HepaGam B: Prevent Hepatitis B Recurrence in Liver Transplant Surgery

Largest organ in the body, liver weighs about three pounds and performs many functions, such as: Regulating, synthesizing (Bile - helps carry away waste and break down fats in the small intestine during digestion), storing (processing of hemoglobin for use of its iron content), secreting, transforming and breaking down many different substances in the body, including clearing the blood of drugs and other poisonous substances. Also, regulates blood clotting. Approximately twenty -- five percent of cardiac output of blood flows to the liver.

Hepatitis inflammation of the liver is contagious and caused by one of three viruses: A, B or C. Hepatitis A: Mostly commonly found in children. When a small amount of the virus, which lives in the stool (feces or poop) contaminates foods, water, milk or especially shellfish, which is then ingested. Considered to be a mild infection, and does not cause chronic liver disease. Hepatitis B (serum hepatitis): Virus spreads through infected body fluids, such as blood, saliva, semen, vaginal fluids, tears and urine. Approximately 8,500 new cases are reported annually in the United States. Exposure to hepatitis B virus: Two types of infection that can result -- acute (short lived) or chronic (long -- term). About one percent of acute hepatitis B (fulminant hepatitis) patients die due to liver damage in this early stage. Approximately ten percent of hepatitis B patients develop chronic, life -- long infection. People with chronic hepatitis B may not develop symptoms, but become "carrier's" and can spread the disease to others. Also, increases chance of permanent liver damage, including cirrhosis and liver cancer. Hepatitis C: Virus spread by direct contact with infected person's blood (drug needles, body piercing with un-sterilized tools, blood transfusions, sexual contact, and transmission from mother to newborn) and attributed to chronic liver disease. The leading cause of liver transplants in the United States. Symptoms of hepatitis: Foul breath, jaundice, a bitter taste in the mouth, dark or "tea-colored' urine, and white, light or "day-colored" stools. Hepatitis A may show mild or no symptoms, especially children with this disease.

The second most major organ transplant is liver after the kidney. Removing a diseased liver and replace it with a healthy liver from an organ donor. In 2002, 5,300 liver transplants were performed in the United States, and more then 17,000 people in the USA are waiting for a liver transplant. Most common 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.