Kiren Mitruka, MD, MPH

Medical Officer- care and treatment

Division of Viral Hepatitis

Centers for Disease Control and Prevention

Hepatitis B and C Prevention Strategies,

United States

1st International Meeting on Hepatitis Cure and Eradication

November 6, 2014

Division of Viral Hepatitis

National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention

Persons Living With Viral Hepatitis B and C, United States

Virus

Prevalence % Unaware of

infection

Deaths (2006)

Hepatitis B 800,000 – 1.4

million ~ 65% 3,000

Hepatitis C 3-4 million 50-75% 15,000

2

Mortality associated with Hepatitis B, Hepatitis C, and HIV United States,

1999–2010

K Ly et al, Ann Intern Med 2012; 156:271-8

0

1

2

3

4

5

6

7

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Rat

e p

er

10

0,0

00

Pe

rso

ns

Year

Hepatitis B

Hepatitis C

HIV

United States Viral Hepatitis Action Plan, 2011 (updated 2014) : Priority Areas

Educate providers and communities

to reduce health disparities

Improve testing, care and treatment

Strengthen surveillance

Eliminate transmission of vaccine-

preventable hepatitis

Reduce viral hepatitis caused by drug-use

behaviors

Protect patients and workers from healthcare-

associated hepatitis

Overview of Hepatitis B Virus Prevention and Control

Vaccination

All infants, beginning at birth

All children and adolescents (through age 18)

Adults in high-risk groups (e.g., STD, MSM, IDU, HIV-infected)

Reducing perinatal transmission Screening for HBsAg* in pregnancy and post exposure prophylaxis of newborn

Screening for infection

High risk groups

Foreign-born persons from countries with prevalence ≥2%

Education and raising awareness

Testing and linkage to care programs

* Hepatitis B surface antigen

Hepatitis B Vaccine Policy and Rates of

Acute Hepatitis B, United States,1980–2011

6

0

2

4

6

8

10

12

14

Cas

es/

10

0,0

00

po

pu

lati

on

Year

All US infants,

1991

Ages 0-18 years, 1999

Adults <60 years with Diabetes

Birth dose, 2006

High-risk groups,*

1982

Infants of HBsAg-positive women, 1984

*Health care providers, MSM, IDU, hemodialysis patients, household & sexual partners of persons with chronic HBV,

persons in certain institutional settings, e.g., inmates of long-term correctional facilities.

Source: National Notifiable Disease Surveillance System (NNDSS)

Universal maternal

HBsAg testing 1988

Estimated Number of Births to HBsAg-Positive Pregnant Women

U.S., 1993-2009

0

10000

20000

30000

Nu

mb

er

of

liv

e b

irth

s

Year

Smith, E.A., et al., The national Perinatal Hepatitis B Prevention Program, 1994-2008. Pediatrics, 2012. 129(4): p. 609-16. 7

19,048

24,804

U.S. Perinatal Hepatitis B Prevention Program

Created in 1990 to assist in elimination of

perinatal hepatitis B transmission

Programs in 64 public health jurisdictions

50 states, 6 cities, 8 territories and freely associated

island nations

Fosters collaboration with healthcare providers, laboratories,

hospitals, nursery staff, and families

8

http://www.cdc.gov/hepatitis/HBV/PerinatalXmtn.htm

Perinatal Hepatitis B Prevention

Screen all pregnant women

First prenatal visit and retest at or prior to

delivery if at risk

Link to care and treatment if infected

Post-exposure prophylaxis to newborn

HBIG and single antigen Hepatitis B vaccine

within 12 hours of birth

Timely completion of HBV vaccine series

Post-vaccination serologic testing 1-2 months

after completion of vaccine series, not before

9 months of age

Revaccinate if not protected

• HBsAg-negative and antibody to

hepatitis B surface antigen (≥10mlU/mL)

9

MMWR Dec 2005

Percentage of Infants of HBsAg*-Positive

Mothers Completing Case Management,

CDC Perinatal Program, 1993–2009

* Hepatitis B surface Antigen.

Data Source: National Center for Immunization and Respiratory Disease, CDC, as of 8/2013

0

20

40

60

80

100

19

93

19

94

19

95

19

96

19

97

19

98

19

99

20

00

20

01

20

02

20

03

20

04

20

05

20

06

20

07

20

08

20

09

Pe

rce

nt

infa

nts

Year

Vaccine/HBIG at birth

3 doses by 6-8 months

Post-vaccination testing

95%

73%

58%

CDC and USPSTF* Recommendations

for Hepatitis B Testing

Populations with >2% prevalence1,2

Foreign born

US-born to parents born in high

prevalence regions (>8%)

Other: MSM, IDU, HIV + persons, household contacts or sexual partners of

HBV+

Candidates for immunosuppression therapy

Screening and treatment cost effective

$29,230/QALY 3

* US Preventive Services Task Force 1 MMWR 2008; 57 (No. RR-8):1-20; 2 LeFevre Screening for Hepatitis B Virus Infection in Nonpregnant Adolescents and Adults: U.S.

Preventive Services Task Force Recommendation Statement, May 2014 3Eckman, MH, CID 2011:52 11

Raising Awareness

http://www.cdc.gov/knowhepatitisb/materials.htm 12

Building Capacity in Hepatitis B Testing and

Linkage to Care at 9 Sites Serving Persons at

Risk*: 9/2012-9/2014, preliminary results**

Goals Achieved %Achieved

Persons tested for HBsAg

17,000 14,694 86%

Persons tested HBsAg+

802 (5%) 4-8% range

Persons received results

85% 691 86%

Persons referred to care,

treatment, and preventive

services

75% 635 79%

Persons attended first

medical appointment

406 64%

13 * Foreign-born person from intermediate/high endemic areas; **Receipt of data ongoing

Community-Based Hepatitis B Programs 10/2014–9/2016

Goal: To improve the capacity of healthcare

providers to identify and link foreign-born

individuals with chronic hepatitis B to care

14

Number of awards 3

Eligibility Established coalition of public

health, academic centers, and

primary care providers (PCP)

One year award amount $300,000

Project period 2 years

Total project period funding $1.8 million

CDC RFA- PS 14-1414

Hepatitis C Virus: Prevention and Control

Primary Prevention (prevent infection)

Screen blood supply

Ensure safe therapeutic injection practices

Practice universal precautions in medical practices

Counsel infected person to reduce transmission risk behavior

Reduce illicit drug use and ensure safety (e.g., needle exchange)

Secondary prevention (prevent disease)

Test to detect active infection

Counsel to avoid alcohol intake

Vaccinate for hepatitis A and B

Treat with antivirals

Adapted from Thomas D. Nature Medicine July 2013 : ( 19) 850-859

Impact of Prevention Measures

on Hepatitis C Virus (HCV) Infection in United States

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

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

Recent Increases in HCV Infection

17

Between 2007 and 2012 50% increase in case reporting

200% increase in 17 states

Risk factors • ~ 70% persons who inject drugs

• Previous oral prescription

narcotic use

• Equally male to female

• Young, ages 18 to 29 years

• White

• Rural and suburban

Zibbell J, et al. AJPH 2014; Suryprasad AG, et al. CID 2014

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

Birth cohort represent

81% of adult chronic infections

73% HCV deaths

Prevalence ~6 times higher (3.29%

vs 0.55% other ages)

No reported risk factors: 44%

Benefit of treatment, with SVR

reducing

Liver cancer risk: 70%

All-cause mortality: 50%

MMWR August 17, 2012 / 61(RR04);1-18 ; Armstrong, et al. Ann Int Med. 2006.; Kramer, Et al., Hepatology 2011; Backus LI, Clin Gastroenterol Hepatol. 2011; Morgan RLAnn Intern Med. 2013

USPSTF* and CDC Recommendations for HCV Testing

One time screening test for persons born 1945-1965

without ascertainment of risk (USPSTF Grade B)

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

* US Preventive Services Task Force . Updated recommendation for screening June 2013

MMWR Aug 2012.; Moyer VA, Ann Int Med 2013. *

Health Impact of Birth Cohort Recommendations

Outcome Birth Cohort Testing with Therapy

PegIFN-Riba + Telapravir

Additional identified cases 809,000

Cirrhosis cases averted 203,000

Decompensated cirrhosis

cases averted 74,000

Hepatocellular carcinoma

cases averted 47,000

Transplants averted 15,000

Deaths from hepatitis C virus

averted 121,000

Medical costs averted $2.5B

Cost/QALY gained $35,700

Rein DB, Annals of Internal Medicine. 2011.

Know More Hepatitis Campaign Strategies

National Educational Campaign

News/Media Advocacy

Opinion Leader Outreach

Professional Education

Partnership

Engagement

Social

Media

Broadcast

(Radio/ TV Public Service

Advertising)

Digital Media

Educating Communities

22

Airport Diorama

Highway Billboard

Treatment as Prevention Strategy to reduce HCV Prevalence

Martin NK et al . Hepatology 2013

23

Cure and Prevention (CaP): Models for Persons Who Inject Drugs (PWID)

Model under development to estimate the impact of targeted

treatment on incidence and prevalence associated with

prevention strategies*

Targeted treatment to active injectors within social networks

Assess reductions in morbidity & mortality and reinfection rates

Use existing datasets to model case-studies for U.S. settings

Rural versus urban

New treatment and associated costs

Develop estimates of cost, and cost-effectiveness to achieve

desired health outcomes

24 * Includes concurrent evidence-based interventions needles exchange and opioid agonist treatment

Building Capacity in Hepatitis C Testing and

Linkage to Care at 22 Sites Serving Persons

at Risk*: 9/2012–9/2014, preliminary results*

Continuum of care Goals Achieved %Achieved

Persons tested for HCV Antibody

and HCV RNA

47,400 43,768 92%

Persons tested anti-HCV + 5,796 (13%)

Range 3-51%

Persons received RNA test 85% 3,557 61%

Persons received RNA

results

85% 2,189 83%

Persons referred to care,

treatment, and preventive

services

75% 2,078 79%

Persons began treatment 15% 70 3%

25 *Receipt of data ongoing

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

26

Number of awards 3

Eligibility Established coalition of

public health, academic

centers, and primary care

Average one year award amount $1.5 million

Project period 4 years

Total project period funding $20 million

CDC RFA- PS 14-1413

Community-based Programs to Test and Cure

Hepatitis C: Outcomes

Initial targets

An annual increase in testing, diagnosis, and cure by of ≥ 50%, with at least

• 10,000 persons tested

• 2000 persons diagnosed

• 2500 cured

Targets to be revisited during project period

Community-based Programs to Test and Cure

Hepatitis C: Package of Services

Identify and educate target population

Incorporate HCV testing among 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: insurance enrollment, free

testing, and improve quality of care through use of EMR

American Medical Association Performance Measures Updated (2013)

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

Additional performance measures on prevention (vaccination, alcohol

consumption counseling, HCC screening)

29

Viral Hepatitis Prevention in the United States

Improve primary prevention: reduce transmission

Strengthen the continuum of HBV and HCV testing,

care, and treatment

Enhance surveillance to detect and interrupt

transmission

Build evidence base for policy development and to

guide interventions

30