1. Community-Based HCV Testing
Stacey B. Trooskin MD PhD
Director of Viral Hepatitis Programs
Philadelphia FIGHT Community Health Centers

2. HCV 101

3. Natural History of HCV Infection
75-85%
Acute
HCV
Chronic
HCV
Hepatic
Inflammation
Alcohol, HIV, and hepatitis B may accelerate fibrosis
15-25%
Hepatic
Fibrosis
Spontaneous
Resolution
20% in 20 yrs
Cirrhosis
2 – 4% per yr
2 – 5% per yr
Hepatocellular
Carcinoma
Hepatic
Decompensation
Seeff LB. Hepatology 2002;36 (Suppl 1):S35-46.

4. Extrahepatic manifestations associated with HCV
Hematologic
Mixed cryoglobulinemia
Aplastic anemia
Thrombocytopenia
Non Hodgkin’s b-cell lymphoma
Ocular
Corneal Ulcer
Uveitis
Vascular
Necrotizing Vasculitis
Polyarteritis Nodosa
Dermatologic
Porphyria cutanea tarda
Lichen planus
Cutaneous necrotizing vasculitis
Neuromuscular
Weakness/ myalgia
Peripheral neuropathy
Arthritis/Arthralgias
Renal
Glomerulonephritis
Nephrotic syndrome
Autoimmune Phenomena
CREST syndrome
Neuropsychiatric
Depression

5. Sources of Infection for Persons with Newly Diagnosed HCV
Unknown 10%
Other 5%
Transfusion
prior to 1992
10%
Sexual 15%
CDC, National Hepatitis C prevention strategy 2001.

6. Seroprevalence of HCV: 170M to 200M worldwide
JP Messina et al. Hepatology. 2015; 61(1):77-87.

7. Epidemiology of HCV in the US
Most common blood-borne infection in the US
3.2 million to 5.2 million persons chronically infected
Birth cohort : 3.27% antibody positive
Non-Hispanic blacks: 6.31%
Non-Hispanic whites: 2.92%
Mexican American/ other: 2.78%
50% to 75% of individuals chronically infected with HCV are unaware of their infection
Much of what we know about HCV in the US comes from NHANES- a study which includes non institutionalized US civilians
Chak E. Liver Internat. 2011, 2:
Smith BD. AASLD poster #394, 2011
Armstrong GL. Annals of Int Med, ; 

8. Treatment cascade for people with chronic HCV infection
Yehia B. PLoS One. 2014; 9(7) e

9. Sexual Transmission of HCV
HCV RNA in semen / vaginal secretions
Risk of HCV transmission by sexual contact in monoinfected:
Long-term monogamous partnerships: 0.6%/year
Multiple partners / at-risk for STIs: 1.8%/year
HIV coinfection  rate of sexual transmission
Increase in the incidence of HCV reported in HIV-positive MSM
Swiss cohort: 18-fold increase in incidence rates from 1998 to 2011
Behavioral factors and viral factors
In 2004–2005, a significant increase in the incidence of HCV was reported in HIV-positive MSM in Europe, followed by reports from the USA, Australia and Asia
urban-centred, aged in their 30s/40s with well controlled HIV, and in most cases denying a history of IDU
0.23 (95% CI 0.08–0.54)/100 person-years in 1998 to 4.09 (95% CI 2.57–6.18) in 2011.
Terrault N. Hepatology 2002;36:S99-105
Wandeler G. Clin Infect Dis 2012; 55:1408–1416
Bradshaw D. Curr Opin Inf Dis 2013; 26(1):66-72

10. Prevalence of HIV/HCV co-infection is high
Shared routes of transmission
30% of HIV+ are coinfected
~400,000 HIV/HCV + in U.S.
Prevalence of HCV in HIV+ individuals varies based on likely mode of acquisition:
~ 90% in IVDU
60-85% in hemophiliacs
4-8% in MSM
Sherman KE. Clin Infect Dis; 2002; 34:831–7
Rockstroh JK. J Infect Dis 2005; 192:992–1002

11. CDC Recommendations for HCV testing
Birth Cohort based screening
All individuals born between 1945 and 1965 should be tested at least once for HCV
All individuals outside of this cohort with a HCV risk factor should be screened
Cost-effective
1-time cohort screening would identify about 86% of undiagnosed cases, compared with 21% with risk-based screening
US Preventive Services Task Force: Grade B recommendation
Will mention work with prevention point here to the first bullet point:
CDC. MMWR 2012;61(No. RR-4).
Rein DB. Ann Intern Med. 2012;156(4):263-70

12. AASLD/IDSA: Who should be treated?
Treatment is recommended for all patients with chronic HCV infection, except those with short life expectancies that cannot be remediated by treating HCV, by transplantation, or by other directed therapy. Patients with short life expectancies owing to liver disease should be managed in consultation with an expert. Rating: Class I, Level A

13. Current Challenges in HCV Care
Restrictive criteria for drug approval for many payers
Documented history of abstinence from alcohol and drugs for at least 6 months prior to treatment
For a recipient with a history of substance dependence need a blood alcohol level and UDS to document abstinence
Metavir fibrosis score of F3 or F4
HIV may not be a mitigating factor
Arduous prior authorization process for providers
Significant improvement seen in PA Medicaid
Barua S et al., Ann Intern Med. 2015;163(3):
Canary LA et al., Ann Intern Med. 2015;163(3):

14. When insurance will not cover drugs what are the options?
Wait for new drugs to be approved
No guarantee that those will be covered/ patient will qualify
Wait until patient qualifies
Sobriety
Worsening fibrosis
Take legal action
Apply to patient assistance programs to obtain free drug
There is only one company that does this currently
Financial information to qualify
Proof that patient does not qualify for insurance
Challenging to navigate

15. Advocacy in Philadelphia
Philadelphia-area collective dedicated to improving the continuum of hepatitis C prevention, care, and support services in Philadelphia
Put in slide about Drexel primary care c a difference.
Fqhc network doing this with CDC-
Workgroup for hepcap provider network. X academic insitutions, liver transplant programs, hepcap members
34 fqhcs in Philadelphia
X # of pcps in Philadelphia
These are the things that we have, - examples of success. We need more programs like these.
11networks,
3000 primary care docs
Look at us in Philadelphia!!!!!

17. Next HepCAP meeting Wednesday Oct 7th
500 S Broad Street, Department of Public Health
5:30pm

18. HCV Counseling and Testing

19. HCV Counseling Assess baseline knowledge
Open Ended ?: “Tell me what you know about HCV”
Share basic information through conversation
What is hepatitis C?
How do you get it?
CDC recommendations for testing
What a reactive test result means, what a negative test result means
Potential for cure with treatment
Risk factor ascertainment/ Data collection

20. Electronic Data Collection
REDCap is a secure web application that allows secure data collection to acquire participant information and risk assessment factors. This data will be collected while waiting for the rapid antibody test results.
All data will be entered on iPads, laptops, and desk computers and will be protected by encryption and firewalls.

21. Paper-form Data Collection
Paper forms can be used to acquire participant information and risk assessment factors if an electronic survey is not available. This data will be collected while waiting for the rapid antibody test results.
All data must be transported in a secure lock box and shredded or filed after entry.

22. Non-Reactive Test Result
Sharing test results
Non-Reactive Test Result
You are likely not likely infected with HCV
Possible “window period” if ongoing risk and a chance of recent exposure
Retest in 3 to 6 months
HCV antibodies were not detected in the specimen

23. So the test is reactive. Now what?
Reactive Test Result
You have been exposed to HCV
Cannot tell from this test if you are chronically infected or if you have cleared the virus.
Need confirmatory testing
HCV PCR quantitative
HCV antibodies were detected in the specimen

24. Provide Reassurance
All patients with reactive test result should be reminded of the following
15-25% of individuals will have cleared the virus on the own
If they are chronically infected, HCV is CURABLE
All patients with a reactive test result must receive confirmatory testing

25. HCV Confirmatory Testing Protocol

26. Confirmatory Testing Protocol
Blood draw completed using two purple top tubes with at least 3 ml in each tube
Blood is stored and transported in cooler at 2-25̊ C
Samples MUST be handled according to the lab protocol established by the agency responsible for testing
Record date and time of sample drawn, and be sure to note that results have been returned to the tester and the client has been informed of his or her results

27. Optional Daily Log
Date
Initials
Birthday
Consent Signed?
Reactive Result
Survey Completed?
Confirmatory test?
Taken to lab?
31-Mar LM
8/15/1976 1 BA
8/3/1979 JW
8/12/1980
Testing staff may wish to use this chart or something similar to keep organizational records of all people tested e

28. Daily Reporting
Each day by close of business, one person from each testing site must log or submit the following:
How many participants consented to the study today?
How many Rapid Result HCV tests were performed today?
How many Rapid Result tests were positive?
Provide initials and DOB of each positive Rapid Result test
How many confirmatory tests were performed today?
If a participant refused or was unable to provide a sample for confirmatory testing, please explain briefly.
Submit this information to the proper staff person

29. Linkage Protocol

30. ? Physician or other designee receives confirmatory test results
Notifies Linkage Coordinator ?
Calls patient with result
Calls testing staff
Testing staff calls patient with results
Insurance status assessed
Insured w/ PCP: Needs referral and HCV appt
Insured w/o PCP: Needs PCP, then referral and HCV appt
Uninsured: Needs to see a benefits coordinator or be referred to FQHC