Doing
Battle With HCV
Claus J. Fimmel, M.D.
Hepatitis C virus (HCV) infection has emerged as a major health care problem in the US veteran population. The growing awareness of its importance is reflected in the recent mandate by the Department of Veterans Affairs to perform HCV testing on all veterans at risk for the disease and to manage patients according to the Center for Disease Control and Prevention guidelines. Interferon/ribavirin combination therapy is available to VA patients, and Congress has earmarked $230 million for HCV diagnosis and treatment for the year 2000 VA budget.
Gastroenterologists practicing in the VA system have noticed a drastic increase in HCV-related morbidity over the past years. However, the full impact of the disease is unknown. This is due to the lack of epidemiological data that would allow one to estimate the number of affected patients and to calculate the HCV-related expenditures.
The
study by Ramsey Cheung in this issue of the American Journal of Gastroenterology
provides a first systematic and detailed report on HCV antibody seroprevalence,
risk factors, genotypes, and age distribution of infected patients. The
data were obtained in a retrospective analysis of the Palo
Alto VA Healthcare
system.
Over
a period of 6 yrs, (1992-1998), approximately one-fifth of the approximately
40,000 veterans living in this predominantly suburban area were tested
for HCV antibodies by a second generation ELISA assay. The test was positive
in 2985 subjects, corresponding to a point prevalence of 35%. The
overwhelming majority of these patients were found to be viremic, as confirmed
by PCR
analysis. As
pointed out by the authors, the high rate of seropositivity is likely to
be affected by selection and referral bias, as patients were tested
based on the presence of HCV risk factors or abnormal liver tests.
To
obtain a more representative seroprevalence rate, the author measured HCV
antibodies in 126 consecutive patients involved in blood-borne exposure
accidents and obtained a prevalence rate of 18%. This number may still
be an overestimate, as it excludes a majority of veterans who do not use
the VA for their healthcare. Nevertheless, the reported rate is remarkably
similar to those reported in smaller studies on outpatient veterans in
San Francisco and hospitalized patients in Washington, DC.
The true nationwide HCV antibody prevalence in veterans is unknown. Recent
estimates-based on rather crude sampling methods-suggest a rate of 7-9%.
Analysis of the data obtained by Cheung suggests that 7% may be too low
an estimate; in his study, 7% would be correct if all of the approximately
31,000 untested veterans were HCV-negative-an unlikely scenario! In any
event, the percentage of HCV-infected veterans will be substantially higher
than the 1.8% reported for the overall US population.
Based on these data and on the observation that approximately 6.7% of all veterans (1.7 of 25.6 million) receive medical care at VA hospitals, a conservative estimate would be that approximately 2 million veterans are HCV-infected, and that 200,000-300,000 of them may be cared for at VA hospitals nationwide. The latter number may grow, as HCV-infected veterans may turn to the VA for the first time in their lives to obtain affordable antiviral therapy for their disease.
The obligation to evaluate, counsel, and treat these patients represents a formidable challenge to primary care providers and gastroenterologists. The costs of drug therapy alone will be staggering, even when taking into account that the VA is obtaining interferon/ribavirin combination therapy at a discount (the VA pharmacy costs for a 40-wk treatment course are approximately $10,000). The percentage of patients who are treatment candidates is unclear.
Based on the experience in our center and others over the past 3 yr, the majority of HCV-infected patients have contraindications for antiviral therapy, including illicit drug use and alcohol abuse, psychiatric disease, noncompliance, inadequate social support for the self-administration of parenteral medications, life-threatening extrahepatic morbidity, and the presence of decompensated cirrhosis. However, even treating only 10% of all infected subjects would result in drug costs in excess of $200 million. Additional expenditures will be incurred by performing HCV and HAV vaccinations, ancillary laboratory radiological testing (including HCV genotyping, HCV-RNA measurements, imaging, and tumor marker studies to detect hepatocellular carcinoma), and last but not least, for the treatment of HCV-induced liver cirrhosis, including liver transplantation.
Having recognized the problem and its magnitude, is the VA ready to do battle with HCV? In a time of personnel cutting and cost containment, the answer to this question is not clear. HCV treatment is time consuming and labor intensive and requires dedicated personnel. Alliances with the pharmaceutical industry, as already established with the manufacturers of interferon/ribavirin, will provide much needed reinforcement but will not win the war.
The
data provided by Cheung provide a rationale for the VA to strengthen further
and support its troops, foremost, its gastroenterologists and their staff.
Their contribution will be critical for the success of a campaign that
will last well into the second decade of the new millennium.