FDA Approves New Hepatitis B Treatment
Baraclude Slows the Disease by Hampering the Hepatitis B Virus
March 30, 2005 -- The FDA has approved Baraclude (entecavir) to treat chronic in adults.
Baraclude slows the progression of chronic hepatitis B by interfering with the virus that causes the disease, says the FDA.
Nearly 1.25 million people in the U.S. are infected with the hepatitis B virus, according to the CDC.
In America, 5,000 people per year die of hepatitis B and related liver problems, says drug company Bristol-Myers Squibb, Baraclude's maker, in a news release.
Hepatitis B: Dangerous but Treatable
Chronic hepatitis B is a serious disease caused by the hepatitis B virus. The virus attacks the liver and can cause lifelong infection, cirrhosis, liver cancer, liver failure, and death.
When infected, most adults get rid of the infection on their own. The virus can be spread through blood, unprotected sex, shared or reused needles, and from an infected mother to her newborn baby during delivery, says the Hepatitis B Foundation.
"Most infected adults are able to get rid of the hepatitis B virus without any problems. However, most infected babies and children are unable to get rid of the virus and develop chronic infections," says the Foundation.
Hepatitis B is the world's most common liver infection. There is a hepatitis B vaccine, which is recommended for all children and high-risk adults, such as medical professionals.
Drugs are also available to help get rid of chronic hepatitis B.
Cancer Risk Factor
Chronic hepatitis B infection can lead to liver cancer. Up to 80% of liver cancers are caused by chronic hepatitis B, according to a news release from Baraclude's maker, Bristol-Myers Squibb. Those cancers kill more than half a million people worldwide, the drug company's news release cites.
'Significant Improvement' Noted by FDA
The FDA's approval was based on three clinical studies that compared Baraclude with another hepatitis B drug, lamivudine.
In all three studies, patients treated with Baraclude showed significant improvement in the liver inflammation caused by HBV and an improvement in the degree of liver scarring, says the FDA.
In addition, a higher percentage of patients treated with Baraclude showed significant improvement compared with lamivudine.
The major side effects associated with Baraclude were typical for hepatitis B treatment, says the FDA. Those side effects include severe worsening of hepatitis B after stopping Baraclude, headache, abdominal pain, diarrhea, fatigue, and dizziness.
Patients who discontinue the drug should be monitored at repeated intervals over a period of time for liver function, says the FDA. Bristol-Myers Squibb Company will conduct a large postmarketing study of Baraclude. That study will evaluate the risks of cancers and liver-related complications, says the FDA.