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