1. CA study outcomes: HCV in the California Prisons & Reinfection in IDUs Sue Currie Program Director, Hepatitis C in the California Prisons Project Director, Program Development, Virology, CCO Research Specialist, University of California, San Francisco August 8 th, 2008

2. Topics to Be Covered HEPCAP Study HALO Study Take Home Points: Impact on you as a provider

3. Hepatitis in Correctional Settings: the California Experience

4. HEPCAP OBJECTIVES *HCV infection among inmates - entry  *HCV infection among correctional staff  *HCV treatment candidacy among staff  *Hepatitis A virus infection among inmates  *Inventory HCV education, prevention and training materials for staff and inmates  *HCV infection among inmates - exit (parolees) 

5. Hepatitis C Among Inmates: Prisoner Entry Study What is the prevalence of HCV infection among inmates? What are the risks and behaviors associated with HCV? Are there differences between men and women? Do inmates know their HCV status?

6. HEPCAP Prisoner Entry Study Spring / Summer 2002 “Piggybacked” on CDC’s Hepatitis C Pilot 472 inmates volunteered out of 615 approached 3 CDC facilities: 2 male, 1 female Great support from CO’s, MTAs and other Staff Involved a blood sample and a one-to-one risk interview with inmates at reception at these facilities

7. HEPCAP Prisoner Entry Study Results 34% prevalence of HCV antibody HCV infection among inmates is associated: –with gender (39% female vs 32% male) –with race (60% White, 53%Latino, 20%Af-am) –IDU (65% vs 10%)

8. HEPCAP Prisoner Entry Study Results Among those with no history of IDU, HCV was associated w/ total time incarcerated Parole violators almost twice as likely to have HCV No associations with tattooing, snorting or assaults Only 32% had ever tested for HCV but 73% had tested for HIV

9. HEPCAP Prisoner Entry Study Results 77% HS Education or below 7% English as a second language 77% volunteered to participate w/o incentive Women get tested more than Men

10. Strategies for Counseling, Prevention, and Education  Prevention Message = blood to blood  Develop programs at Juvenile facilities, with first-time offenses and/or first-time drug convictions  Prisoners are diverse: different messages for different cultures, gender, languages, level of need  “If you build it they will come”: voluntary testing and education should be encouraged and provided

11. Strategies for Counseling, Prevention, and Education  Double-dipping: testing for HIV - why not HCV too?  Community and Public health issue:  Parole violations / release  More collaboration with public health is needed  Vaccination programs for hepatitis A and B  Treatment opportunities  Peer education: Cost-effective option  $$$$: Extra correctional staff / support is required to deal with HCV prevention and disease management

12. Hepatitis C Among Correctional Staff HEPCAP Staff Study Given the large number of infected inmates: What is the prevalence of HCV infection among correctional staff? Does it differ by job duties? Are staff at risk of HCV infection? How can we prevent transmission among staff? What can we do to support HCV positive staff?

13. HEPCAP Staff Study Involved an interview, pre-test counseling and education and blood test for HCV 1,401 hours spent 1-1 with correctional staff 10 months across the state Participation > expected = longer period at each facility Included 6 facilities (4 CDC/2 CYA)

14. HEPCAP Staff Study Who participated? 1,012 staff participated 78% return for test results 83% had never been tested for HCV Included staff from all job categories at each facility –36.6% correctional officers –17.7% health care persons (including MTAs) –27.0 % non-medical, non-custodial –18.3% administrative staff – 4.0% other

15. HEPCAP Staff Study Results: THE GOOD NEWS… 2.1% prevalence of HCV antibody (confirmed) Comparable to the general US population

16. HEPCAP Staff Study Results: THE BAD NEWS… 57% of correctional staff reported blood or bodily fluid exposures at work 37% believed that they didn’t always have time to follow universal precautions

17. HEPCAP Staff Study Preliminary Results: While working at corrections: 10% had been stuck by a needle or syringe 13% had been stuck or cut with another sharp object 35% blood/body fluid splash/skin contact (excluding their eye, nose or mouth) 15% blood/ body fluid splash/direct contact with their eyes, nose or mouth

18. HEPCAP Staff Study Preliminary Results: Odds of exposures vary by job: 54: 1Medical staff ever being stuck or cut with a needle compared to admin staff 7:1Correctional officers ever being stuck or cut with a sharp object compared to admin staff 2:1Non-medical, non-custodial staff ever having blood / body fluid splash or make contact with their direct skin OR eye, nose or mouth compared to admin staff.

19. Strategies for prevention, education and counseling: Correctional Staff  Universal precautions in a correction-specific environment (ie. locked doors) needs to be addressed  Include all job areas (with exposures) AND staff levels in BBP and related training  “If you build it they will come”

20. Strategies for prevention, education and counseling: Correctional Staff  “Different strokes for different folks”: provide different types of training - on-the-job, take home, “outside experts”, more frequent and shorter  Encourage testing: Possible link with annual TB testing or hepatitis A/B vaccine programs?  Support: Immediate response, increase post- exposure support, decrease paperwork!!

21. HCV Resources for Staff and/Or Inmates: All facilities had HCV prevention materials available: in various media (print, video, posters, etc) Areas for improvement: standardization, improve quality, temporal relevance, accessibility/applicability in all units or job areas, proactive vs. reactive Some excellent peer education models (ie.kitchen at 1 prison) Whose responsibility? Often dependent on unpaid staff/inmate initiative Inmates and Staff want more!!

22. WHAT NEXT? Still a lot of work to be done: High prevalence, high risk behaviors of inmates and parolees Continued BBP exposures to staff Prevention and education is CHEAP Inmates and staff want more HCV testing, education and support

23. THANKS TO YACA (CDC, CYA AND PAROLE REGION #2) AND CCPOA HEPCAP WANTS TO THANK YACA, THE CDC, THE CYA, INMATES, WARDENS, CCPOA, CORRECTIONAL OFFICERS, MTAS, PAROLE ADMINISTRATORS AND STAFF WHO PARTICIPATED IN, OR ASSISTED US IN OUR INMATE, PAROLEE AND CORRECTIONAL STAFF STUDIES

24. A prospective study to examine persistent HCV reinfection in injection drug users who have previously cleared the virus Sue Currie, Daniel Tracy, Sally George, Hui Shen, James Ryan, Alan Kennedy, Michael Kim, Alexander Monto University of California, San Francisco San Francisco VA Medical Center

25. Background IDU is a primary and efficient route of HCV transmission NHANES data suggest 48.4% of all HCV positive persons have hx of IDU Pre-2002: Recent IDU was a common exclusion for HCV antiviral treatment 2002: NIH Consensus Statement broadened criteria to include recent IDUs for consideration for HCV Tx 2006: Still limited access to HCV Tx for recent IDUs, partly due to concern for HCV reinfection

26. Background (cont’d) Is the concern for HCV reinfection founded? Studies in chimpanzees suggest that clearance of HCV is associated with immunological resistance to reinfection Limited longitudinal data in humans

27. Study Purpose To determine whether IDUs who have resolved the HCV virus and who continue to inject drugs get reinfected with HCV

28. Methods Longitudinal cohort:  396 HCV antibody positive persons current  History of injection drug use at enrollment Baseline and q 6-monthly follow-up:  HCV risk factor data (including detailed drug use history)  Serum collected Serial serum samples tested for HCV RNA using quantitative and qualitative assays

29. Methods (cont’d) Inclusion Criteria: 3 or more visits (baseline and at least 2 follow up visits) Resolvers: persons who were HCV antibody positive and HCV RNA negative through spontaneous resolution OR HCV antiviral treatment Reinfection: persons with documented HCV viral resolution followed by the presence of HCV RNA at 2 or more visits

30. Results 224 persons with 3 or more visits 186 chronic HCV RNA positive 38 resolvers: 29 spontaneous and 9 HCV tx- associated No difference in age, income, HIV status, recent alcohol use between groups Resolvers were more likely:  female  less educated  have had a hx of incarceration  not to have been injecting drugs at enrollment

31. Results (cont’d): Over 1,391 person years of follow-up 103 participants reported IDU at some or all of their follow-up visits for a total of 399 person- years of IDU No difference in length of time of IDU between resolvers and chronic HCV RNA+ group

32. Results: Baseline demographics and behaviors of study population All N=224 (%total) Resolvers N=38 (%) Chronic HCV RNA+ N=186 (%)p-value Age (Mean +-STD)& range47.0+-8.046.2+-7.6 30 - 71 47.2+-8.0 28 - 76 0.47 Male186(83.0%)24(63.2%)162(87.1%)0.0006 Race/Ethnicity Asian8(3.6%)2(5.3)6(3.2%)0.80 Black75(33.5%)9(23.7%)66(36.4%)0.11 Latino21(9.4%)1(2.6%)20(10.7%)0.11 Other16(7.1%)4(10.5%)12(6.5%)0.73 Caucasian104(46.4%)22(57.9%)82(44.1%)0.12 Deceased48(21.4%)10(26.3%)38(20.4%)0.63 >High school Education92(41.4%)18(47.4%)74(39.8%)0.33 Hx of Homelessness85(39.4%)13(34.2%)72(38.7%)0.48 HIV Positive54(37.5%)10(26.3%)44(23.7%)0.64 Hx of Incarceration173(78.6%)31(81.6%)142(76.3%)0.63 IDU at baseline116(51.8%)17(44.7%)99(53.2%)0.34 IDU at follow-up103(46.0%)16(42.1%)87(46.8%)0.72 Recent ETOH98(44.1%)12(31.6%)86(46.2%)0.12 >50 Lifetime Sex Partners68(30.6%)13(34.2%)55(29.6%)0.52

33. Follow-up of Study Population (N = 224) AllResolved HCVChronic HCV RNA+ N22438186 Total person-years of follow- up 1,3872131,174 Median (IQR) years of follow-up 6.3(3.8 - 8.6)5.1(3.3 - 7.1)4.1( 3.1 - 7.8) Total # of IDU in follow-up1031687 Total person-years of IDU in follow-up 399.358.0341.3 Median (IQR) years of IDU in follow-up 3.2(1.5 – 5.9)2.6(1.3 – 5.7)3.3 (1.8 – 5.9)

34. HCV RNA Results of HCV Resolvers AllHCV Tx Associated Resolvers Spontaneous Resolvers N38929 Total number of persons with IDU during followup 16214 Total number of person- months of IDU followup without reinfection (yrs) 682 (56.8) 42 (3.5) 640 (53.3) Number of HCV Reinfections1*0 Reinfection Rate, per 100 person-years of IDU 1.750.001.89 *Reinfected individual has GT2, HCV RNA VL >5million IU/ml

35. Conclusions In HCV resolvers, despite active IDU and therefore potential ongoing exposure to HCV virus, reinfection appears to be a rare event Concern for reinfection should not be a barrier to HCV antiviral treatment for persons who are at risk for ongoing or future IDU Majority of IDUs who were treated did not re-engage in drug use Further study is required to evaluate possible factors associated with protective immunity against HCV reinfection

36. Limitations IDU is based on self report No current GT data available on Spontaneous resolvers Since rate of reinfection is so low, it is hard to identify other potential factors associated with it

37. Acknowledgements  HALO (Hepatitis and Liver Outcomes Study Team): Alex MontoDaniel TracySally George Rosemary McQuaidJames RyanTigist Belaye Michael KimAlan KennedyTeresa Wright  396 persons who participated in this study  Sponsored in part through NIDA and the National Institutes of Health (R01DA13737-01)  Roche Molecular Systems, Inc. for providing Amplicor HCV Monitor 2.0 assay kits for HCV RNA testing

38. Take Home Points  Incidence of HCV in prisons is low – for staff and for inmates  Missed opportunities for healthcare:  Vaccinations  Testing and screening  Liver health assessment  Concern for HCV Reinfection should not be a barrier to treatment considerations

39. HCV Education & Resources VA Hepatitis C Website –http://www.hepatitis.va.gov Centers For Disease Control & Prevention –1-888-4 HEPCDC –http://www.cdc.gov/ncidod/diseases/hepatitishttp://www.cdc.gov/ncidod/diseases/hepatitis National Institutes Of Health –http://health.nih.gov Support Groups