HEPATITIS WEB STUDY Hepatitis C Testing Recommendations 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 Last Updated: February 28, 2013

Hepatitis web study

Disclosure Information •  Speaker’s Bureau and Consultant: Gilead Sciences

Hepatitis web study

Hepatitis C Testing Recommendations in the U.S. §  CDC HCV Testing Recommendation §  Rationale for Birth Cohort HCV Testing Recommendations §  Goals and Potential Impact of HCV Birth Cohort Testing

Hepatitis web study

CDC HCV Testing Recommendations

Hepatitis web study

1998 – CDC Risk-Based HCV Screening Recommendations

§ 

HCV screening based on risk for infection: •  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 recognized exposure: •  Healthcare, emergency medical, and public safety workers after needle sticks, sharps, or mucosal exposures to HCV-positive blood •  Children born to HCV-positive women

Source: CDC and Prevention.

Hepatitis web study

Morbidity and Mortality Weekly Report 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

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

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

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

Hepatitis web study

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.

Hepatitis web study

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

Hepatitis web study

Rationale for Birth Cohort HCV Testing Recommendations

Hepatitis web study

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.

Hepatitis web study

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

3.2 - 4.1 Million Persons Living with Chronic HCV

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

Hepatitis web study

Age-Adjusted Mortality Rates from HBV, HCV, & HIV United States, 1999-2007 7 HIV

Rate per 100,000 PY

6 5 4

Hepatitis C

3 2 1

Hepatitis B

0 1999

2000

2001

2002

2003

2004

2005

2006

2007

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

Hepatitis web study

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

Persons with Chronic Hepatitis C and no Cirrhosis in 2005 45,000

Deaths

40,000 35,000

Number

30,000 25,000 20,000 15,000 10,000 5,000

0

2010 2014 2018 2022 2026 2030 2034 2038 2042 2046 2050 2054 2058

Year Source: Rein DR, et al. Dig Liver Dis. 2011:43:66-72.

Hepatitis web study

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

Persons with Chronic Hepatitis C and no Cirrhosis in 2005 45,000

Peak

40,000

Deaths

35,000

Number

30,000 25,000 20,000 15,000 10,000 5,000

0

2010 2014 2018 2022 2026 2030 2034 2038 2042 2046 2050 2054 2058

Year Source: Rein DR, et al. Dig Liver Dis. 2011:43:66-72.

Hepatitis web study

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

Persons with Chronic Hepatitis C and no Cirrhosis in 2005 45,000

Deaths

40,000 35,000

Number

30,000 25,000

Without treatment an estimated 1,071,229 20,000 persons will have died from hepatitis C by 2060 15,000 10,000 5,000

0

2010 2014 2018 2022 2026 2030 2034 2038 2042 2046 2050 2054 2058

Year Source: Rein DR, et al. Dig Liver Dis. 2011:43:66-72.

Hepatitis web study

NHANES Survey, United States, 2001-2008

Awareness of HCV Infection Status Knowledge of HCV Infection Unaware of HIV infection 21%

Unware ! 50%!

Aware! 50%!

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

Hepatitis web study

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

Hepatitis web study

Therapy for Hepatitis C: Historical Milestones

Sustained Virologic Response (%)

100

Timeline 1986

1998

2001

2002

80

2011

70

60

55 42

40

34

39

16

20 6

0

IFN 6m

IFN 12m

IFN + RBV 6m

IFN + RBV 12m

PegIFN 12m

PegIFN + RBV 12m

PegIFN + RBV + PI 6-12m

Hepatitis web study

Therapy for Hepatitis C

Projected SVR Rates with Multiple DAAs Timeline 1986

1998

2001

2002

2011

Sustained Virologic Response (%)

100

2014

90

80

70 55

60 42 40

34

39

16

20 6 0

IFN 6m

IFN 12m

IFN + RBV IFN + RBV 6m 12m

PEG 12m

PEG + RBV 12m

PEG + RBV + PI 6-12m

Multiple DAAs 3m

Hepatitis web study

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

Prevalence of HCV Antibody, by Year of Birth 7.0

1988–1994

1999–2002

HCV Prevalence(%)

6.0 5.0 4.0 3.0 2.0 1.0 0 1910

1920

1930

1940

1950

1960

1970

1980

1990

Year of Birth Source: Armstrong GL, et al. Ann Intern Med. 2006;144:705-14.

Hepatitis web study

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

Prevalence of HCV Antibody, by Year of Birth 7.0

1988–1994

1999–2002

HCV Prevalence(%)

6.0 1945-1965

5.0 4.0 3.0 2.0 1.0 0 1910

1920

1930

1940

1950

1960

1970

1980

1990

Year of Birth Source: Armstrong GL, et al. Ann Intern Med. 2006;144:705-14.

Hepatitis web study

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

Hepatitis web study

Goals and Projected Impact of Birth-Cohort Screening

Hepatitis web study

Goals for Birth Cohort Hepatitis C Testing in U.S. Improve Survival & Quality of Life

HCV Testing

HCV Diagnosis

Link to Care for HCV

Treat HCV

Prevent New HCV Infections

Hepatitis web study

Goals for Birth Cohort Hepatitis C Testing in U.S. Improve Survival & Quality of Life

HCV Testing

HCV Diagnosis

Link to Care for HCV

Prevent New HCV Infections

Hepatitis web study

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.

Hepatitis web study

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 1200000

Persons

1000000 800000

Risk-Based Testing + PR

994,291

Birth-Cohort Screening + PR and DAA 791,053

591,172

600000

470,879

400000

360,388 286,699 230,784

200000

183,595 75,752 60,268

0

Compensated Decompensated Hepatocellular Liver Transplant Cirhosis Cirhosis Carcinoma

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

HCV-Related Deaths

Hepatitis web study

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

0

Compensated Decompensated Hepatocellular Cirhosis Cirhosis Carcinoma Liver Transplant

HCV-Related Deaths

-15,484

Difference

-50000

-47,189 -73,689

-100000

-120,879 -150000

-200000 -203,238 -250000 Source: Rein DB, et al. Ann Intern Med. 2012:156:263-70.

Hepatitis web study

HCV Testing of Persons Born 1945-1965

Cost Effectiveness Compared with other Screening Tests 11,000

Colorectal CA (> age 50)

15,700

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

30,000

HTN Screening (> age 18)

35,700

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

38,000

HIV Screening (age 13-64)

49,000

Breast CA Screening (> age 40) 0

10000

20000

30000

40000

50000

60000

Cost per QALY ($) Source: Rein, DB et al Ann Intern Med 2012:156:263-70.

Hepatitis web study

CDC Birth Cohort HCV Testing Recommendations in U.S. : Summary § 

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

Hepatitis web study

End

This presentation is brought to you by Hepatitis Web Study & the Hepatitis C Online Course Funded by a grant from the Centers for Disease Control and Prevention

Hepatitis web study