ALF Position Statement

American Liver Foundation Statement
Full Statement To Consensus Conference
Research Strategy For Hepatitis C

March 25,1997

... [W]e believe that the needs of people with hepatitis C, as well as those of their healthcare providers, will be fully addressed only if we adhere to the following equation: An improved understanding about hepatitis C plus increased access to this information add up to significant improvements in HCV care. Simply stated, we must remain focused on the agenda that will be established here, and we must empower people affected by HCV to make informed decisions about their healthcare.

... In moving forward with our work to combat this burgeoning public health concern, ALF believes that several critical issues require amplification and a heightened response. Chief among these are issues pertaining to increased awareness, screening and diagnosis, hepatitis C treatment options, and access to care.

Therefore, the American Liver Foundation strongly urges the panel to endorse or embrace the following imperatives:

  • First ... HCV awareness must be increased among the general public and medical community. A broad-based public education campaign, involving, for example, high profile communications vehicles such as advertising, public service announcements, outreach efforts, and in-school programs, must be orchestrated to elevate the public's understanding about HCV risks and symptoms. The primary targets of this campaign should include, vulnerable population groups - such as African Americans and Hispanics - and those individuals who may be at risk due to, for example, blood product use prior to 1990, intravenous drug use, and other activities that involve blood-to-blood contact. Moreover, all efforts must be made to equip primary care physicians with the information required to optimize recognition and effective management of HCV, with appropriate support from specialists.
  • Second ... Screening and diagnosis should be available to everyone who needs it. Any American who may be at risk of hepatitis C infection, who exhibits symptoms of the disease, or who, in any way, may be even remotely concerned about potential HCV infection should undergo a hepatitis C antibody test. Any individual who tests positive for antibodies to HCV should then undergo further testing to confirm the diagnosis.
  • Third ... information pertaining to treatment options should be available to everyone who needs it. When hepatitis C infection is diagnosed, all patients - regardless of their hepatitis profile - should be provided with the full spectrum of information available to them. This would include information about available treatment options, the risks and benefits of these treatments, and the probability of therapeutic success associated with them. Only in this way will we realize the benefits of an educated and empowered patient base. The decision to treat a patient diagnosed with hepatitis C should be made by the patient in consultation with his or her physician.
  • Fourth ... effective hepatitis C treatment should be available to everyone who needs it. When a patient and his or her physician pursue a treatment course, all avenues for access to care should be readily available to them. Each month, the American Liver Foundation responds to anywhere from 8,000
  • to 14,000 calls from the public. A large number of these calls are from people who are already being compromised by managed care obstacles. It is critically important that the Consensus Development Panel clearly emphasize in its report that all patients should have equal access to treatment regardless of the source of healthcare coverage.

Several other issues are equally significant for the panel to consider, and these include prevention, regulatory expediency, research, and resources.

Prevention. There clearly are self-evident risk factors involving blood-to-blood contact that can be communicated to the public. It is also the responsibility of our research community to further study the role of sexual and perinatal transmission of HCV, as well as other cases with no apparent cause. To facilitate such efforts, ALF offers the use of its resources - our 800 number and newsletter - to help disseminate information about related routes of transmission.

FDA Priority. While industry is making significant strides in the investigation of new, more effective treatments for HCV, a much more heightened R&D response is required. We believe that the growing number of individuals affected by hepatitis C, and the comparable inadequacy of existing treatments for the majority of these patients, dictates that investigational therapies related to this disease be "fast tracked" by FDA.

Research. The American Liver Foundation believes that research efforts surrounding hepatitis C need to be much more sharply focused or fine-tuned. This belief has been backed up or made evident by several presentations here. We are encouraged by the existing partnership between industry, various academic institutions, and the government. However, to fortify the resultant efforts of this partnership, we suggest that these relationships be formalized, thereby creating a clearer focus for all parties involved. Once formalized, we strongly recommend that the efforts of this research partnership be focused on outcomes research related to antiviral therapy, the development of safe and effective vaccines, and further study of the epidemiology and natural history of HCV. Attached for the Panel's review is an overall research strategy developed by ALF's Scientific Advisory Council. We urge you to give this serious consideration.

Resources. Advances in the understanding, recognition and care of hepatitis C - and the related imperatives set forth by ALF to realize these gains - involve a concomitant need for resources. Collectively, our ability to respond effectively and to overcome the challenges posed by hepatitis C - today and into the future - will be directly related to the resources we are able to leverage against this tremendous public health concern. The American Liver Foundation's Scientific Advisory Council advises that a substantial (10-fold) annual increase in funding for ten years be directed at hepatitis, and that these resources be used to propel much-needed educational and research efforts forward.

Again, Mr. Chairman, we are tremendously encouraged by the attention this conference is bringing to bear on the broad spectrum of needs related to hepatitis C, and we look forward to more important meetings and future collaborations with NIH and others gathered here. Thank you for your time and consideration.