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HEPATITIS WEB STUDY

Christian B. Ramers, MD, MPH Assistant Medical Director, Family Health Centers of San Diego HIV/HCV Distance Education Specialist, Northwest AETC University 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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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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Hepatitis web study Source: CDC and Prevention. MMWR. 2012:RR61:1-32.

Recommendations and Reports / Vol. 61 / No. 4 August 17, 2012

Recommendations for the Identification of Chronic Hepatitis C Virus Infection Among

Persons Born During 1945–1965

U.S. Department of Health and Human ServicesCenters for Disease Control and Prevention

Morbidity and Mortality Weekly Report

Continuing Education Examination available at http://www.cdc.gov/mmwr/cme/conted.html.

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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

Y Y 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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Hepatitis web study

Rationale for Birth Cohort HCV Testing Recommendations

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1968 World Health Organization Guidelines Criteria 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

Hepatitis web study Source: Ly KN, et al. Ann Intern Med. 2012:156:271-8.

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

Rat

e pe

r 100

,000

PY

Year

HIV

1999 2000 2001 2002 2003 2004 2006 2007 2005

5

4

3

2

1

0

7

6

Hepatitis C

Hepatitis B

Hepatitis web study Source: 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 2005

Num

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

Hepatitis web study Source: 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 2005

Num

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 Peak

Hepatitis web study Source: 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 2005

Num

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

Hepatitis web study Source: Denniston M, et al. Hepatology. 2012:55:1652-61.

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

Unaware of HIV infection

21%

Knowledge of HCV Infection

Aware!50%!

Unware !50%!

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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

6

16

34 42 39

55

70

0

20

40

60

80

100

IFN 6m

IFN 12m

IFN + RBV 6m

IFN + RBV 12m

PegIFN 12m

PegIFN + RBV 12m

PegIFN + RBV + PI

6-12m

Sust

aine

d Vi

rolo

gic

Res

pons

e (%

) 1986 1998 2001 2002

Timeline 2011

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Therapy for Hepatitis C Projected SVR Rates with Multiple DAAs

6 16

34 42 39

55

70

90

0

20

40

60

80

100

IFN 6m

IFN 12m

IFN + RBV 6m

IFN + RBV 12m

PEG 12m

PEG + RBV 12m

PEG + RBV + PI

6-12m

Multiple DAAs

3m

Sust

aine

d Vi

rolo

gic

Res

pons

e (%

)

1986 1998 2001 2002

Timeline 2011 2014

Hepatitis web study Source: 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 Pr

eval

ence

(%)

1910

1988–1994 1999–2002 7.0

6.0

5.0

4.0

3.0

2.0

1.0

0 1920 1930 1940 1950 1960 1970 1980 1990

Hepatitis web study Source: 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 Pr

eval

ence

(%)

1910

1988–1994 1999–2002 7.0

6.0

5.0

4.0

3.0

2.0

1.0

0 1920 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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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

HCV Testing

HCV Diagnosis Treat HCV Link to Care

for HCV

Hepatitis web study

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

Improve Survival &

Quality of Life

Prevent New HCV Infections

HCV Testing

HCV Diagnosis

Link to Care for 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 1945-1965 Projected 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.

994,291

360,388

230,784

75,752

591,172

791,053

286,699

183,595

60,268

470,879

0

200000

400000

600000

800000

1000000

1200000

Compensated Cirhosis

Decompensated Cirhosis

Hepatocellular Carcinoma

Liver Transplant HCV-Related Deaths

Pers

ons

Risk-Based Testing + PR

Birth-Cohort Screening + PR and DAA

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HCV Testing of Persons Born 1945-1965 Projected 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.

-203,238

-73,689

-47,189

-15,484

-120,879

-250000

-200000

-150000

-100000

-50000

0

Compensated Cirhosis

Decompensated Cirhosis

Hepatocellular Carcinoma Liver Transplant

HCV-Related Deaths

Diff

eren

ce

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

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

49,000

38,000

35,700

30,000

15,700

11,000

0 10000 20000 30000 40000 50000 60000

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)

Cost per QALY ($)

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Hepatitis web study

§  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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