Placing the United States on the Path Toward the Elimination of Hepatitis C as a Public Health Threat

Transcription

1 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

2 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 ) Action Plan for Prevention, Care, and Treatment of Viral Hepatitis (Updated ) Action Plan for Viral Hepatitis Prevention, Care, and Treatment United States (2011) DVH Strategic Plan ( ) In development: A National Strategy for the Elimination of Hepatitis B and C (2017) CDC role in 61% of USG actions

3 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 Year of Birth These persons who inject drugs (PWIDs) are mainly: Young (aged 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

4 Stage of Liver Disease Among HCV Infected Persons, United States, % 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 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

5 Total Cases Total Cases Total Cases Total Cases HCV Prevalence and Disease Trends 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, ,000-40,000 35,000 30,000 25,000 20,000 15,000 10,000 5, 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 80,000 60,000 40,000 20, Base 2015 Base 2013 Base 2015 Base

6 Impact of HCV Testing, Care, and Curative Treatment Test: Persons born (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

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8 Percent Percent HCV Antibody Tested by Birth Year Group MarketScan Insurance Claims Data, ,5 4 3,5 3 2,5 2 1,5 1 0, Birth Year Group Other birth years

9 Percent Primary Diagnosis Code for HCV Antibody Testing, Among the Birth Cohort, in MarketScan Insurance Claims Data Liver Related Findings General Medical Examination STD Screening or Exposure History Other Specified Viral Diseases Other Tests or Findings

10 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

11 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 RNA follow-up testing within 30 days of Ab+ result Quest Reflex policy 26 LabCorp CDC unpublished data

12 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 HCV testing for public housing clients, Philadelphia % anti-hcv+ 92% tested for RNA 63% RNA + 89% Of HCV RNA+ 75% Coyle C, MMWR, May 2015

13 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 % Year Reilley B, MMWR 2016

14 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/ / Total Number of Patients 26 % 114 Patients Treated by Pharmacists

15 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

16 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

17 Rate per 100,000 Births Rates of Infants Born to HCV Infected Women, Kentucky and the United States 2011, of 67 births 1 of 308 births Kentucky Year of Infant United Birth States

18 Global Health, Outbreak & Surveillance Technology (GHOST) Reveals Transmission Networks Indiana 2015 HCV positive- 599 HIV Positive- 116 (19%) HIV Negative 483 (81%) HIV positive HCV Positive- 116 (92%) HCV Negative- 9 (8%) Major Cluster 130 persons; 50 with mixed genotypes Multiple introductions of HCV and super infections

19 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 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) (0.31, (0.13, 3.82) 0.65) (0.53, 2.05) (0.24, 0.95) 0.76 (0.44, 1.33) 0.47 (0.27, 0.80) Favours no NSP/OST % Weight Favours no MAT+SSP P Vickerman, unpublished data 1. Palmateer Addiction 2010; 2. Hagan JID 2011; 3. Platt Cochrane 2016

20 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.

21 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

22 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