Viral Hepatitis C Testing

Recommendations for Persons Born

1945-1965

Local Health Departments and Hepatitis C: Webcast 1.3

Presented by:

Claudia Vellozzi, M.D., M.P.H.

Chief, Prevention Branch, Division of Viral Hepatitis

Centers for Disease Control and Prevention (CDC)

Role of Public Health in HCV

Prevention

Public Health Core

Functions - Institute

of Medicine, 1988

Guided by

research…

• Assessment

• Policy Development

• Assurance

Outline

Assessment and policy development leading to

recommendations

Public health strategies to provide assurance in

implementing recommendations

3

Assessment and Policy Development for the Viral Hepatitis C Testing Recommendations for

Persons Born 1945-1965

4

Impact of Prevention Measures on Hepatitis C Virus (HCV) Infection in U.S.

Alter MJ JAMA 1990; Jagger J, J infect Dis Pub Health 2008; CDC.gov/hepatitis; 5

0

2

4

6

8

10

12

14

16

18

20

Anti-HCV test licensed

1992

1986 Indirect blood screening for HCV

and HIV prevention measures

Needle stick Safety

and Prevention Act

2001

Year

Discovery

of HCV

1989

22,000 new acute HCV cases reported in 2012

Prevalence of Current HCV Infection Among Persons in the United States

6

Prevalence

Civilian, Non-Institutionalized

Populations

(NHANES)

2.7 million

(2.2-3.2 million)

1.0% (0.8%-1.2%)

Estimated HCV Infection

Among Homeless and

Incarcerated Persons

(Not Included in NHANES)

360,000-840,000

22%-52%

Denniston M, Ann Int Med 2014. Chak E, Liver Int 2011.

Two of Three Americans Living with HCVWere Born During 1945-1965

Reflects historical high

HCV incidence before

viral discovery in 1989

Five-fold higher

prevalence than other

US adults (3.39% vs

0.55%)

81% of all HCV+ US adults

Of all HCV-related

mortality in US, 73% were

born in this cohort

Smith, AASLD Liver Meeting 2011. Armstrong, Ann Int Med 2006. Kramer, Hepatology 2011. Ly, Ann Int Med 2012. 7

7.0

6.0

5.0

4.0

3.0

2.0

1.0

0.0

7.0

6.0

5.0

4.0

3.0

2.0

1.0

0.0

0 10 20 30 40 50 60 70

1910 1920 1930 1940 1950 1960 1970 1980 1990

Age at Time of Survey, y

Year of Birth

1988–1994

1999–2002

1988–1994

1999–2002

Pro

po

rtio

n A

nti

-HC

V-P

os

itiv

e,

%P

rop

ort

ion

An

ti-H

CV

-Po

sit

ive

, %

1945

Age 20-59

Characteristic Odds

Ratios

Age Categories

(20-39 referent)

Age 40-49 6.0 (3.2-11.1)

Age 50-59 9.5 (5.3-16.8)

Race-Ethnicity

(all others referent)

Non-Hispanic Black 1.6 (1.1-2.3)

High School Education

(high school or more referent)

Less than High School/GED 2.0 (1.2-3.3)

Family Income

(>2.0 times poverty level referent)

<2.0 times poverty level 3.7 (2.6-5.3)

Age ≥ 60

Characteristic Odds Ratios

Age Categories

(≥ 70 referent)

Age 60-69 6.0 (3.2-11.1)

Race-Ethnicity

(all others referent)

Non-Hispanic Black 10.0 (4.9-20.1)

Adjusted Odds Ratios for the Presence of

HCV RNA: NHANES 2003-2010

Denniston M, Ann Int Med 2014 8

The Growing Burden of Hepatitis C in the United States

Of 2.7 million HCV-infected persons in primary care

1.47 million will develop cirrhosis

350,000 will develop hepatocellular carcinoma (HCC)

897,000 will die from HCV-related complications

Rein D, Dig Liver Dis 2010.9

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

Num

ber

of

Indiv

iduals

Year

Deaths

DCC

HCC

0

1

2

3

4

5

6

Rat

e p

er

10

0,0

00

Pe

rso

ns

Year

Reported Deaths 19,368

Median age- 59 years

Increases in Hepatitis C Mortality

10

39%42%

34%

16%6%

0

20

40

60

80

100

IFN IFN/RBV PEG/

RBV

IFN IFN/

RBV

Peg-IFN

(PEG)

Adapted from Strader DB, et al. Hepatology. 2004;39:1147-71

1991 1999 2001 2002 2011 2014

Advances in HCV Therapy

11

54 – 56%

Peg/RBV

DAA

67-72%

>90%

All oral

DAA

HCV Deaths Averted with Birth Cohort Testing Using Different Treatments

12

0

50,000

100,000

150,000

200,000

250,000

300,000

350,000

NoTreatment

PR PRPI, PR PRS/SR SS/SR

De

ath

s A

ve

rte

d

Treatment Type

PR = Pegylated Interferon plus Ribavirin for all genotypes, PRPI; PR = PR plus a protease inhibitor for genotype 1, PR for genotypes 2/3;

PRS/SR = pegylated interferon, ribaviron, and sofosbuvir for genotype 1, and sofosbuvir plus ribavirin for genotypes 2 and 3;

SS/SR = Sofosbuvir and Simeprevir for genotype 1, and sofosbuvir and ribavirin for genotypes 2 and 3.

Rein, D. B., The Cost-effectiveness, Health Benefits, and Financial Costs of New Antiviral Treatments for Hepatitis C Virus CID 2015

Risk-based Recommendations for HCV Screening

Since 1998, CDC recommendations included risk-

based screening

Injection drug use

Blood transfusion before 1992 and other blood exposures

HIV infected persons

45%-85% of infected persons remained unidentified

Barriers to testing

Lack of clinician awareness of HCV testing guidelines

Clinician reluctance to ask about risks

Patient reluctance to disclose or failure to recall risks

13MMWR 1998;47 (No. RR-19); Roblin, et al.. Am J Man Care 2011. Spradling, et al., Hepatology, 2012. Southern, et al., J Viral Hepat,. Shehab TM, et

al. Hepatology, 1999.; Shehab TM. J Viral Hepat, 2001.;Shehab TM, et al. Am J Gastroenterol, 2002.; Serrante JM, et al. Fam Med, 2008.

Broader HCV Testing Recommendation in 2012One time Test for Persons Born 1945 –1965

Prevalence ~6 times higher

than other ages (3.29% vs

0.55%)

Represent 81% of adult

chronic infections and 73%

HCV deaths

Benefit of treatment, with

SVR reducing

Liver cancer risk: 70%

All-cause mortality: 50%

No reported risk factors:

44%

14

Combined Birth-cohort and Risk-based Testing Effectively Identify HCV-infected Patients

0

10

20

30

40

50

60

70

80

90

100

Birth cohort testing Risk based only Birth cohort + risk based

68 %

27%

77%

Indications for Testing for Persons Reported with HCV

15Mahajan R, Am J Pub Health 2013 Aug

CDC and USPSTF Updated Recommendations for HCV Testing

One time screening test for persons born 1945-1965

Major risk

Past or present injection drug use

Other risks

Received blood/organs prior to June 1992

Received blood products made prior to 1987

Ever on chronic hemodialysis

Infants born to HCV infected mothers

Intranasal drug use

Unregulated tattoo

History of incarceration

Medical

Persistently elevated ALT

HIV (annual testing)

MMWR Aug 2012. Moyer VA, Ann Int Med 2013. http://www.hcvguidelines.org 16

Assurance for the Viral Hepatitis C Testing Recommendations for Persons Born 1945-1965

17

HCV Testing Linked to Care and Treatment Yields Health Benefits

The goal of HCV therapy is a sustained virologic

response (SVR)

SVR is the suppression of HCV to undetectable

levels in the blood usually determined 12 weeks after

the end of treatment

SVR represents a cure of HCV infection

Reduces risks of liver cancer and mortality

70% reduction in hepatocellular carcinoma

90% reduction in liver related mortality

50% reduction in all cause mortality

Rein D, Ann Int Med 2012, Eckman , CID, 2013,;McEwan, Hepatology2013,;McGarry, Hepatology 2012, Liu S, Plos One 2013

18

HCV Test, Care, and Cure Continuum, United States

19

1.6 M

(50%) 1.2 M

(38%)750,000

(23%) 360,000

(11%)200,000

(6%)

Holmberg S, et al, NEJM, 2013

Educate Communities:Know More Hepatitis

National Multi-Media Campaign

Goals:

Increase awareness of hepatitis C

Encourage testing of those born 1945-1965

Campaign Implementation:

Phase I – August 2012

Phase II – January 2015

Audiences:

Primary Care Providers

Consumers (Born from 1945 to 1965)

20

Know More Hepatitis

National Multi-Media Campaign Strategies

• Help with dissemination from state and local partners

• Primarily donated time and space

21

Campaign materials & how to use them

to help implement Know More Hepatitis

• Website

• Fact sheets

• Infographics

• Posters

• Video PSAs

• Live read radio scripts

• Buttons & Badges

• Shareable digital content

• Resources for providers

• Personalized recommendations based on

CDC’s hepatitis testing and vaccination

guidelines

Online Viral Hepatitis Risk Assessment

23

Testing Algorithm for Identifying Current Hepatitis C Virus (HCV) Infection (2013)

CDC. Testing for HCV infection: An update of guidance for clinicians and laboratorians. MMWR. 2013;62(18).24

* For persons who might have been exposed to HCV within the past 6 months, testing for HCV RNA or follow-up testing for HCV antibody is

recommended. For persons who are immunocompromised, testing for HCV RNA can be considered.

† To differentiate past, resolved HCV infection from biologic false positivity for HCV antibody, testing with another HCV antibody assay can be

considered. Repeat HCV RNA testing if the person tested is suspected to have had HCV exposure within the past 6 months or has clinical

evidence of HCV disease, or if there is concern regarding the handling or storage of the test specimen.

HCV

RNANot detected Detected+-

No current HCV infectionNo HCV antibody detected Current HCV infection

Link to careAdditional testing as appropriate†

STOP*

+-

Early Identification and Linkage to Care Capacity Building

Hepatitis C virus testing and linkage to care: 24 sites

funded 9/2012–9/2014

PWID (10)

Community Health Centers (7)

Settings to strengthen care and treatment (2): Project ECHO

Other: HIV/STD clinic, liver clinics, emergency departments

Community based programs to improve healthcare

capacity to test and cure hepatitis C: 3 sites funded

9/2014–9/2018

Improve primary care capacity to test and cure

Leverage Affordable Care Act

Build surveillance capacity to monitor outcomes and impact

25

1945-1965 Birth Cohort Testing* & Linkage to Care

Oct 2012 - Sept 2014

No. Tested = 43,068

3694

2848

2020

1646

1198

0

500

1000

1500

2000

2500

3000

3500

4000

HCV Ab Reactive RNA Tested from AbPositive

Persons RNA Positive Referred to Medical Care Attended 1st Medical Appt

9%

77%

71%

81%

73%

26

*Venues Include: Health Departments; Hospitals; Corrections; SheltersPrevention and Public Health Funding and Secretary's Discretionary Funding

HCV Testing of Persons Born 1945-1965 in Two University Medical Center Emergency

Departments

27

Extension for Community Health care

Outcomes (ECHO)

Expand PCP capacity in

HCV management

Rural and underserved

populations

Use videoconferencing

Share “best practices”

Case based learning

Similar SVR achieved

as those in HCV clinics

28N Engl J Med 2011;364:2199-207.

During 9/2012 –2/2014

Trained 66 PCP predominantly from rural settings

Most PCP (93%) with no experience in HCV care

Of 280 patients, 129 (46%) received treatment

• More than twice that observed in other CDC studies

29

Community-based Programs to Test and Cure Hepatitis C: 9/2014 –9/2018

Goal: develop package of services to improve

healthcare capacity to test and cure

Identify and educate target population

Incorporate HCV testing in primary care practices

Implement regular consultation of primary care provider with

HCV specialists

Case management

Monitor outcome and community impact via data system

Leverage Affordable Care Act: free testing, insurance

enrollment, and improve quality of care through use of EMR

30CDC RFA- PS 14-1413

Health Care ReformImpact on Viral Hepatitis Prevention

Insurance coverage for those with preexisting,

chronic disease

Testing covered as a non-copay preventive service

Incentive for adoption of health information

technology to care for patients

Emphasis on quality of provider care: use of

performance measures

31

American Medical Association Performance Measures Updated

Screening

One-time screening: patients at risk (injection drug use ever, blood

transfused prior to 1992, or born during 1945–1965)

Annual HCV screening: patients who are active injection Drug Users

Care and treatment

Referral to treatment for patients identified with HCV Infection

Sustained Virologic Response (SVR)

Confirmation of Hepatitis C viremia

Hepatitis C RNA and genotype testing before initiating treatment

HCV RNA testing between 4-12 weeks after treatment start

Discontinuation of antiviral therapy if inadequate response

Screening for HCC in patients with Hepatitis C Cirrhosis

Additional performance measures on prevention (vaccination,

alcohol consumption counseling, HCC screening)

Yellow= newly developed performance measures

Summary: U.S. Strategies to Enhance HCV Testing and Care

Broader testing recommendations, risk based and

birth-cohort

Multiple efforts to increase uptake

Education, capacity building , performance measures

Community based programs to improve healthcare

capacity to test and cure hepatitis C

Better linkage to care crucial to realize full potential of advances

in treatment

Challenges: under-diagnosis, access to care, and

cost of medications

33

Local Strategies to Enhance HCV

Testing and Care

• Gather community data to guide service delivery and inform policy

• Improve reporting

• Update professional training/ public awareness

• Assist in the expansion of HCV testing

• Target providers and health systems with interventions to promote

delivery of HCV testing and care

– Promote development of clinical decision tools and performance

measures

• Use to monitor and report back to providers and health systems

• Convene stakeholders

– Meetings with Medicaid, other payers,

– Presentations to providers, public health officials, others

• Participate in policy development

• Work in conjunction with the state Viral Hepatitis Prevention

Coordinator

34

Webcast 1.1 Hepatitis C: Where Are We Now?

Webcast 1.2 The National Viral Hepatitis Action Plan

Webcast 1.3 Viral Hepatitis C Testing Recommendations for

Persons Born 1945-1965

Webcast 1.4 Leveraging Partnerships to Address Hepatitis C:

Philadelphia’s Model

All materials available at www.naccho.org/hepatitisc

Local Health Departments and Hepatitis C NACCHO Educational Series

NACCHO’s educational series is supported by an educational grant from Janssen Therapeutics,

Division of Janssen Products, LP and funding from Gilead Sciences, Inc.