C1_2 Michael Saag Chronic Disease in Longer-Term HIV Patients
Transcript of C1_2 Michael Saag Chronic Disease in Longer-Term HIV Patients
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The International AIDS Society–USA
Strategies forAntiretroviral Therapy:
When to Start, How to Finish
Michael S. Saag, MDProfessor of Medicine
The University of Alabama at Birmingham
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M Saag, UAB
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HIV Infected Cells
Uninfected Resting CD4+ Lymphocytes
Uninfected Activated CD4+ Lymphocytes
Antiretroviral Rx
Latently Infected CD4+ Lymphocytes
HIV virions
M Saag, UAB
Vir
al L
oad
101
102
1
0310
4
105
10
6
0 2 4 6 8 10 12
Weeks
T1/2 = 1.1 days
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RNA+ cells in Lymph node vs RNA in Plasma
HIV RNA+ cells/106 LN cells0.1 1 10 100 1000 10000
Pla
sma
Vira
l Loa
d (c
opie
s/m
l)
10
100
1000
10000
100000
1000000
10000000
<50
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At steady state, when an actively producing cell dies, it is replaced by how many newly infected cells?
A. OneB. Twenty-fiveC. One hundredD. One thousandE. It depends on the viral load
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M Saag, UAB
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VL = 100,000
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VL < 50
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Vir
al L
oad
101
102
1
0310
4
10
5
106
0 2 4 6 8 10 12
Weeks
T1/2 = 1.1 days
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Goals of Antiretroviral Therapy
• Prevent Clinical Progression• Prevent Resistance
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NEJM, 1993
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Impact of Replication on Resistance
0
10
20
30
40
50
60
High
Like
lihoo
d of
Res
istan
ce
Degree of Suppression
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Case 1
–30 yo white man–Diagnosed on routine insurance examination–PMHx remarkable for HTN, diet controlled–No medications–Understands treatment issues and wants to
begin therapy if you think it is appropriate
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If his viral load is 30,000 c/ml, at which CD4 count would you recommend starting
therapy?A. 750 cells / ulB. 500 cells / ulC. 350 cells / ulD. 300 cells / ulE. 250 cells / ulF. ≤ 200 cells / ulG. Would observeH. Would treat at any CD4 count
[Default][MC Any][MC All]
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When To Start Treatment? – Summary of Current Guidelines
Guidelines symptoms orCD4 <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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CD4 Count at Initiation of ARV 2003-2005
Egger M, 14th CROI; 2007; Abstract 62.
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Which of the following convinces you MOST to start therapy earlier in course of
HIV infection?
A. Cohort Study Results (NA-ACCORD / ART-CCB. Consequences of unchecked viral replication
(Inflammation / Harm)C. Improved tolerability / convenience of newer ARV
regimensD. Treatment reduces transmission of HIV E. Cost SavingsF. I have my own personal reasons!
[Default][MC Any][MC All]
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Inverse 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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.51
24
Haz
ard
Rat
io f
or A
IDS
or
Dea
th
0 100 200 300 400 500CD4 threshold (cells/mm3)
Hazard ratios for AIDS or death, adjusted for lead times and unseen events
Comparison Hazard ratio (95% CI)276-375 vs 376-475 1.19 (0.96 to 1.47) 251-350 vs 351-450 1.28 (1.04 to 1.57) 226-325 vs 326-425 1.21 (1.01 to 1.46)
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A Randomized Clinical Trial of Early Versus Standard Antiretroviral
Therapy for HIV-infected Patients with a CD4 T Cell Count of 200 – 350
cells/ml (CIPRAHT001)
Daniel Fitzgerald, MDThe GHESKIO Centers, Haiti
Weill Cornell Medical College, USA
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Baseline CharacteristicsEarly
(n=408)Standard (n=408)
Median age (years) 40 40
Male – n (%) 167 (41%) 179 (44%)
Median CD4 T cells/ml 280 282
Body Mass Index, kg/m2 21.4 21.0
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Clinical Endpoints
Early (n=408)
Standard (n=408)
Hazards Ratio
(p value)
Death 6 23 4.0(.0011 )
Incident Tuberculosis
18 36 2.0(.0125 )
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Slide 31
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Case 1
–30 yo white man–Diagnosed on routine insurance examination–PMHx remarkable for HTN, diet controlled–No medications–Understands treatment issues and wants to
begin therapy if you think it is appropriate– VL is 30,000 c/mL– CD4 is 650 cells/ul
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If his viral load is 30,000 c/ml, and his CD4 count is 650 cells/ul, at what age would
you recommend starting therapy?
A. 20 yrsB. 30 yrsC. 40 yrsD. 50 yrsE. 60 yrsF. 70 yrsG. Would treat at any ageH. Would not treat
[Default][MC Any][MC All]
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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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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 I have my own personal reasons!
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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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So ….what is the harm?(Pick the most compelling reason)
A. Destruction of lymphoid tissueB. InflammationC. Increased Cardiovascular eventsD. Increased incidence of certain
malignanciesE. Increased ‘aging’F. Accelerated cognitive declineG. Another reason[Default]
[MC Any][MC All]
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Question 1 – Cognitive Differences Detected?
*
*
Lower scores reflect better function.Trails A - Sig. Dif. for Age and HIVTrails B – Sig. Dif. For HIV
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Question 1 – Cognitive Differences Detected?
*
Higher scores reflect better function.Finger Tapping - Sig. Dif. for HIV
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Question 2 – Differences in TIADLs in Older and Younger Adults with
and without HIV?
*
*
Lower scores reflects better function.Age, HIV, and AgeXHIV effects observed.
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Question 2 – Differences in TIADLs in Older and Younger Adults with
and without HIV?
Lower scores reflects better function.Age, HIV, and AgeXHIV effects observed for Total Score.
*
*
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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 I have my own personal reasons!
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Willig, et al, AIDS, 2008
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1st Line ARV Therapy: 2003- 2007
McKinnell, et al, AIDS Pt Care & STDs, 2010
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Does treating HIV lead to reduced transmission of HIV?
A. YesB. NoC. Depends on the sexual practices!
[Default][MC Any][MC All]
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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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TNT: Based on the association of viral load and HIV transmission risk
0
5
10
15
20
25
30
Viral load (HIV-1 RNA copies/mL) and HIV transmission
Tran
smis
sio
n r
ate
per
100
Per
son
-Yea
rs
<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
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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 I have my own personal reasons!
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Prevention of Transmission
• TEST and TREAT – Testing and Linkage to Care (TLC+)
National AIDS Strategy…
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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 I have my own personal reasons!
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Cost-Effectiveness of Early vs. Deferred ART
“Starting ART earlier … rather than later … is a cost-effective strategy (by the generally accepted benchmark in the US).”
ART Initiation
Incremental Lifetime Costs
Incremental Discounted
QALY* Gained
Cost Per Life-Year Gained
Cost PerQALY* Gained
CD4 >350 vs 200-350 $19,074 0.75 (0.61) $25,567 $31,226
CD4 200-350 vs < 200 $28,066 1.27 (1.09) $22,064 $25,806
Mauskopf JA, et al. JAIDS 2005;39:562-569.
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Case 1
–30 yo white man–Diagnosed on routine insurance examination–PMHx remarkable for HTN, diet controlled–No medications–Understands treatment issues and wants to
begin therapy if you think it is appropriate
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If his viral load is 30,000 c/ml, at which CD4 count would you recommend
starting therapy?
A. 750 cells / ulB. 500 cells / ulC. 350 cells / ulD. 300 cells / ulE. 250 cells / ulF. ≤ 200 cells / ulG. Would observeH. Would treat at any CD4 count[Default]
[MC Any][MC All]
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START (Strategic Timing of ART) Study• INSIGHT Network: multinational• Study population: adults with CD4 >500• Study treatment:
– Immediate ART– CD4 <350
• Study endpoints:– Serious AIDS-defining illness, non-AIDS illness, death
• Sample size:– N=900 (pilot for feasibility)– N=4000 (definitive)
• Duration: ~6 yrs.
http://insight.ccbr.umn.edu/official_documents/START/protocol_documents/START_ProtocolSynopsis.pdf
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CD4 Count at Initiation of ARV 2003-2005
Egger M, 14th CROI; 2007; Abstract 62.
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Which of the following convinces you MOST to start therapy earlier in course of HIV infection?
A. Cohort Study Results (NA-ACCORD / ART-CC)B. Consequences of unchecked viral replication
(inflammation / harm)C. Improved tolerability / convenience of newer ARV
regimensD. Treatment reduces transmission of HIVE. Cost savingsF. I have my own personal reasons![Default][MC Any][MC All]
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Case 1
–30 yo White Male–Diagnosed on routine insurance examination–PMHx remarkable for HTN, diet controlled–No medications–Understands treatment issues and wants to
begin therapy if you think it is appropriate
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If his viral load is 30,000 c/ml, at which CD4 count would you recommend starting therapy?
A. 750 cells / ulB. 500 cells / ulC. 350 cells / ulD. 300 cells / ulE. 250 cells / ulF. ≤200 cells / ulG. Would observeH. Would treat at any CD4 count[Default][MC Any][MC All]
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END of SESSION 1