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HepaGam B: Prevention of Hepatitis B recurrence in liver transplant surgery

reason for liver transplant in adults is cirrhosis (Chronic liver disease in which normal liver cells are damaged and are the replaced by scar tissue. Most commonly caused by alcoholism and hepatitis A, B (HBV) or C or end stage liver disease. According to the American Cancer Society, Cirrhosis is the seventh leading cause of death by disease. Survival rate of liver transplants for adults is 60 - 75 percent and children 80 - 90 percent. If the liver is donated at a different location, it must be transferred to the transplant recipient location under sterile refrigerated conditions within 8 to 20 hours. Transplants are usually not offered to people with ongoing drug or alcohol problems, since the outcome of success is greatly diminished. In most situations patients are placed on a national waiting list for liver transplants.

Major concern for liver transplant recipients, who have already been exposed to hepatitis B, increased risk of re-infection from the virus, and can cause liver failure or liver cancer. In April 2007, Cangene Corporation (Winnipeg, Canada) reported that the Food and Drug Administration approved HepaGam B; prevent hepatitis B recurrence following liver transplantation in hepatitis B antigen (Any substance capable of inducing a specific immune response. Antigen or viral marker that appears in a blood test after being infected.), positive liver transplant patients. Also, product was approved in 2007 by Health Canada for prevention of hepatitis B recurrence following liver transplantation in adult patients. HapaGam B is purified antibody (Produced from human plasma, which is collected at U.S. licensed plasma centers from healthy donors.) or hyperimmune that specifically attacks hepatitis B virus (stimulates an immune response to the virus). Patients must receive injections at the time of the liver transplant and throughout their lives. The FDA said: The product reduced the infection recurrence rate to about 13 percent from 86 percent among liver transplant recipients who participated in clinical trials. Common adverse reactions included headache (6%), cold symptoms/flu (10%), and light headiness /fainting (3%). In 2006, the FDA approved HepaGam B to prevent hepatitis B infection acquired by sexual contact exposure, and in unborn infants whose mother's had been exposed to the virus.

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