Entecavir treatment for up to 5 years in patients with hepatitis b e antigen-positive chronic hepatitis B
(2010) Hepatology — Vol. 51, n° 2, p. 422-430 (2010)
Files
pdfdocument.pdf
Restricted Access - Adobe PDF
- 371.02 KB
Details
- Authors
- 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. Copyright © 2009 by the American Association for the Study of Liver Diseases.
- Affiliations
Citations
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 (Original work published 2010)