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

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 year 1 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 seen N=61 N% Medical facility2236.1 Detox2134.4 Jail711.5 Other914.8 Unknown23.3

13. Reasons PCR not done N=61 N% Patient did not return for follow-up2439.4 Facility does not do PCR testing1829.5 Patient referred to specialty clinic for follow- up 58.2 Patient died, incapacitated34.9 Patient does not have insurance/cannot pay for test 11.6 PCR test inconclusive11.6 Unknown914.7

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