[Congressional Record Volume 148, Number 77 (Wednesday, June 12, 2002)]
[Extensions of Remarks]
[Pages E1016-E1018]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                         THE HEPATITIS C CRISIS

                                 ______
                                 

                        HON. BILL PASCRELL, JR.

                             of new jersey

                    in the house of representatives

                         Tuesday, June 11, 2002

  Mr. PASCRELL. Mr. Speaker, I rise today to call attention to the 
health care crisis posed by Hepatitis C infection, and to highlight 
promising news about awareness of the need for

[[Page E1017]]

testing and the development of new treatment options. As the attached 
article from The New York Times demonstrates. Hepatitis C, estimated to 
affect more than 4 million Americans, is a growing public health threat 
that rivals that of AIDS. Although new infections are decreasing, the 
incidence of Hepatitis C virus (HCV) infection is increasing as 
individuals who were infected years ago are just now learning of their 
infection. Even as recently as last week, a Boston Globe article 
discusses significant increases in Hepatitis C cases, noting that 
public awareness campaigns encouraging people to get tested are having 
an impact.
  Hepatitis C is a blood-borne disease that can lead to liver scarring, 
liver failure or cancer. It is the leading diagnosis leading to liver 
transplantation. Hepatitis C affects people from all walks of life, 
although veterans, individuals who received blood transfusions prior to 
1992, intravenous drug users, health care and emergency workers and 
hemophiliacs are at greatest risk of infection. Because of the long 
period of time between HCV infection and the onset of symptoms, health 
experts believe that the incidence of known Hepatitis C infection will 
continue to increase substantially in the coming years. The costs 
associated with Hepatitis C, estimated at $5.6 billion in 1997, can 
also be expected to rise.
  The good news is, as more people become tested and learn of their HCV 
infection, medical science has made important treatment advances. In 
the early 1990's treatment for Hepatitis C was only moderately 
successful at eliminating the virus from the bloodstream. Advances in 
the past decade have made marked improvements. The Hepatitis Foundation 
International estimates that currently 50 to 60 percent of patients 
respond to treatment initially and that lasting clearance of the virus 
occurs in about 10 to 40 percent of patients. Additionally, some 
patients who are not cured find that treatment can delay the need for a 
liver transplant, an important consideration given the critical 
shortage of organs available for transplant.
  Despite these advances, new treatment regimens are desperately needed 
in this area. Other options are in various stages of research and 
development for these patients and I have sent a letter with several of 
my colleagues to the Secretary of Health and Human Services to 
encourage him to expedite review of such products as determined 
appropriate by the Food and Drug Administration. In addition, I have 
also sent a letter to the Labor, Health and Human Services, Education, 
and Related Agencies Appropriations Subcommittee requesting the Centers 
for Disease Control and Prevention (CDC), the National Institute of 
Allergy and Infectious Diseases (NIAID), and the National Institute of 
Diabetes and Digestive and Kidney Diseases (NIDDK) to include language 
that will recognize and address the intensity of Hepatitis C and 
language that encourages research for better treatment options for 
those in high-risk populations.
  In the meantime, a growing number of Americans, like the patient 
described in The Times article, will discover their infection in the 
coming decade. I am hopeful that medical science, together with sound 
public policy, will do everything possible to help these Americans 
fight their disease and continue to lead productive lives.

                [From the New York Times, May 14, 2002]

            More Are Finding Permanent Cures for Hepatitis C

                            (By Julie Bain)

       Five years ago, R. Scott Bromley, then 57, was returning 
     from a trip to Sicily with friends when he felt a nagging 
     pain in his right side. he was scheduled for an annual 
     checkup the next day, and he learned from a blood test that 
     his liver enzymes were elevated.
       Not a big drinker, Mr. Bromley, a New York architect, told 
     the doctor that while in Italy, ``You have a little wine 
     before dinner on the piazza, a little wine during dinner, a 
     little wine after dinner,'' and suggested maybe that was the 
     cause of the unusual numbers.
       Two weeks later he was tested again, with the same result. 
     He was referred to a specialist in liver disease and, after 
     further tests, hepatitis C was diagnosed. The doctor told him 
     he could have been harboring the virus for 30 years or more 
     with no symptoms. What's more, the disease could be life 
     threatening. Mr. Bromley was devastated.
       More than four million people have hepatitis C in the 
     United States, five times as many as are infected with H.I.V.
       ``It's the bulk of my practice,'' said Dr. Hillel Tobias, 
     the medical director of the Liver Transplant Service at New 
     York University Medical Center.
       The reason is not that new cases are being contracted. New 
     cases have declined 80 percent in the last decade, mainly 
     because blood transfusions have not been risk factors in that 
     period, thanks to testing for the virus. But because the 
     disease takes so long to progress, more patients are learning 
     that they have hepatitis C while in their 40's and 50's and 
     that they contracted the virus many years ago.
       The annual death toll, about 10,000 a year in the United 
     States, is expected to increase for another decade to as many 
     as 30,000 before declining, according to the American Liver 
     Foundation.
       Unlike hepatitis A and B, there is no vaccine for hepatitis 
     C, and the virus can lead to serious liver disease, like 
     cirrhosis or liver cancer. Hepatitis C patients make up the 
     largest percentage of people requiring liver transplants. But 
     with new treatments, more are now finding permanent cures.
       Some misconceptions exist about the way the hepatitis C 
     virus is spread, said Dr. Eugene R. Schiff, a professor of 
     medicine and the director of the Center for Liver Disease at 
     the University of Miami School of Medicine. ``The 
     unequivocally major mode of transmission is blood to blood,'' 
     he said. An estimated 300,000 Americans now infected got the 
     disease from a transfusion before 1990.
       ``Sexual transmission has been way overplayed,'' he said. 
     ``So has transmission from mother to baby. It's uncommon, 
     probably less than 3 percent for either of those, quite the 
     opposite from hepatitis B.''
       Drugs injected by needle also pose blood-to-blood risks. 
     ``The classic hepatitis C patient today is a very upstanding 
     50-year-old lawyer who once tried a needle when he was in 
     college,'' Dr. Tobias said. ``In the 70's, a lot of kids in 
     college tried needles once.''
       Tattoo needles can also spread the disease.
       Because of the lack of symptoms, many cases go undetected 
     until the disease is advanced, although a test can detect 
     antibodies to the virus before it affects the liver.
       Starting in 1992, the treatment of choice was alpha 
     interferon, injected three times a week for a year. This 
     antiviral protein can kill the virus, as well as boost the 
     immune system. The rate of permanent viral clearance was 8 to 
     10 percent, Dr. Tobias said. About five years ago, this 
     treatment was combined with ribavirin, another antiviral 
     agent. With both drugs taken together, a permanent cure rate 
     of about 25 percent was achieved. One reason the rate was not 
     higher was that the interferon was cleared out of the blood 
     so quickly.
       Current treatment is pegylated interferon, a long-acting 
     form of the treatment that maintains a sustained blood level 
     for a week. Approved by the Food and Drug Administration in 
     2001, it brought the cure rate up to about 50 percent. ``And 
     if you add ribavirin to it,'' Dr. Tobias said, ``you get to 
     over 60 percent.''
       Five years ago Mr. Bromley began treatment with alpha 
     interferon, and within two and a half months he was down to a 
     level of zero virus. But the side effects were devastating. 
     ``I didn't sleep well, my sex life was all screwed up, I lost 
     40 pounds and the interferon changed my whole personality,'' 
     he said.
       Then, just a year after he was off the drug, the virus 
     rebounded, even higher than it was before.
       There is no clear correlation between the viral count and 
     what's going on in the liver, the real danger zone.
       ``I have patients with advanced liver disease whose viral 
     counts are fairly low,'' Dr. Tobias said, ``and I have 
     patients with very little liver disease whose viral counts 
     are very high. Similarly, there are people who have normal 
     enzymes and still have significant hepatitis C.''
       That's why a liver biopsy is usually required to help 
     determine treatment.
       For Mr. Bromley, whose tests showed little damage to his 
     liver, it was a tough decision whether to undergo a second 
     treatment. But a year and a half later, he began 48 weeks of 
     interferon and ribavirin, and this time the side effects were 
     even worse. ``I couldn't sleep,'' he said. ``I began 
     forgetting things. I would fall down in the middle of the 
     street. I became very depressed.''
       But the treatment worked, and Mr. Bromley has been free of 
     the virus for more than three years.
       Other patients refuse a second treatment, saying the side 
     effects, including flulike symptoms and depression, aren't 
     worth it.
       ``But,'' said Dr. Tobias, ``they should be retreated with 
     the pegylated interferon because a significant number of them 
     will respond to it.''
       Those who previously did not respond with interferon have 
     about a 20 percent chance of being cured if they are 
     retreated with the pegylated interferon. Those who have 
     relapsed after successful treatment have a chance of 
     receiving a permanent cure of greater than 50 percent. 
     Evidence also suggests that even if a patient doesn't lose 
     the virus, the anti-inflammatory activity of the pegylated 
     interferon slows the progression of the disease. Some 
     patients who have advanced liver disease go on lifetime 
     reduced-dose interferon, which can delay the need for a liver 
     transplant.
       New treatments in development may replace interferon an 
     ribavirin, or be added to them in a drug cocktail, similar to 
     AIDS and H.I.V. treatments. Vertex and Eli Lilly recently 
     announced that they were developing a protease inhibitor that 
     could prevent the virus from making infectious copies of 
     itself. Even more promising, say doctors, is a polymerase 
     inhibitor, which may also stop the virus from replicating. 
     Another possibility is a ribozyme, which may cut the 
     hepatitis C virus ``like a scissors,'' said Dr. Schiff.
       None of these treatments, however, will be available for 
     several years.
       A vaccine remains a challenge because hepatitis C has eight 
     different molecular configurations that are constantly 
     changing and mutating. A vaccine would require developing an 
     immune response to a part of the

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     virus that is relatively stable across all the variations.

     

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