Expert Panel’s Decision to Recommend Against Routine HCV Screening Draws Community Ire
“Inconsistent With Other Bodies”
In March of 2004, the U.S. Prevention Services Task Force’s “Screening for Hepatitis C Virus Infection in Adults: Recommendation Statement” was published in the Annals of Internal Medicine. The USPSTF found insufficient evidence — based on long-term health outcomes — “to recommend for or against routine screening for HCV infection in adults at high risk for infection.” Tracy Swan reports.
The USPSTF is an independent panel of experts in prevention and primary care that systematically reviews the evidence of effectiveness and develops recommendations for clinical preventative services. The USPSTF is commissioned by the Agency for Healthcare Research and Quality, which is a program of the Department of Health and Human Services.
The USPSTF Recommendation Statement is not consistent with recommendations from other entities. Expert panels convened by the Department of Health and Human Services, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Veteran’s Administration (VA) and the American Association for the Study of Liver Diseases concur; they recommend testing for people who are at risk for hepatitis C:
- People who have shared injection equipment, even once;
- Anyone who has been notified that they received blood from a donor who later tested positive for hepatitis C;
- Anyone who received a blood transfusion or solid organ transplant before July 1992;
- Recipients of clotting factor(s) made before 1997;
- Anyone who has ever been on long-term kidney dialysis;
- Persons with evidence of liver disease such as persistently elevated ALT levels; and
- Because of the overlapping modes of transmission, HCV testing is recommended for all HIV-positive people.
What is the impact of this recommendation? According to Andi Thomas, founder and Executive Director of Hep-C Alert and President of the National Hepatitis C Advocacy Council, “We’ll see it over time, as the USPSTF Recommendation Statement gets incorporated into evidence-based prevention programming, CME activities and the education of new doctors.”
In fact, a CME program incorporating these guidelines has already appeared on Medscape. The inconsistency between the USPSTF Recommendation Statement and the HCV screening recommendations from NIH and CDC are listed only in the last three bullet points (of 21). One of two “Pearls for Practice” summarizing this CME states:
“There is insufficient evidence that newer treatments improve long-term health outcomes and disease progression. The USPSTF also cannot determine the benefits vs. harms of screening adults at high risk at this time.”
The failure to recommend HCV testing for high-risk individuals has disturbing implications for the fundamental right to medical care. People at risk for a chronic, potentially life-threatening illness are entitled to testing, even in the absence of data on the long-term outcomes of those treated for the condition. The Recommendation Statement may have a deleterious effect on public health; without testing, key prevention opportunities are forfeited as people with hepatitis C go undiagnosed.
Under-funded entitlement programs may use the USPSTF Recommendation Statement as a rationale for denying reimbursement for HCV testing. This will have the greatest impact on those at highest risk for HCV infection: current and former injection drug users (up to 90% may be infected), prisoners (estimated prevalence of 30-40%), and African American men from 40 to 49 years of age, among whom HCV is far more prevalent than the general population (9.8% vs. 1.8%).
According to Thomas, “this is a symptom of a much bigger problem: the lack of funded infrastructure for hepatitis C services in the U.S.” Thomas and her colleagues at the National Hepatitis C Advocacy Council have written legislation to create the needed infrastructure (see www.hepcnetwork.org/legislation.htm for more information about the Hepatitis C Epidemic Prevention and Control Act).
The CDC just announced that they are trimming two million dollars from their already meager Viral Hepatitis budget; now less funding will be going towards integration of HCV education and testing into HIV programming (among other demonstration projects). We need these programs; what benefits people who are at risk for, or infected with, hepatitis C will benefit coinfected people as well. Hepatitis C is an opportunistic infection of HIV disease. End-stage liver disease resulting from hepatitis C coinfection has become a leading cause of death among people with HIV.
Response to U.S. Preventative Services Task Force Recommendations on Screening for HCV Infection
The Treatment Action Group (TAG) believes the U.S. Preventative Services Task Force (USPSTF) should reconsider their recent recommendation on routine screening for persons at high risk of infection with the hepatitis C virus (HCV). The USPSTF “… found insufficient evidence to recommend for or against routine screening for HCV infection in adults at high risk for infection … and no evidence that screening for HCV in adults at high risk leads to improved outcomes.”
TAG believes that this recommendation is ill advised for several reasons:
- The USPTF recommendation does not benefit individual and public health. Individuals who are at high risk for a serious, potentially life-threatening illness deserve the opportunity to find out whether or not they are actually infected, regardless of the amount of data on long-term treatment outcomes.
- The USPTF recommendation can be used by third-party payors and under-funded entitlement programs as a rationale to withhold reimbursement for HCV testing. Lack of coverage for HCV testing will be especially devastating for high-prevalence populations such as current and former injection drug users, prisoners, homeless persons and the poor.
- HCV is a transmissible disease. Diagnosis of transmissible diseases such HCV is a cornerstone of prevention of new infections. People who are aware of their HCV status can take proactive steps to prevent transmission to others.
- HIV-positive people are at high risk for HCV coinfection, due to overlapping modes of transmission. HCV is prevalent among people with HIV infection, approximately 300,000 of whom are HCV coinfected. Hepatitis C is an opportunistic infection of HIV disease because HIV accelerates HCV disease progression and increases risk of mortality; HCV-related end-stage liver disease has become a leading cause of mortality in people with HIV. Expert panels convened by The U.S. Public Health Service (USPHS), the Centers for Disease Control (CDC), the National Institutes of Health (NIH), the American Association for the Study of Liver Diseases (AASLD) and the Veteran’s Administration (VA) all recommend HCV screening for all HIV-positive persons. Are people with HIV, a high-risk population, included in this recommendation?
- According to the NIH’s 2002 Consensus Statement on Management of Hepatitis C, “All patients with chronic hepatitis C are potential candidates for antiviral therapy.” It would be outrageous not to recommend screening of individuals at high risk for any other illness, particularly for a disease that can be eradicated with treatment.
- The majority of people with HCV in the United States have been infected for at least 15 years, and will become more vulnerable to complications from HCV in upcoming years. It is estimated that complications such as cirrhosis, liver failure and hepatocellular carcinoma will increase dramatically in the next fifteen years, not for lack of effective treatment, but for lack of knowledge. Most people who have HCV are unaware that they are infected. Screening of high-risk individuals, and treatment for those who require it may save thousands of lives.
The USPSTF recommendation contradicts screening recommendations from expert panels at the U.S. Public Health Service, the Centers for Disease Control, National Institutes of Health, the American Association for the Study of Liver Diseases, and the Veteran’s Administration. TAG shares the concerns of the American Association for the Study of Liver Diseases and the American Liver Foundation regarding the U.S. Preventative Services Task Force (USPSTF) Recommendation on Screening for Hepatitis C Virus Infection in Adults.