HBeAgpositive CHB.

Original languageEnglish
Pages (from-to)422-430
Number of pages9
JournalHepatology
Volume51
Issue number2
DOIs
Publication statusPublished - 2010 Feb 1

All Science Journal Classification (ASJC) codes

  • Hepatology

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    Chang, T-T., Lai, C. L., Yoon, S. K., Lee, S. S., Coelho, H. S. M., Carrilho, F. J., Poordad, F., Halota, W., Horsmans, Y., Tsai, N., Zhang, H., Tenney, D. J., Tamez, R., & Iloeje, U. (2010). Entecavir treatment for up to 5 years in patients with hepatitis b e antigen-positive chronic hepatitis B. Hepatology, 51(2), 422-430. https://doi.org/10.1002/hep.23327