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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)
Survival Data – Years After AIDS Diagnosis
MMWR Weekly June 2, 2006 / 55(21);589-592
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
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
Improved Life Expectancy with Modern ARV Therapy
Hogg, et al. Lancet, 2008
Updated from Chen, et al, 8th CROI, 2001
8 Year Survival in HAART Era8 Year Survival in HAART Era
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%
Key Point:
Many (? Most) HIV infected patients in the US don’t know they are infected
• Universal, opt-out testing is needed
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
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
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
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
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?
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
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
Slide 16
Prevention of Transmission
TEST and TREAT – Testing and Linkage to Care (TLC+)
National AIDS Strategy…
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
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
Mean Annual Total Patient Costs by CD4 Count (cells/ul)
Mean Annual Total Patient Costs by Component
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
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
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
Policy implications
• Provision of antiretroviral and other essential medications Funding for ADAPs
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
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
Who will take care of these patients?
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
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
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
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.
Thanks
UAB 1917 Clinic Cohort supported by UAB CFAR (grant P30-AI27767), CNICS (grant 1 R24-AI067039-1), and the Mary Fisher CARE Fund