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Hepatitis web study
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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Hepatitis web study
Disclosure Information
• Speaker’s Bureau and Consultant: Gilead Sciences
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Hepatitis web study
Hepatitis web study
§ 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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Hepatitis web study
Hepatitis web study
CDC HCV Testing Recommendations
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Hepatitis web study
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
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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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.
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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
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Hepatitis web study
Hepatitis web study
Rationale for Birth Cohort HCV Testing Recommendations
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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.
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Hepatitis web study
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
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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
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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
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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
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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
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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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Hepatitis web study
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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Hepatitis web study
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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Hepatitis web study
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
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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
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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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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
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Hepatitis web study
Hepatitis web study
Goals and Projected Impact of Birth-Cohort Screening
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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 Treat HCV Link to Care
for HCV
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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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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.
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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
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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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
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
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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
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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Hepatitis web study
Hepatitis web study
End
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