Telbivudine versus Lamivudine in Patients with Chronic Hepatitis B

  • Lai C
  • Gane E
  • Liaw Y
  • et al.
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Abstract

Background Reducing hepatitis B virus (HBV) replication to minimal levels is emerging as a key therapeutic goal for chronic hepatitis B. Methods In this double-blind, phase 3 trial, 1370 patients with chronic hepatitis B were randomly assigned to receive 600 mg of telbivudine or 100 mg of lamivudine once daily. The primary efficacy end point was noninferiority of telbivudine to lamivudine for therapeutic response (i.e., a reduction in serum HBV DNA levels to fewer than 5 log10 copies per milliliter, along with loss of hepatitis B e antigen [HBeAg] or normalization of alanine aminotransferase levels). Secondary efficacy measures included histologic response, changes in serum HBV DNA levels, and HBeAg responses. Results At week 52, a significantly higher proportion of HBeAg-positive patients receiving telbivudine than of those receiving lamivudine had a therapeutic response (75.3% vs. 67.0%, P=0.005) or a histologic response (64.7% vs. 56.3%, P=0.01); telbivudine also was not inferior to lamivudine for thes...

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APA

Lai, C.-L., Gane, E., Liaw, Y.-F., Hsu, C.-W., Thongsawat, S., Wang, Y., … Brown, N. A. (2007). Telbivudine versus Lamivudine in Patients with Chronic Hepatitis B. New England Journal of Medicine, 357(25), 2576–2588. https://doi.org/10.1056/NEJMoa066422

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