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HEPATITIS WEB STUDY

Christian B. Ramers, MD, MPHAssistant Medical Director, Family Health Centers of San DiegoHIV/HCV Distance Education Specialist, Northwest AETCUniversity of Washington School of Medicine

Hepatitis C Testing Recommendations

Last Updated: February 28, 2013

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Disclosure Information

• Speaker’s Bureau and Consultant: Gilead Sciences

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CDC HCV Testing Recommendation

Rationale for Birth Cohort HCV Testing Recommendations

Goals and Potential Impact of HCV Birth Cohort Testing

Hepatitis C Testing Recommendations in the U.S.

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Hepatitisweb study

CDC HCV Testing Recommendations

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1998 – CDC Risk-Based HCV Screening Recommendations

Source: CDC and Prevention.

• Persons who ever injected illegal drugs

• Persons with selected medical conditions, including- receipt of clotting factor concentrates produced before 1987;- ever on chronic (long-term) hemodialysis; and- persistently abnormal alanine aminotransferase levels

• Prior recipients of transfusions or organ transplants (before July 1992)

HCV screening based on risk for infection:

• Healthcare, emergency medical, and public safety workers after needle sticks, sharps, or mucosal exposures to HCV-positive blood

• Children born to HCV-positive women

HCV screening based on recognized exposure:

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Hepatitisweb studySource: CDC and Prevention. MMWR. 2012:RR61:1-32.

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2012 CDC Birth Cohort HCV Testing Recommendations

In addition to testing adults of all ages at risk for hepatitis C virus:

Adults born during 1945 to 1965 should receive 1-time testing for HCV

without prior ascertainment of HCV risk.

All persons identified with HCV infection should receive:

- A brief alcohol screening and intervention as clinically indicated,

- Referral to appropriate care and treatment services for HCV infection,

- Post-test counseling

Source: Source: CDC and Prevention. MMWR. 2012:RR61:1-32.

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Hepatitis C Testing Methods

YY Y• Screening: Hepatitis C Antibody Testing

- Highly sensitive and specific

- Reactive test indicates current or resolved infection

• Supplemental: Nucleic Acid Testing

- Quantitative and qualitative HCV RNA tests used

- Positive test indicates active infection

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Hepatitisweb study

Rationale for Birth Cohort HCV Testing Recommendations

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1968 World Health Organization GuidelinesCriteria for New Screening Programs

When considering general public health screening programs, the following factors should be considered:

Relevance: Is the condition an important public health problem with a well-understood natural history and a latent phase?

Feasibility: Is there an effective intervention? Is a screening test available, easy to use, accurate, and acceptable to the population?

Effectiveness: Does early diagnosis and treatment affect outcomes?

Cost Effectiveness: Is the cost of the screening program worth the investment in terms of health benefit gained?

Adapted from: Wilson JMG and Jungner G. Principles and Practice of Screening for Disease. WHO. 1968.

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Sources: Armstrong GL, et al. Ann Intern Med. 2006;144:705-14. Chak E, et al. Liver Int. 2011;31:1090-101.

Estimated Prevalence of Chronic Active Hepatitis C in U.S.

3.2 - 4.1 Million Persons Living with Chronic HCV

Hepatitisweb studySource: Ly KN, et al. Ann Intern Med. 2012:156:271-8.

Age-Adjusted Mortality Rates from HBV, HCV, & HIV United States, 1999-2007

Rate

per

100,0

00 P

Y

Year

HIV

1999 2000 2001 2002 2003 2004 2006 20072005

5

4

3

2

1

0

7

6

Hepatitis C

Hepatitis B

Hepatitisweb studySource: Rein DR, et al. Dig Liver Dis. 2011:43:66-72.

Forecasted 2010-2060 Annual HCV-Related Deaths in the United States

Persons with Chronic Hepatitis C and no Cirrhosis in 2005N

um

ber

Year

2010

Deaths

2014 2018 2022 2026 2030 2034 2038 2042 2046 2050 2054 2058

40,000

35,000

30,000

25,000

20,000

15,000

10,000

5,000

0

45,000

Hepatitisweb studySource: Rein DR, et al. Dig Liver Dis. 2011:43:66-72.

Forecasted 2010-2060 Annual HCV-Related Deaths in the United States

Persons with Chronic Hepatitis C and no Cirrhosis in 2005N

um

ber

Year

2010

Deaths

2014 2018 2022 2026 2030 2034 2038 2042 2046 2050 2054 2058

40,000

35,000

30,000

25,000

20,000

15,000

10,000

5,000

0

45,000Peak

Hepatitisweb studySource: Rein DR, et al. Dig Liver Dis. 2011:43:66-72.

Forecasted 2010-2060 Annual HCV-Related Deaths in the United States

Persons with Chronic Hepatitis C and no Cirrhosis in 2005N

um

ber

Year

2010

Deaths

2014 2018 2022 2026 2030 2034 2038 2042 2046 2050 2054 2058

40,000

35,000

30,000

25,000

20,000

15,000

10,000

5,000

0

45,000

Without treatment an estimated 1,071,229 persons will have died from hepatitis C by 2060

Hepatitisweb studySource: Denniston M, et al. Hepatology. 2012:55:1652-61.

NHANES Survey, United States, 2001-2008Awareness of HCV Infection Status

Unaware of HIV infection

21%

Knowledge of HCV Infection

Aware50%

Unware 50%

Chart Title

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Source: WHO Hepatitis C Fact Sheet http://www.who.int/immunization/topics/hepatitis_c/en/index.html

Burden of disease related to HCV

 Outcome Key Facts

Cirrhosis• Develops in 20% of those who are chronically

infected with HCV over 20-30 years

Decompensated Cirrhosis• High risk of mortality from ruptured esophageal

varices, bacterial peritonitis, hepatorenal syndrome/renal failure, encephalopathy

Hepatocellular Carcinoma • Fastest growing Cancer in the US • 76% associated with chronic HCV infection• 4% annual incidence in those with cirrhosis

Liver Transplantation • HCV responsible for 65% of liver transplants

worldwide

HCV Mortality• Estimated at 16,000/year• Likely to peak ~2030

Burden of Liver disease expected to triple in next 10-20 yrs

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Therapy for Hepatitis C: Historical Milestones

0

20

40

60

80

100

6

16

34

42 39

55

70

Su

sta

ine

d V

iro

log

ic R

es

po

ns

e (

%)

1986 1998 2001 2002

Timeline

2011

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Therapy for Hepatitis CProjected SVR Rates with Multiple DAAs

0

20

40

60

80

100

6

16

3442 39

55

70

90

Su

sta

ine

d V

iro

log

ic R

es

po

ns

e (

%)

1986 1998 2001 2002

Timeline

2011 2014

Hepatitisweb studySource: Armstrong GL, et al. Ann Intern Med. 2006;144:705-14.

NHANES Survey: United States, 1988-1994 and 1999-2002

Prevalence of HCV Antibody, by Year of Birth

Year of Birth

HC

V P

revale

nce(%

)

1910

1988–1994 1999–20027.0

6.0

5.0

4.0

3.0

2.0

1.0

01920 1930 1940 1950 1960 1970 1980 1990

Hepatitisweb studySource: Armstrong GL, et al. Ann Intern Med. 2006;144:705-14.

NHANES Survey: United States, 1988-1994 and 1999-2002

Prevalence of HCV Antibody, by Year of Birth

Year of Birth

HC

V P

revale

nce(%

)

1910

1988–1994 1999–20027.0

6.0

5.0

4.0

3.0

2.0

1.0

01920 1930 1940 1950 1960 1970 1980 1990

1945-1965

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Rationale for One-Time HCV Testing of All Persons Born in United States during 1945 to 1965

• Hepatitis C is a major current & future health problem in United States

• Testing can identify persons before onset of severe HCV-related disease

• Hepatitis C infection can be cured with treatment

• Bulk of HCV problem in United States involves persons born 1945-1965

• Approximately 50% of persons with HCV remain unaware of HCV status

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Hepatitisweb study

Goals and Projected Impact of Birth-Cohort Screening

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Goals for Birth Cohort Hepatitis C Testing in U.S.

Improve Survival &

Quality of Life

Prevent New HCV Infections

HCVTesting

HCVDiagnosis

Treat HCVLink to Care

for HCV

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Goals for Birth Cohort Hepatitis C Testing in U.S.

Improve Survival &

Quality of Life

Prevent New HCV Infections

HCVTesting

HCVDiagnosis

Link to Carefor HCV

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HCV Testing of Persons in 1945-1965 Birth Cohort CDC Recommendations for Post Test Counseling

• Refer or obtain advice for care of HCV - experienced primary care provider or specialist

• Educate patient on how to protect liver from further harm- Immunization against Hepatitis A and B- Brief alcohol screening and intervention- Limit exposure to hepatotoxic drugs (e.g. acetaminophen)

• Counsel obese patients on diet & weight Loss- Especially BMI ≥25kg/m2

• Advise on decreasing risk of transmission to others- Donation of blood, tissue, semen- Use of razors, toothbrushes, nail clippers

Source: CDC and Prevention. MMWR. 2012:61(RR-4):1-32.

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HCV Testing of Persons Born 1945-1965Projected Benefit of One Time Birth Cohort Testing

Clinical Outcomes Associated with Risk Based versus Birth Cohort HCV Testing

Source: Rein DB, et al. Ann Intern Med. 2012:156:263-70.

0

200000

400000

600000

800000

1000000

1200000

994,291

360,388

230,784

75,752

591,172

791,053

286,699

183,595

60,268

470,879

Risk-Based Testing + PR

Birth-Cohort Screening + PR and DAA

Pers

on

s

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HCV Testing of Persons Born 1945-1965Projected Benefit of One Time Birth Cohort Testing

Cases Averted with Birth Cohort HCV Testing versus Risk Based HCV Testing

Source: Rein DB, et al. Ann Intern Med. 2012:156:263-70.

-250000

-200000

-150000

-100000

-50000

0

-203,238

-73,689

-47,189

-15,484

-120,879Dif

fere

nce

Hepatitisweb studySource: Rein, DB et al Ann Intern Med 2012:156:263-70.

HCV Testing of Persons Born 1945-1965Cost Effectiveness Compared with other Screening Tests

Breast CA Screening (> age 40)

HIV Screening (age 13-64)

HCV Screen (1945-65) + PEG-IFN/RIB/DAA

HTN Screening (> age 18)

HCV Screen (1945-65) + PEG-IFN/RIB

Colorectal CA (> age 50)

0 10000 20000 30000 40000 50000 60000

49,000

38,000

35,700

30,000

15,700

11,000

Cost per QALY ($)

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Perform one-time HCV testing of all persons born 1945-1965

Continue risk-based HCV screening

Sound rationale exists for birth-cohort screening

Potential for large impact of birth-cohort testing

CDC Birth Cohort HCV Testing Recommendations in U.S. :

Summary

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End

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