Bristol-Myers Squibb Company has announced data from a four-year cohort (ETV-022/901, n=146), which showed that 91 per cent (98/108) of patients treated with Baraclude (entecavir) suppressed the amount of hepatitis B virus in the blood, or viral load, to undetectable levels1 at week 192.

Suppression of viral load to undetectable levels is a measure of antiviral treatment response; maintenance of viral load suppression is an important goal of chronic hepatitis B treatment. The results are being presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

Patients in this cohort were nucleoside naïve e-antigen (HBeAg)-positive patients with chronic hepatitis B infection. HBeAg is a viral protein identified as a marker of active replication of the hepatitis B virus. Patients in this cohort were initially treated with Baraclude 0.5 mg in study ETV-022 and continued treatment with Baraclude 1 mg by enrolling in study ETV- 901 with a less than or equal to 35 day treatment gap.

Resistance monitoring in this cohort identified one patient with genotypic resistance to Baraclude at week 139 who had a virologic breakthrough at week 148.

"The data indicate that Baraclude maintained viral suppression through four years of treatment in this patient population," said Hugo Cheinquer, M D, Universidade Federal Do Rio Grande Do Sul, Porto Alegre, Brazil. "That a majority of Baraclude patients had undetectable viral load at four years with one patient developing resistance is very encouraging news for physicians who treat this chronic disease."

Safety events in this cohort were consistent with prior experience. Five deaths were reported in this cohort; no deaths were attributed to Baraclude (entecavir). Twelve per cent of patients experienced a serious adverse event. The most common adverse events occurring in greater than or equal to 10 percent of patients were: upper respiratory tract infection (31 percent), headache (21 percent), cough (17 percent), diarrhoea (16 percent), influenza (17 percent), nasopharyngitis (16 percent), pyrexia (12 percent) and upper abdominal pain (10 percent).

Discovered at Bristol-Myers Squibb, Baraclude is a nucleoside analogue indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication with either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. In addition to the United States, Baraclude has been approved in more than 60 countries and regions around the world.

Baraclude is a prescription medicine used for chronic infection with hepatitis B virus (HBV) in adults where the virus is multiplying and damaging the liver. Baraclude does not cure HBV or stop the spread of HBV to others. People should not take Baraclude if they are allergic to it or any of its ingredients. Baraclude has not been studied in children and is not recommended for anyone less than 16 years of age.