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
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Disclosure Information
• Speaker’s Bureau and Consultant: Gilead Sciences
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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
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CDC HCV Testing Recommendations
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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.
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Source: 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
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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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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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.
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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.
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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.
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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.
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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.
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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.
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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
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Therapy for Hepatitis C: Historical Milestones
Sustained Virologic Response (%)
100
Timeline
1986
1998
2001
2002
2011
80
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 612m
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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
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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.
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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.
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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
HCV
Testing
HCV
Diagnosis
Link to Care
for HCV
Treat HCV
Prevent New
HCV Infections
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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
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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
1200000
Risk-Based Testing + PR
Persons
1000000
800000
994,291
Birth-Cohort Screening + PR and DAA
791,053
591,172
600000
470,879
400000
360,388
286,699
230,784
183,595
200000
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
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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
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.
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HCV Testing of Persons Born 1945-1965
Cost Effectiveness Compared with other Screening Tests
Colorectal CA (> age 50)
11,000
HCV Screen (1945-65) + PEG-IFN/RIB
15,700
HTN Screening (> age 18)
30,000
HCV Screen (1945-65) + PEG-IFN/RIB/DAA
35,700
HIV Screening (age 13-64)
38,000
Breast CA Screening (> age 40)
49,000
0
10000
20000
30000
40000
50000
60000
Cost per QALY ($)
Source: Rein, DB et al Ann Intern Med 2012:156:263-70.
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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
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End
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Funded by a grant from the Centers for Disease Control and Prevention
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