Treatment of Hepatitis B e Antigen-Positive Chronic Hepatitis with Telbivudine or Adefovir: A Randomized Trial

View larger version (43K): [in this window] [in a new window]   Figure 1. Study flow diagram. Of 208 patients screened, 72 patients did not meet inclusion or exclusion criteria and 136 eligible patients were randomly assigned. 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 (group A), adefovir (group B), or adefovir for 24 weeks and then telbivudine for the remaining 28 weeks (group C), respectively. One adefovir recipient withdrew before the week-24 analysis; 1 additional adefovir recipient and 2 telbivudine recipients withdrew before the week-52 analysis.

View larger version (23K): [in this window] [in a new window]   Figure 2. Changes in serum hepatitis B virus markers from baseline to week 52. Patients in the groups labeled "adefovir" or "telbivudine" received 52 weeks of adefovir (group B) or telbivudine (group A) treatment, respectively. Patients in the group labeled "adefovir/telbivudine" received 24 weeks of adefovir followed by 28 weeks of telbivudine (group C). Top. Mean serum HBV DNA levels. Bottom. Proportions of patients with HBeAg seroconversion.