Download Hepatitis C is a liver infection caused by the Hepatitis C virus (HCV

Hepatitis C Screening
Opportunities & Challenges for
U.S. Emergency Departments
http://www.al.com/business/index.ssf/2014/01/which_hospital_in_your_city_ha.html
Richard Rothman, MD, PhD
• Professor Emergency Medicine, The Johns Hopkins University
Yu-Hsiang Hsieh, PhD
• Associate Professor Emergency Medicine, The Johns Hopkins University
James Galbraith, MD
• Associate Professor Emergency Medicine, University of Alabama at
Birmingham
Douglas White, MD
• Associate Clinical Professor Emergency Medicine, Alameda
County Medical Center-Highland, University of California San Francisco
Overview
I.
Background and Rationale
II. Who to Test? Recent data from the ED setting
III. Universal Screening: Findings from the front
lines
IV. Real-world Challenges: Lessons from the ED
V. Q and A
I. Hepatitis C:
Background /Rationale
What it is?
• Contagious infectious disease caused
by an RNA virus
How is it acquired/transmitted?
•
•
•
•
Most commonly by direct contact with blood from an infected person
Pre ~1990s: Primarily via blood transfusions or organ transplantation
Currently: Primarily via sharing needles/equipment (intravenous drug users)
Other routes (less common): Sexual contacts, Maternal-fetal, Sharing
personal items (e.g. razor blades), Tattooing
http://www.hepatitisc.uw.edu/go/evaluation-staging-monitoring/natural-history/core-concept/all
http://www.mobieg.co.za/articles/stds/hepatits
Hepatitis C (what happens?)
Acute Hepatitis C Virus infection:
• Short-term illness < 6 months of exposure
• Acute leads to chronic infection for most
people
Time….
Chronic Hepatitis C virus infection:
• Long-term illness which can last a lifetime
• Potential for serious liver problems,
including cirrhosis (scarring of the liver)
liver cancer and death
http://www.mobieg.co.za/articles/stds/hepatits
http://www.hepatitisc.uw.edu/go/evaluation-staging-monitoring/natural-history/core-concept/all
20 – 30 years
HCV – Disease burden
Worldwide
• 130–150 million chronic HCV
• ~350,000 HCV related deaths/year
United States
• 3.5 million with chronic HCV
• ~15,000+ HCV related deaths/year
• Significant reduction (screening blood supply)
• Emerging epidemic (IDUs)
• Epidemiology not fully characterized
• ~50% remain unaware of their infection
http://aidafoundation.com/hepatitis-c-info
https://www.cdc.gov/hepatitis/statistics/
http://www.hepatitisc.uw.edu/pdf/screening-diagnosis/epidemiology-us/core-concept/all
HCV: Disease Burden in US
The number of deaths due
to hepatitis C is at an alltime high in the US and
exceeds those attributable
to 60 other infectious
diseases including HIV and
tuberculosis
Ly KN, et al. Rising Mortality Associated With Hepatitis C Virus in the United States, 2003-2013. Clinical Infectious Diseases.
2016;62(10):1287-1288.
What’s possible regarding control and treatment?
• The good news
• Antiviral medicines can CURE approximately 90% of persons with hepatitis C
reducing risk of death from liver cancer and cirrhosis
• The challenge
• Typically indolent (clinically silent)
• Optimal systems for screening, linkage to care and treatment remain under
development
• Resource constraints
Who should be screened for Hepatitis C Virus?
2012 CDC Screening Recommendations AUGMENTED
prior targeted screening recommendations
• IVDU
• Recipients of clotting factors*, solid organ
transplant
• Hemodialysis patients
• HIV
• Persons with signs/symptoms of liver disease**
• Children born to HCV positive mothers
*before 1987; before 1992’; **e.g. elevated AST
Addition of ‘birth cohort’:
• Adults born between 1945-1965
(75% of those infected with HCV fall in this cohort)
Why EMERGENCY DEPARTMENTS?
• Front Door Health System
• Open 24/7
• Critical component of the
public health infra-structure
• > 140 million visits/year
• ~50% US population use ED
at least one visit /year
• EDs have track record
experience /success public
health interventions*
• Challenged by increasing
demands
*Woollard, et al AEM 2009 Nov;16(11):1138-42.
http://www.acepnow.com/wp-content/
Rationale for ED HIV/HCV Screening
Populations Known to Be Disparate
Users of U.S. ED Services:
Uninsured, Medicaid Recipients,
Non-Whites,
Persons Living Below U.S. Poverty Level
Known to Be Disproportionately Affected
with HIV / HCV Infection
&
Often Lack Access to Primary CareBased Preventative Screening
Communities in Crisis: Is There a Generalized HIV Epidemic in Impoverished Urban Areas of the United
States, CDC 2012 http://www.cdc.gov/hiv/pdf/statistics_poverty_poster.pdf
Can EDs be part of the solution?
Building on models of success….
~1 decade experience in ED based integrated testing
at the Johns Hopkins Emergency Department
•
•
•
Process/Models
Regulatory/Ethical
Impact/Outcomes
Numerous examples of success and
evolution towards unified and streamlined
models
Fig. 2 . Proportion of HIV-positive individuals virally suppressed and HIV incidence estimates (2001-2013).The
grey triangles denote the proportion of HIV-positive patients with an HIV viral load <400 copies/ml in each
identity-unlinked serosurvey. The black circles represent cross-sectional HIV incidence estimates determined by
a validated multiassay algorithm with a window period of 101 days and a 0% false recent misclassification rate.
Vertical lines indicate 95% confidence intervals.
AIDS. 30(1):113-120, January 2, 2016
Similarities Between HIV and HCV
• Silent, indolent
• Under-recognized by providers
• Stigmatized: Association with stigmatizing behavior
• High morbidity and mortality if left unrecognized
• Screening, diagnosis, LTC has a significant impact
ED Screening for HIV: Lessons learned
and evolving paradigm with HCV
HIV*
• Large numbers of patients can be effectively screened
• Processes established for streamlining screening, LTC and treatment
• Systems for reimbursement and sustainability have been achieved
HCV*
• Ongoing research required to better understand epidemiology
• Diagnostic algorithms are distinct/ evolving and can be complex
• Pilot programs and implementation science required
• Policy changes and longitudinal sustained partnerships required
*Tie-in with clinical mission
Who to Test: Recent Data from the ED Setting
II. Evaluation of CDC Recommendations for
HCV Testing in an Urban Emergency
Department
Yu-Hsiang Hsieh, PhD
Associate Professor
Richard Rothman1,2, Oliver Laeyendecker3, Gabor Kelen1, Ama
Avornu1, Eshan Patel3, Jim Kim1, Risha Irvin2, David Thomas2
and Thomas Quinn3
1Dept.
of Emergency Medicine, 2Div. of Infectious Diseases, Dept. of Medicine,
Johns Hopkins University, and 3National Institute of Allergy and Infectious Diseases, NIH
This work was supported by NIH grants K01AI100681 and R37013806 and the Division of Intramural Research, NIAID, NIH
Background
•
One-time baby boomer birth cohort screening is added in the 2012
CDC revised HCV screening recommendations. In 2013, USPSTF
recommends HCV screening for adults at high risk (including birth
cohort screening) at Grade B.
•
EDs are considered a key venue for HCV testing because of their
history of success in HIV screening given the populations they serve.
•
High Seroprevalence of HCV infections (chronic or ever) in ED
patients.
•
Risk-based targeted plus birth cohort screening would miss 50%.
(Merchant, 2013)
Objectives
• To determine the overall burden of undocumented HCV
infection in an urban ED
• To evaluate CDC recommendations for one-time HCV
testing in “baby boomers” in an urban ED
Methods
Setting:
• An urban adult ED with 66,000 annual census; high HCV
seroprevalence
Study Period:
• 8 weeks (24h/d), 06/2013–08/2013
Design:
• Cross-sectional identity-unlinked seroprevalence study methodology
• Sociodemo/HCV information from the administrative and EMR
database
• Waste blood samples were tested for HIV and HCV infection (HCV
EIA)
• “Undocumented HCV infection” was operationally defined as
presence of anti-HCV Ab in the absence of evidence of HCV
infection in EMR.
Prevalence of Anti-HCV Ab in 4,713 ED
Patients by Known Status
n= 204 (31.3%)
n= 4061 (86.2%)
HCV Ab Positive
n= 652 (13.8%)
HCV Ab Negative
Documented Infection
n= 448
(68.7%)
Undocumented Infection
Prevalence of Anti-HCV Ab
by Age, Sex, and Race
Prevalence of Anti-HCV Ab (%)
30
25
20
15
10
5
0
Prev. of Anti-HCV Ab (%)
Prevalence of Anti-HCV Ab by Selected
Groups under CDC Recommendations
70
60
50
40
30
20
10
0
HIV+
HIV-
Boomer+ Boomer-
IDU+
IDU-
Proportion of Undocumented HCV Infection
by Baby Boomer Birth Cohort
Undocumented
Documented
Undocumented HCV (%)
Non-Baby Boomers
Baby Boomers
100%
80%
60%
40%
20%
0%
Non-B
F
BF
Non-B
M
BM
Non-B
F
BF
Non-B
M
BM
Prevalence of Undocumented HCV Infection
by Age, Race and Sex
Black Male
Non-Black Male
Undocumented HCV Infection (%)
14
Black Female
Non-Black Female
Baby
Boomers
12
10
8
6
4
2
0
18-24
25-34
35-46
47-57
58-68
Age (years)
69-74
75-84
85 &
older
Distribution of 204 Undocumented HCV
Infection by Baby Boomer, HIV, and IDU
0%
Non-IDU, HIV (-), Baby Boomer
11%
49%
11%
Non-IDU, HIV (-), Non-Baby Boomer
Non-IDU, HIV (+), Baby Boomer
1%
Non-IDU, HIV (+), Non-Baby Boomer
3%
IDU, HIV (-), Baby Boomer
IDU, HIV (-), Non-Baby Boomer
IDU, HIV (+), Baby Boomer
25%
IDU, HIV (+), Non-Baby Boomer
Conclusions
• High seroprevalence of HCV infection in our ED, indicating
that urban EDs could be a valuable venue for HCV testing.
• Birth cohort testing would augment identification of
undocumented HCV infections two fold.
• However, 25% would still remain undiagnosed, suggesting
the need to consider modification of the CDC
recommendations in ED settings.
Universal Screening: Findings from the Front Lines
III. Outcomes of HCV Testing in
Urban Emergency Departments
James Galbraith, MD
Associate Professor of Emergency Medicine
University of Alabama at Birmingham
Targeted HCV Testing in US EDs
Galbraith JW. Hepatitis C Virus Screening: An Important Public Health Opportunity for United States Emergency
Departments. Annals of Emergency Medicine. 2016;67(1):129-130.
ED “Integrated” HCV Testing
Engagement
Testing
Counselling
Referral
• Nursing
• Physicians
• Hospital
laboratory
• ED providers
• Linkage
coordinator
UAB Targeted HCV Testing
(Birmingham, AL)
Baby Boomer AB+ Prevalence 11.6%
Uninsured
55 (16.9%)
271
Public / Medicaid
48 (16.8%)
238
Other 22 6 (13.3%)
Medicare
Private
Galbraith JW, Franco RA, Donnelly JP, et al. Unrecognized chronic
hepatitis C virus infection among baby boomers in the emergency
department. Hepatology. 2014: Sep 1. doi: 10.1002/hep.27410. [Epub
ahead of print]
39 (8.0%)
446
19 (5.0%)
359
0
100
200
Non-Reactive
300
400
Reactive
500
600
Highland Hospital Targeted HCV Testing
(Oakland, CA)
Factors associated with testing hepatitis C virus antibody positive: unadjusted and
adjusted ORs.
Number
Tested, N
[2,581]
HCV Antibody
Reactivity 267
(10.3%)
Unadjusted OR
(95% CI), N
[2,580]
Adjusted OR*
(95% CI), N
[1,995]
Birth cohort
Born after 1965
1,113
68 (6.1)
Born 1945–1965
1,420
Born before 1945
[Reference]
[Reference]
195 (13.7)
2.5 (1.8–3.3)
3.6 (2.4–5.3)
47
4 (8.5)
1.4 (0.5–4.1)
2.8 (0.8–10.3)
No
1,741
112 (6.4)
[Reference]
[Reference]
Yes
255
98 (38.4)
9.1 (6.6–12.5)
10.8 (7.4–15.5)
Unknown
585
57 (9.7)
1.6 (1.1–2.2)
IDU Ever
White DAE, Anderson ES, Pfeil SK, Trivedi TK, Alter HJ. Results of a Rapid Hepatitis C Virus Screening and Diagnostic
Testing Program in an Urban Emergency Department. Annals of Emergency Medicine. 2016;67(1):119-128.
Pragmatic Targeted Screening Missed the Mark
Identifying non-baby boomer targets
(IDUs) is challenging
• 85% of persons tested were baby boomers
or older at UAB
• UAB tests for IDU risk accounted for <5% of
all test orders
• Incidental (non-risk based) tests of persons
born after 1965 revealed 10% HCV-Ab
prevalence at UAB
Stigma barriers
• Provider - not asking IDU questions
• Patient – recall bias, privacy
Universal HCV Testing Eligibility
• Born after 1944*
• Age >13 - 18 years*
• Medically stable for HCV
questionnaire
• Self-reports no prior HCV diagnosis
• No prior test result in the EHR
*Eligibility slightly differs by ED site
UAB Universal Testing
Data 9/3/13 to 1/19/16
Birth Cohort Testing Proportions
After 1965
4.5
1945-1965
Before 1965
4.4
Daily Testing Rates
32
Universal
screening
implemented
Sept 15, 2015
80.7
63.7
14.8
2013
2016
TARGETED
UNIVERSAL
Combined Site Universal Testing Outcomes
UAB
(Birmingham, AL)
Highland
(Oakland, CA)
Hopkins
(Baltimore, MA)
10/2015 -03/2016
10/2015 – 03/2016
12/2015 – 08/2016
Total tested
5,972
2,900
3789
Total HCV+
(prevalence%)
458
(7.7%)
166
(5.7%)
240
(6%)
Baby boomer HCV+
(prevalence%)
231
(10.5%)
98
(13.7%)
136
(13.5%)
Born after 1965 HCV+
(prevalence%)
227
(6.0%)
68
(3.1%)
104
(3.9%)
Time period of analysis
Universal ED HCV Testing –
Birth Cohort by Race
UAB
(Birmingham, AL)
Highland
(Oakland, CA)
Hopkins
(Baltimore, MA)
10/2015 –
03/2016
10/2015 –
03/2016
12/2015 –
08/2016
White Prevalence
9.5%
13.0%
*M 5%
F 3%
Black Prevalence
11.8%
17.3%
M 26%
F 10%
White Prevalence
11.7%
3.2%
*M 10%
F 7%
Black Prevalence
2.0%
3.5%
M 3%
F 1%
Time period of analysis
Baby Boomer cohort
(Born 1945-1965)
Younger cohort
Born After 1965
*Hopkins non-black male and female results shown
Implications of Universal Testing Outcomes
– Heroin Epidemic & HCV Eradication
1st Wave
“Baby Boomers”
2nd Wave
Predominantly IDU
Centers for Disease Control and
Prevention (CDC). (2011). Hepatitis
C virus infection among adolescents
and young adults: Massachusetts,
2002-2009. MMWR. Morbidity and
Mortality Weekly Report, 60(17),
537–541.
Implications of
Universal Testing
Outcomes - Surveillance
• High volume of unique
visitors
• Well-positioned to identify
IDU
• Wide geographic reach
• Sizable HCV yield that
allows for identification of
high prevalence geographic
clusters
Donnelly JP, Franco RA, Wang HE, Galbraith JW. Emergency Department Screening for
Hepatitis C Virus: Geographic Reach and Spatial Clustering in Central Alabama. Clinical
Infectious Diseases. 2015;62(5):613-616. doi:10.1093/cid/civ984.
IV. Real-World Challenges:
HCV Testing Lessons Learned from the
Emergency Department
Doug White, MD
Associate Clinical Professor of Emergency Medicine
Alameda County Medical Center-Highland
University of California San Francisco
Challenges (and Solutions)
1. Continuum of care completion
2. Cost
3.“Best” screening model
HCV Screening Continuum of Care
HCV Continuum
of Care:
UAB
and HH
Figure 1. Emergency
Department
C Virus
Figure
1. ED HCVHepatitis
Continuum
of CareContinuum of Care
600
532
500
435
Number of Patients
400
301
300
200
82%
158
69%
52%
61%
100
97
25%
24
79%
19
0
HCV antibody
Positive
Viral Load
Performed
Chronically
Infected
Follow Up
Arranged
Follow Up
Attended
Treatment
Initiated
Sustained Viral
Response
Time (days)
Time from HCV positive ab test to stages of the ED HCV
Continuum of Care*
400
350
300
250
200
150
100
50
0
271
145.5
103.5
Time to RNA
completion
Time to
Time to
Follow up
Treatment
Attendance
Initiation
*Diamonds represent median days from screening to cascade stage
Bars represent interquartile range
Challenge – Test Algorithm Completion
Challenge – Test Algorithm Completion
Solution - Test Algorithm
Completion
Screening packets
EMR Prompts
Precautions
Solution - Test Algorithm
Completion
Reflex Viral Load Testing
Challenges
• Specimen handling requirements
• 1 vs 2 tube
• Cross contamination
Challenge - Linkage
• Predicated on completion of test algorithm
• High numbers positives + limited capacity
• High-no show rates
• Uninsured
• Homeless, phoneless
• Drugs, alcohol, psychiatric illness
Solution - Linkage
• Linkage coordinator
• Insurance enrollment
• Case management
• Test algorithm completion
• Centralized treatment referral
• Community partnerships
• Primary care treatment
Alameda County HCV Linkage Map
Alameda Health System
Other
Referral network expansion
Beyond specialists
FQHC / primary care treaters
Alameda Health Consortium
Challenge – Cost
•Screening
•Programmatic
•Treatment
Challenge - Screening Costs
• Prior to 2013, access to screening limited
Grade B Recommendation
Baby Boomers (1-time screen)
Risk
Challenge - Screening Costs
2014
• Cover HCV screening according to USPSTF
• Emergency Departments EXCLUDED
• Intended for Primary Care physicians
• Annual wellness visit
• Comprehensive prevention plan
https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=272
Solution – Screening Costs
• Extend CMS coverage beyond primary
care
• Medical Center
• Demonstrate clinical need for resource
expansion
• Laboratory costs absorbed by hospital
Challenge – “Best” Screening Model
• Screening model satisfies “everyone”
•
•
•
•
Maximal screening
Integrated
Sustainable
Low-impact
• Screening guidelines
• Not intended for ED
• Impractical
• Universal screening?
Solution – “Best” Screening Model
• Streamline processes
• Smart EMR utilization
• Balance public health screening goals with acute
care mission
•
•
•
•
Leverage existing resources
Competing priorities
No gold standard model
Any test better than no test
V. Discussion and Q&A
• Please submit questions via the webinar
question function or by emailing Tina Broder,
[email protected]
• Archives of today’s webinar slides and recording
will be posted on www.nvhr.org