Download Michael Saag: Clinical Care

Clinical Care: 2010
Institute of Medicine Committee on HIV
Screening and Access to Care
Michael Saag, MD, FIDSA
University of Alabama, Birmingham
Director, 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
ZDV NVP 3TC
ddI SQV RTV
d4T
IDV
1996
2000
EFV
ABC
LPV
TDF
NFV
1997
1998
1999
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
T20
2004
2009
TPV
2005
DRV
Maraviroc, Raltegravir
Etravirine
2006
2007
2008
Improved Life Expectancy with
Modern ARV Therapy
Hogg, et al. Lancet, 2008
8 Year Survival in HAART Era
Updated from Chen, et al, 8th CROI, 2001
CD4 Count at HAART Initiation
1996
1997
1998
1999
2000
2001
2002
2003
2004
Median
CD4
% CD4
< 200
115
180
221
212
197
277
210
220
207
62.8%
53.8%
47.8%
49.3%
50.1%
39.5%
48.8%
47.2%
49.1%
2005
2006
2007
2008
Median
CD4
% CD4
< 200
278
300
296
310
39.6%
35.4%
35.2%
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
IAS-USA:
CD4 200- CD4 >350
350
treat
treat
Therapy should be
considered and
decision
individualized
treat
treat
treat*
JAMA 2008
<www.iasusa.
org>
DHHS:
<www.aidsinfo.
nih.gov>
* Split opinion > 500
Slide 10
Reasons for Earlier Initiation of Therapy
 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
Inverse Probability Weighted Cox
Regression Multivariate Analysis
Slide 11
Relative
Hazard
(RH)*
95%
Confidence
Interval
P-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)
Baseline CD4 count (per 100
cells/mm3)
1.6
1.5, 1.8
<0.001
0.9
0.7, 1.0
0.083
*Stratified by Cohort and Year
• 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…
40 years on Rx
CD4 650/ul
35 years on Rx
5 years
CD4 500/ul
30
35
40
45
50
55
AGE (years)
60
65
70
Slide 13
Relative Time on Treatment…
40 years on Rx
HARM?
CD4 650/ul
35 years on Rx
5 years
CD4 500/ul
30
35
40
45
50
55
AGE (years)
60
65
70
Slide 14
Most New Infections Transmitted by
Persons who Do Not Know Their Status
~25%
Unaware
of
Infection
account for…
~75%
Aware
of
Infection
Source: G. Marks et al. AIDS 2006
~54%
New
Infections
~46%
of New
Infections
Slide 15
30
Female-to-Male
Transmission
Male-to-Female
Transmission
All subjects
25
20
15
10
>50 000
10 000-49 999
3500-9999
400-3499
<400
>50 000
10 000-49 999
3500-9999
400-3499
<400
>50 000
10 000-49 999
3500-9999
0
400-3499
5
<400
Transmission rate per 100 Person-Years
TNT: Based on the association of viral
load and HIV transmission risk
Viral load (HIV-1 RNA copies/mL) and HIV transmission
Quinn TC, et al. NEJM 2000; also Fideli U, et al. AIDS Res Hum Retrovir 2001
Slide 16
Prevention of Transmission

TEST and TREAT
– Testing and Linkage to Care (TLC+)
National AIDS Strategy…
Blueprint for HIV Treatment Success
Retention in Care
HIV Dx


Linkage
to Care
ARV
Receipt
ARV
Adherence
Outcome
s
Adherence research has traditionally focused
on ARV medications
Growing interest in expanding HIV adherence
to include linkage & retention in care
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
Expanding the spectrum of adherence
Retention in Care
HIV Dx
Linkage
to Care
ARV
Receipt
ARV
Adherence
Outcome
s
One-third of pts. w/ known
HIV infection are not
engaged in care
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.
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
Overall expenditures
CD4 strata
(cells/mL)
Total
ARV
NonARV
Hospital
Other
Outpt.
Physician/c
linic
< 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
$18,640
$10,500
$4,240
$2,342
$1,199
$359
All
Patients with CD4 counts < 50 expend 2.6 times more
health care dollars than those with CD4 counts > 350
(P<0.001)
Change in clinical status
$45,000
CD4 Declined
CD4 Unchanged
CD4 Improved
$40,000
Mean Annual Cost
*
$35,000
$30,000
* P=0.003
*
$25,000
*
$20,000
$15,000
$10,000
$5,000
$0
CD4 <50
CD4 50-199
CD4 200-349
CD4 Category (cells/ul)
CD4 >=350
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