C. Everett Koop, M.D., SC. D.
Former U.S. Surgeon General
Statement on Hepatitis C
of liver cancer. The report emphasized the absence of a vaccine against hepatitis C infection and noted that while interferon-A therapy is effective in some cases, most patients do not respond or experience a subsequent relapse. The report outlined nine important areas for further research that must be undertaken if we are to have any chance of reducing the devastation of the hepatitis C virus.
Of particular interest, the report noted the need for:
- continued epidemiological studies with a particular focus on minorities and lower socioeconomic groups;
- research to define the natural history of hepatitis C with a focus on identifying the factors associated with progression to cirrhosis;
- research on how the virus results in liver cell injury or liver cancer;
- basic science to develop the cell culture system necessary to develop effective anti-viral therapies that will inhibit the replication of the virus and stop or delay the progression of liver disease;
- studies of the interaction between hepatitis C and other diseases such as diabetes mellitus;
- clinical research to develop new diagnostic tests for HCV infection;
- clinical trials to identify optimal treatment regimens for those who do not respond to interferon therapy;
- research to develop a safe and effective vaccine;
- research to identify the most effective strategies for educating at-risk groups and assuring access to diagnosis and treatment. In summary, we have a long way to go and much work to do if we are to gain the upper hand in the battle against hepatitis C.
Unlike many other viral diseases, hepatitis C, if detected and treated, can often be cured. I want to stress that there are very few viral diseases about which this can be said - certainly not about AIDS. Treatment with alpha interferon over a period of 12 to 18 months will reduce the viral count or "load" below detectable levels for 25 percent of the treated population, and will improve liver functioning for another 25 percent who still have evidence of the virus. In addition, new combination therapies, such as alpha interferon with ribavirin, that are expected to be approved this year show promise of raising the "cure" rate to 45 percent or higher.
One of the big problems we have with public awareness of hepatitis C is that it is often confused with other forms of hepatitis that are preventable and not as deadly. Unfortunately, this confusion is not helped by public education efforts that discuss hepatitis in general. We need to end this confusion. Hepatitis C - unlike other forms of hepatitis - is a very serious life-long infection for which there is no vaccine, that is not self-limiting, and that will, for many of those infected, lead to serious liver disease, organ failure, and premature death.
When most people hear the word "hepatitis," they think of hepatitis A.
Hepatitis A is a food- or water-borne illness, usually transmitted through the contamination of food with fecal matter. It is a short term, acute disease, against which the body develops its own defenses. While there is an immunization for hepatitis A, there is no particular treatment, although the disease usually resolves itself within a month. Very few people die of hepatitis A. There are fewer than 150,000 new cases of hepatitis A per year.
Hepatitis B is another, very different form of hepatitis. Hepatitis B is, like C, a blood borne virus. However, B can be readily transmitted through exchange of body fluids. There is an effective vaccine for hepatitis B that is now being given to young children and to people who travel abroad.
Hepatitis B usually appears in acute form, with over 70 percent of these cases resolved by the body's defenses. Only 20 to 30 percent of hepatitis B cases become chronic. There are between 150,000 and 300,000 new cases of hepatitis B a year. The sum of hepatitis cases other than C is fewer than half a million.
Hepatitis C is a very different disease. The hepatitis C virus is not as easily transmitted as A or B. When there is an exposure, however, the patient almost always contracts the disease. There is no vaccine for hepatitis C and it is not likely there will ever be one. The body does not have natural defenses, so that the patient that contracts the disease develops it in chronic form and, without treatment will carry it for life. The only known treatment for it is alpha interferon, which is effective in eliminating the disease for about 20 to 30 percent who seek treatment. While there are fewer than 200,000 new cases of hepatitis C a year, there are a large number of people (over 4.5 million) who are carrying chronic HCV infections.
We stand at a critical point with
hepatitis C. We have very sensitive and reliable screening available - and will soon have these in forms suitable for mass screening. We have a hope of curing the disease for some and improving liver functioning for others, and this hope grows every day with new research and new treatments. We have a consensus in the medical community on management of the disease. We are still within the window of opportunity where we can head off serious liver disease for a large portion of the infected population. If we do not act, we will see a tragic increase in liver disease, in the demand for liver transplants, and in the death rate from hepatitis C related liver failure.
Education about the virus is key, for both the public and doctors. Remarkably, virtually none of those who have this disease know they have it. We are in virgin territory. We can significantly increase recognition of the disease. We can vastly increase screening, detection, and treatment. We can have a significant impact, if we act now.
The U.S. Department of Health and Human Services is prepared, as you know, to launch its first serious effort to fight this disease. Based on the recommendations of its Advisory Commission on Blood Safety and Availability, the Department is preparing to launch a substantial lookback to identify blood donors who were found to be HCV positive once screening became available and to notify anyone receiving blood from these donors in the period between 1987 and 1992. While this lookback will be a massive undertaking for the Department, we need to recognize that it will affect only a very small portion of those who are at risk for HCV infection.
The guidance currently being developed may limit the lookback population to those who received blood from donors who were later confirmed HCV positive through two tests: an initial screening test and a confirmatory test. There are many more people infected through transfusions of blood from HCV positive donors whose donation predated the availability of screening in 1987, or whose blood was only screened once.
I commend the Secretary for her leadership in launching this initiative. It is good to have her interest, and that of her colleagues, on this issue.
The Department's leadership on hepatitis C, however, does not reflect what I otherwise perceive to be a general reluctance within the