RATIONALE:

The Importance of HCV Infection:

• There are 200-400 million chronic HCV carriers in the world.
• 20% will develop cirrhosis/hepatocellulary carcinoma (HCC).
• About half of these are caused by HCV and half by HBV.
• The vast majority of cases of HCC occur in the developing world.

HCC is one of the world's MOST COMMON CANCERS.

HBV and HCV are the two hepatitis viruses that cause chronic infection and lead to cirrhosis and liver cancer. HBV is transmitted by blood and blood products, contaminated injections and sexually. About 200 million persons, 1 million in the US, are chronically infected. The prevalence varies between 0.1 and 20% in different parts of the world and is highest in Africa and Asia. Clinical evidence of cirrhosis and/or liver cancer occurs about 20-40 years after infection in about 20% of those infected.

The Hepatitis C virus (HCV) affects about 4 million persons in the U.S., and about 2-400 million worldwide. About 85% of the above chronically affected people will develop chronic liver disease: chronic hepatitis, characterized by debilitating fatigue and in many cases recurrent jaundice and cirrhosis of the liver, leading to the accumulation of fluid in the abdominal cavity (ascites), and bleeding from intestinal varices. Lastly, people with chronic HCV infection are at high risk in later life of developing liver cancer, and consequently, HCV is the most common cause of liver cancer in many parts of the world.

On Thursday, March 5, 1998, HCV infection received rare attention at a congressional hearing. Dr. David Satcher, the newly appointed Surgeon General, announced a program to track down the estimated one million persons who had received blood transfusions before sensitive tests became available. The former Surgeon General, Dr. C. Everett Koop stated that only 225,000 of the 4.5 million persons affected in the United States were aware that they had an incurable and often deadly virus infection. Connecticut Republican Christopher Shays, chairman of the subcommittee, stated the public concern about hepatitis C has been overshadowed by AIDS.

Treatment for those identified as being infected with HCV is relatively unsuccessful, with the best current treatment (Pegylated Interferon alpha and Ribavarin) estimated to provide useful therapy in about 50% of cases at the cost of fairly severe side effects. Present treatment costs $20,000 - $35,000/year and is thus, unaffordable in the developing world.

If HCV is to be controlled, a vaccine is needed. None is presently available. New approaches to treatment involving immunotherapy are beginning to be studied. Immunotherapy may eliminate the infection by raising the level of cell mediated immunity in infected persons by newer forms of immunization. This approach could provide effective treatment of the chronic infection without side effects, and at an affordable cost.

As hepatitis B and C infections and associated diseases are primarily a problem in the developing world, they receive low priority for funding by the pharmaceutical and vaccine industry, and by the federal government. Furthermore, treatments that are available in the developed world are totally unaffordable in the developing world.

A vaccine for HCV is badly needed in the developing world where the infection is spreading rapidly due to the use of unsterilized syringes, however, major vaccine manufacturers are not pursuing this, as an HCV vaccine HCV vaccine is only needed for certain high risk populations such as drug users, homosexuals, medical personnel, and family members of chronic HCV carriers.

For this reason, HRF feels it is important to focus its support for the development of affordable therapies and preventative vaccines.

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Scientific members of HRF and the Chimpanzee Sanctuary are available to lecture on Hepatitis, AIDS Research, and Chimpanzee welfare.

The Foundation thanks Adobe's Gifts in Kind program for their generous contribution.

The Hepatitis Research Foundation would like to thank the Don and Rita Lee Foundation for their continuous support for immunotherapy of chronic HCV infection.

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