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  DDW 2009
May 30 - June 4, 2009
McCormick Place: Chicago, Illinois
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Entecavir Maintains a High Genetic Barrier to HBV Resistance Through 6 Years in Naïve Patients
  Digestive Disease Week 2009, McCormick Place, Chicago Illinois, May 30-June 4, 2009 Reported by Jules Levin
D.J. Tenney1, K.A. Pokorowski1, R.E. Rose1, C.J. Baldick1, B.J. Eggers1, J. Fang1, M.J. Wichroski1, U. Diva1, D. Xu1, R.B. Wilber1, H. Brett-Smith1 & U.H. Iloeje1 1Research and Development, Bristol-Myers Squibb Company, United States
Summary of Results
· Resistance is rare through 6 years
- 1.2% cumulative probability of genotypic resistance.
· The 6 year cumulative probability of genotypic resistance is 57%. - 74/187 (40%) patients achieved HBV DNA < 300 c/mL while on treatment with ETV; of those 74 patients, only 5 (7%) subsequently developed genotypic ETV resistance.
· ETV has high potency and high genetic barrier to resistance in nucleoside-naïve patients (Figure 6).
· In lamivudine-refractory patients, ETV potency and genetic barrier are reduced and an incremental increase in resistance is demonstrated over time (Figure 6).
- Favorable prognostic subgroups can be identified by early response to treatment.








· No two drugs have data that can be directly compared to each other as they are limited by differences in study populations and analysis methodologies. · The above figure shows that ETV has a favorable resistance profile in naïve patients over a period of multiple years.
· For naïve patients, the rollover results in treatment with a higher ETV dose in Study 901. · The rollover process may have facilitated patient drop-out. · Study design favored early discontinuation of those who were successfully treated based on patient management endpoints.
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8. Liaw YF, et al. Gastroenterology 2009;136:486-495.
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