The FDA ( Food and Drug Administration ) approved Baraclude ( Entecavir ) tablets and oral solution for the treatment of chronic hepatitis B in adults.

Baraclude is indicated for the treatment of chronic hepatitis B infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases ( ALT or AST ) or histologically active disease.

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 ( CDC ) , approximately 1.25 million Americans are chronically infected with the HBV virus.

Baraclude is an antiviral agent designed to slow the progression of chronic hepatitis B by interfering with viral replication.

Baraclude is a nucleoside analogue with a recommended dosage of a single 0.5-milligram tablet once-daily for chronic hepatitis B patients beginning treatment for the first time ( nucleoside-naïve patients ), and a single 1-milligram tablet once-daily for patients experiencing resistance to Lamivudine ( Lamivudine-refractory patients ).

Baraclude should be taken once daily on an empty stomach ( at least 2 hours after a meal and 2 hours before the next meal ).

FDA based its approval of Baraclude on the results of three studies in which Baraclude was compared to another antiviral 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.

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.

Lactic acidosis and hepatotoxicity have happened in some people taking drugs like Baraclude.

Baraclude may cause hepatotoxicity.
This may occur with liver enlargement ( hepatomegaly ) and fat in the liver ( steatosis ).
Signs of liver damage are: jaundice, darkening of the urine, lightening in the color of stools, not feeling like eating food for several days or longer, nausea, or having lower stomach pain.

The patients who discontinue Baraclude should be monitored at repeated intervals over a period of time for liver function.

It is not known if Baraclude is safe to use during pregnancy, and if Baraclude helps to prevent a pregnant mother from passing HBV to her child.
A woman should not breast-feed if she is taking Baraclude.

Bristol-Myers Squibb, the manufacturer of Baraclude, has committed to conducting a large post-marketing study of Baraclude ( Entecavir ) to evaluate the risks of cancers and liver related complications.

Source:

- FDA
- Bristol Myers Squibb


XagenaMedicines2005