Placing the United States on the Path Toward the Elimination of Hepatitis C as a Public Health Threat John W. Ward, M.D Division of Viral Hepatitis National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention Centers for Disease Control and Prevention National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention Division of Viral Hepatitis
Domestic Strategies and Plans to Prevent Viral Hepatitis Transmission and Disease Institute of Medicine Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C (2010) Action Plan for Prevention, Care, and Treatment of Viral Hepatitis (Updated 2014-2016) Action Plan for Prevention, Care, and Treatment of Viral Hepatitis (Updated 2017-2020) Action Plan for Viral Hepatitis Prevention, Care, and Treatment United States (2011) DVH Strategic Plan (2016-2020) In development: A National Strategy for the Elimination of Hepatitis B and C (2017) CDC role in 61% of USG actions
Proportion Anti-HCV-Positive, % He United States has Epidemics of HCV Transmission and Disease Rising Number of New Acute HCV Cases Related to Injection Drug Use HCV seroprevalence highest for persons born 1945-1965 7.0 6.0 5.0 4.0 3.0 2.0 1.0 1965 0.0 1910 1920 1930 1940 1950 1960 1970 1980 1990 Year of Birth These persons who inject drugs (PWIDs) are mainly: Young (aged 20-29 yrs); White; roughly equal gender distribution Non-urban (suburban, rural); and Previous oral prescription opioid us and heroin 6 fold higher prevalence than others (3.39% ) 81% of all HCV infected adults 73% of HCV related deaths Averge age at death- 59 yrs. Suryaprasad, CID 2014, Denniston Ann Int Med 2014; cdc.gov/hepatitis
Stage of Liver Disease Among HCV Infected Persons, United States, 2010-2013 90% 80% 70% 60% 50% 40% From 9.8 M persons tested for HCV None/mild Moderate Advanced/cirrhosis 30% 20% 10% 0% All HCV infected n=150,473 Born 1945-1965 n=109,276 Born after 1965 n=36073 FIB-4 score was calculated using the formula (age aspartate aminotransferase)/(platelet alanine aminotransferase) and advanced fibrosis or cirrhosis was FIB-4 > 3.25., Klevens, M, CID 2016
Total Cases Total Cases Total Cases Total Cases HCV Prevalence and Disease Trends 2013-2015 With and Without New Intervention United States Total Infected Cases (Viremic) Liver related Deaths 3,500,000 3,000,000 2,500,000 2,000,000 1,500,000 1,000,000 500,000-40,000 35,000 30,000 25,000 20,000 15,000 10,000 5,000-2013 Base 2015 Base 2013 Base 2015 Base HCC Decompensated Cirrhosis 40,000 35,000 30,000 25,000 20,000 15,000 10,000 5,000-100,000 80,000 60,000 40,000 20,000-2013 Base 2015 Base 2013 Base 2015 Base http://polarisobservatory.org/polaris/hepc.htm
Impact of HCV Testing, Care, and Curative Treatment Test: Persons born 1945-1965 (representing 75% of all persons living with HCV infection) Persons who inject drugs Care and Treatment: ~90% cure with one to several pills/day for 8-12 weeks Benefits: 73% reduction in liver cancer 93% reduction in liver-related mortality Impact: Prevention of 321,000 HCV deaths Decreased HCV transmission to others van der Meer JAMA 2012; Morgan Ann Int Med 2012; Rein CID 2015; Martin, CID 2013
Percent Percent HCV Antibody Tested by Birth Year Group MarketScan Insurance Claims Data, 2005-2014 4,5 4 3,5 3 2,5 2 1,5 1 0,5 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Birth Year Group 1945-1965 Other birth years
Percent 30 25 Primary Diagnosis Code for HCV Antibody Testing, Among the Birth Cohort, in MarketScan Insurance Claims Data 20 2005 2009 2014 15 10 5 0 Liver Related Findings General Medical Examination STD Screening or Exposure History Other Specified Viral Diseases Other Tests or Findings
Barriers Limit Access to HCV Testing, Care, and Treatment Poor provider knowledge Lack of clinical decision tools Limited public health data to monitor performance Few patient navigators per volume Denial of CMS reimbursement for testing (e.g, ED, in-patients) and treatment Cost of HCV therapy 100% 80% 60% 40% 20% 0% Holmberg et al., Hepatitis C in the U.S. N Engl J Med 2013
Percent w/ 30d follow-up among Ab+ MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY Key Strategies to Improve Access to HCV Testing, Care and Curative Therapy Reflex RNA Testing 120 100 RNA follow-up testing within 30 days of Ab+ result 95 80 60 40 20 32 Quest Reflex policy 26 LabCorp 33 0 2013 2014 2015 2016 CDC unpublished data
Key Strategies Improve Access to HCV Testing, Care, and Curative Therapy Underserved, Black / Hispanic population 75% homeless 37% uninsured 58% public insurance Care coordination Sign up for insurance Schedule clinic visits Monitor patient progress through care Patient Assistance 250 200 150 100 HCV testing for public housing clients, Philadelphia 50 0 11% anti-hcv+ 92% tested for RNA 63% RNA + 89% Of HCV RNA+ 75% Coyle C, MMWR, May 2015
HCV antibody screening Key Strategies Improve Access to HCV Testing, Care, and Curative Therapy Provider Education and Clinical Decision Tools 35% 30% 25% 20% 15% 10% 5% Indian Health Service HCV antibody testing among persons born during 1945-1965 0% 2012 2013 2014 2015 Year Reilley B, MMWR 2016
500 450 400 350 300 250 200 150 100 50 0 Key Strategies Improve Access to HCV Testing, Care, and Curative Therapy Move from Speciality to Primary Care HCV Treatments by Pharmacists in Cherokee Nation Health Service 10/2014 10/2016 446 Total Number of Patients 26 % 114 Patients Treated by Pharmacists
Recent Actions Cost of Treatment and Influence on Access- United States USG cautions states about restrictive HCV treatment policies November 5, 2015 Approval of ZEPATIER with list price $54,600, January 2016 Reports of falling drug prices (VA ~$17K) Legal actions remove restrictions on disease severity in some states- May 2016 ~ 500 K treated/cured
Change in HCV Incidence is Associated with Increases in Injection Drug Use 30,500 new HCV infections in 2014 Suryaprasad, CID 2014, Zibbell MMWR 2015
Rate per 100,000 Births Rates of Infants Born to HCV Infected Women, Kentucky and the United States 2011, 2014 1800 1600 1400 1200 1000 800 600 400 200 0 1 of 67 births 1 of 308 births 2011 2012 2013 2014 Kentucky Year of Infant United Birth States
Global Health, Outbreak & Surveillance Technology (GHOST) Reveals Transmission Networks Indiana 2015 HCV positive- 599 HIV Positive- 116 (19%) HIV Negative 483 (81%) HIV positive - 125 HCV Positive- 116 (92%) HCV Negative- 9 (8%) Major Cluster 130 persons; 50 with mixed genotypes Multiple introductions of HCV and super infections
Syringe Service Pprovision (SSP) and Medication-assisted Treatment (MAT) Reduce Injecting Risk Behaviour: Limited evidence for effect on HCV transmission 1,2 New Cochrane systematic review offers new data MAT decreases risk by 50% SSP decreases risk by 56% (in Europe) MAT+SSP jointly decrease risk by 71% Reference High NSP coverage Hope, 2011 Bruneau, 2015 Van Den Berg, 2007 Palmateer, 2014 Subtotal (I-squared = 64.4%, p = 0.038). Low NSP coverage Hope, 2011 Van Den Berg, 2007 Palmateer, 2014 Subtotal (I-squared = 29.6%, p = 0.242). Overall (I-squared = 62.2%, p = 0.014) NOTE: Weights are from random effects analysis Favours MAT+SSP.01 125 Favours NSP/OST Risk Ratio (95% CI) 0.17 (0.02, 1.54) 0.63 (0.37, 1.07) 0.15 (0.06, 0.40) 0.24 (0.10, 0.60) 0.29 (0.13, 0.65) 0.29 1.08 (0.31, (0.13, 3.82) 0.65) 10.54 1.04 (0.53, 2.05) 18.03 0.48 (0.24, 0.95) 0.76 (0.44, 1.33) 0.47 (0.27, 0.80) Favours no NSP/OST % Weight 4.85 20.26 13.66 14.81 53.58 17.85 46.42 100.00 Favours no MAT+SSP P Vickerman, unpublished data 1. Palmateer Addiction 2010; 2. Hagan JID 2011; 3. Platt Cochrane 2016
Impact of Prevention on HCV incidence United States Lowest incidence in San Francisco and much higher in Indiana Immediate effect of scaling-up MAT+SSP (just MAT in San Francisco) Smaller effect in San Francisco due to existing high coverage of SSP. HCV-treatment further decreases incidence.
CDC Activities to Improve HCV Prevention Among Persons Who Inject Drugs Prevention research RCT of HCV treatment of PWID 1000 patients, eight sites Studies of HCV transmission in non-urban settings- CDC/NIH announcement Improve Surveillance $3,2 M to up to 14 states Priority states with high HCv/HBV incidence Prevention support Federal resources permitted for certain SSP activities Assist establishment of SSP ( training, communications) Consider change in test policies Pregnant women Young persons
Eliminating the Public Health Problem of Hepatitis B and C in the United States 90% of HCV infections are curable; 80% of new HCV infections are preventable The elimination of hepatitis C and hepatitis B as public health threats is achievable Substantial issues must be addressed to meet elimination goals In early 2017, final report will be released with strategies to reach elimination goals