Epidemiology of Hepatitis C in United States

1. Epidemiology of Hepatitis C in United States Jan Drobeniuc, MD, PhD Division of Viral Hepatitis Centers for Disease Control and Prevention

2. Hepatitis C (1989-…) • Virus: Spherical, Lipoprotein-enveloped, ~30 nm • Positive single-stranded RNA ~10 kb • Family: Flaviviridae • High genetic diversity: 6 genotypes • Most common genotypes in the US: 1a and 1b • Source: Human (blood/body fluids) • Route of transmission: Parenteral • Mean incubation period: 6 w (2–26w)

3. Acute Hepatitis C- A Challenging Diagnosis By Exclusion May take 2-3 months from exposure for anti-HCV seroconversion • Acute symptomatic infection: Discrete onset of symptoms consistent with acute viral hepatitis, usually jaundice or elevated LFT • Laboratory criteria: Serum ALT levels >400 IU/L, and IgM anti-HAV negative, and IgM anti-HBc negative and Anti-HCV positive by EIA, verified by an additional more specific assay (e.g. RIBA™ for anti-HCV or nucleic acid testing for HCV RNA)

4. Incidence* of Acute Hepatitis C in United States, 1992-2009† DVH/CDC., Viral Hepatitis Surveillance in United States, 2009 Report * Per 100,000 population.; † Until 1995, acute hepatitis C was reported as acute hepatitis NANB

5. Acute Hepatitis C Reports by Risk Exposure, United States, 2009

6. Acute Hepatitis C Reports by Risk Behavior, United States, 2009

7. Epidemiology of Acute Hepatitis C • Injection drug users • Healthcare associated • Sexual transmission? • Among heterosexuals • Among HIV-infected MSM and women • Perinatal transmission? • Tattoos?

8. Age Distribution of Confirmed Hepatitis C Cases among IDU, MA, 2002- 2008* HCV: The Next Generation *Holmberg S., Research in progress

9. Interview Findings (25 IDUs) Mean age started using drugs: 13.4

10. “Emerging” Risk Factor in Healthcare Settings - Unsafe Injections • Aware of ~20 outbreaks/clusters in last 10 years (no required reporting) • Inadequate injection syringe hygiene has led to transmissions in many settings, both hospital and non-hospital healthcare settings such as: • Colonoscopy and other med/surg clinics • “Alternative” care (chelation therapy) • Dialysis units * Thompson et al, Ann Intern Med 2009; 150:33-39. Also: http://www.cdc.gov/hepatitis/Outbreaks/

12. Indirect Syringe ReuseHCV Outbreak Investigation at the Colonoscopy Clinic, NV, 2008 • Syringes were reused to withdraw multiple doses for individual patients • Residual volume in single dose propofol vials was used for subsequent patients • The vial became the vehicle for HCV spread

13. Other Outbreaks in Healthcare Setting • In 1998-2011: Eleven outbreaks occurred in outpatient hemodialysis units due to breaks in infection control practice • >80 outbreak-associated cases of HCV • 2,000 persons notified for screening • In 2009 an outbreak occurred because of syringe contamination during drug diversion (stealing) by an HCV-infected hospital surgery technician • 24 outbreak-associated cases of HCV • 8,000 persons notified for screening

14. Routes of Transmission Patient-to-patient • Syringe reuse • Direct: Using the same syringe from patient to patient • Indirect: accessing shared medication vials with a used syringe • Reuse of single dose vials contaminated by above practices • Other infection control breaches during hemodialysis Needle vs Syringe Reuse Some providers do not understand that simply changing the needle on a used syringe is risky Provider-to-patient Transmissions occur through contamination of medication vials or syringes by staff diverting (stealing) medication

15. Most Common Medications Contaminated and then Reused • Vials of medication (propofol, fentanyl) used for sedation • Occured with use of vials larger than needed for a single patient taken into treatment area instead of remaining in the clean medication preparation area • Vials of saline for IV line flushes • Occured with use of vials larger than needed for a single patient taken into treatment area instead of remaining in the clean medication preparation area • IV saline bag improperly used to draw up IV line flushes

16. Is this the whole picture? IDENTIFIED OUTBREAKS Asymptomatic infection Difficulty identifying single healthcare exposure Under-reporting of cases Barriers to investigation Resource constraints Under-recognition of healthcare as risk

17. Laboratory Collaboration • Notification of potentially exposed patients for serologic screening • to detect additional cases • provide appropriate medical care for infected • prevent secondary transmissions • Specimen collection for molecular epidemiologic investigation from known cases • determine degree of relatedness between cases • some indication of length of infection

18. Molecular Epidemiology of HCV Outbreak, Colonoscopy Clinic, NV, 2007-2008 Holmberg SD, Clin Liver Dis 14 (2010) 37–48 / Courtesy of Y. Khudyakov

19. Prevention of Health Care Associated Transmissions State Health Departments may work with: • local hospital infection control officers and teams • Improve surveillance and investigation capacity • local outpatient healthcare facility managers and staff • Ensure healthcare provider education and training • state government entities that regulate and perform licensing and monitoring of healthcare facilities. CDC: Division of Viral Hepatitis (DVH) works closely with Division of Healthcare Quality Promotion (DHQP), • education campaigns about safe injection practices based on outbreaks and investigation findings, • development and dissemination of national infection control guidelines.

20. CMS Infection Control Survey Tool for Ambulatory Surgical Centers http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter09_37.pdf

21. Education of Health Care Providers and Patients

22. Engineering Safer Systems • Develop safer systems to prevent infections in the context of parenteral medication delivery • Examples of options/approaches • Autodisable syringes • Prefilled syringes • “Right-sized” vials • Tamper-evident packaging

23. The Burden of HCV Despite falling incidence, a substantial burden of disease is due to the chronic HCV infections- major cause of CLD in US. Estimated prevalence of HCV in the US 1.3% - 2.7–3.9 million are HCV-infected 65%–75% remain unaware of their infection. In the absence of treatment >150,000 will die From BP Bell et al, Am J Gastroenterol 2008; 103:1-10

24. CHRONIC HCV: US Health Departments Reporting Chronic Hepatitis C via NNDSS Reporting Chronic Hepatitis C (n=36) Does Not Report Chronic Hepatitis C (n=13)

25. Chronic Hepatitis C- Silent KillerThe Growing Burden of Mortality from Viral Hepatitis in the US, 1999-2007* *Ly K. et al., AASLD, 2011

26. Demographic Characteristics of Deaths in HCV Patients, US, 2007 *Adjusted Odds Ratio

27. Prevalence-based Strategy To Focus Testing of Persons Born 1945-1965 • Prevalence 5.3 times higher than others • 3.29% vs 0.55% • Represents 81% of 3.2 M adults with HCV • 67% have medical insurance • Represents 73%of all HCV-associated mortality • 45%-85% of infected persons are unidentified • HCV therapy can eliminate HCV infection • Reduce costs associated with disability • Hep C-related $21,000 versus $5,500 for others • At least 22 new drugs in phase II/III

28. Conclusions- I • Distinguishing acute/chronic/resolved infections is a major surveillance challenge. • IDU remain the main driver of the HCV epidemic in the United States. • A substantial proportion of HCV infections are acquired in healthcare settings.

29. Conclusions- II • Increasing number of deaths among HCV-infected persons surpass those among HIV-infected persons. • The relatively young age of most HCV-infected persons who are dying—i.e., 45-64 years old – portends a large and increasing health care burden. • Institute of Medicine (IOM) (2010) and US Health and Human Services (HHS) Action Plan (2011) call for an intensified, coordinated national effort to improve the prevention of new cases and the detection and treatment of chronic cases.

30. Priorities for Hepatitis C Surveillance and Prevention • Conduct surveillance to monitor transmission and disease, and clinical prevention services access and impact • Support and improve prevention of HCV transmission particularly among youth and young adults • Increase the proportion who are aware of their HCV infection status and linked to prevention and clinical care services

31. Acknowledgements • John Ward • Scott Holmberg • MoninaKlevens • Anne Moorman • Bryce Smith • Kathleen Ly • Nicola Thompson • SaleemKamili • YuryKhudyakov

32. Thank you!Presenting author contact: jqd6@cdc.govhttp://www.cdc.gov