Transcript Enhanced Chronic Hepatitis C Surveillance, 2009-11

Unmet Need for
Hepatitis C PCR Testing,
New York City,
2009-2010
Emily McGibbon, MPH
June 2011
CSTE Annual Conference
Hepatitis C (HCV) – the basics
• Bloodborne virus
• Main modes of transmission:
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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
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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)
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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
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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
Data error
N=11
Resides
outside NYC
N=3
Met
inclusion criteria
N=186
Completion rate =
186/186 (100%)
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%)
PCR not done – facilities seen N=61
N
%
Medical facility
Detox
Jail
22
21
7
36.1
34.4
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 followup
5
8.2
Patient died, incapacitated
3
4.9
Patient does not have insurance/cannot
pay for test
1
1.6
PCR test inconclusive
1
1.6
Unknown
9
14.7
Challenges to enhanced
surveillance
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Not typical patient population
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Physician who answered questionnaire
may not know much about patient
• High proportion without PCR
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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
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Select patients whose enhanced
surveillance investigations were closed >9
months prior
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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
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Ellen Gee
Duyang Kim
Bianca Malcolm
Grace Malonga
Meredith Rossi
Allan Uribe
Tim Wen
Janette Yung
Sharon Balter
Jennifer Baumgartner
Katherine Bornschlegel