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Hepatitis C: Hepatitis C Virus
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Hepatitis C (once called non-A, non-B hepatitis) is a liver disease caused by a recently identified blood-borne virus. Discovered in 1989, this strain of acute viral hepatitis causes approximately 20,000 new infections in the US each year.
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The Hepatitis C virus (HCV) is a small (50 nm in size), enveloped, single-stranded, positive sense RNA virus. It is the only known member of the hepacivirus genus in the family Flaviviridae. There are six major genotypes of the hepatitis C virus, which are indicated numerically (e.g., genotype 1, genotype 2, etc.).
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According to Dr. Eugene Schiff (University of Miami), the Hepatitis C virus (HCV) emerged in the U.S. population beginning in the 1960s, related to blood transfusion and injection drug use. The extent of the problem was only apparent after 1990 when reliable HCV blood tests first became available. Studies indicate that over the first 20 years of chronic HCV infection, 20% of chronically infected patients will develop cirrhosis, and many of those will progress to liver cancer. HCV-associated end-stage liver disease is a leading indication for liver transplantation in the USA and the developed western world.
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The majority of patients with chronic Hepatitis C will never develop a complication related to this disease. Hepatitis C is a slow-working virus and usually, signs of inflammation in the liver don’t show up until 10-20 years after the exposure. However, if undetected/untreated, HCV can cause cirrhosis (scarring of the liver), liver failure, and liver cancer. About 20-30%% of patients develop cirrhosis within 20 to30 years after the onset of infection. Liver damage due to chronic hepatitis C is the leading cause of liver transplants in the United States. The most important risk factor for developing cirrhosis and cancer is alcohol.
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Hepatitis C virus (HCV) infection is frequent in human immunodeficiency virus (HIV)-infected patients. It is known to have an aggressive course in significantly immunosuppressed patients, and cirrhosis C has become one of the main causes of mortality in HIV-HCV coinfected patients since the improvement of antiretroviral therapy. The reasons for this severe fibrotic evolution are unclear.
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Civacir is an investigational human polyclonal antibody product that contains antibodies to the hepatitis C virus (HCV). In February 2006, Nabi Biopharmaceuticals announced that Civacir had been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). This designation facilitates the development of products that treat serious diseases where an unmet medical need exists. Civacir has ... gained Orphan Medicinal Product (OMP) designation in Europe. If a product with OMP designation is the first to receive marketing authorization in Europe for its designated indication, the product will be entitled to 10-year market exclusivity, thereby preventing a similar drug from receiving authorization for the same indication during this period. Civacir also has Orphan Drug Status in the United States.
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Hepatitis C Virus