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Hepatitis C Baby Boomer

Screening and Linkage to Care Programs in the US

Camilla S. Graham, MD, MPHDivision of Infectious Disease

Beth Israel Deaconess Medical Centercgraham@bidmc.harvard.edu

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Disclosures

• I have no disclosures

Efficient Identification of Patients with HCV

4 -5 million people with

HCV in US25%

diagnosed with HCV

50 million “risk identified” or ~80

million 1945-1965 cohort who need to be tested

for HCV in US1

Treatment and Management

1Tomaszewski Am J Public Health 2012; 102 (11):e101

Improve Diagnosis

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Who Should Be Tested for HCVCDC Recommendations• 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

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

*Only pertains to persons with normal liver enzymes; if elevated liver enzymes need HBV and HCV testingSmith at al. Ann Intern Med 2012; 157:817-822. Moyer et al. Ann Intern Med epub 25 June 2013

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Deaths Due to HCV Infections Now ExceedThose Due to HIV Infection

Ly KN et al. Ann Intern Med. 21 February 2012;156(4):271-278; Mahajan, IDSA 2013

15,106

12,734

Number of HCV-related deaths may be over 60,000 because of

under-reporting on death certificates

5

0

200

400

600

800

1000

1200

1400

1600

1800

<1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Years to death from date of HCV diagnosis

Num

ber

of death

s

N=8,499

Median interval: 3 years Median age: 53 years

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.

Timing of Mortality Among Known HCV Cases in Massachusetts, 1992-2009

Lijewski, et al, 20126

Screening of Baby Boomers May Prevent >120,000 Deaths Due to HCV Infection

› 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 screening1. Rein D et al. Ann Intern Med. 2012;156(4):263-270; 2. McGarry LJ et al. Hepatology. 2012;55(5):1344-1355.

1,070,840 new cases of HCV identified with birth-cohort

screening

552,000 patients treated

364,000 patients cured* 121,000 deaths

averted†

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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) 10

Initial Hepatitis C Testing and EvaluationWho Should Be Tested for Hepatitis C?New: Anyone born between 1945 and 1965 should be tested once, regardless of risk factorsIn 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 1945-1965?• 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

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)

1Example 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

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 the primary care provider: Monitoring guidelines; 2010; http://www.hcvadvocate.org/hepatitis/factsheets_pdf/PCP_web_10.pdf

Hepatitis C Antibody (HCV Ab)1

Positive (+)

Check HCV RNA (viral load)

Positive (+)

Hepatitis C infection

Evaluation and referral

Negative (-) STOP here if no concern for acute infection or severe immunosuppression. If so, check HCV RNA.

Negative (-)These people are NOT chronically infected. • 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.

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PCP Education Example: Screening in Clinic

1,000 adult

patients

330 baby

boomers

10 HCV

antibody positive

7 HCV RNA

positive

3 with more advanced

fibrosis

4 with mild fibrosis

Efficiently identify birth cohort 1945-1965:• Electronic

prompt

~1/3 of adults are in 1945-

1965 cohort

• 1 of 30 baby boomers

• 1 of 23 men baby boomers

• 1 of 12 African American men baby boomers

15%-30% of HCV antibody patients will

spontaneously clear

Up to 25% of baby boomers

may havecirrhosis

75% of cirrhotic patients are

men

Davis, Gastro 2010; 138: 513 12

Number of HCV Antibody Tests Performed In Four Week Intervals

1/1/2

012

3/1/2

012

5/1/2

012

7/1/2

012

9/1/2

012

11/1/2

012

1/1/2

013

3/1/2

013

5/1/2

013

7/1/2

013

9/1/2

013

11/1/2

013

1/1/2

014

3/1/2

0140

500

1000

1500

2000

2500

Total TestsBoomersNon-Boomers

Beth Israel Deaconess Medical Center, Boston, MA, Quality Outcomes Data, 1/22/14

HCV Antibody Test Volume Increased after EMR Prompt

1/1/2

012

3/1/2

012

5/1/2

012

7/1/2

012

9/1/2

012

11/1/2

012

1/1/2

013

3/1/2

013

5/1/2

013

7/1/2

013

9/1/2

013

11/1/2

013

1/1/2

014

3/1/2

0140

200

400

600

800

1000

1200

1400

1600

Boomers

BoomersAverage = 303 tests/4 weeks

CDC 1945-1965 testing

guidelinesAverage = 438 tests/4 weeks

EMR prompt

Average = 1192 tests/4 weeks

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 (%)

All Boomers 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)

All Non-Boomer 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)

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

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AllScripts Hepatitis C Prompt

Drexel’s “C a Difference” developed the following AllScripts alerts to help providers adhere to CDC Hepatitis C testing recommendations1) 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

AllScripts Hepatitis C Prompt

Courtesy of Stacey Trooskin, Drexel & HepCAP

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

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 Sheets3. Birth Cohort Prompt Implementation Support4. Continuing Medical Education (CME) resources5. Coding & Billing Details6. Provider Training Modules7. Links to Treatment Guidelines

Website: http://nvhr.org/content/welcome-nvhr-hepatitis-c-baby-boomer-resources-page

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Similar Peak in HCV Prevalence at Age 55 (in 2005) Globally

Mohd Hanafiah; Hepatology 2013; 57:1333

PATIENTS

SCIENCE PRODUCTS SOLUTIONS

Toward a world where diagnosis guides the way to health for all people

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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

Accelerate access

• Facilitate national policy and develop- ment of rollout plans

• Help MoHs identify gaps, coordinate solutions, and deploy experts

• Develop QA tools& strategies

Guide use& policy

• Lead clinical trials• Define evidence

needs• Support WHO

development of guidelines

Shapethe agenda

• Measure and communicate impact of Dx• Shape Dx ecosystem to foster willingness to invest/pay• Lead global discussion on emerging Dx topics

Barbara Bulc (bbulc@gd-impact.org); Foundation for Innovative New Diagnostics

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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