Hepatitis C Baby Boomer
Screening and Linkage to Care
Programs in the US
Camilla S. Graham, MD, MPH
Division of Infectious Disease
Beth Israel Deaconess Medical Center
cgraham@bidmc.harvard.edu
1
Disclosures
• I have no disclosures
2
Efficient Identification of Patients with HCV
50 million “risk
identified” or ~80
million 19451965 cohort who
need to be
tested for HCV in
US1
4 -5 million
people with
HCV in US
25%
diagnosed
with HCV
Treatment and
Management
Improve
Diagnosis
1Tomaszewski
Am J Public Health 2012; 102 (11):e1013
Who Should Be Tested for HCV
CDC Recommendations
USPSTF Grade B Recs*
•
•
Everyone born from 1945 through
1965 (one-time)
•
Past or present injection drug use
•
Sex with an IDU; other high-risk sex
•
Blood transfusion prior to 1992
•
Persons with hemophilia
•
Long-term hemodialysis
•
Born to an HCV-infected mother
•
Incarceration
•
Intranasal drug use
•
Receiving an unregulated tattoo
•
Occupational percutaneous
exposure
•
Surgery before implementation of
universal precautions
•
•
•
•
•
•
•
•
Everyone born from 1945 through
1965 (one-time)
Persons who ever injected illegal
drugs
Persons who received clotting factor
concentrates produced before 1987
Chronic (long-term) hemodialysis
Persons with persistently abnormal
ALT levels.
Recipients of transfusions or organ
transplants prior to 1992
Persons with recognized
occupational exposures
Children born to HCV-positive
women
HIV positive persons
4
*Only pertains to persons with normal liver enzymes; if elevated liver enzymes need HBV and HCV testing
Smith at al. Ann Intern Med 2012; 157:817-822. Moyer et al. Ann Intern Med epub 25 June 2013
Deaths Due to HCV Infections Now Exceed
Those Due to HIV Infection
15,106
12,734
Number of HCV-related
deaths may be over
60,000 because of
under-reporting on death
certificates
5
Ly KN et al. Ann Intern Med. 21 February 2012;156(4):271-278; Mahajan, IDSA 2013
Timing of Mortality Among Known HCV
Cases in Massachusetts, 1992-2009
1800
Median interval: 3 years
Median age: 53 years
Number of deaths
1600
1400
1200
1000
800
600
400
200
0
<1
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Years to death from date of HCV diagnosis
N=8,499
76,122 HCV diagnoses were reported to the MDPH between 1992 and 2009, 8,499 of
these reported HCV cases died and are represented in the figure. Data as of 1/11/2011.
6
Lijewski, et al, 2012
15
16
17
Screening of Baby Boomers May Prevent >120,000
Deaths Due to HCV Infection
1,070,840 new cases of HCV
identified with birth-cohort
screening
552,000 patients treated
364,000 patients
cured*
121,000 deaths
averted†
› Birth-cohort screening in primary care would identify 86% of all undiagnosed cases in
the birth cohort, compared with 21% under risk based screening1
› Cost effectiveness of HCV screening is comparable to cervical cancer or cholesterol
screening (cost/QALY gained with protease inhibitor+IFN+RBV = $35,700)
Markov chain Monte Carol simulation model of prevalence of hepatitis C antibody stratified by age, sex, race/ethnicity, history of injection drug use, and natural history of chronic hepatitis C.
*With pegylated interferon and ribavirin plus DAA treatment.
†Deaths due to decompensated cirrhosis or hepatocellular carcinoma within 1945-1965 birth cohort. 470,000 deaths under birth cohort screening vs 592,000 deaths under risk-based screening
1. Rein D et al. Ann Intern Med. 2012;156(4):263-270; 2. McGarry LJ et al. Hepatology. 2012;55(5):1344-1355.
7
BIDMC/CareGroup Experience
• Network of academic hospitals, primary care
practices, community health centers that share a
common electronic medical record system
– 5,500 clinicians and ~1.5 million patients
• Implemented a prompt in EMR for a one-time
anti-HCV test in all patients born from 1945-1965
who had no prior record of testing, while
continuing risk-based testing
– Went live on June 4, 2013
– In the first ten months, we tested a total of 20,000
people for HCV
Steps to Implement Birth Cohort HCV Testing
• Build a core team: Primary Care, Infectious Disease, Hepatology,
Database Management, and Clinical Pathology
• Implement a one-time electronic prompt for anti-HCV antibody testing
for all patients born from 1945 through 1965 who have no record of
HCV antibody testing
• One-page educational tool for providers and one for patients (samples
at KNOW MORE HEPATITIS/CDC and NVHR.org)
• Email notification to affected clinicians
• HCV nurse educator
– Help facilitate patient referral in the Liver Center and Infectious Diseases
Clinic
• Slide deck for presentations to primary care providers about HCV
(sample at NVHR.org)
• Collaboration with Laboratory Services
– Expand capacity for increased volume of HCV Ab and RNA tests
– Add language to results page (or a second prompt) for all positive HCV
antibody tests informing clinicians to order an HCV RNA test to determine
the presence of active HCV infection
– Generates a report of all positive HCV antibody tests for follow up
Address Primary Care Provider Concerns
• Address misconceptions about hepatitis C:
– Hepatitis C causes substantial morbidity and mortality
– Patients can have normal labs and exam and have cirrhosis
– It is nearly impossible to implement comprehensive risk-based
screening in general population primary care
– Hepatitis C is curable and most patients will not require IFN
– Many patients will not require a liver biopsy
• Expect that PCPs will test all patients with reactive anti-HCV
Ab tests for HCV RNA
• Engage PCPs for alcohol screening and counseling,
vaccinations, transmission risk reduction, referral for
addiction treatment and harm reduction counseling
• Remind PCPs about value of identifying cirrhotic patients
before they develop complications
• Provide support (education/nursing support, emails,
telemedicine)
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Initial Hepatitis C Testing and Evaluation
Who Should Be Tested for Hepatitis C?
New: Anyone born between 1945 and 1965
should be tested once, regardless of risk
factors
In addition, patients with the following risk factors:
• Elevated ALT (even intermittently)
• A history of illicit injection drug use or intranasal
cocaine use (even once)
• Needle stick or mucosal exposure to blood
• Current sexual partners of HCV infected persons
• Received blood/organs before 1992
• Received clotting factors made before 1987
• Chronic hemodialysis
• Infection with HIV
• Children born to HCV-infected mothers
Why Test People Born Between 19451965?
• 76% of the ~4 million people with HCV infection
in the US are baby boomers
• In the 1945-1965 cohort:
• All: 1 out of 30
• Men: 1 out of 23
• African American men: 1 out of 12
• Up to 75% do not know they have HCV
• 73% of HCV-related deaths are in baby boomers
What Can Happen to People with
Hepatitis C?
• It is important to identify if patients have cirrhosis
• Patients with cirrhosis are at risk for liver cancer
(HCC) and liver decompensation (ascites, variceal
bleed, hepatic encephalopathy, jaundice)
• Hepatitis C is curable, and cure reduces the risk of
severe complications, even with cirrhosis
• Refer patients to a specialist who has experience
treating hepatitis C to see if they need treatment
Hepatitis C Antibody
(HCV Ab)1
Negative (-)
STOP here if no concern for acute
infection or severe immunosuppression.
If so, check HCV RNA.
Positive (+)
These people are NOT chronically infected.
Check HCV RNA
(viral load)
Negative (-)
•
Positive (+)
Detectable HCV Ab with negative HCV RNA
can occur with spontaneous clearance of
infection ( about 25% of people exposed to
HCV will clear; verify HCV RNA negative in 4
to 6 months) or with treatment of HCV.
Hepatitis C infection
1Example
Evaluation and referral
ICD-9 codes for HCV antibody testing:
• V73.89: screening for other specified viral disease
• 790.4: nonspecific elevation of levels of
transaminase; use if patient ever had an elevated ALT
Counsel Patients with HCV Infection About Reducing Risk of
Transmission
• Do not donate blood, body organs, other tissue, or semen
• Do not share personal items that might have small amounts of blood (toothbrushes, razors,
nail-grooming equipment, needles) and cover cuts and wounds
• HCV is not spread by hugging, kissing, food or water, sharing utensils, or casual contact
• If in short term or multiple relationships, use latex condoms. No condom use is
recommended for long-term monogamous couples (risk of transmission is very low)
Initial Management
• Evaluate alcohol use (CAGE, AUDIT-C) and recommend stopping use
• Vaccinate for hepatitis A and hepatitis B if not previously exposed
• Evaluate sources of support (social, emotional, financial) needed for HCV treatment
Smith BD et al. MMWR. August 17, 2012/61(RR04); 1-18. Adapted from Winston et al. Management of hepatitis C by the11
primary care
provider: Monitoring guidelines; 2010; http://www.hcvadvocate.org/hepatitis/factsheets_pdf/PCP_web_10.pdf
PCP Education Example: Screening
in Clinic
1,000
adult
patients
Efficiently identify
birth cohort 19451965:
• Electronic
prompt
330
baby
boomers
~1/3 of
adults are
in 19451965
cohort
10
HCV
antibody
positive
•
•
•
1 of 30 baby
boomers
1 of 23 men
baby boomers
1 of 12 African
American men
baby boomers
7 HCV
RNA
positive
3 with more
advanced
fibrosis
4 with mild
fibrosis
15%-30% of
HCV antibody
patients will
spontaneously
clear
Up to 25% of
baby boomers
may have
cirrhosis
75% of cirrhotic
patients are
men
12
Davis, Gastro 2010; 138: 513
Number of HCV Antibody Tests Performed
In Four Week Intervals
2500
2000
1500
Total Tests
1000
Boomers
Non-Boomers
500
3/1/2014
1/1/2014
11/1/2013
9/1/2013
7/1/2013
5/1/2013
3/1/2013
1/1/2013
11/1/2012
9/1/2012
7/1/2012
5/1/2012
3/1/2012
1/1/2012
0
Beth Israel Deaconess Medical Center, Boston, MA, Quality Outcomes Data, 1/22/14
HCV Antibody Test Volume Increased after
EMR Prompt
Boomers
Average = 1192
tests/4 weeks
1600
EMR
prompt
1400
1200
CDC 19451965 testing
guidelines
1000
800
600
Average = 303
tests/4 weeks
Average = 438
tests/4 weeks
Boomers
400
200
3/1/2014
1/1/2014
11/1/2013
9/1/2013
7/1/2013
5/1/2013
3/1/2013
1/1/2013
11/1/2012
9/1/2012
7/1/2012
5/1/2012
3/1/2012
1/1/2012
0
Beth Israel Deaconess Medical Center, Boston, MA, Quality Outcomes Data, 6/5/14
More Women Tested for HCV but
More Men are Anti-HCV Positive
Group
Number (%) Tested for
HCV Ab
Anti-HCV Seroprevalence (%)
13,107
2.3%
Boomer women
7,555 (58%)
1.4% (34% of HCV Ab+ results)
Boomer men
5,552 (42%)
3.6% (66% of HCV Ab+ results)
7,022
2.6%
Non-Boomer women
4,023 (57%)
1.9% (42% of HCV Ab+ results)
Non-Boomer men
2,999 (43%)
3.5% (58% of HCV Ab+ results)
All Boomers
All Non-Boomer
Beth Israel Deaconess Medical Center, Boston, MA, Quality Outcomes Data, 6/5/14
Examples of HCV Prompts in
EHRs
National Viral Hepatitis Roundtable
(NVHR) HCV Testing Project
RI HCV Birth Cohort Prompt in EPIC
Courtesy of Lynn Taylor, Lifespan & RI Defeats Hep C
RI HCV Birth Cohort Prompt in EPIC
Courtesy of Lynn Taylor, Lifespan & RI Defeats Hep C
Example: EPIC Resources
• Pre-loaded content to support hepatitis C
testing in the 1945 - 1965 birth cohort into the
foundation system
– Need to turn the functioning on as is, or with
modifications
– Uses the Health Maintenance reminders
(modifiers) and Population Management tools
– Standing orders for anti-HCV antibody test,
patient reminders sent out to MyCharts, and
development of reporting workbenches
Example: EPIC Resources
• EPIC Earth
• EPIC "Community Library" has e
– Examples of hepatitis C decision support programs
from other EPIC users
• EPIC podcast for providers about hepatitis C
decision support:
– https://userweb.epic.com/Thread/32100
• Powerpoint presentation of interventions in
EPIC to improve HCV testing
• Project team support
AllScripts Hepatitis C Prompt
Drexel’s “C a Difference” developed the following AllScripts alerts to help providers
adhere to CDC Hepatitis C testing recommendations
1) All individuals who were born between 1945 and 1965 who have not been
previously tested for HCV will have this alert in the chart:
For these patients, type “hcvscreen” to order HCV antibody screening with reflex
confirmatory PCR quantitative testing
Courtesy of Stacey Trooskin, Drexel & HepCAP
21
AllScripts Hepatitis C Prompt
2) All individuals who have had a reactive HCV antibody test or have an ICD-9 code
consistent with chronic HCV infection, but have not had confirmatory PCR quantitative
testing in the last 5 years will have this alert:
For these patients, type “hcvconfirmatory” or “hcvconfirm” to order HCV RNA PCR
quantitative testing
Courtesy of Stacey Trooskin, Drexel & HepCAP
FIB-4 Screening: Boston Healthcare for the
Homeless - Centricity
Courtesy of Maggie Beiser, BHCHP
Additional Provider Resources for HCV
Testing at NVHR
1. Importance of Screening in Uncertain Treatment
Climate Fact Sheet for Providers
2. Primary Care Provider Handouts & Fact Sheets
3. Birth Cohort Prompt Implementation Support
4. Continuing Medical Education (CME) resources
5. Coding & Billing Details
6. Provider Training Modules
7. Links to Treatment Guidelines
Website: http://nvhr.org/content/welcome-nvhrhepatitis-c-baby-boomer-resources-page
Similar Peak in HCV Prevalence at Age
55 (in 2005) Globally
25
Mohd Hanafiah; Hepatology 2013; 57:1333
Toward a world where diagnosis guides the
way to health for all people
FIND : Turning complex diagnostic challenges into simple
solutions to transform lives and overcome diseases of poverty
Catalyze
development
• Lead dynamic
needs definition
• Support program
for manufacturers
• Scout technology
• Match-make
• Provide specimens
Guide use
& policy
• Lead clinical trials
• Define evidence
needs
• Support WHO
development
of guidelines
Accelerate
access
• Facilitate national
policy and development of rollout plans
• Help MoHs identify
gaps, coordinate
solutions, and
deploy experts
• Develop QA tools
& strategies
Shape • Measure and communicate impact of Dx
• Shape Dx ecosystem to foster willingness to invest/pay
the
agenda • Lead global discussion on emerging Dx topics
SCIENCE
PRODUCTS
SOLUTIONS
PATIENTS
Barbara Bulc (bbulc@gd-impact.org); Foundation for Innovative New Diagnostics
26
Thanks
NVHR Community Partners:
• HepCAP – Philadelphia
• Caring Ambassadors –
Chicago
• Hep C Connection –
Denver
• Mass Viral Hepatitis
Coalition
• Hepatitis Education
Project – Seattle
• RI Defeats Hep C
• Hep Free Hawaii
Beth Israel Deaconess
Medical Center HCV Birth
Cohort Testing Team:
• Nid Afdhal
• Rachel Baden
• Gila Kriegel
• Brian Halbert
• Meredith Rourke
• Gary Horowitz
To join the collaboration with NVHR, contact Tina Broder, tbroder@nvhr.org
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