Bristol-Myers Squibb Company Phase IIIb Comparison of BARACLUDE Monotherapy Versus BARACLUDE Plus Tenofovir Combination Shows No Statistical Difference Between Study Arms

Bristol-Myers Squibb Company

today announced 96-week results from the BE-LOWTM study, a Phase IIIb clinical trial comparing BARACLUDE monotherapy (0.5mg once daily) with BARACLUDE (0.5mg once daily) plus tenofovir (300mg once daily) in treatment-naïve adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B (

) with compensated liver disease. In this study, no statistically significant difference was observed between the two treatment arms in the primary efficacy endpoint of HBV DNA <50 IU/mL (approximately 300 copies per mL)1 at 96 weeks: 76.4% in the BARACLUDE monotherapy arm and 83.2% in the BARACLUDE plus tenofovir arm (p=0.0882). Overall, both study arms had similar safety profiles. Serious adverse events (SAEs) in this study were reported in 6.6% (12/182) of patients in the BARACLUDE monotherapy arm and in 7.1% (14/197) of patients in the BARACLUDE plus tenofovir arm. These data were reported today at the 62nd annual meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, California (Abstract #223, presented orally during the Presidential Plenary Session on Viral Hepatitis).