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By: Advisory Committee on Blood Safety and Availability
Date: August 1997
Source: Advisory Committee on Blood Safety and Availability. "Bloodsafety Resolution—August 1997." Available online at http://www.hhs.gov/bloodsafety/resolutions/resaug97.html; website home page: http://www.hhs.gov (accessed March 21, 2003).
About the Organization: The Blood Safety and Availability Advisory Committee was established in the early 1990s to prevent a reoccurrence of the tragedy of the 1980s in which HIV (human immunodeficiency virus) was transmitted to many people through the national blood supply. The committee is made up of consumer advocates, bioethics experts, public health lawyers, health educators, transfusion experts, and hematology (blood) experts. Their task is to advise the Secretary of Health and Human Services on a wide range of issues related to the national blood supply. The committee met for the first time on April 24, 1997.
The blood supply plays a vital role in the American health system. About three to four million Americans receive transfusions of whole blood or blood products, such as platelets or plasma. The safety of the blood supply is of national importance. Several government and private organizations work to ensure the safety of the blood supply. It is primarily the responsibility of the Food and Drug Administration (FDA) to regulate the blood industry.
During the 1990s, the overseers of the national blood supply were diligent in trying to ensure its safety. The AIDS epidemic of the 1980s fostered a mind-set of proactiveness toward blood supply safety. The Blood Safety and Availability Advisory Committee met several times during 1997 to discuss the hepatitis C virus and the safety of the blood supply.
The word hepatitis means inflammation of the liver. Hepatitis can be caused by many things, such as excessive alcohol consumption, drugs, or viruses. The five major viruses that cause inflammation of the liver are hepatitis A, B, C, D, and E. Each of these viruses causes a different type of liver disease. An important characteristic of hepatitis viruses is whether they cause acute or chronic disease. Hepatitis viruses A and E cause only acute disease. These illnesses can be severe, even fatal, but once the disease runs its course, the virus is eliminated from the body.
In contrast, chronic hepatitis usually never goes away. The virus persists in the blood of infected individuals indefinitely. Infection with the hepatitis C virus causes chronic hepatitis. The actual disease progression varies widely from person to person, but typically the virus slowly causes damage to liver cells over a period of ten to fifteen years. During this time, most people are completely unaware they are infected, but the hepatitis C virus has ravaged the liver of so many people that it is the leading cause of liver transplants today. Tens of thousands of Americans die each year from complications arising from hepatitis C.
During the late 1970s and throughout the 1980s, hepatitis viruses were common blood contaminants. At this time, scientists were only able to identify the hepatitis A and B viruses, but another hepatitis virus was showing up in the blood supply as well. In fact, this hepatitis was the most prevalent viral contaminant in blood at the time. Based on testing, they knew it was related to hepatitis, but it was neither hepatitis A nor B.
The identification of hepatitis C and the development of blood-screening tests led many Americans to learn they had a serious disease. In 1987, Chiron Corporation researchers discovered the hepatitis C virus. This allowed for the development of an enzyme-linked immunosorbent assay (ELISA) test for hepatitis C around 1990. ELISA is the most widely used and most effective method to detect antibodies (immune-fighting proteins the body makes to fight specific pathogens, like viruses). One of the recommendations of the Blood Safety and Advisory Committee was to do a "lookback" at all the blood that tested positive for non-A and non-B hepatitis in the 1980s and early 1990s and notify both donors and recipients, who received letters in the mail informing them that they may harbor a potentially deadly virus.
Historically, viral infections have been very hard to treat, but a new antiviral treatment using interferon A has been successful in eliminating hepatitis C in some patients. Until interferons were purified and produced on a large scale, there were few antiviral medications. However, interferon A combined with another antiviral medication called Ribavirin has been very effective against hepatitis C. Many patients are virus free after undergoing the combination treatment. These people can actually say they have been cured of hepatitis C, something unheard of previously.
Primary Source: "Bloodsafety Resolution—August 1997" [excerpt]
SYNOPSIS: The Blood Safety and Availability Advisory Committee met several times in 1997 to discuss the ramifications of the hepatitis C virus for the safety of the national blood supply. In August that year, the committee issued the following resolution.
DATE: August 18, 1997
TO: Interested Parties
FROM: Stephen D. Nightingale, MD, Executive
Advisory Committee on Blood Safety and
SUBJECT: Committee Resolution of August 12,
Hepatitis C virus (HCV) is a major cause of chronic liver disease which can progress to cirrhosis and liver failure in some infected persons, usually over the course of 20 or more years. An estimated 4 million Americans have been infected with HCV, of whom about 7% may have acquired their infection from blood transfusion, most before 1992. The first donor screening test for HCV infection was introduced in 1990, and an improved second generation screening test was introduced in 1992. Since 1992, the availability of a confirmatory test has made possible the more precise identification of persons who may have been infected with HCV, and it has become apparent that
- Many HCV-infected persons are unaware of their infection because it may remain silent for many years;
- Persons with HCV infection may benefit from treatment or behavioral interventions.
In view of these considerations and the Committee's belief that persons who may have received blood or blood components from an HCV-infectious donor should be notified of the risks associated with transfusion of the blood or blood components they received, we recommend to the Secretary of Health and Human Services the following:
- a program to educate providers of medical care regarding the importance of identification of persons at risk for HCV infection, including those who received blood or blood components prior to 1992, and the appropriate measures for prevention, counseling, diagnosis, and treatment;
- an aggressive and sensitive public education campaign to notify and test recipients transfused prior to 1992;
- a targeted lookback program triggered by donors detected as HCV-confirmed positive by second generation screening and supplemental testing (1992 and after). This lookback should extend to January 1987 or 12 months prior to the donor's most recent negative second generation HCV test and should include tracing
- recipients of blood or blood components from HCV-confirmed positive donors who had previously tested negative by a second generation test for HCV infection between 1992 and the present;
- recipients of blood or blood components from HCV-confirmed positive donors who had previously tested negative by a first generation test for HCV infection between 1990 and 1992; and
- recipients of blood or blood components from HCV-confirmed positive donors who had no prior HCV test.