David Satcher, M.D., Ph.D.

Surgeon General of the United States
Assistant Secretary of Health
Statement on Hepatitis C

Good morning. I am David Satcher, the Surgeon General of the United States and the Assistant Secretary of Health in the Department of Health and Human Services. I am here today to discuss a major public health crisis: the hepatitis C epidemic. Mr. Chairman, I know how much this issue concerns you, and I commend you and your staff for your diligent pursuit of it.

Hepatitis C is a grave threat to our society. About 170 million people around the world are infected, and at least 4 million of them reside in the United States. About 85 percent of those infected develop chronic liver disease, and about 10 to 20 percent eventually develop cirrhosis of the liver, about 20 years after the onset of their infection. Hepatitis C is the most common cause of liver failure in patients who require liver transplantation. Although the incidence of hepatitis C in the United States has declined by over 80 percent since the 1980s, there are still about 30,000 new cases each year, and each year about 10,000 people in this country still die of hepatitis C. We conservatively estimate the total cost of hepatitis C to our society at $600 million dollars per year.

The estimate that there are 4 million infected individuals in the United States is based on tests of blood samples obtained during the CDC's Third National Health and Nutrition Examination Survey (NHANES). This is a very extensive survey that the CDC conducts on a representative sample of the entire population of the United States. The fourth NHANES, scheduled to begin later this year, will contain additional questions about potential risk factors for hepatitis C, so that we can gain a more precise estimate of how this disease is actually transmitted in our society. The estimate that there are still about 30,000 new cases of hepatitis C each year is obtained from the Sentinel Counties Study of Viral Hepatitis, which the CDC has been conducting since 1979.

We know that many Americans infected with hepatitis C are unaware they have the disease. Unfortunately, many of them cannot be readily identified, because the disease does not cause symptoms until it is far advanced. However, there is one group that can be identified: the roughly one million people who have received blood from a donor who subsequently tested positive for hepatitis C. In 1996, this Subcommittee formally recommended that steps be taken to ensure that these individuals be notified of their potential infection so that they might seek diagnosis and treatment. On January 28, Secretary Shalala announced just such a plan to notify people who received blood from a potentially infected donor of their risk. I will be in charge of implementing this plan.

In accordance with the Secretary's directive, we will first attempt to notify directly those at greatest risk. There are roughly 300,000 people who have somewhere between a 40 to 70 per cent risk of hepatitis C. They have this risk because they received blood from a donor who later tested positive for hepatitis C after June of 1992, when an accurate screening test for hepatitis C was introduced. A Guidance to Industry from the FDA which will announce the details of this lookback will be published soon in the Federal Register.

However, lookback will not reach everyone at risk, no matter how diligent our efforts. For example, it will not reach the 20 percent of recipients whose donors never return to give blood, and are therefore never discovered to have hepatitis C. At the present time we do not feel that lookback would be an effective means of reaching those who received blood from a donor who was

never tested directly for hepatitis C or who was only screened with the first generation test, which missed many who were truly infected and falsely identified even more who were not infected. Finally, lookback will also not reach the large majority of those who acquired hepatitis C from a source other than blood. This is a particularly important consideration now, because we have reduced the risk of hepatitis C from blood transfusion to less than 1 per 100,000 transfusions, and we expect this risk to decrease further in the future. The procedures for eliminating hepatitis C virus from clotting factors were introduced over a decade ago.

For all these reasons, lookback alone is not enough. I have therefore directed the CDC to lead the second component of of the plan, which is to develop educational programs for health care professionals and the public at large to support recognition, diagnosis, counseling, and testing of those at risk for hepatitis.

The third component of our plan is to evaluate carefully the success of both our direct and general notification efforts, and take additional steps to address unmet needs as we identify them. We have proposed an aggressive time table for implementing these programs, and we will actively monitor their progress at the highest level of the Department through the Public Health Service Blood Safety Committee, which I chair.

Secretary Shalala has made the Department's policy in this matter very clear. As she said on January 28 of this year, "... these steps are only the first phase of a comprehensive plan to address this significant public health problem. It is my intention to reach effectively as many people at risk as we can." I want to underscore these words. Everyone we believe to be at risk of having hepatitis C will be targeted by the Department's plan.

As part of the Department's efforts to educate the public about risk of hepatitis, we must be aggressive about discussing prevention. Hepatitis C is transmitted by blood. Hemodialysis patients are at high risk of hepatitis C infection, as are those who have used injection drugs, even if only occasionally and only in the distant past. Perinatal transmission occurs, though much less efficiently than transmission of hepatitis B or HIV. Sexual transmission within monogamous relationships appears rare, but there may be greater risks for those with multiple partners. The risk from transfusion is now very small, less than 1 per 100,000 transfusions, and we will take advantage of every opportunity available to reduce this risk even further.

There is no cure for hepatitis C. However, treatment is improving. Recent experience with interferon alpha treatment indicates that more prolonged therapy, and the combination of interferon alpha with ribavirin, may provide substantial additional benefit to certain patients. Although these new treatments show promise, much better ones are needed. I am cautiously encouraged by the commitment of the pharmaceutical industry to the development of protease and helicase inhibitors of

the hepatitis C virus.

What we really need, of course, is a vaccine against this disease. There are vaccines against hepatitis A and hepatitis B, and there is ongoing work on a vaccine against hepatitis C. However, we cannot underestimate the complexity of this task, particularly because of the rapid rate at which the virus mutates, and we must nurture the basic and clinical research that will be necessary to support vaccine development.

Research is the foundation of our struggle against hepatitis C. As you know, the hepatitis A and hepatitis B viruses were discovered at the NIH. Dr. Baruch Blumberg, the discoverer of hepatitis B, received the Nobel Prize for his work. This work led to the appreciation that there was at least one more hepatitis virus to be found. The major one of these, hepatitis C, was identified in 1989.

The discovery of the hepatitis C virus permitted the development of progressively more sensitive tests for the presence of hepatitis C in human blood. The first blood donor screening test was licensed in May 1990, only a year after the virus was identified. This test measured antibody to a single hepatitis C antigen. This test identified nearly 90 per cent of patients with transfusion-associated non-A, non-B hepatitis. However, this test had limitations, notably a 24 week window period between the time a subject was infected with hepatitis C and the time the test could detect antibodies to hepatitis C in the subject's blood.

The more effective blood donor screening test was introduced in June of 1992. This "second generation" test measured antibodies to three different hepatitis C antigens, and it reduced the window between infection and detection from 24 to 12 weeks. The date at which this test was introduced is the point in time around which our lookback and public education efforts revolve.

Direct funding for research on hepatitis C among all the institutes at NIH will increase from $25.3 million in 1997 to $29.8 million in 1998 and $34.4 million in 1999. A steering committee has recently been formed to provide more focused oversight of the hepatitis C research effort. The dollar amounts for NIH-sponsored hepatitis C virus research do not, of course, include funds spent on epidemiologic research by the CDC and funds spent on both basic and applied research by the FDA.

The NIH intramural program is focused on virologic, immunologic, and clinical studies which will support therapeutic and vaccine development, as well as the advancement of basic scientific knowledge. Dr. Stephen Feinstone of the FDA's Center for Biologics Research and Review, who was a member of the team that discovered hepatitis A, recently reported the construction of an infectious clone of the hepatitis C virus, an important step towards the eventual development of a vaccine. Extramural programs include for newly established Hepatitis C Cooperative Research Centers, which among their other works conduct studies of the natural history of hepatitis C in African Americans, Native Alaskans, and children. Studies of the natural history of hepatitis C after liver transplantation are also under way.

Let me conclude by reemphasizing that the Department of Health and Human Services joins in your concern regarding the impact of hepatitis C on our nation's health. I want to thank you for this opportunity to describe our efforts to control and, ultimately, eradicate this terrible disease. I would be delighted to answer any questions the Committee may have.