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Home > About Us > About Advocacy > Hepatitis C Testimony

Testimony on Efforts to Combat Hepatitis C

Statement of the American Liver Foundation on efforts to combat Hepatitis C, presented to the United States House Government Reform Committee the Honorable Thomas M. Davis, III, Chairman, by James L. Boyer, MD, Chair, National Board of Directors, Washington D.C., December 14, 2004.

Dr. James L. Boyer, MD
Chair, National Board of Directors
American Liver Foundation

Mr. Chairman, my name is James Boyer, and I am Chairman of the Board of the American Liver Foundation (ALF). I serve as the Ensign Professor of Medicine, Departments of Internal Medicine and Digestive Diseases, and am the Director of the Liver Center at Yale University School of Medicine. I also had the honor two years ago to serve as the Chairman of the NIH Hepatitis C Consensus Conference.

Mr. Chairman, the American Liver Foundation (ALF) is a national voluntary health organization dedicated to the prevention, treatment and cure for hepatitis and other liver diseases through research and education. ALF has a nationwide network of chapters that provides information to hundreds of thousands of patients and families through its Web site and Helpline every year. Ninety percent (90%) of the inquiries we receive are about hepatitis with more than seventy five percent (75%) of those calls requesting information about hepatitis C. This distribution of calls reflects the significant health threat posed by hepatitis and, therefore, the public’s interest in an aggressive research response to the problem of hepatitis and other liver diseases.

On behalf of the American Liver Foundation, I would like to express our appreciation to you for convening today’s hearing on efforts to combat hepatitis C. Hepatitis C, as you know, is caused by the hepatitis C virus (HCV) and is now the most common chronic blood-borne viral infection in the United States, affecting approximately four million people. Data from the Centers for Disease Control and Prevention (CDC) indicates that between 4 and 5 million Americans (approximately 2% of the population) are infected with HCV, of which at least 2.7 million are chronically infected. Another approximately 30,000 become newly infected annually. Chronic HCV is responsible for 40-60% of liver disease in the U.S and accounts for the majority of liver transplants. Additionally, 8,000-10,000 Americans die each year from HCV-related liver disease.

Efforts to fight hepatitis C have been hindered by several significant factors. There is not a vaccine for HCV, and while treatments are available, they are only successful in approximately 50% of the cases, and are significantly less effective among African American populations. Treatments are also very expensive and have significant side effects. Furthermore, HCV does not present itself in symptoms for many years, often not until serious liver damage has occurred and other health related illnesses are found. This fact stresses the importance of testing and screening programs for at risk populations. Hepatitis is most efficiently transmitted by exposures that involve direct blood-to-blood contact. Risk groups include: those who received a blood transfusion prior to 1992, blood clotting agents prior to 1987, persons with a history of intravenous drug use, health care workers and others in employments settings with possible exposure to blood products or needle stick accidents, and children born to HCV infected mothers.

It has been the view of the ALF and the American Association of the Study of Liver Diseases (AASLD) that the most effective means of combating hepatitis C is to increase and sharpen the focus of liver disease research. In order to advance this interest, ALF has championed the Liver Disease Research Enhancement Act. We feel passage of this legislation is vital in order to establish the national research leadership and to create a dynamic and targeted research program.

The Liver Disease Research Enhancement Act would create a Center within NIDDK that will be focused solely on liver and liver-related diseases research. This bill will create a Liver Disease Research Advisory Board which will review and update the NIH Liver Disease Research Action Plan every two years. The plan will guide future NIH funding decisions and help the liver diseases research community prioritize research efforts. In addition the bill provides new authorities necessary to help insure that the scientific opportunities identified by the Liver Disease Research Action Plan are adequately funded.

There are two important blueprints for additional research that I would like to bring to the Committee’s attention: first is the unfinished research agenda created by the NIH sponsored June, 2002 Hepatitis C Consensus Conference. The major research recommendations made by the Consensus Conference were as follows:

  • Educate the American public on the transmission of HCV in order to better identify affected individuals and to institute preventive measures.

  • Develop reliable, reproducible, and efficient culture systems for propagating HCV and expand basic research in the pathogenic mechanisms underlying hepatic fibrosis.

  • Promote the standardization and wide availability of diagnostic tests for HCV infection and its complications, leading to early diagnosis and the implementation of appropriate treatment practices.

  • Promote the establishment of screening tests for all groups at high risk of HCV infection, including IDUs and incarcerated individuals.

  • Expand the delineation of disease manifestations, noninvasive tests, and the role of the liver biopsy, so that the application of current treatment practices may be refined.

  • Establish a Hepatitis Clinical Research Network for the purpose of conducting research related to the natural history, prevention, and treatment of hepatitis C.

  • Organize RCTs to extend treatment to special populations not represented in current clinical trials and to determine the applicability of accepted antiviral drug combinations to populations such as children and adolescents, and patients with acute hepatitis. Effective approaches are needed for drug users receiving drug treatment, alcohol abusers, prisoners, patients with stabilized depression, those with co-infection with HIV, patients with decompensated cirrhosis, and HCV infections in transplant recipients. Such efforts should lead to decreased morbidity and mortality from the disease, as well as a decrease in the reservoir of disease.

  • Institute measures to reduce transmission of HCV among IDUs, including providing access to sterile syringes through needle exchange, physician prescription, and pharmacy sales; and expanding the Nation's capacity to provide treatment for substance abuse. Physicians and pharmacists should be educated to recognize that providing IDUs with access to sterile syringes and education in safe injection practices may be lifesaving.

  • Evaluate strategies to interrupt mother-to-infant transmission of HCV.

  • Compare new therapies to current treatments in nonresponders, to include not just antiviral agents but also combinations of antifibrotic drugs, immunomodulatory agents, and alternative therapies.

  • Encourage a comprehensive approach to promote the collaboration among health professionals concerned with management of addiction, primary care physicians, and specialists involved in various aspects of HCVÐ to deal with the complex societal, medical, and psychiatric issues of IDUs afflicted by the disease.

  • Seek appropriate support from governmental agencies and the private sector to address urgent research questions concerning the epidemiology and treatment of this disease.

Much more needs to be done to fund additional research and to meet the goals outlined by the Consensus Conference.

The second major blueprint to guide the research agenda is the Liver Disease Research Action Plan nearing completion at NIH, which was started in response to the Congressional interest. The Action Plan consists of 16 chapters on specific topic areas of liver disease research, as well as introductory and summary chapters. One chapter is specifically focused on hepatitis C. Each chapter was written by staff of the Liver Disease Research Branch at NIDDK based on advice and input from a 5- to 8-person Working Group of research investigators, academicians, physicians, and concerned laypersons, as well as a representative from the Liver Disease Subcommittee. Each chapter includes an introductory and background section, a summary of recent advances, a central section describing important research goals in the future, and a final section describing steps to achieve the goals. Each chapter is followed by a 3-by-3 matrix containing 9 to 16 concisely worded research goals. The goals are categorized in the matrix as either low-, medium-, or high-risk and as short-, medium-, or long-term. The Action Plan also includes introductory chapters that provide an overview of the burden of liver disease in the United States and rationale for developing an Action Plan.

As we look forward to the convening of the new Congress, we urge that efforts be redoubled to pass the Liver Disease Research Enhancement Act, and to fully fund the research recommendations presented by the Consensus Conference on Hepatitis C and the Liver Disease Research Action Plan.

Thank you for giving the ALF this opportunity to testify.

Page updated: October 4th, 2011


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