Unmet Need for Hepatitis C PCR Testing, New York City, 2009-2010

1. Emily McGibbon, MPH June 2011 CSTE Annual Conference Unmet Need forHepatitis C PCR Testing,New York City, 2009-2010

2. Hepatitis C (HCV) – the basics • Bloodborne virus • Main modes of transmission: • Injection drug use • Transfusion before 1992 • Perinatal transmission rate = 6% • Sexual transmission low; conflicting data in literature

3. HCV – the basics cont’d • No test for acute infection • Usually leads to chronic infection • In 10-15% infection spontaneously resolves • Patients asymptomatic or have mild illness for years • 15-20% with chronic HCV develop liver cirrhosis

4. HCV antibody test • Screening test • Positive EIA (with high signal-to-cutoff ratio) or RIBA reportable to NYC DOHMH • If positive, could indicate: • Either acute or chronic infection • Resolved infection • False positive • If resolved infection, antibody positive for life but does not confer immunity to reinfection

5. HCV NAT test • Positive Nucleic Acid Test (NAT), e.g. PCR, reportable to NYC DOHMH • Indicates current HCV infection • Fewer labs perform this test • $$$ compared to antibody test

6. Patients with positive HCV antibody need PCR test • About 10-15% of antibody-positive patients are not infected • Without PCR, patients do not know infection status • Unclear what clinicians are telling patients when antibody positive and PCR not done

7. HCV in New York City • About 10,000 patients newly reported per year1 • High volume and limited staff • No routine investigation (unless acute) • Limited data on epi of HCV in NYC 1) http://www.nyc.gov/html/doh/downloads/pdf/cd/cd-hepabc-surveillance-report-08-09.pdf

8. Enhanced HCV surveillance -methods • On-going enhanced surveillance – July 2009 • Sample 20 patients every 2 months • Newly reported • NYC residents or unknown address • DOB known • Physician questionnaire (fax or phone) • Demographics • Risk factors • Reasons for testing • Treatment, hepatitis A and B vaccination • Counseling on transmission and alcohol use

9. Laboratory investigation • MD’s interpretation of lab results • Copy of most recent lab results • If PCR not done • Ask why not • Request PCR be ordered (letter) • Send guidelines, explain why PCR is needed • Track PCR results prospectively

10. Results Total sampled (Diagnosed April 2009 - November 2010) N=200 Did not meet inclusion criteria N=14 Met inclusion criteria N=186 Data error N=11 Resides outside NYC N=3 Completion rate = 186/186 (100%)

11. Lab status Met inclusion criteria N=186 PCR negative N=36 (19.4%) PCR positive on initial report N=77 (41.4%) PCR positive after DOHMH follow-up N=12 (6.4%) PCR not done N=61 (32.8%)

12. PCR not done – facilities seenN=61

13. Reasons PCR not done N=61

14. Challenges to enhanced surveillance • Not typical patient population • Physician who answered questionnaire may not know much about patient • High proportion without PCR • Patients seen in detox/jails • May not do PCR testing • Patients lost to follow-up • PCR negative not reportable

15. Patient #1 • Tested antibody positive while in detox • Facility does not do PCR testing • Referred patient to specialist for follow-up (standard practice) • No positive PCR ever reported

16. Patient #2 • 23 year-old student, tested antibody positive as screening for school • Only risk factor is immigrating from Ukraine (high-prevalence country) in 1993 • MD told him he had HCV • Patient did not go back to initial MD as far as we know • No PCR as far as we can tell

17. Patient #3 • 5 reports of antibody positive results from different detox facilities • No PCR as far as we can tell

18. Patient #4 • Antibody positive this year, reported to us for first time • Had prior positive antibody test in 2005, tested PCR negative in 2006 • Likely had HCV in past but resolved infection • Should not have been retested for antibody!

19. Conclusions • If PCR not done: • Infection status for patients often remains unknown • Difficult to assess patients’ needs • Difficult to know when to stop investigating • Of 200 sampled: • 36 were PCR negative • Meet case definition for chronic/resolved HCV • Probably not infected

20. Health Department response • Interview multiple providers if learn about another MD who may know patient better • Developed clinical bulletin about HCV diagnosis and care, emphasizing need for PCR • Started additional follow-up for patients where PCR not done

22. PCR follow-up project • Select patients whose enhanced surveillance investigations were closed >9 months prior • Patients where PCR not done (N=61) • Contact all known clinicians • Was PCR ever done? • Started project Feb 23, 2011 – 37 cases to follow up on

23. Next steps? • Continue educating providers about importance of PCR testing • Clinical staff • Detox, jail staff: social workers, counselors • Lobby to make PCR test more available/affordable for detox and jails

24. Acknowledgements • Ellen Gee • Duyang Kim • Bianca Malcolm • Grace Malonga • Meredith Rossi • Allan Uribe • Tim Wen • Janette Yung • Sharon Balter • Jennifer Baumgartner • Katherine Bornschlegel