BARACLUDE data show low resistance over 5 years in nucleoside-naive hepatitis ...(BARACLUDE (entecavir) in nucleoside-nave...)

Data Results

Results from these studies prior to this year five analysis were previously announced on April 14, 2007.

Nucleoside-nave data

• The incidence of BARACLUDE resistance in patients in nucleoside-nave studies over time is low, with a cumulative probability of genotypic BARACLUDE resistance of 1.2 percent through five years.
• No nucleoside-naive patient developed resistance (n=108) in year five.
• 93 percent of the nucleoside-naive patients taking BARACLUDE were able to achieve and maintain an undetectable viral load (HBV DNA < 300 copies/mL) through year five (n=108).

Lamivudine-refractory data

• The results in lamivudine-refractory patients in years one through five were consistent with the finding that the pre-existence of lamivudine-resistant substitutions resulted in an increase in the emergence of BARACLUDE resistance, with a cumulative probability of genotypic resistance of 51 percent through five years.
• In year five, 43 percent of lamivudine-refractory patients had virologic breakthrough with BARACLUDE resistance (n=33).
• During this resistance monitoring program, 72 of the 187 lamivudine-refractory patients achieved undetectable viral load ( < 300 copies/mL) and of these, three patients subsequently developed genotypic resistance to BARACLUDE.

Indication and Important Safety Information About BARACLUDE (entecavir) 0.5 mg/1 mg Tablets

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