Transcript CA study outcomes: HCV in the California Prisons

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 8th, 2008
Topics to Be Covered
• HEPCAP Study
• HALO Study
• Take Home Points: Impact on you
as a provider
Hepatitis in Correctional Settings: the
California Experience
HEPCAP OBJECTIVES
*HCV infection among inmates - entry
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*HCV infection among correctional staff
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*HCV treatment candidacy among staff
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*Hepatitis A virus infection among inmates
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*Inventory HCV education, prevention and
training materials for staff and inmates
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*HCV infection among inmates - exit (parolees)

Hepatitis C Among Inmates:
Prisoner Entry Study
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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?
HEPCAP Prisoner Entry Study
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Spring / Summer 2002
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“Piggybacked” on CDC’s Hepatitis C Pilot
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472 inmates volunteered out of 615 approached
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3 CDC facilities: 2 male, 1 female
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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
HEPCAP Prisoner Entry Study Results
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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%)
HEPCAP Prisoner Entry Study Results
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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
HEPCAP Prisoner Entry Study Results
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77% HS Education or below
7% English as a second language
77% volunteered to participate w/o
incentive
Women get tested more than Men
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
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
Hepatitis C Among Correctional Staff
HEPCAP Staff Study
Given the large number of infected inmates:
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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?
HEPCAP Staff Study
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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)
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
HEPCAP Staff Study Results:
THE GOOD NEWS…
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2.1% prevalence of HCV antibody
(confirmed)
Comparable to the general US population
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
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
HEPCAP Staff Study Preliminary Results:
Odds of exposures vary by job:

54: 1
Medical staff ever being stuck or cut with a needle
compared to admin staff

7:1
Correctional officers ever being stuck or cut with a
sharp object compared to admin staff
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2:1
Non-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.
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”
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 postexposure support, decrease paperwork!!
HCV Resources for Staff and/Or Inmates:
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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!!
WHAT NEXT?
Still a lot of work to be done:
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High prevalence, high risk
behaviors of inmates and parolees
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Continued BBP exposures to staff
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Prevention and education is CHEAP
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Inmates and staff want more HCV
testing, education and support
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
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
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
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
Study Purpose
To determine whether IDUs who have
resolved the HCV virus and who
continue to inject drugs get reinfected
with HCV
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
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
Results
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224 persons with 3 or more visits
186 chronic HCV RNA positive
38 resolvers: 29 spontaneous and 9 HCV txassociated
No difference in age, income, HIV status, recent
alcohol use between groups
Resolvers were more likely:
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female
less educated
have had a hx of incarceration
not to have been injecting drugs at enrollment
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 personyears of IDU
No difference in length of time of IDU between
resolvers and chronic HCV RNA+ group
Results: Baseline demographics and behaviors of study population
All
N=224 (%total)
Resolvers
N=38 (%)
Chronic HCV RNA+
N=186 (%)
46.2+-7.6
30 - 71
47.2+-8.0
28 - 76
0.47
186(83.0%)
24(63.2%)
162(87.1%)
0.0006
Asian
8(3.6%)
2(5.3)
6(3.2%)
0.80
Black
75(33.5%)
9(23.7%)
66(36.4%)
0.11
Latino
21(9.4%)
1(2.6%)
20(10.7%)
0.11
Other
16(7.1%)
4(10.5%)
12(6.5%)
0.73
Caucasian
104(46.4%)
22(57.9%)
82(44.1%)
0.12
Deceased
48(21.4%)
10(26.3%)
38(20.4%)
0.63
>High school Education
92(41.4%)
18(47.4%)
74(39.8%)
0.33
Hx of Homelessness
85(39.4%)
13(34.2%)
72(38.7%)
0.48
HIV Positive
54(37.5%)
10(26.3%)
44(23.7%)
0.64
Hx of Incarceration
173(78.6%)
31(81.6%)
142(76.3%)
0.63
IDU at baseline
116(51.8%)
17(44.7%)
99(53.2%)
0.34
IDU at follow-up
103(46.0%)
16(42.1%)
87(46.8%)
0.72
Recent ETOH
98(44.1%)
12(31.6%)
86(46.2%)
0.12
>50 Lifetime Sex Partners
68(30.6%)
13(34.2%)
55(29.6%)
0.52
Age (Mean +-STD)& range
Male
47.0+-8.0
p-value
Race/Ethnicity
Follow-up of Study Population (N = 224)
All
Resolved HCV
Chronic HCV RNA+
N
224
38
186
Total person-years of followup
1,387
213
1,174
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-up
103
16
87
Total person-years of IDU in
follow-up
399.3
58.0
341.3
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)
HCV RNA Results of HCV Resolvers
All
HCV Tx Associated
Resolvers
Spontaneous
Resolvers
N
38
9
29
Total number of persons with
IDU during followup
16
2
14
Total number of personmonths of IDU followup
without reinfection (yrs)
682
(56.8)
42
(3.5)
640
(53.3)
Number of HCV Reinfections
1*
0
1*
Reinfection Rate, per 100
person-years of IDU
1.75
0.00
1.89
*Reinfected individual has GT2, HCV RNA VL >5million IU/ml
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
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
Acknowledgements
 HALO (Hepatitis and Liver Outcomes Study Team):
Alex Monto
Rosemary McQuaid
Michael Kim
Daniel Tracy
James Ryan
Alan Kennedy
Sally George
Tigist Belaye
Teresa 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
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
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/hepatitis
• National Institutes Of Health
– http://health.nih.gov
• Support Groups