Virologic Response to HAART Among Incarcerated HIV Individuals THAB0503

1
Virologic Response to HAART Among Incarcerated
HIV Individuals - THAB0503
D. Wohl, A. Fleg, S. Napravnik, M. Williams, R.
Boyce, N. Kiziah, C.A. Harrell, and B. White The
University of North Carolina The North Carolina
Department of Correction
2
HIV is Concentrated in Prisons Worldwide

• A recent analysis of data from 152 poor and
  mid-income nations found that the prevalence of
  HIV in prisoners is often greater than that of
  the general population and was gt10 in
• Brazil, Burkina Faso, Cameroon, Côte dIvoire,
  Cuba, Estonia, Indonesia, Lithuania, Malawi,
  Malaysia, Romania, Rwanda, Slovakia, South
  Africa, Ukraine, Vietnam, Yemen, and Zambia.
• In many nations, incarceration for IDU and
  activities related to drug procurement drives HIV
  prevalence in correctional settings.

Dolan K, et al, Lancet Infect Dis 2007 7 3241.
3
Incarceration in the US

• 1 in every 99 adults in the US is incarcerated
• The prison population in 2007 was 1.6 million (7
  are women)
• Another 723,000 are in jails
• Incarceration rates - Men (18y)
• 1 in 106 White
• 1 in 36 Latino
• 1 in 15 AA
• 1 in 9 age 20-34y
• Incarceration rates - Women (35-39y)
• 1 in 335 White
• 1 in 297 Latina
• 1 in 100 AA

4
HIV in US Prisons and General Population (2004)

• State federal prisons
• 1.8 of inmates known to be HIV positive
  (n23,046)
• Males 1.7 (n20,668)
• Females 2.4 (n2084)
• HIV prevalence 4 to 5 times that of the general
  population
• Approximately 20-25 of HIV individuals in the
  US passed through a prison or jail in 1997.

HIV Prevalence
All Prisoners(State and Federal)
Prevalence ()
General Population
98 99 00 01 02 03
04
Year
Estimated. Reported.
Maruschak LM. Bur Justice Stat Bull. November
2006. Hammet T. Am J Public Health 2002
5
US AIDS Mortality (2003)Prisons and General
Population

• State prisons (2003)
• Percentage of deaths due to AIDS (ages 15-54
  years) was gt1.5 times that of the general
  population
• Inmates 8.0
• General population 4.4

AIDS-Related Deaths ( of all deaths)
State Prisoners
Percent of All Deaths
General Population
95 96 97 98 99 00 01 02 03 04
Maruschak LM. Bur Justice Stat Bull. November
2006.
6
Methods

• Aim
• To determine the proportion of prison inmates
  naïve to HIV therapy who achieve viral
  suppression (lt400 c/mL) following initiation of
  combination antiretroviral (ARV) therapy among
• Design
• Observational clinical cohort study
• Subjects
• All known HIV inmates of the NC state prison
  system
• Initiating HIV therapy any time from 2000 2006

7
Methods

• Setting
• NC state prison system HIV prevalence of 2.0
  with voluntary HIV screening at entry
• HIV care is provided on site by five University
  of North Carolina based HIV specialists
• All FDA-approved ARVs are on formulary
• Baseline genotyping adopted in 2006
• Per prison policy, PIs but not NRTIs or NNRTIs
  are administered via directly observed therapy
  (DOT)
• Analyses
• Proportion of patients with a viral load lt 400
  c/mL following the initiation of HAART
• Changes in CD4 cell count during HAART
• Rate of HAART discontinuation

8
Results Baseline Characteristics

• 160 patients initiated ARV therapy 2000-2006

ARVs in each class NNRTI EFV (91), NVP
(9) PI NFV (85), RTV (2) PI/r LPV/r
(100) NRTI ABC/3TC/AZT (100)
9
Results lt 400 c/mL (ITT) Median time observed
on therapy 26 weeks (IQR 12, 70)
lt 400 Copies/mL ITT ------ 95 CI

• Virologic failure (HIV RNA gt400 c/mL) at 6 -
  12 months 25.5

10
Results CD4 Change
11
Results Treatment Discontinuation
Median time observed on therapy 26 weeks (IQR
12, 70)
12
Results lt 400 c/mL (ITT) Median time observed
on therapy 26 weeks (IQR 12, 70)
lt 400 Copies/mL ITT ------ 95 CI

• Virologic failure (HIV RNA gt400 c/mL) at 6 -
  12 months 25.5

13

• GS903 TDF/3TC/EFV compared to d4T/3TC/EFV
• lt 400 Copies/mL ITT

Gallant, J. E. et al. JAMA 2004292191-201.
14
Rate of Virologic Failure ofFirst Regimens Is
Declining
Hopkins HIV Cohort (1996-2002)
5 Observational Cohorts (1996-2002)

• All patients starting HAART (n1255)
• Virologic failure (HIV RNA gt400 c/mL) at 6 months
  (Plt0.01 for trend)
• 1996 56.2
• 1997-8 45.8
• 1999-00 29.7
• 2002-02 27.6

• All patients starting HAART (n4143)
• Virologic failure (HIV RNA gt500 c/mL) at 6 -12
  months (Plt0.001 for trend)
• 1996 40
• 1997 42
• 1998 39
• 1999 34
• 2000 31
• 2001 30
• 2002 25

Moore RD, et al. JAIDS. 200539195-198 Lampe F,
et al. Arch Intern Med. 2006166521-528.
15
Benefits of HAART are lost with prison release
HIV RNA Change
CD4 Cell Counts
1.29
554
Baseline End of study
446
P0.018
P0.003 P0.013
Change (log10 copies/mL)
CD4 Cell Count (cells/mm3)
224
157
-0.03
Baseline 2.91
Baseline 2.60
Incarcerated Prisoners (n30)
Re-Incarcerated Prisoners (n15)
Incarcerated Prisoners (n30)
Re-Incarcerated Prisoners (n15)
Stephenson BL, et al. Public Health Rep.
20051208488.
16
Unsafe sex common during periods of freedom
Pre-Release n86
Post-Release n84

• High rate of unsafe sex especially among main
  partners
• Half of the partners were perceived by
  participant to be HIV uninfected
• One third of each group thought it somewhat or
  very likely they would infect a partner

Stephenson B, Wohl D, et al. Int J STD AIDS. 2006
17
Conclusions

• Rate of virological suppression during HIV
  therapy among incarcerated men and women
  initiating ARVs was high and comparable to those
  achieved during clinical trials and in larger
  free world clinical cohorts.
• Treatment discontinuation rates were low.
• These data reinforce a message that quality HIV
  care is achievable in a correctional setting,
  especially when such care is delivered by
  clinicians well-versed in HIV medicine.
• However, the benefits of HAART accrued in prison
  are threatened after release.
• Support programs that bridge the gap between
  incarceration and freedom are essential to
  continued individual as well as public health.

18
Thanks UNC CFAR Criminal Justice Working
Group Becky White David Rosen Andy
Kaplan Carol Ann Harell Carol Golin Anthony
Fleg Anna Scheyette Ross Boyce Cathy Fogel Marc
Kolman Catie Cunningham Sonia Napravnik Bob
Michael Michele Bailey Danielle Haley Monique
Williams Joanne Earp Kelly Green Sharon
Weir Bob Devellis Maria Khan Mike Bowling Peter
Maffly-Kipp Andrea Heckert Ada Adimora Lisa
Hightow
NCDOC Paula Smith, MD Faye Duffin, RN and HIV
Outreach Nurses Nichole Kiziah, PharmD Polly
Ross, MD Laura Yates, MSW
19
Results VL lt400 c/mL

• Median time observed on therapy 26 weeks (IQR
  12, 70)

100 90 80 70 60 50 40 30 20 10 0
with VL lt400 c/mL
3m 6m 12m Any time w/in 18m n
144 105 73 143