The Food and Drug Administration (FDA) announced the approval of Baraclude (entecavir) tablets and oral solution for the treatment of chronic hepatitis B in adults. Chronic hepatitis B is a serious disease caused by the hepatitis B virus (HBV) that attacks the liver. The virus can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death. According to the Centers for Disease Control and Prevention, approximately 1.25 million Americans are chronically infected with the HBV virus.
Baraclude slows the progression of chronic hepatitis B by interfering with viral reproduction.
FDA based its approval of Baraclude on the results of three studies in which Baraclude was compared to another anti-viral drug, lamivudine.
In all three clinical studies, patients treated with Baraclude showed significant improvement in the liver inflammation caused by HBV and an improvement in the degree of liver fibrosis (scarring). In addition, a higher percentage of patients treated with Baraclude showed significant improvement compared to lamivudine.
The major adverse events associated with the use of Baraclude were of the type typically seen with HBV therapy. They include severe, acute exacerbation of hepatitis B after discontinuation of Baraclude, headache, abdominal pain, diarrhea, fatigue, and dizziness. The labeling for Baraclude states that patients who discontinue Baraclude should be monitored at repeated intervals over a period of time for liver function.
Baraclude’s sponsor, Bristol-Myers Squibb Company of Wallingford, Conn., has committed to conducting a large post-marketing study of Baraclude (entecavir) to evaluate the risks of cancers and liver related complications.
From U.S. FDA
