Strong 3-year findings for B-MS' Baraclude

6 November 2006

US drug major Bristol-Myers Squibb reported positive data from a three-year cohort which showed that Baraclude (entecavir) suppressed viral load to undetectable levels in 90% of nucleoside-naive chronic hepatitis B e-antigen (HBeAg) positive patients at week 144 who continued on treatment from week 96.

In this cohort, undetectable HBV DNA levels were defined as less than 300 copies/mL of blood as measured by polymerase chain reaction. The results of this three-year cohort were presented at the 57th annual meeting of the American Association for the Study of Liver Diseases, held in Boston.

Patients in this long-term cohort had previously received 96 weeks of Baraclude treatment in the ETV-022 study, which compared the efficacy and safety of 0.5mg of the agent versus lamivudine in nucleoside-naive chronic HBeAg-positive subjects. In this three-year cohort , normalization of alanine aminotransferase was noted in 80% of patients at week 144 of therapy. All subjects in this cohort were HBeAg-positive at the end of their treatment in study ETV-022 study: 33% lost HBeAg and 16% achieved HBeAg seroconversion by week 144.

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