HCV Infection in the United States

Transcription

1 New York State Department of Health HCV Infection in the United States ~4 million in the U.S. infected with chronic hepatitis C virus (HCV) 17,000 new infections per year 75 percent of adults with hepatitis C are baby boomers In the next 10 years, cost estimated > $80 billion 1 Deaths from HCV exceed deaths from HIV 2 New, more effective treatments 75% Undiagnosed 25% 75% of those infected with HCV are undiagnosed 1 McHutchison, J. Chronic Hepatitis C: An age wave of disease burden. Am J Manag Care Oct;11(10 Suppl):S Holmberg, Ly, Xing. The increasing burden of mortality from viral hepatitis in the United States. Ann Intern Med Jul 17;157(2):150. 1

2 OraQuick Rapid HCV Antibody Test The first and only FDAapproved rapid HCV antibody test for use with: Fingerstick whole blood Venipuncture whole blood Results in just 20 minutes Clinical performance with >98% accuracy CLIA waived OraQuick Rapid HCV Antibody Test - Intended Use Persons with signs or symptoms of hepatitis and persons at risk for hepatitis C infection Individuals 15 years of age and older Not for use with women known to be pregnant 2

3 Who to test? Had ever injected illegal drugs Were ever on chronic hemodialysis Received blood transfusions or solid organ transplants before July 1992 Received clotting factor concentrates made before 1987 Known exposure to Hepatitis C Living with HIV Has signs or symptoms of liver disease (persistent abnormal ALT) Children born to mothers who have Hepatitis C Adults born from 1945 through 1965 should receive e one-time testing for HCV without prior ascertainment of HCV risk factor status Current CDC Risk and Medical Indication-Based Guidelines, 1998 NEW CDC Expanded HCV Screening Recommendations, August 16, 2012 Benefits to Using HCV Rapid Testing at LHD STD Clinics Serve at-risk populations Already offer wide array of services, including hepatitis vaccination Can run HIV and HCV rapid tests side by side More appealing to clients Same day results Finger stick Convenient one-stop shop More appealing to staff Finger stick vs. blood draw 3

4 NYS HCV Rapid Testing Program Launched in April 2012 FREE HCV rapid test kits available to programs serving at risk individuals Program eligibility Infrastructure to support rapid testing Valid CLIA permit Polices and procedures QC Plan Blood borne pathogen policy Space/equipment Staff Training Data collection and reporting Written linkage agreement with provider Minimum can perform HCV diagnostic testing No other resources to purchase test kits HCV Rapid Test Algorithm Rapid Test Reactive Result Referral* HCV diagnostic testing * Exploring the option for on-site HCV diagnostic testing 4

5 Referrals and Referral Tracking Programs must have written linkage agreements for referrals At a minimum, provider that can perform HCV diagnostic testing (HCV RNA by PCR) Referral appointments must be tracked Release of information signed by clients On-going Requirements for Enrolled Programs Monthly Data Reporting Periodic conference calls Announced site visits Monitor compliance Provide TA Facilitate successful implementation and quality service delivery 5

6 Ordering Test Kits Ordering application on NYSDOH Health Commerce System website Must show proof of linkage agreement Kits shipped from NYSDOH Distribution Center Controls shipped from OraSure Staff Training Opportunities Web cast for program administrators Overview of the OraSure HCV rapid test and statewide screening program Integrating HIV and HCV screening Basic information about HCV transmission, epidemiology, spectrum of illness, diagnosis and treatment. Participants will learn how to deliver HIV and HCV pre and post test messages Training web site: 6

7 New Educational Materials Booklet and on-line video targeting g young people (< 30 years of age) Highlights HCV prevention messages for IDU, tattoo and body piercing To be posted on MTV Hepatitis B and C Testing Palm Cards 7

8 Technical Assistance NYSDOH HCV Rapid Testing Program Colleen Flanigan Device training, questions related to test device Tricia Stampfli Staff Training on HIV, STD and Viral Hepatitis Additional Resources NYSDOH Hepatitis Web Site titi Click on Hepatitis C Rapid Antibody Testing OraSure Technologies, Inc. Centers for Disease Control and Prevention 8

9 Contact Information Colleen Flanigan