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Clinical Care: 2010
Institute of Medicine Committee on HIV Screening and Access to Care
Michael Saag, MD, FIDSAUniversity of Alabama, BirminghamDirector, Center for AIDS Research
Chair, HIV Medicine Association (HIVMA)
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Survival Data – Years After AIDS Diagnosis
MMWR Weekly June 2, 2006 / 55(21);589-592
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How Did We Get Here?
Sequential exposure to effective “monotherapy” in a population of largely adherent, aggressively treated patients created a cohort of individuals with highly-resistant HIV
1996 1997 1998 19992000
ZDV NVP 3TC EFV LPV
ddI SQV RTV ABC TDF
d4T IDV NFV
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New HAART Era
After years of sequential “monotherapy” many patients with MDR are now entering a period where more than one new medication may be readily available
2004 2005 2006 2007 2008 2009
T20 TPV DRV Maraviroc, Raltegravir Etravirine
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Improved Life Expectancy with Modern ARV Therapy
Hogg, et al. Lancet, 2008
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Updated from Chen, et al, 8th CROI, 2001
8 Year Survival in HAART Era8 Year Survival in HAART Era
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CD4 Count at HAART InitiationCD4 Count at HAART Initiation
Median Median CD4CD4
% CD4 % CD4 < 200< 200
19961996 115 62.8%
19971997 180 53.8%
19981998 221 47.8%
19991999 212 49.3%
20002000 197 50.1%
20012001 277 39.5%
20022002 210 48.8%
20032003 220 47.2%
20042004 207 49.1%
Median Median CD4CD4
% CD4 % CD4 < 200< 200
20052005 278 39.6%
20062006 300 35.4%
20072007 296 35.2%
20082008 310 29.4%
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Key Point:
Many (? Most) HIV infected patients in the US don’t know they are infected
• Universal, opt-out testing is needed
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Slide 9
When To Start Treatment? – Summary of Current Guidelines
Guidelines symptoms or
CD4 <200
CD4 200-350
CD4 >350
IAS-USA:JAMA 2008
<www.iasusa.org>
treat treat Therapy should be considered and decision individualized
DHHS:<www.aidsinfo.
nih.gov>
treat treat treat*
* Split opinion > 500
symptoms
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Slide 10
Cohort Study Results (NA-ACCORD / ART-CC)
Consequences of unchecked viral replication (Inflammation / Harm)
Improved tolerability / convenience of newer ARV regimens
Treatment reduces transmission of HIV Cost Savings
Reasons for Earlier Initiation of Therapy
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Slide 11Inverse Probability Weighted Cox Regression Multivariate Analysis
*Stratified by Cohort and Year
Relative Hazard (RH)*
95% Confidence
IntervalP-value
Deferral of HAART at 351-500 1.7 1.4, 2.1 <0.001
Female Sex 1.1 0.9, 1.5 0.290
Older Age (per 10 years) 1.6 1.5, 1.8 <0.001
Baseline CD4 count (per 100 cells/mm3) 0.9 0.7, 1.0 0.083
• Results were similar when restricting the analysis to the 77% of participants with baseline HIV RNA data• Adjusted RH for deferral vs. immediate treatment was also 1.7 95% C.I. 1.4, 2.2; p <0.0001• HIV RNA was not an independent predictor of mortality
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Slide 12
Relative Time on Treatment…
30 35 40 45 50 55 60 65 70AGE (years)
CD4 650/ul
CD4 500/ul
40 years on Rx
35 years on Rx
5 years
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Slide 13
Relative Time on Treatment…
30 35 40 45 50 55 60 65 70AGE (years)
CD4 650/ul
CD4 500/ul
40 years on Rx
35 years on Rx
5 years
HARM?
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Slide 14
Most New Infections Transmitted by Persons who Do Not Know Their Status
~25% Unaware
of Infection
~75% Aware
of Infection
account for…
~54% New
Infections
~46% of New
Infections
Source: G. Marks et al. AIDS 2006
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Slide 15
0
5
10
15
20
25
30
Viral load (HIV-1 RNA copies/mL) and HIV transmission
Tra
nsm
issi
on
rat
e p
er 1
00 P
erso
n-Y
ears
<40
0
400
-349
9
350
0-99
99
10 0
00-4
9 99
9
>50
000
Quinn TC, et al. NEJM 2000; also Fideli U, et al. AIDS Res Hum Retrovir 2001
<40
0
400
-349
9
350
0-99
99
10 0
00-4
9 99
9
>50
000
<40
0
400
-349
9
350
0-99
99
10 0
00-4
9 99
9
>50
000
All subjectsMale-to-FemaleTransmission
Female-to-MaleTransmission
TNT: Based on the association of viral load and HIV transmission risk
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Slide 16
Prevention of Transmission
TEST and TREAT – Testing and Linkage to Care (TLC+)
National AIDS Strategy…
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ARV Receipt
Retention in Care
Outcomes
HIV DxLinkage to Care
ARV Adherence
Adapted from: Giordano et al. Curr HIV/AIDS Rep 2005;2:177-183, Samet et al. AIDS 2001;15:77-85, Eldred & Malitz. AIDS Pt Care STDs 2007;21:S1-2; Tobias et al. AIDS Pt Care STDs 2007;21:S3-8
Blueprint for HIV Treatment Blueprint for HIV Treatment SuccessSuccess
Adherence research has traditionally focused on ARV medications
Growing interest in expanding HIV adherence to include linkage & retention in care
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ARV Receipt
Retention in Care
Outcomes
HIV DxLinkage to Care
ARV Adherence
Expanding the spectrum of Expanding the spectrum of adherenceadherence
25% of HIV-infected individuals in the U.S.
are undiagnosed
20-40% of newly diagnosed pts. fail to
establish care w/in 6 mos.
One-third of pts. w/ known HIV infection are not
engaged in care
Glynn & Rhodes. National HIV Prevention Conference 2005, Abstract 595, Gardner et al. AIDS 2005;19:423-431, Mugavero et al. Clin Infect Dis 2007;45:127-130, Fleming et al. 9th CROI 2002, abstract 11
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Mean Annual Total Patient Costs by CD4 Count (cells/ul)
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Mean Annual Total Patient Costs by Component
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CD4 strata (cells/L)
Total ARV Non-ARV
Hospital Other Outpt.
Physician/clinic
< 50 $36,532 $10,885 $14,882 $8,353 $1,909 $533
50-199 $23,864 $11,862 $6,685 $3,369 $1,416 $532
200-349 $18,274 $11,935 $3,452 $1,186 $1,365 $336
> 350 $13,885 $9,407 $1,855 $1,408 $930 $285
All $18,640 $10,500 $4,240 $2,342 $1,199 $359
Patients with CD4 counts < 50 expend 2.6 times more health care dollars than those with CD4 counts > 350
(P<0.001)
Overall expenditures
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Change in clinical status
$0
$5,000
$10,000
$15,000
$20,000
$25,000
$30,000
$35,000
$40,000
$45,000
CD4 <50 CD4 50-199 CD4 200-349 CD4 >=350
CD4 Category (cells/ul)
Mea
n A
nn
ual
Co
st
CD4 DeclinedCD4 UnchangedCD4 Improved*
*
*
* P=0.003
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Major Focus of Appropriations:Provision of medications
• The majority of the new dollars in the current iteration of the RW appropriation of the President’s budget is targeted for Part B
• Over the last 8 years most increases in the RW Care Act have gone to ADAP
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Policy implications
• Provision of antiretroviral and other essential medications Funding for ADAPs
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Reality Check
• Operating budget of our clinic: $4.2 M / yr
(1800 active pts)
• Third party payment ~ $ 800,000/yr
• RW Title III $495,000/yr– Flat Funded for > 10 years– 2.5% cut in 2006– Despite 120% increase in patient volume over
last 8 years
• Part B funds ~ $1.0 M since 2007
• Annual Deficit ~ $1.8 M per year
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Key Points
• Mortality is much higher when patients are diagnosed late in the course of infection (CD4 < 200 /ul)
• The majority (> 50%) of newly diagnosed patients are diagnosed late (except preg Women)
• Many (? Most) HIV infected patients in the US don’t know they are infected
• Universal, opt-out testing is needed
With more universal testing, a 25 -50% increase in patient volume will occur
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Who will take care of these patients?
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Policy implications
• Provision of antiretroviral and other essential medications– Funding for ADAPs
• Need dramatic increase in funding to increase clinic capacity Increase Part C funding Provide incentives for younger MDs to
go into HIV Medicine
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Provision of medications
• “Every American who needs HIV treatment and care should have access to it”
• “People who are HIV-positive need essential medications”
• “Without the drugs, providing care is difficult to impossible”
PACHA. Achieving and HIV-Free Generation; IDSAnews 2006;16(1):7
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Provision of HIV CARE
• “Every American who needs HIV treatment and care should have access to it”
• “People who are HIV-positive need essential medications”
• “Without the drugs, providing care is difficult to impossible”
• “Without qualified HIV care providers and clinics, HIV drugs mean nothing”
PACHA. Achieving and HIV-Free Generation; IDSAnews 2006;16(1):7
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EDITORIAL COMMENTARY
Which Policy to ADAP-T:
Waiting Lists or Waiting Lines?
Michael S. Saag
University of Alabama at Birmingham Center for AIDS Research
Clinical Infectious Diseases 2006;43:1365-1367© 2006 by the Infectious Diseases Society of America. All rights reserved.
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Thanks
UAB 1917 Clinic Cohort supported by UAB CFAR (grant P30-AI27767), CNICS (grant 1 R24-AI067039-1), and the Mary Fisher CARE Fund