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The US Preventive Services Task Force (USPSTF) made recommendations on screening for hepatitis C virus (HCV) infection in the 16 March issue of Annals of Internal Medicine (volume 140). Some of these recommendations are not in line with those of the Centers for Disease Control (CDC) and the National Institutes of Health (NIH) Consensus Panel, as endorsed by the American Liver Foundation.
The Summaries for Patients document, written in Q&A format, reads as follows:
What does the USPSTF suggest that patients and doctors do?
Patients and doctors should be aware that there are no studies that prove that screening for HCV infection during routine health care improves patient outcomes. The USPSTF recommends against testing for HCV infection in patients who have no specific risk factors for HCV infection and no symptoms of liver disease. The USPSTF recommends neither for nor against routine testing for HCV infection for patients with specific risk factors for HCV infection.
The American Liver Foundation believes that, by failing to support the importance of testing those at risk for hepatitis C, the USPSTF trivializes a serious public health problem, for which substantial scientific evidence and FDA-approved tools and therapies demonstrate that diagnosis and treatment are beneficial. The ALF also believes that the USPSTF’s lack of recommendation for testing for HCV in patients who have no specific risk factors may confuse the public and undermine current screening recommendations that are in practice.
The seriousness of USPSTF’s position is underscored by the fact that over 80% of the more than 4 million Americans infected with HCV do not know that they are infected. Identifying those infected through testing is a matter of national health urgency.
The primary concern of the ALF is the USPSTF recommendation that there is insufficient evidence to recommend for or against routine screening of high-risk adults effectively provides a rationale for health care providers to stop HCV testing for highest risk individuals and for third party payers not to reimburse for the testing. This flies in the face of the accumulated expertise and findings of the Centers for Disease Control (CDC) and the National Institutes of Health (NIH) Consensus Conference Panel on the Management of Hepatitis C. CDC and Consensus Conference recommendations are based on the intermediate outcomes regularly curing people of HCV infection.
Most of those with HCV have been infected for more than 15-20 years. For those who are vulnerable to HCV-induced liver damage, this passage of time without therapeutic intervention can lead to serious morbidity, liver transplantation or death.
At this time, there are no long term follow-up studies (10-20 years) comparing outcomes of patients treated with combination therapy vs. those that were not. This length of follow-up is needed for HCV for, when it progresses, it moves very slowly. And there is no data on prognosis of patients at risk identified by screening. Until such data are available, it remains prudent to screen those at risk for this infection and to assess their need for treatment. While more long term data is needed, there is abundant data about intermediate outcomes regarding curing patients of HCV infection.
In addition, the ALF believes that:
Hepatitis C awareness must be increased among the general public and within the medical community.
Screening and diagnosis should be available to everyone who needs or wants it.
Information regarding treatment options should be available to anyone who needs it.
Effective hepatitis C treatment must be available to anyone who needs it.
The American Liver Foundation also has grave concerns over the unfortunate recommendation from the USPSTF that interventions designed to reduce liver injury from other causes, such as counseling to avoid alcohol misuse and immunization against hepatitis A and hepatitis B, demonstrate limited evidence of the effectiveness of these interventions. For the millions of Americans with hepatitis C these interventions help maintain the health and stability of an impaired liver. Also of great concern to the American Liver Foundation is the apparent dismissal of liver biopsies by the USPSTF, long the “gold standard” through which to determine levels of liver disease and liver damage.
Current estimates indicate that deaths from hepatitis C will outpace deaths from HIV by the end of this decade. Without screening of those at risk, and the use of directed therapy, we won't be able to change this. Also, the majority of liver transplants in this country are the result of chronic hepatitis C infection and substantial scientific evidence demonstrates that the burden is projected to increase.
March 16, 2004
From the President of the American Association for the Study of Liver Diseases (AASLD):
A study was published today in the Annals of Internal Medicine entitled Screening for Hepatitis C Virus Infection: Recommendations from the U.S. Preventive Services Task Force, concluding that it "found no evidence that screening for HCV infection in adults at high risk leads to improved long-term health outcomes". It is critical that the contents of this study be understood and not misinterpreted.
The report points out that "Antiviral treatment can successfully eradicate HCV, but data on long-term outcomes in the populations likely to be identified by screening are lacking."
While this statement is true, it would be erroneous and dangerous to conclude from it that screening of high-risk populations, therefore, is not a public health benefit to the American people.
There are no data on long-term studies of the effectiveness of screening and treatment. The reason for this is that the disease can often take 20 or more years before symptoms appear and effective treatments for the disease using combination therapies have only been developed in the past 6 years and further improved in the past two years.
The report is correct when it says in its final paragraph:
Complications from chronic HCV infection present an enormous health burden that is expected to increase 2- to 4-fold over the next 2 to 4 decades. Further research to more accurately determine the benefits and harms of screening is of paramount importance. (p. 475)
Researchers will not be able to determine the "benefits and harms of screening" unless there is screening of high-risk populations. To misinterpret the report to say that such screening should be stopped would be a terrible mistake with grave consequences over the next two decades.
The study correctly points out some key data about infection with the hepatitis C virus that argue strongly in favor of screening of high-risk populations:
Hepatitis C is the most common chronic bloodborne pathogen in the United States.(p.465)
Approximately 2.3% of adults 20 years or older are positive for anti-HCV and 55% to 84% of these have chronic infection. (p.465)
Most of those infected are not aware of it and, therefore, can and do spread the disease. (p.465)
In the U.S., HCV is associated with 40% of cases of chronic liver disease and 8,000 to 10,000 deaths per year. (p. 465)
In addition, it should be noted that HCV is a leading cause of cirrhosis, a common cause of hepatocellular carcinoma (HCC) and the leading cause of liver transplantation in the United States. Early and effective treatment of HCV holds the potential to reduce the number of liver transplants needed and to alleviate the current severe shortage of donor organs.
This study makes a valuable contribution to the public debate about addressing the epidemic of HCV in the United States. Other contributions on the subject include the AASLD practice guidelines for the diagnosis, management and treatment of hepatitis C which are posted on the AASLD web site and published in the April issue of HEPATOLOGY. AASLD looks forward to continuing to participate in the discussion as our members make valuable contributions to the research on this important and deadly disease.
Bruce R. Bacon, MD, President,
American Association for the Study of Liver Diseases (AASLD)
AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD's vision is to prevent and cure liver diseases. The Web site is www.aasld.org.
U.S. Preventive Services Task Force Hepatitis C Screening Recommendations
Q&A FROM THE CDC
Q1. Why has CDC developed this Q and A?
A1. CDC has developed this document to address questions that might arise about how and why the hepatitis C screening recommendations for adults made by the United States Preventive Services Task Force (USPSTF) differ from those previously published by CDC.
The USPSTF is an independent panel of experts in primary care and prevention that systematically reviews the evidence of effectiveness and develops recommendations for clinical preventive services. The Task Force and its review of published research are supported by the Agency for Healthcare Research and Quality, Department of Health and Human Services.
The USPSTF makes recommendations based on review of the published literature and a strict set of criteria. The primary basis for their findings are whether there is sufficient evidence (e.g., data on effectiveness) that the intervention (service) improves important long-term, health outcomes (e.g., mortality, morbidity, quality of life) and that benefits outweigh harms.
Q2. What are the USPSTF hepatitis C screening recommendations?
A2. The Task Force:
recommended against routine screening for hepatitis C virus (HCV) infection in the general U.S. population because of the low prevalence of infection
found insufficient evidence to recommend for or against routine HCV screening in adults at high risk for infection because there is no evidence yet that such screening leads to improved long-term health outcomes.
Q3. Are the USPSTF hepatitis C screening recommendations consistent with CDC hepatitis C screening recommendations?
A3. The Task Force recommendation against routine screening for HCV infection in the general population is the same as CDC’s recommendation. In addition, the Task Force recommendation that health care providers test for HCV infection persons with signs (e.g., elevated ALT) or symptoms of liver disease also support CDC’s recommendation.
The recommendation that there is insufficient evidence for or against HCV testing in adults at high risk for infection differs from current recommendations made by CDC, NIH and other professional organizations because there are criteria other than evidence of improved long-term outcomes that can support recommendations for routine testing.
Q4. Why does CDC recommend HCV testing routinely for persons at increased risk?
A4. About 2.7 million persons are chronically infected with HCV, and most of these are adults 30-59 years old. A major focus of current prevention activities is to reduce progression or severity of chronic disease as this cohort ages. Identification of HCV infected persons provides the opportunity for medical evaluation to determine disease status and possible treatment, and to obtain information on how they can prevent further harm to their liver (e.g., reduce alcohol intake, hepatitis A and hepatitis B immunization, substance abuse treatment). In addition, identification of HCV infected persons provides the opportunity for counseling on how to prevent transmission to others.
Q5. Who is the target audience for CDC’s recommendations?
A5. CDC’s hepatitis C screening recommendations are intended to serve as a resource for health professionals, public health officials, and organizations involved in the development, delivery, and evaluation of prevention and clinical services.
Q6. Who are the persons, most likely to be infected with HCV, that CDC recommends be tested?
A6. Persons most likely to be infected with HCV for whom testing should be offered routinely are:
persons who ever injected illegal drugs;
persons who received clotting factor concentrates produced before 1987 (e.g., those with hemophilia);
persons who were ever on chronic (long-term) hemodialysis;
persons with persistently abnormal liver enzymes (i.e., alanine aminotransferase levels); and
persons who received a transfusion of blood or blood components or an organ transplant before July 1992.
Persons for whom CDC recommends routine testing based on a recognized exposure are:
health care, emergency medical, and public safety workers after needle sticks, sharps, or mucosal exposures to HCV-positive blood; and
children born to HCV-positive women.
Q7. How did CDC select these persons for screening routinely?
A7. These recommendations were made based on various considerations, including established epidemiologic relationships between risk factors and acquiring HCV infection, the prevalence of risk behaviors in the population, the prevalence of HCV infection among persons with a risk behavior, and the need for persons with a recognized exposure to be evaluated for infection.
Q8. When and where were CDC’s hepatitis C screening recommendations published?
A8. Hepatitis C screening recommendations were published by CDC in 1998 in: Centers for Disease Control and Prevention. Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease. MMWR 1998;47(No.RR-19). These recommendations are available on the internet at:
Q9. What was the process used to develop CDC hepatitis C screening recommendations?
A9. These recommendations were developed by CDC based on extensive review of available knowledge and after consultation with a panel of experts, including representatives from federal agencies, state and local public health departments, professional medical organizations, blood banking organizations, and community groups.
Q10. Why did the USPSTF’s conclude that there is insufficient evidence to recommend for or against routine screening of adults at increased risk for hepatitis C?
A10. Currently the data are insufficient to determine whether long term outcomes are improved in HCV infected patients who receive antiviral treatment for chronic hepatitis. However, controlled clinical trials have shown that antiviral therapy for chronic hepatitis C results in the intermediate outcomes of eradication of virus and improved liver histology in an average of 50% of treated patients. These intermediate benefits may be surrogates for long-term benefits. In addition, the Food and Drug Administration has licensed treatment for chronic hepatitis C based on short and intermediate term outcomes and a conclusion that the benefit of treatment outweighs potential harms.
Q11. Are there important gaps in the information needed to determine the health benefits of HCV screening?
A11. There is a need for further research to evaluate the long-term effectiveness of antiviral therapy for chronic hepatitis C. In addition, it is not known whether counseling HCV-infected persons leads to behavior changes that would reduce transmission or reduce liver damage from alcohol and/or drug abuse, and studies are needed to determine the effectiveness of these interventions.
Because of the variability in the progression of HCV infection, it is important to define more precisely the risk of developing clinically important liver disease and factors that accelarate disease progression. In addition, studies are needed to identify HCV infected persons who would most likely benefit from antiviral therapy as measured by decreased mortality and morbidity, and improvement in quality of life.
It is known that patients with chronic hepatitis C are more likely to have fulminant disease if they are infected with hepatitis A virus and the Advisory Committee on Immunization Practices recommends hepatitis A vaccination for persons with chronic hepatitis C. However, the effectiveness of this intervention has not been evaluated.
In addition, research is needed to determine the screening benefit of identification and counseling of uninfected persons who are at increased risk for HCV infection and other bloodborne infections such as hepatitis B and HIV/AIDS.
Q12. Is CDC planning any changes in implementation of the National Hepatitis C Prevention Strategy?
A12. At this time CDC continues to support implementation of hepatitis C prevention activities and evaluation of the effectiveness of these activities.
The National Hepatitis C Prevention Strategy is available on the internet at:
The principal components of this strategy are:
education of health care and public health professionals to improve the identification of persons at risk for HCV infection and to ensure appropriate counseling, diagnosis, medical management, and treatment;
education of the public and persons at risk for infection about risk factors for HCV transmission, and the need for testing and medical evaluation;
clinical and public health activities to identify, counsel, and test persons at risk for HCV infection, and medical evaluation or referral for those found to be infected;
outreach and community-based programs to prevent practices that put people at risk for HCV infection, and to identify persons who need to get tested;
surveillance to monitor acute and chronic disease trends and to evaluate the effectiveness of prevention and medical care activities; and
research to better guide prevention efforts.