FDA Approves Test for Hepatitis B

Hepatitis B (HBV) is the most serious type of viral hepatitis. According to the World Health Organization around 2 billion people worldwide are infected each year. In the United State, the Centers for Disease Control and Prevention estimates about 1.25 million people currently have chronic hepatitis B. Individuals with chronic hepatitis B spread the infection to approximately 60,000 people each year and 5,000 people die annually from hepatitis B complications.

There is more than one type of hepatitis, but all effect the liver. Hepatitis B is caused by the HBV virus, and can be spread from mother to child during birth; it can be spread during unprotected sex, and by the use of infected needles.

Hepatitis can cause the liver to stop functioning or it may lead to cirrhosis or liver cancer, severe illness and even death. There are medications available to help stop the progression of the illness and there are vaccinations available to stop the spread of the disease. 

With the FDA approval of a nucleic acid test for HBV, health care professionals have a tool for measuring the progress of antiviral therapy in patients with chronic HBV infections. The COBAS TaqMan HBV Test extracts and amplifies sections of viral DNA from human plasma or serum. The sections are measured to establish a baseline before beginning treatment. The same tests are used to judge an individuals response to therapy during treatment. The level of hepatitis B virus should decrease with successful treatment. The test is used in conjunction with other clinical evaluations from biochemical and serological testing.

Daniel G Schultz, M.D., director FDA’s Center for Devices and Radiological Health said “Measuring a patient’s HBV viral load is an important aspect of managing chronic hepatitis B infections. The COBAS TaqMan HBV Test gives health care providers a new and sensitive tool for this process.”

Hepatitis B is a highly infectious disease but it will not be spread from casual contact such as shaking hands; the transmission of the disease requires body fluids such as blood, semen, or vaginal fluid. An individual who has the disease may exhibit no symptoms and may pass the disease on unknowingly. The Centers for Disease Control (CDC) now recommends vaccination for all newborns in order to prevent infection of hepatitis B. Babies generally would not produce the antibodies to keep themselves from becoming infected. Vaccination should be considered for all others who may be a risk for infection because of job, travel, or lifestyle. It is far easier to prevent HBV than effect a cure, even with the help of the new HBV test.