Comments on United States
Preventive Services Task Force
Draft Hepatitis C Screening
Guideline
Brian R. Edlin, MD, FACP, FIDSA
Senior Principal Investigator
National Development and Research Institutes
Professor of Medicine
SUNY Downstate College of Medicine
Associate Professor of Public Health and Medicine
Weill Cornell Medical College
New York, New York
December 12, 2012
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United States Preventive Services Task
Force (USPSTF)
• Serves a critically important function for the nation by
providing a fresh, unbiased set of eyes on issues of
central importance to patients, physicians, and health
systems.
• Performs rigorous and systematic reviews of literature
• Uses an analytic framework whose elements (included
and omitted) guide the outcome
• Uses a process for evaluating the evidence and drawing
conclusions from them that is opaque and subjective
Edlin Hepatology 2013
United States Preventive Services Task
Force (USPSTF)
Two step process
1. Rigorous and systematic reviews of literature
• Elements of analytic framework may guide the outcome
• E.g., harms of screening (e.g. labeling) are assumed
whether or not there is evidence of them, while inherent
benefits of knowing one’s status (e.g. autonomy) are not
considered
2. Evaluation of evidence and writing of recommendations
• Process not described or detailed
• Opaque and subjective
Edlin Hepatology 2013
United States Preventive Services Task
Force (USPSTF)
2004 Hepatitis C Screening Guideline
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Do not screen asymptomatic adults for hepatitis C
Harms > benefits
Harms: labeling, liver biopsies, adverse treatment effects
No evidence that treatment results in clinical benefit
Caused confusion and controversy
• NIH, CDC, FDA, VHA, IDSA, AASLD, ACG, AGA, IOM
recommended hepatitis C screening and treatment
Edlin Hepatology 2013
United States Preventive Services Task
Force (USPSTF)
2013 Hepatitis C Screening Guideline
• TBA
26 November 2012 Draft Guideline
• “Consider” screening asymptomatic adults b. 1945-1965
• “Grade C” recommendation (“small” net benefit)
• Screen people who injected illicit drugs or received
blood before 1992 (“Grade B” recommendation)
• Open for public comment until December 24, 2012
Edlin Hepatology 2013
United States Preventive Services Task
Force (USPSTF)
26 November 2012 Draft Guideline
• The draft guideline does not recommend asking patients
if they have ever injected illicit drugs and testing them for
hepatitis C if they say yes.
• It only recommends testing people already known to
have injected drugs.
• USPSTF does not recommend asking anyone if they have
ever used illicit drugs at all.
www.uspreventiveservicestaskforce.org/uspstf08/druguse/drugrs.htm
United States Preventive Services Task
Force (USPSTF)
2004 Hepatitis C Screening Guideline
• Carry considerable weight with healthcare payers and
public health agencies
• Affordable Care Act mandates universal insurance
coverage of USPSTF grade A or B recommendations
• Set back public health efforts to control hepatitis C
► 67 million b.1945-65 saw primary care provider in US in 2006
► Screening would have detected 1.2 million infections and
averted 82,000 deaths
Rein Ann Intern Med 2012;156:263-70.
Edlin Hepatology 2013
USPSTF Hepatitis C Screening Guideline
This Analysis
• Reviews USPSTF procedures for key steps in its process
• Makes recommendations to strengthen the process
and the nation’s hepatitis C screening policy
Edlin Hepatology 2013
United States Preventive Services Task
Force (USPSTF) Methods
• USPSTF believes that it “stands as an independent arbiter of
the evidence, and, as such, has set the standard for
evidence-based recommendations for the delivery of
clinical preventive services.”
Guirguis-Blake Ann Intern Med 2007;147:117-22.
• But USPSTF decisions require value judgments, which it says it
makes by “striving to consider what it believes are the
general values of most people.”
Harris Am J Prev Med 2001;20(3 Suppl):21-35.
USPSTF Procedure Manual. AHRQ Pub. No. 08-05118-EF. 2008.
• This is not an evidence-based method.
Edlin Hepatology 2013
USPSTF Hepatitis C Screening Guideline
Benefits of Hepatitis C Screening
(USPSTF considered only the first of these)
• Access antiviral treatment
• Educate oneself and make an informed choice about
antiviral treatment
• Monitor developments in the rapidly evolving field of
HCV drug development
• Obtain health insurance so that treatment will be an
option in the future
Edlin Hepatology 2013
USPSTF Hepatitis C Screening Guideline
Benefits of Hepatitis C Screening,
cont’d
(USPSTF considered none of these)
• Be vaccinated against hepatitis A and B
• Take other steps to avoid complications of hepatitis C,
such as avoiding or getting treated for HIV infection or
alcohol consumption, and avoiding hepatotoxic
medications and herbal remedies
• Take steps to avoid transmitting the infection to others,
including loved ones
Edlin Hepatology 2013
USPSTF Hepatitis C Screening Guideline
Benefits of Hepatitis C Screening: Reducing Alcohol
Consumption
• USPSTF recommends screening and counseling for unhealthy
alcohol consumption because of evidence that it is effective.
• USPSTF did not consider this evidence for the hepatitis C
guideline because the research was not carried out
specifically in people with hepatitis C.
• No reason is given for thinking this evidence would not apply
to people with hepatitis C. This seems to carry the fear of
extrapolation to extreme and inordinate lengths.
USPSTF Hepatitis C Screening Guideline
Benefits of Hepatitis C Screening: Autonomy
• People with hepatitis C gain autonomy when they learn
their status because they can take steps to address it.
• Ethical principles guiding the practice of medicine and
public health emphasize the importance of autonomy.
• USPSTF does not consider the importance of autonomy to
patients.
Edlin Hepatology 2013
Studies Modeling Hepatitis C Screening
Screening Persons Born in 1945-65
• Would avert 78,000-121,000 deaths
• Would avert 10,000-19,000 liver transplant (relieving
shortage of livers, saving lives of others awaiting organs)
Rein Ann Intern Med 2012;156:263-70.
McGarry Hepatology 2012;55:1344-55.
Screening Persons Aged 20-69
• Would avert up to 200,000 deaths
Coffin Clin Infect Dis 2012;54:1259-71.
These benefits are not “small”!
Edlin Hepatology 2013
USPSTF Hepatitis C Screening Guideline
• USPSTF dismissed one of these 3 studies, saying it assumed
>75% of people with hepatitis C would develop cirrhosis.
This is incorrect, however. The study assumes 54% of
people will develop cirrhosis over a lifetime (many
decades) with hepatitis C.
Even if the true benefits of screening are one-tenth of
what these 3 studies estimate, they are still not “small.”
USPSTF Hepatitis C Screening Guideline
Groups with an elevated hepatitis C prevalence
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Persons born between 1945 and 1965
Men
African Americans
Persons with diabetes or other medical illnesses
Persons with mental health conditions
Persons with illicit substance use (injected or
noninjected)
Edlin Hepatology 2013
USPSTF Hepatitis C Screening Guideline
Groups with an elevated hepatitis C prevalence, cont’d
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Hemodialysis patients
Persons lacking health insurance
Persons living in poverty
Homeless persons
Persons in correctional institutions
Persons receiving unsafe medical injections
Persons born in a high-prevalence country
Edlin Hepatology 2013
USPSTF Hepatitis C Screening Guideline
Groups with an elevated hepatitis C prevalence, cont’d
• Persons who had a blood transfusion before 1992
• Persons with < 12 years of education
• Persons who have had 10 or more sexual partners in
their lifetime
• Persons who had sex before they were 18
• Most people belong to one or more of these groups.
• Everyone should be screened for hepatitis C.
Recommendations to Improve USPSTF
Guideline Process
1. Adopt a balanced approach to evaluating the benefits
and harms of screening
2. Consider the preponderance of the evidence
3. Acknowledge the validity of SVR as a surrogate endpoint
4. Consider the wide variation in hepatitis C prevalence in
diverse patient populations
5. Be transparent about its value judgments
6. Federal insurance mandates should consider guidelines
written by CDC and NIH and not only USPSTF
Edlin Hepatology 2013
United States Preventive Services Task
Force (USPSTF) Draft Guideline
USPSTF Draft Hepatitis C Screening Guideline
• The USPSTF draft Hepatitis C Screening Guideline is open
for public comment until December 24, 2012.
• To comment, visit:
www.uspreventiveservicestaskforce.org/draftrec2.htm
Click on the comment box in the upper right corner of
the main screen panel (not the banner)
• Comment!