Treatment of Hepatitis B e Antigen–Positive Chronic Hepatitis with Telbivudine or Adefovir

  1. Henry L.Y. Chan, MD;
  2. E. Jenny Heathcote, MD;
  3. Patrick Marcellin, MD;
  4. Ching-Lung Lai, MD;
  5. Mong Cho, MD;
  6. Young M. Moon, MD;
  7. You-Chen Chao, MD;
  8. Robert P. Myers, MD;
  9. Gerald Y. Minuk, MD;
  10. Lennox Jeffers, MD;
  11. William Sievert, MD;
  12. Natalie Bzowej, MD, PhD;
  13. George Harb, MD;
  14. Ralf Kaiser, PhD;
  15. Xin-Jian Qiao, ScD;
  16. Nathaniel A. Brown, MD; and
  17. and the 018 Study Group*
  1. From The Chinese University of Hong Kong, Hong Kong, China; University of Toronto, Toronto, Ontario, Canada; Hôpital Beaujon, Clichy, France; Pusan National University Hospital, Busan, Korea; Severance Hospital, Seoul, Korea; Tri-Service General Hospital, Taipei, Taiwan; University of Calgary, Calgary, Alberta, Canada; University of Manitoba, Winnipeg, Manitoba, Canada; University of Miami, Miami, Florida; Monash University, Melbourne, Victoria, Australia; California Pacific Medical Center, San Francisco, California; Novartis Pharmaceuticals, East Hanover, New Jersey; and Idenix Pharmaceuticals, Cambridge, Massachusetts.
    1. Figure 1.
      View larger version:
      Figure 1. Study flow diagram.

      Primary exclusion criteria are listed; some patients met more than 1 exclusion criterion. One patient assigned to adefovir withdrew before initiation of treatment; thus, the intention-to-treat sample was 135 patients, of whom 45, 44, and 46 were assigned to receive telbivudine, adefovir, or adefovir for 24 weeks and then telbivudine for the remaining 28 weeks, respectively. One adefovir recipient withdrew before the week-24 analysis; 1 additional adefovir recipient and 2 telbivudine recipients withdrew before the week-52 analysis. ALT = alanine aminotransferase; HBeAg = hepatitis B e antigen; HBV = hepatitis B virus.

    2. Figure 2.
      View larger version:
      Figure 2. Changes in serum hepatitis B virus (HBV) markers from baseline to week 52.

      Top. Mean serum HBV DNA levels. Bottom. Proportion of patients with hepatitis B e antigen (HBeAg) seroconversion. ADV = adefovir; ADV/LdT = adefovir to telbivudine; LdT = telbivudine.

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    1. Ann Intern Med December 4, 2007 vol. 147 no. 11 745-754
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