VA Testimony of Thomas L. Garthwaite, MD before Congress on June 9, 1999

United States Department of Veterans Affairs

STATEMENT OF
THOMAS L. GARTHWAITE, M.D.
DEPUTY UNDER SECRETARY FOR HEALTH
DEPARTMENT OF VETERANS AFFAIRS
BEFORE THE
SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS AFFAIRS,
AND INTERNATIONAL RELATIONS
COMMITTEE ON GOVERNMENT REFORM
U. S. HOUSE OF REPRESENTATIVES

June 9, 1999

Mr. Chairman and members of the committee, I am pleased to appear before you today to discuss VA’s efforts to respond to health problems caused by hepatitis C infection.

Since the issuance of the patient evaluation and diagnostic guidelines in June of last year, VA has made significant progress in combating hepatitis C infection (HCV) in our patients. These efforts include the further development and full implementation of our Emerging Pathogens Registry, the preparation and dissemination of enhanced guidelines for diagnosis and treatment, the establishment of Centers of Excellence in HCV, the completion of a large national surveillance project, and the expansion of educational and informational activities for both patients and providers throughout the VA.

Registry

The Emerging Pathogen Registry (EPR) is a national database that includes the results of all HCV antibody tests performed VA-wide and a compilation of the unique veteran patients whose tests indicate infection with HCV. The Registry can also be accessed to determine the medical center and Veterans Integrated Service Network (VISN) to which individual HCV patients are assigned. At the end of calendar year 1998, approximately 26,000 veterans had positive tests for HCV and were in the registry.

VHA is in the process of merging Registry data with data from our Pharmacy Benefits Management Program. This merger of data should enable us to generate a list of individual patients who have been prescribed interferon alone or in combination with ribavirin. Most such patients are under treatment for HCV although a few might be receiving the drugs for other reasons. A review of patients who have tested positive but who are not on drug treatment is planned and will allow us to understand the reasons behind a decision to not treat. At present, we have only expert opinion regarding the proportion of HCV-positive patients who are appropriate for treatment with current therapy. We believe VA will provide the first sizeable database in the United States to assess treatment strategies.

Centers of Excellence

Four months ago, two Centers of Excellence in Hepatitis C were established by VHA; these are located at the Medical Centers in San Francisco and Miami. The Centers are currently involved in a number of projects, including:

Modification of our current diagnostic guidelines to maximize the identification of HCV patients while minimizing the cost of detection,
Drafting recommendations for counseling veteran patients regarding HCV,
Developing, in cooperation with the American Liver Foundation (ALF), veteran-specific educational materials,
Developing a VHA Cooperative Studies Protocol for a formal epidemiologic study of HCV in the VA,
Conducting clinical research on new drugs for the treatment of HCV. These therapies include compounds such as long acting (pegylated) interferon, inhibitors of inosine monophosphate dehydrogenase, and cytokines (such as interleukin). The VA Centers have been directly involved in the development of all the current FDA-approved treatments for HCV and will continue their government-industry collaborative activities.

Surveillance Study

Veteran patients have risk factors known to be associated with HCV infection more often than the civilian population. Thus, we have suspected that the prevalence of HCV in our patients is significantly higher than that in the general population. However, the only data available were from relatively small studies in urban medical centers. On March 17, 1999, VA conducted the largest single HCV surveillance study in the United States. Approximately 26,000 veteran patients who were having blood drawn on that date for any reason agreed to be tested for HCV. Nationwide, 8% of those tested were antibody-positive. This prevalence is more than fourfold the national rate reported by the Centers for Disease Control and Prevention. We expected geographic variations in the observed proportion of HCV-positive patients and our results confirmed that assumption. Both the conditions necessary for completion of this testing on a single day, as well as the preliminary information on the local and national demographics of patients tested, have led us to conclude that 8% is more likely than not to be a low estimate of the true prevalence of HCV in VA patients. Risk factor questionnaires from this surveillance day are currently being analyzed and may be used to adjust or modify our diagnostic guidelines.

Education

A national symposium on HCV in VA was held on June 2-4. Representatives from every VISN were in attendance to hear presentations reviewing the epidemiology, natural history, diagnosis and treatment of HCV, presented by speakers with clinical and research expertise in public health, infectious disease, hepatology, and pharmacology. Each attendee was provided a detailed handbook on HCV, and a VA-specific set of slides. Slide sets will also be made available to all VA medical centers. The attendees are expected to act as a "core group" for HCV information and education to providers in each Network.

A web page has been established for VA providers and patient support groups. The site contains up-to-date clinical information on HCV, lists of current treatment trials, and data on advances in research.

Outreach

VA is working with the American Liver Foundation to target specific educational and informational programs to veterans. VA has been in contact with several Veteran Service Organizations and the Foundation, and has participated in editing and reviewing the information provided. VA will endeavor to work with both groups in a partnership for outreach within the veteran community.

VA is committed to minimizing any inconsistencies in the screening and testing of patients. As we have published and implemented our testing guidelines, our rate of testing for HCV has doubled (FY1998 to FY1999). To further increase testing in appropriate cases, we are studying the development of a reminder system in our VISTA patient care information system that will remind clinicians to screen and test high-risk patients who have not been previously screened or tested. In addition, we are enlisting coordinators at the network and medical center level to track and ensure compliance.

Summary

Mr. Chairman, VA has come a long way in a short period of time with regard to meeting the health needs of veterans with hepatitis C. We have additional work to do. We look forward to working with Congress to assure that current treatments are available to veterans and that better treatments for this serious disease are developed. This concludes my statement. I will be pleased to respond to the committee’s questions.