unmet need for hepatitis c pcr testing, new york city, 2009-2010
DESCRIPTION
Emily McGibbon, MPH June 2011 CSTE Annual Conference. Unmet Need for Hepatitis C PCR Testing, New York City, 2009-2010. Hepatitis C (HCV) – the basics. Bloodborne virus Main modes of transmission: Injection drug use Transfusion before 1992 Perinatal transmission rate = 6% - PowerPoint PPT PresentationTRANSCRIPT
Unmet Need forHepatitis C PCR Testing,
New York City, 2009-2010
Emily McGibbon, MPHJune 2011
CSTE Annual Conference
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
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
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
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
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
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
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
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
Results
Total sampled (Diagnosed April 2009 -
November 2010)N=200
Did not meet inclusion criteria
N=14
Met inclusion criteria
N=186
Data errorN=11
Resides outside NYC
N=3
Completion rate = 186/186 (100%)
Lab status
Met inclusion criteriaN=186
PCR negativeN=36 (19.4%)
PCR positive on initial reportN=77 (41.4%)
PCR positive after DOHMH
follow-upN=12 (6.4%)
PCR not doneN=61 (32.8%)
PCR not done – facilities seen N=61
N %
Medical facility 22 36.1
Detox 21 34.4
Jail 7 11.5
Other 9 14.8
Unknown 2 3.3
Reasons PCR not done N=61
N %
Patient did not return for follow-up 24 39.4
Facility does not do PCR testing 18 29.5
Patient referred to specialty clinic for follow-up
5 8.2
Patient died, incapacitated 3 4.9
Patient does not have insurance/cannotpay for test
1 1.6
PCR test inconclusive 1 1.6
Unknown 9 14.7
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
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
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
Patient #3
• 5 reports of antibody positive results from different detox facilities
• No PCR as far as we can tell
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!
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
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
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
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
Acknowledgements
• Ellen Gee• Duyang Kim• Bianca Malcolm• Grace Malonga• Meredith Rossi• Allan Uribe• Tim Wen• Janette Yung• Sharon Balter• Jennifer Baumgartner• Katherine Bornschlegel