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'HCV Test & Treat': Routine HCV Screening for All, Rapid HCV Test in Clinic. Baby Boomers, High Risk Populations.
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from Jules: below are 2 letters published in the May 7 2013 issue of Annals of Internal Medicine addressing the CDC recommendation to screen 'baby boomers', those born during 1945-1965, and a letter in response from the CDC's John Ward & Bryce Smith. My response as I have always maintained is we should screen everyone in the USA for HCV, "HCV Test & Treat" like in HIV, but the difference is HCV is curable & will be with 12 weeks therapy without interferon; it could be implemented by including HCV testing in the regular panel of bloodwork one receives upon visiting a clinician's office OR & I prefer this method, we should regularly use HCV rapid testing in the healthcare provider's office at the clinic upon a visit, this would prevent a person not knowing they have HCV because they never returned to get results or address poor communication between patient & healthcare provider, AND if the antibody test were positive or the rapid test positive this SHOULD automatically provide a signal that followup HCV panel should be performed including HCV-RNA. Considering that we soon will have new HCV therapies that are IFN-free, 12 weeks in duration and will be able to 'cure' most people, this is a very unique time in medical history requiring a unique novel response. For the first time in medical history we will be able to cure a virus, a viral infection, with limited duration of therapy, with a relatively innocuous therapy & for a relatively very brief duration of therapy. We need to institute a system that is responsive to this unique time in medical history & to take advantage of this opportunity. To do so is cost effective & saves lives, the cost of not doing this is a tremendous cost & burden to the healthcare system, with as HCV+ patients age & progress in disease over the next 10 years the cost associated with advancing liver disease is in the billions of dollars in care, for those with cirrhosis, decompensated cirrhosis, liver cancer (HCC), and end stage liver disease. The burden of these costs will accrue to all levels of government, particularly cities & states, to private insurers, to Medicaid & to Medicare. It is less costly to implement a system that may seem in the beginning to be a bit more costly & cumbersome but in the end will save money & lives. So, in sum we should TEST EVERYONE in the USA for HCV & use the rapid HCV test. We could design a system that uses both, including HCV screening in the panel of bloodwork every person receives when visiting their clinic & also use the rapid HCV test, we could very easily design a system that utilizes both.
Hepatitis C Virus Testing of Persons Born During 1945-1965
Richard B. Lynn, MD
[+] Article and Author Information
TO THE EDITOR:
Recommendations by the Centers for Disease Control and Prevention (CDC) (1) have expanded screening for hepatitis C virus (HCV) from those at increased risk for infection to the entire age cohort born during 1945-1965. This recommendation was based on the relatively high risk for infection in this group. Consideration was given to benefit versus risk for the individual patient as well as a cost analysis for screening the age cohort population (2). However, the cost analysis should have been performed for a different population: the group that was added to the screening recommendations-those in the age cohort who are not at increased risk for infection.
This age cohort has a relatively high incidence of HCV, but a large portion of the infected persons is derived from the relatively small group of those who are at high risk. Although numerous risk factors are listed, an earlier study (3) reported that one half of the risk for HCV infection for persons between the ages of 20 and 59 years comes from the 1.1% who had ever injected illicit drugs. Adding the 3.4% who received a transfusion before 1992 and the 6.1% with 20 or more lifetime sexual partners accounts for three quarters of the risk for HCV infection. If persons with an elevated alanine aminotransferase level are also tested, 93.5% of the HCV-infected population would be identified.
In justifying the new guidelines, the CDC states that the accuracy of patient recall of risk behaviors decreases over time, but this assumption is based on a meta-analysis about HIV-infected patients that compared 1-, 3-, and 6-month recall (4). Of interest, for "heroin use" and "number of sex partners," 6-month recall was the best. This assumption of poor recall for healthy patients being considered for HCV screening is not adequately evidence-based. I, for one, born in 1956, am confident that I would remember if I had ever injected drugs, received a blood transfusion, or had 20 or more sexual partners.
If the high-risk group is excluded from the age cohort, the result is a large population with a low risk for infection. I suspect that a cost analysis of screening for HCV of this low-risk population would find it not to be cost-effective. In addition, the benefit versus risk of screening this low-risk population would need to be considered.
The key point is that the CDC has added this large population-those born during 1945-1965 who are not at increased risk-to their recommendations for HCV screening. This recommendation would result in the screening of millions of additional persons and cost billions of dollars. Before this step is taken, cost-effectiveness studies and benefit-versus-risk analyses should be done for this low-risk population. At this point, what screening should be recommended to an individual patient who reliably claims not to be at increased risk for HCV is unclear.
References
1
Smith BD, Morgan RL, Beckett GA, Falck-Ytter Y, Holtzman D, Ward JW. Hepatitis C virus testing of persons born during 1945-1965: recommendations from the Centers for Disease Control and Prevention. Ann Intern Med. 2012;157:817-22.
PubMed
2
Rein DB, Smith BD, Wittenborn JS, Lesesne SB, Wagner LD, Roblin DW, et al. The cost-effectiveness of birth-cohort screening for hepatitis C antibody in U.S. primary care settings. Ann Intern Med. 2012;156:263-70.
PubMed
CrossRef
3
Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006;144:705-14.
PubMed
CrossRef
4
Napper LE, Fisher DG, Reynolds GL, Johnson ME, et al. HIV risk behavior self-report reliability at different recall periods. AIDS Behav. 2010;14:152-61.
PubMed
CrossRef
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Letters | 7 May 2013
Hepatitis C Virus Testing of Persons Born During 1945-1965
Ephraim Back, MD, MPH
[+] Article and Author Information
TO THE EDITOR:
The HCV screening guideline released by the CDC promotes universal screening of all persons born during 1945-1965 (1 - 2). Although this strategy will identify many previously undiagnosed persons who are chronically infected with HCV, it will also lead to many persons being falsely diagnosed with past HCV infection.
Per a 2003 CDC guideline on HCV testing, the proportion of false-positive HCV antibody test results among immunocompetent populations with anti-HCV prevalence less than 10% averages approximately 35% (range, 15% to 60%). This testing guideline warns that "not relying exclusively on anti-HCV screening-test-positive results to determine whether a person has been infected with HCV is critical" and recommends that all positive screening results be verified with a "supplemental test with high specificity" (3).
The HCV nucleic acid test, which is currently recommended for confirmation, can distinguish between active and past infection but not between true- and false-positive results. The HCV recombinant immunoblot assay (RIBA), which can verify true infection, is unfortunately unavailable in the United States. Although the CDC guideline acknowledges that certain harms ("worry or anxiety while waiting for test results, insurability") can result from universal screening, it does not address the very real harm of false diagnosis (with implications about past or present risk behaviors), which can occur in one third of persons who test positive.
Furthermore, the current guideline published in the Morbidity and Mortality Weekly Report: Recommendations and Reports does not even consider the possibility of false-positive results, stating that "a person whose anti-HCV test is reactive should be considered to either 1) have current HCV infection or 2) have had HCV infection in the past that has subsequently resolved (i.e., cleared)" (2). At the very least, before adopting universal screening by using a highly sensitive HCV antibody test with no highly specific confirmatory test, physicians need to receive accurate information about the interpretation of HCV antibody tests to be able to appropriately counsel patients who test positive for these antibodies.
References
1Smith BD, Morgan RL, Beckett GA, Falck-Ytter Y, Holtzman D, Ward JW, et al. Hepatitis C virus testing of persons born during 1945-1965: recommendations from the Centers for Disease Control and Prevention. Ann Intern Med. 2012;157:817-22.
PubMed
2Smith BD, Morgan RL, Beckett GA, Falck-Ytter Y, Holtzman D, Teo CG, et al. Centers for Disease Control and Prevention. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965. MMWR Recomm Rep. 2012;61: ((RR-4)) 1-32.
PubMed
3Alter MJ, Kuhnert WL, Finelli L, Centers for Disease Control and Prevention. Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2013;52: ((RR-3)) 1-13.
PubMed
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Hepatitis C Virus Testing of Persons Born During 1945-1965
Bryce D. Smith, PhD; Deborah Holtzman, PhD; and John W. Ward, MD
[+] Article and Author Information
See Also:
· Hepatitis C Virus Testing of Persons Born During 1945-1965:
Recommendations From the Centers for Disease Control and Prevention
This letter concerns the article(s):
· Hepatitis C Virus Testing of Persons Born During 1945-1965
· Hepatitis C Virus Testing of Persons Born During 1945-1965
IN RESPONSE:
We agree with Dr. Lynn's assertion that effective screening for a history of injection drug use, receipt of blood products before 1992, and testing for elevated alanine aminotransferase levels would identify most chronic HCV infections among persons born during 1945-1965. The CDC has recommended risk-based screening since 1998 (1). Unfortunately, risk-based screening alone has had limited success, because 45% to 85% of infected persons are unaware of their infection (2). Not only are persons unaware of having had a risk that led to infection, studies have also shown that physicians often do not ask their patients about high-risk behaviors, especially behaviors considered sensitive. Furthermore, even when alanine aminotransferase levels are persistently elevated, only a minority of patients are tested for HCV (3 - 4).
Consequently, risk-based testing alone is insufficient to reduce HCV-associated morbidity and mortality, which is increasing in the United States. Augmenting risk-based testing with testing of the 1945-1965 birth cohort, a population accounting for 76% of persons who have been infected with HCV, is thus a reasonable strategy to overcome the problems of patient disclosure and physician reluctance to solicit risk information (5).
Dr. Lynn also asserts that the cost-effectiveness analysis should have been based on a birth-cohort population that excluded persons at high risk for infection. Because birth-cohort testing applies to persons at all levels of risk born during those years, excluding persons at high risk from the cost-effectiveness analysis model would be inappropriate. The model that the CDC developed is most sensitive to the high costs of treatment. In our sensitivity analysis, the costs of testing account for only about 10% of the total cost of the intervention and therefore have a relatively small effect on its cost-effectiveness (6).
Although this is less cost-effective at lower prevalence levels, the difference that would result from removing those that had already been tested would not be sufficient to change the conclusion that the overall intervention is cost-effective. Another challenge is the lack of data on the proportion of high-risk persons who have not yet been tested, limiting our ability to estimate the number of persons who would be tested.
Dr. Back expresses concern that implementing the recommendation would result in many persons receiving false-positive diagnoses of HCV infection. However, 2003 guidelines for laboratory testing and result reporting of HCV antibodies recommended following a weak reactive HCV antibody test with RIBA to confirm antibody status, thus minimizing false-positive results for antibodies (7).
Because RIBAs are no longer available, the CDC recommends an HCV RNA test, thus focusing on identification of HCV viremia rather than antibody positivity. In this way, the presence of current HCV infection can be determined.
Testing to detect current HCV infection is a 2-step process. First, HCV antibody tests identify persons exposed to HCV (but do not determine active infection status). Then, HCV RNA testing (using nucleic acid tests) determines whether someone is currently infected. Therefore, an anti-HCV-positive result that is HCV RNA-negative cannot be a false-positive diagnosis of infection, because the interpretation of those results is that the patient is not infected.
The CDC's birth cohort recommendation shifts the focus away from HCV antibodies to identification of infection, because this provides clinically actionable data. Identification of current infection is the first step toward prevention services that can reduce the risk for transmission to others, slow fibrosis progression, and evaluate clinical markers to make decisions about providing treatment to reduce HCV-related morbidity and mortality.
References
1Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. Centers for Disease Control and Prevention. MMWR Recomm Rep. 1998;47: ((RR-19)) 1-39.
PubMed
2Smith BD, Morgan RL, Beckett GA, Falck-Ytter Y, Holtzman D, Teo CG, et al. Centers for Disease Control and Prevention. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965. MMWR Recomm Rep. 2012;61: ((RR-4)) 1-32.
PubMed
3Spradling PR, Rupp L, Moorman AC, Lu M, Teshale EH, Gordon SC, et al. Chronic Hepatitis Cohort Study Investigators. Hepatitis B and C virus infection among 1.2 million persons with access to care: factors associated with testing and infection prevalence. Clin Infect Dis. 2012;55:1047-55.
PubMed
CrossRef
4Rein DB, Wagner D, Brown K, Fallon M, Federman A, Massoud, et al. Hepatitis C antibody testing and follow-up in primary care settings: a retrospective study of four large, primary care service centers infection among persons born during 1945-1965 in the United States. Presented at the 2012 National Summit on HIV and Viral Hepatitis Diagnosis, Prevention and Access to Care, Washington, DC, 26-28 November 2012.
5Smith BD, Patel N, Beckett G, Ward JW. Comparison of hepatitis C virus infection screening strategies: elevated alanine aminotransferase levels versus birth cohort. Presented at the 2011 American Association for the Study of Liver Disease Liver Meeting, San Francisco, California, 4-6 November 2011.
6Rein DB, Smith BD, Wittenborn JS, Lesesne SB, Wagner LD, Roblin DW, et al. The cost-effectiveness of birth-cohort screening for hepatitis C antibody in U.S. primary care settings. Ann Intern Med. 2012;156:263-70.
PubMed
CrossRef
7Alter MJ, Kuhnert WL, Finelli L, et al. Centers for Disease Control and Prevention. Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2003;52: ((RR-3)) 1-13.
PubMed
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