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Baraclude Patients Achieve Virologic Suppression to Undetectable Levels

November 5, 2007

Ninety-one percent of hepatitis B patients treated with Bristol-Myers Squibb’s (BMS) Baraclude in a four-year cohort had undetectable levels of the virus in their blood at week 192. 

Patients in this cohort were nucleoside naive e-antigen (HBeAg)-positive patients with chronic hepatitis B infection. HBeAg is a viral protein identified as a marker of active replication of the virus. 

At week 192 of Baraclude (entecavir) treatment, 91 percent of patients achieved undetectable viral load and 86 percent achieved alanine aminotransferase normalization. During years three and four, an additional 41 percent of patients lost HBeAg and 16 percent achieved HBeAg seroconversion, BMS said.

Five deaths were reported in the study, but none was attributed to Baraclude. The most common adverse events were upper respiratory tract infection (31 percent), headache (21 percent), cough (17 percent), diarrhea (16 percent), influenza (17 percent), nasopharyngitis (16 percent), pyrexia (12 percent) and upper abdominal pain (10 percent).