Interim data from Bristol-Myers Squibb's BARACLUDE study for chronic hepatitis B patients

Bristol-Myers Squibb (NYSE: BMY) today announced 48-week data from an ongoing study (ETV-048) of chronic hepatitis B patients with decompensated cirrhosis, in which BARACLUDE demonstrated greater viral suppression compared to adefovir. The new BARACLUDE data were presented today at the 60th Annual Meeting of the American Association for the Study of Liver Diseases.

Decompensated cirrhosis is characterized by severe scarring of the liver caused by chronic liver inflammation, including inflammation associated with chronic hepatitis B infection. It is estimated that 15 to 25 percent of chronic hepatitis B patients die from complications of liver disease. Currently, the median survival rate in decompensated patients is two to three years, with only 28 percent of patients surviving for more than five years. The treatment of chronic hepatitis B patients with decompensated cirrhosis remains an area of unmet medical need, and these patients often require liver transplant.

“This study represents an important first step in addressing an unmet medical need, as this is one of the first comparative studies to evaluate the safety and efficacy of antiviral therapy in this difficult-to-treat patient population,” said Professor Hugo Cheinquer, ETV-048 study investigator and associate professor of gastroenterology and hepatology, Universidade Federal Do Rio Grande Do Sul, Porto Alegre, Brazil. “Chronic hepatitis B is a lifelong disease and these data suggest that treatment with BARACLUDE may offer chronic hepatitis B patients with decompensated cirrhosis a treatment option.”