1. 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 `

2. 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

3. 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

4. United States Preventive Services Task Force (USPSTF) 2004 Hepatitis C Screening Guideline 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

5. 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

6. 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

7. 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 United States Preventive Services Task Force (USPSTF) 2004 Hepatitis C Screening Guideline ► 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

8. 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

9. 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.” 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.” This is not an evidence-based method. United States Preventive Services Task Force (USPSTF) Methods Edlin Hepatology 2013 Guirguis-Blake Ann Intern Med 2007;147:117-22. Harris Am J Prev Med 2001;20(3 Suppl):21-35. USPSTF Procedure Manual. AHRQ Pub. No. 08-05118-EF. 2008.

10. 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 Benefits of Hepatitis C Screening (USPSTF considered only the first of these) USPSTF Hepatitis C Screening Guideline

11. 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 Benefits of Hepatitis C Screening, cont’d (USPSTF considered none of these) USPSTF Hepatitis C Screening Guideline

12. 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. Benefits of Hepatitis C Screening: Reducing Alcohol Consumption USPSTF Hepatitis C Screening Guideline

13. 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. Benefits of Hepatitis C Screening: Autonomy USPSTF Hepatitis C Screening Guideline Edlin Hepatology 2013

14. 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) Edlin Hepatology 2013 Coffin Clin Infect Dis 2012;54:1259-71. Screening Persons Born in 1945-65 Screening Persons Aged 20-69 Would avert up to 200,000 deaths Rein Ann Intern Med 2012;156:263-70. McGarry Hepatology 2012;55:1344-55. Studies Modeling Hepatitis C Screening These benefits are not “small”!

15. 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

16. 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 Groups with an elevated hepatitis C prevalence USPSTF Hepatitis C Screening Guideline

17. 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 Groups with an elevated hepatitis C prevalence, cont’d USPSTF Hepatitis C Screening Guideline

18. 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 Groups with an elevated hepatitis C prevalence, cont’d USPSTF Hepatitis C Screening Guideline Most people belong to one or more of these groups. Everyone should be screened for hepatitis C.

19. 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 Recommendations to Improve USPSTF Guideline Process Edlin Hepatology 2013

20. 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!