HEPATITIS WEB STUDY Hepatitis C Testing Recommendations Christian

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

Source: CDC and Prevention. MMWR. 2012: RR 61: 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: CDC and Prevention. MMWR. 2012: RR 61: 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 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 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 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 6 m IFN 12 m IFN + RBV 6 m IFN + RBV 12 m Peg. IFN + RBV 12 m RBV + PI 612 m 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 6 m IFN 12 m IFN + RBV 6 m IFN + RBV 12 m PEG + Multiple RBV 12 m RBV + PI 6 DAAs 3 m -12 m 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 ≥ 25 kg/m 2 • 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 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 Liver Transplant Cirhosis Carcinoma HCV-Related Deaths Difference -15, 484 -50000 -47, 189 -73, 689 -100000 -120, 879 -150000 -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 Colorectal CA (> age HCV 50) Screen (1945 -65) + PEGHTN IFN/RIB Screening HCV (> age 18) Screen 11, 000 15, 700 30, 000 (1945 -65) + PEGHIV IFN/RIB/D Screening AA (age 1364) Breast CA 35, 700 38, 000 49, 000 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