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Hepatitis C Screening: An Urgent Priority

Hepatitis C Screening: An Urgent Priority. H. Nina Kim, MD MSc Assistant Professor of Medicine Division of Allergy & Infectious Diseases University of Washington April 24, 2012. No financial conflicts of interest. Burden of Chronic Hepatitis C.

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Hepatitis C Screening: An Urgent Priority

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  1. Hepatitis C Screening: An Urgent Priority H. Nina Kim, MD MSc Assistant Professor of Medicine Division of Allergy & Infectious Diseases University of Washington April 24, 2012 No financial conflicts of interest

  2. Burden of Chronic Hepatitis C • Most common bloodborne chronic viral infection. • Chronic viral hepatitis is 3-5 X more frequent than HIV • No vaccine for hepatitis C. • Serious public health problem in US • Up to 4 million* Americans live with HCV infection • 80% of these have chronic persistent infection • Highest HCV prevalence: • Aged 40-59 • Blacks, Hispanics • Poverty level or below • Incarcerated, homeless, immigrant, active IDUs Armstrong, Annals Intern Med 2006; 144:705. www.cdc.gov/hepatitis/HCV

  3. Subgroups with High HCV Seroprevalence Armstrong, Annals Intern Med 2006; 144:705. Dominitz, Hepatology. 2005;41(1):88-96. Weinbaum, MMWR. 2003 Jan 24;52(RR-1):1-36.

  4. HCV Seroprevalence by Age groupNHANES Armstrong, Ann Intern Med. 2006;144(10):705-14.

  5. Natural History of Hepatitis C 5-25% symptoms Exposure (Acute phase) Exposure (Acute phase) Accelerants: HIV & Alcohol 80% Resolved Chronic Chronic 5-20%* Cirrhosis Cirrhosis Stable 1-5%** ESLD, HCC Transplant Death ESLD, HCC Transplant Death Slowly Progressive * in 20-30 yrs ** per year

  6. Silent Nature of Chronic Hepatitis C • Majority of those infected not yet diagnosed • Only an estimated 25-50% are aware of their HCV infection • Asymptomatic – many unaware they are infected with HCV until they have symptoms of cirrhosis or liver cancer • Screening not being done • Only a small minority (0.5 million) in US have been treated • HCV is leading indication for liver transplantation in U.S. • $30 billion health costs per year • HCV is leading cause of death from liver disease in U.S. • Now up to 12,000 deaths annually Institute of Medicine Report 2010 on Chronic Viral Hepatitis. www.cdc.gov/hepatitis/HCV

  7. Trends in Health Care Resources for HCV in US Grant, et. al. Hepatology 2005; 42(6):1406-1413.

  8. Trends in Health Care Resources for HCV in US Grant, et. al. Hepatology 2005; 42(6):1406-1413.

  9. HCV Disease Progressionin an Aging Population Davis, Gastroenterology. 2010;138(2):513-21.

  10. Mortality for HCV now exceeds that of HIVUS, 1999-2007 Ly et. al. Annals of Intern Med 2012;156:271-278.

  11. So how did we get here?

  12. Gaps in Awareness & Understandingamong those at highest risk • Drug User Intervention Trial enrolled 3,004 young injection drug users (IDUs) in 5 U.S. cities – 34% found to be HCV-positive • 72% of HCV-positive not aware of their status or thought they were negative • More likely to be aware if hx drug treatment or needle exchange • Among 150 patients seeking substance-use treatment at VA medical center • 90% of those HCV-infected were not aware of their status • 41% IDUs did not know or were unsure of how HCV was spread or what complications can develop • Australian study: 42% of IDUs believed being antibody positive for HCV meant you were immune Hagan, Public Health Reports 2006;121(6):713-19. Dhopesh, Am J Drug Alc Abuse 2000;26:703. O’Brien, Addictive Behav 2008;33(12):1602-05.

  13. Lack of Public Awareness Lack of Provider Awareness Lack of Public Resource Allocation • At-risk people do not know that they’re at risk or how to prevent getting infected • At-risk people may not have access to preventive services • Chronically infected people do not know that they are infected • Many medical providers do not screen or know how to manage those infected • Infected people often have inadequate access to testing & medical care • Inadequate disease-surveillance systems both underreport acute/chronic HCV Improved Provider & Community Education Integration & Enhancement of Viral Hepatitis Services Improved Disease Surveillance Institute of Medicine Report 2010 on Chronic Viral Hepatitis.

  14. Goals for Healthy People 2020: • Reduce by 25% number of new hep C cases • Increase awareness of hep C infection from 45% to 66% among those infected http://www.hhs.gov/ash/initiatives/hepatitis/

  15. This alarming trend in hep C can be reversed…We know HCV treatment can save lives and permanently clear HCV virus…

  16. Sustained Virologic Response (SVR)Goal of HCV Treatment Sustained Virologic Response (SVR) 7 HCV RNA negative 24 weeks after cessation of treatment 6 Sustained Virologic Response (SVR) 5 4 HCV RNA Log10 IU/ml End of Treatment 3 24 Weeks 2 Undetectable 1 0 -8 -4 -2 0 4 8 12 16 20 24 32 40 48 52 60 72 Weeks After Start of Therapy Modified From: Ghany MG, et. al. Hepatology. 2009;49:1335-74.

  17. HCV Patients with Advanced Fibrosis:SVR Reduces Mortality & Morbidity Liver-Related Death Liver Failure 50 50 40 40 30 30 Liver Failure (%) Liver-Related Death (%) 20 20 10 10 0 0 0 1 2 3 4 5 6 7 8 0 1 2 3 4 5 6 7 8 Year Year 5-yr occurrence SVR: 4.4% (CI: 0% to 12.9%)No SVR: 12.9% (CI: 7.7% to 18.0%)P = .024 (log likelihood) 5-yr occurrence SVR: 0%No SVR:13.3% (CI: 8.4% to 18.2%)P = .001 (log likelihood) Veldt BJ, et al. Ann Intern Med. 2007;147:677-684.

  18. Sustained Virologic ResponseClinical Outcomes in HIV-HCV Patients Incidence per 100 person-yrs Hepatic decompensation Berengeur et. al. Hepatology 2009; 50:407-413.

  19. Therapy for Hepatitis C: Historical Milestones Timeline 1986 1998 2001 2002 Source: Ghany MG, et. al. Hepatology. 2009;49:1335-74.

  20. Therapy for Hepatitis C: Historical Milestones Timeline 1986 1998 2001 2002 2011 70

  21. Direct-Acting AntiviralsA New Era of HCV Therapy • New standard of care for HCV genotype 1 infection • HCV protease inhibitor + pegIFN / ribavirin  “triple therapy” • Higher SVR rates observed across all patient groups including “difficult to treat” groups (prior tx failures, AA, cirrhotics). • Challenges remain: • Access & tolerability still limited by Peg-IFN + RBV • Pill burden, q8h dosing + meal • Additional side effects • Drug interactions • Resistance? • Cost! • IFN-free era in horizon?

  22. Hepatitis C VirusClasses of Direct-Acting Antivirals NS3/4A protease inhibitor Hepatitis C Proteins Structural Proteins Nonstructural (NS) Proteins C E1 E2 p7 NS2 NS3 NS4A NS4B NS5A NS5B Nucleocapsid Envelope Glycoprotein CysteineProtease Serine Protease Cofactors RNA binding and assembly recognition complex Envelope Glycoprotein Vioporin Serine Protease RNAHelicase Membranous Web Induction RNA-Dependent RNA Polymerase NS5A polymerase inhibitor • NS5B polymerase inhibitors • Nucleoside analogues • Non-nucleoside inhibitors

  23. Hep C Screening is the First Step… Cure Assessment Testing Treatment Counseling Screening

  24. Comprehensive Strategy to Prevent & Control HCV • Primary Prevention • Screen & test blood, plasma, organ, tissue donors • Sterilize plasma-derived products • Infection control practices • Risk reduction & counseling services • Drug treatment & safe syringe/needle access • Secondary Prevention • Identify, counsel & test persons at risk • Medical management of infected persons

  25. What is Recommended for Hep C Screening? Centers for Disease Control, 1998: Yes: “Testing should be offered routinely to persons most likely to be infected with HCV… and be accompanied by appropriate counseling & medical follow-up.” American Association for Study of Liver Diseases, 2009: Yes: “as part of a comprehensive health evaluation, all persons should be screened for behaviors that place them at high risk for HCV infection.” US Preventive Services Task Force, 2004: Not really: “USPSTF found insufficient evidence to recommend for or against routine screening for HCV infection in adults at high risk for infection.”

  26. Who Should be Screened for Hepatitis C?CDC Guidelines, 1998 • Ever injected illegal drugs • Received clotting factors made before 1987 • Received blood/organs before July 1992 • Ever on chronic hemodialysis • Evidence of liver disease (elevated liver enzymes) • Infants born to HCV-infected mothers • HIV infection • After HCV exposure (needlestick injury)

  27. Where Should Screening for Hepatitis C Take Place?CDC Guidelines, 1998 Screen at these venues: • Correctional institutions • HIV counseling & testing sites • Drug treatment facilities • STD treatment programs Screening must include: • Counseling on • What results mean • Whether further testing needs to be done • Referral/linkage to medical care

  28. Targeted Risk-Based ScreeningOnly as good as the asking… • 4,000 primary care physicians mailed survey; 1,412 responded • Most clinicians lack familiarity with HCV: • 73% had < 5 hep C patients in the preceding year • 44% had no experience with treatment of HCV • Only 59% said they asked all patients about hep C risk factors McGinn, Arch Intern Med 2008;168(18):2009-2013.

  29. Risk-based Screening Limitations • Patients uncertain of past exposure history • Reticence to disclose sensitive risk behaviors • Providers reluctant to ask about sensitive risk behaviors • Inconsistent system-wide implementation • Ultimately it has failed… • 40-85% of HCV-infected still undiagnosed McGinn, Arch Intern Med 2008;168(18):2009-2013. Shehab, J Viral Hepat 2001;8(5):377-83. Serrante, Fam Med 2008;40(5):345-51.

  30. Birth Cohort ScreeningCDC, 2012-2013 • We need enhanced easy-to-implement screening guidance that works • Remember: 80% HCV-infected persons born 1945-1965 • Birth cohort screening shown by modeling to be more cost-effective than risk-based screening: • Would identify additional 808,580 HCV cases & prevent 82,000 HCV-related deaths at a cost of $2874 per new case identified • $15,700 per QALY saved assuming standard treatment and $35,700 per QALY saved assuming addition of new antivirals. • Revised CDC guidelines coming… stay tuned. Rein, Annals of Intern Med 2012;156:263-270.

  31. HCV Diagnostic Algorithm Antibody Test EIA for anti-HCV HCV RNA • Negative for HCV InfectionAdditional Testing Recommended if: • Acute HCV suspected • Hemodialysis • Immunocompromised Active HCV InfectionMedical Evaluation RIBA Resolved HCV Infection False-Reactive EIA CDC Guidelines on Hep C Dx, MMWR 2003;52(RR03):1-16.

  32. Counseling the HCV-positive Patient www.cdc.gov/hepatitis/HCV

  33. Counseling the HCV-positive Patient www.cdc.gov/hepatitis/HCV

  34. Rapid Testing for HCVFDA approved, June 2010 • Approved for whole blood, fingerstick • Oral swab testing not yet approved • Antibody test, similar to HIV rapid test • Point-of-care – results x 20 min • Preliminary “positive” – needs confirmatory testing • Sensitivity 79-99% • Specificity 80-100% • Increased feasibility of testing in outreach settings (needle exchange, STD clinics, methadone programs) Smith BD, J Infect Dis. 2011;204(6):825-31.

  35. May 19National Hepatitis Testing Day • Opportunity to remind health care providers and the public who should be tested for chronic viral hepatitis. • Build collective voice around this urgent issue. http://www.cdc.gov/hepatitis/KnowMoreHepatitis.htm

  36. Meeting the Challenges of HCV Parallels with HIV • Both infections can carry stigma • Disproportionate burden among marginalized • Many undiagnosed & untreated • Risk-based screening has proven inadequate in identifying infected persons promptly • Barriers to new life-saving treatments • Increasing complexity of management • Shortage of skilled clinicians • Concerns re cost & reimbursement • But HCV treatment is of limited duration & achieves a cure • Like HIV, we can gain ground with advocacy & education

  37. www.hepwebstudy.org

  38. www.hepwebstudy.org

  39. www.hepwebstudy.org

  40. www.hepwebstudy.org

  41. Questions?

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