THE BODY PROThe HIV Resource for Health Professionals
Faculty: David Wohl, M.D.Associate Professor of Medicine at the University of North Carolina at Chapel Hill
The Body PRO Covers ICAAC/IDSA 2008Washington, D.C.; October 25-28, 2008
Copyright © 2008 The HealthCentral Network, Inc. All rights reserved.
This activity is jointly sponsored by Postgraduate Institute for Medicine and The Body PRO.
David Wohl, M.D.
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
2
Faculty for This ActivityFaculty for This Activity
David Wohl, M.D.
Dr. Wohl is an associate professor of medicine at the University of North Carolina at Chapel Hill, and co-directs HIV services for the North Carolina Department of Corrections. Dr. Wohl is an investigator in the NIAID-sponsored AIDS Clinical Trials Group (ACTG) and a member of the ACTG Complications of HIV Disease Research Agenda Committee. His research focuses on metabolic and infectious complications of HIV and its therapies, as well as issues related to medication adherence and access to care -- particularly among incarcerated inmates with HIV infection.
DisclosuresDr. Wohl has been a consultant for Abbott Laboratories, Tibotec and Merck & Co. He has served on speaker bureaus for Abbott, Gilead, Roche Laboratories, Bristol-Myers Squibb, Boehringer Ingelheim, Tibotec and Merck. In addition, he has received research support from Abbott, Roche and Merck.
This activity is supported by an educational grant from
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
3
STARTMRK: Patient DispositionSTARTMRK: Patient Disposition
Jeffrey Lennox et al. ICAAC/IDSA 2008; abstract H-896a. Reprinted with permission.Copyright © 2008 Merck & Co., Inc., Whitehouse Station, NJ, USA. All Rights Reserved.
281281Treated with RAL*Treated with RAL*
24 (8.5%)24 (8.5%)Discontinued due to:Discontinued due to:
8- Adverse events 8- Adverse events 4- Lack of efficacy 4- Lack of efficacy 3- Lost to follow-up3- Lost to follow-up9- Other events9- Other events
Randomized 1:1 toRandomized 1:1 toRAL or EFV armsRAL or EFV arms
282 282 Treated with EFV*Treated with EFV*
257 (91.5%)257 (91.5%)Completed Completed 48 weeks48 weeks
247 (87.6%)247 (87.6%)Completed Completed 48 weeks48 weeks
35 (12.4%)35 (12.4%)Discontinued due to:Discontinued due to:
17- Adverse events 17- Adverse events 2- Lack of efficacy 2- Lack of efficacy 7- Lost to follow-up7- Lost to follow-up9- Other events9- Other events
*In combination with TDF/FTC
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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STARTMRK: Baseline Characteristics STARTMRK: Baseline Characteristics
Jeffrey Lennox et al. ICAAC/IDSA 2008; abstract H-896a. Reprinted with permission.Copyright © 2008 Merck & Co., Inc., Whitehouse Station, NJ, USA. All Rights Reserved.
RAL* EFV*
# Patients Treated n = 281 n = 282
Age (Mean, Years) 38 37
% Male 81 82
% Non-White 59 56
vRNA Copies/mL (Geometric Mean) 103,205 106,215
% With vRNA > 105 Copies/mL 55 51
Mean CD4+ Count (Cells/μl) 219 217
% With CD4+ ≤ 200 Cells/μl 47 48
% Hepatitis B or C 7 7
% Non-Clade B 21 17
*In combination with TDF/FTC
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
5STARTMRK: Percent of Patients With HIV RNA < 50 Copies/mL (95% CI)(Non-Completer = Failure)
STARTMRK: Percent of Patients With HIV RNA < 50 Copies/mL (95% CI)(Non-Completer = Failure)
Jeffrey Lennox et al. ICAAC/IDSA 2008; abstract H-896a. Reprinted with permission.Copyright © 2008 Merck & Co., Inc., Whitehouse Station, NJ, USA. All Rights Reserved.
281 279 281 279 281 279 278 280 280282 282 282 282 281 282 280 281 281
Raltegravir 400 mg BID*Efavirenz 600 mg QHS*
Number of Contributing Patients
*In combination with TDF/FTC
Weeks
Per
cen
t o
f P
ati
en
ts W
ith
HIV
RN
A <
50
Co
pie
s/m
L
0 2 4 8 12 16 24 32 40 48
0
20
40
60
80
100
82%
Non-InferiorityP Value < 0.001
86%
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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STARTMRK: Time to Virologic Response (HIV RNA < 50 Copies/mL)STARTMRK: Time to Virologic Response (HIV RNA < 50 Copies/mL)
Jeffrey Lennox et al. ICAAC/IDSA 2008; abstract H-896a. Reprinted with permission.Copyright © 2008 Merck & Co., Inc., Whitehouse Station, NJ, USA. All Rights Reserved.
Number of Patients at Risk
282 267 229 158 95 44 17 11 8 6281 214 134 71 42 23 13 8 3 2
Efavirenz 600 mg QHS*Raltegravir 400 mg BID*
Log-Rank
P Value < 0.001
0 2 4 8 12 16 24 32 40 48 56Weeks
0
20
40
60
80
100
Cu
mu
lati
ve V
iro
log
ic
Res
po
nse
Rat
e (%
)
*In combination with TDF/FTC
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
7STARTMRK: Change From Baseline in CD4+ Cell Count (95%)(Observed Failure)
STARTMRK: Change From Baseline in CD4+ Cell Count (95%)(Observed Failure)
Jeffrey Lennox et al. ICAAC/IDSA 2008; abstract H-896a. Reprinted with permission.Copyright © 2008 Merck & Co., Inc., Whitehouse Station, NJ, USA. All Rights Reserved.
∆ (95% CI) =26 (4, 47)
0 2 4 8 12 16 24 32 40 48Weeks
0
50
100
150
200M
ea
n C
ha
ng
e F
rom
Ba
se
lin
eC
D4
+ C
ell
Co
un
t (C
ell
s/m
m3 )
189
163
281 274 277 272 270 266 260 259 258281 272 272 268 269 266 260 254 251
Raltegravir 400 mg BID*Efavirenz 600 mg QHS*
Number of Contributing Patients
*In combination with TDF/FTC
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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STARTMRK: Resistance by Week 48 In Patients With Virologic Failure*STARTMRK: Resistance by Week 48 In Patients With Virologic Failure*
Jeffrey Lennox et al. ICAAC/IDSA 2008; abstract H-896a. Reprinted with permission.Copyright © 2008 Merck & Co., Inc., Whitehouse Station, NJ, USA. All Rights Reserved.
*Virologic failure: Non-responder: (1) HIV RNA > 50 copies/mL at the time of discontinuation or (2) HIV RNA > 50 copies/mL at Week 24 Virologic rebound: HIV RNA > 50 copies/mL (on 2 consecutive measurements at least 1 week apart) after initial response
No known RALNo known RALresistance mutationresistance mutation
n = 5n = 54 Sens to TDF/FTC, 1 not tested4 Sens to TDF/FTC, 1 not tested
Known RALKnown RALresistance mutationresistance mutation
n = 4n = 43 Res to FTC, 1 not tested3 Res to FTC, 1 not tested
IN gene couldIN gene couldnot be amplifiednot be amplified
n = 3n = 3
IN Mutations:IN Mutations:
n = 2n = 2 G140S+Q148H/RG140S+Q148H/R
n = 1n = 1 Y143H+L74M+E92Q+T97AY143H+L74M+E92Q+T97A
n = 1n = 1 Y143RY143R
RAL FailuresRAL FailuresvRNA > 400c/mLvRNA > 400c/mL
n = 12n = 12
No known EFVNo known EFVresistance mutationresistance mutation
n = 3n = 33 Sens to TDF/FTC3 Sens to TDF/FTC
Known EFVKnown EFVresistance mutationresistance mutation
n = 3n = 31 Res to FTC1 Res to FTC
RT geneRT geneno datano data
n = 2n = 2
EFV FailuresEFV FailuresvRNA > 400c/mLvRNA > 400c/mL
n = 8n = 8
VL FailuresVL Failuresn = 27 RALn = 27 RALn = 39 EFVn = 39 EFV
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
9STARTMRK: Most Common‡ Drug-Related¥ Clinical Adverse Events Of Moderate or Severe Intensity
STARTMRK: Most Common‡ Drug-Related¥ Clinical Adverse Events Of Moderate or Severe Intensity
Jeffrey Lennox et al. ICAAC/IDSA 2008; abstract H-896a. Reprinted with permission.Copyright © 2008 Merck & Co., Inc., Whitehouse Station, NJ, USA. All Rights Reserved.
‡Present in ≥ 2% of either treatment group¥Determined by investigator to be possibly, probably or definitely related to any drug in the treatment regimen*In combination with TDF/FTC
8 (2.8) 0 (0.0)Rash
7 (2.5) 0 (0.0)Rash Maculo-Papular
8 (2.8) 3 (1.1)Diarrhea
8 (2.8) 4 (1.4)Fatigue
10 (3.5) 8 (2.8)Nausea
9 (3.2)10 (3.6)Insomnia
18 (6.4) 4 (1.4)Dizziness
13 (4.6)11 (3.9)Headache
n (%)n (%)
EFV*n = 282
RAL*n = 281
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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STARTMRK: Grade 3/4‡ Laboratory AbnormalitiesSTARTMRK: Grade 3/4‡ Laboratory Abnormalities
Jeffrey Lennox et al. ICAAC/IDSA 2008; abstract H-896a. Reprinted with permission.Copyright © 2008 Merck & Co., Inc., Whitehouse Station, NJ, USA. All Rights Reserved.
Laboratory Blood Test Toxicity Criteria‡
RAL*n = 281
EFV*n = 282
n (%) n (%)
Absolute Neutrophil Count < 750 cells/µL 5 (1.8) 3 (1.1)
Hemoglobin < 7.5 gm/dL 2 (0.7) 2 (0.7)
Platelet Count < 50 k/µL 0 (0.0) 1 (0.4)
Fasting LDL Cholesterol ≥ 190 mg/dL 3 (1.1) 10 (3.6)
Fasting Total Cholesterol > 300 mg/dL 0 (0.0) 7 (2.5)
Fasting Triglycerides > 750 mg/dL 1 (0.4) 3 (1.1)
Fasting Glucose > 250 mg/dL 1 (0.4) 0 (0.0)
Total Bilirubin > 2.5 x ULN 2 (0.7) 0 (0.0)
Alkaline Phosphatase > 5 x ULN 0 (0.0) 2 (0.8)
Aspartate Aminotransferase > 5 x ULN 6 (2.1) 5 (1.8)
Alanine Aminotransferase > 5 x ULN 5 (1.8) 6 (2.1)‡Grades 3/4 by DAIDS criteria *In combination with TDF/FTC
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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STARTMRK: Change From Baseline In Fasting Serum Lipids Week 48STARTMRK: Change From Baseline In Fasting Serum Lipids Week 48
Jeffrey Lennox et al. ICAAC/IDSA 2008; abstract H-896a. Reprinted with permission.Copyright © 2008 Merck & Co., Inc., Whitehouse Station, NJ, USA. All Rights Reserved.
64
10
-3
37
16
33
10
-10
0
10
20
30
40
T CHOL HDL-C LDL-C TG
Mea
n C
han
ge
(mg
/dL
)
Lipid-Lowering Rx RAL* # (%) EFV *# (%)
Added Rx 3 (1) 11 (4)
Increased Rx 4 (1) 4 (1)
‡P < 0.001‡
*
*
*In combination with TDF/FTC
‡
‡
‡
-1
0T CHOL/HDL
Mea
n C
ha
ng
e (
Rat
io)
RAL
EFV
P = 0.292
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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ARTEMIS: Phase III Study DesignARTEMIS: Phase III Study Design
Anthony Mills et al. ICAAC/IDSA 2008; abstract H-1250c. Reprinted with permission.
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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ARTEMIS: Viral Load < 50 Copies/mL To Week 48 (ITT-TLOVR)ARTEMIS: Viral Load < 50 Copies/mL To Week 48 (ITT-TLOVR)
Estimated difference in response vs LPV/r for non-inferiority:
PP = 5.6% (95% CI –0.1;11.3) p<0.001
Estimated difference in response vs. LPV/r for non-inferiority:
PP = 5.6% (95% CI –0.1;11.3) P < 0.001
Estimated difference in response vs. LPV/r for superiority:
ITT = 5.5% (95% CI –0.3;11.2) P = 0.062
50
40
30
20
10
0
100
90
80
70
60
84%78%
4 8 12 16 24 36 48Time (weeks)
Pat
ien
ts W
ith
VL
< 5
0 C
op
ies/
mL
(%
[±S
E])
LPV/r QD or BID (n = 346)
DRV/r QD (n = 343)
2
Edwin DeJesus et al. ICAAC 2007; abstract H-718b. Reprinted with permission.
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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ARTEMIS: Viral Load < 50 Copies/mL To Week 96 (ITT-TLOVR)*ARTEMIS: Viral Load < 50 Copies/mL To Week 96 (ITT-TLOVR)*
Anthony Mills et al. ICAAC/IDSA 2008; abstract H-1250c. Reprinted with permission.
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
15ARTEMIS: Virologic Response at Week 96 in the TLOVR Non-VF Censored Population‡
ARTEMIS: Virologic Response at Week 96 in the TLOVR Non-VF Censored Population‡
Anthony Mills et al. ICAAC/IDSA 2008; abstract H-1250c. Reprinted with permission.
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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ARTEMIS: VF Analysis Over 96 WeeksARTEMIS: VF Analysis Over 96 Weeks
Anthony Mills et al. ICAAC/IDSA 2008; abstract H-1250c. Reprinted with permission.
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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ARTEMIS: Median Lipid Levels at Baseline and Week 96ARTEMIS: Median Lipid Levels at Baseline and Week 96
Anthony Mills et al. ICAAC/IDSA 2008; abstract H-1250c. Reprinted with permission.
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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CASTLE: Study DesignCASTLE: Study Design
Jean-Michel Molina et al. ICAAC/IDSA 2008; abstract H-1250d. Reprinted with permission.
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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CASTLE: HIV RNA < 50 Copies/mL (CVR, NC = F)CASTLE: HIV RNA < 50 Copies/mL (CVR, NC = F)
Jean-Michel Molina et al. ICAAC/IDSA 2008; abstract H-1250d. Reprinted with permission.
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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CASTLE: Selected Grade 3-4 Laboratory AbnormalitiesCASTLE: Selected Grade 3-4 Laboratory Abnormalities
Jean-Michel Molina et al. ICAAC/IDSA 2008; abstract H-1250d. Reprinted with permission.
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
21CASTLE: CVR (HIV RNA < 50 Copies/mL) Treatment Outcomes at Week 96 Among Subjects With Advanced Disease
CASTLE: CVR (HIV RNA < 50 Copies/mL) Treatment Outcomes at Week 96 Among Subjects With Advanced Disease
Jean-Michel Molina et al. ICAAC/IDSA 2008; abstract H-1250d. Reprinted with permission.
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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HEAT: MethodsHEAT: Methods
Ben Young et al. ICAAC/IDSA 2008; abstract H-1233.Copyright GlaxoSmithKline. Used with permission, 2008.
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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HEAT: Virologic Failure by Baseline HIV-1 RNA Strata and Failure CriterionHEAT: Virologic Failure by Baseline HIV-1 RNA Strata and Failure Criterion
Ben Young et al. ICAAC/IDSA 2008; abstract H-1233.Copyright GlaxoSmithKline. Used with permission, 2008.
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
24HEAT: Summary of Treatment Emergent Resistance in Subjects With Protocol-Defined Virologic Failure
HEAT: Summary of Treatment Emergent Resistance in Subjects With Protocol-Defined Virologic Failure
Ben Young et al. ICAAC/IDSA 2008; abstract H-1233.Copyright GlaxoSmithKline. Used with permission, 2008.
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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ARIES: Study DesignARIES: Study Design
Kathleen Squires et al. ICAAC/IDSA 2008; abstract H-1250a.Copyright GlaxoSmithKline. Used with permission, 2008.
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
26ARIES: Proportion of Subjects With vRNA < 50 Copies/mL and < 400 Copies/mL Through Week 36, ITT-E Population
ARIES: Proportion of Subjects With vRNA < 50 Copies/mL and < 400 Copies/mL Through Week 36, ITT-E Population
Kathleen Squires et al. ICAAC/IDSA 2008; abstract H-1250a.Copyright GlaxoSmithKline. Used with permission, 2008.
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
27ARIES: Overall and Stratified Results by Baseline Viral Load Through Week 36, ITT-E Population
ARIES: Overall and Stratified Results by Baseline Viral Load Through Week 36, ITT-E Population
Kathleen Squires et al. ICAAC/IDSA 2008; abstract H-1250a.Copyright GlaxoSmithKline. Used with permission, 2008.
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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MERIT: Phase III Trial DesignMERIT: Phase III Trial Design
Michael Saag et al. IAS 2007; abstract WESS104. Reprinted with permission.
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
29MERIT: Percentage of Patients With Undetectable HIV-1 RNA at Week 48 (Primary Endpoint)
MERIT: Percentage of Patients With Undetectable HIV-1 RNA at Week 48 (Primary Endpoint)
Michael Saag et al. IAS 2007; abstract WESS104. Reprinted with permission.
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
30MERIT: Patients With a D/M Tropism Result Using the Enhanced Sensitivity Trofile Assay
MERIT: Patients With a D/M Tropism Result Using the Enhanced Sensitivity Trofile Assay
Michael Saag et al. ICAAC/IDSA 2008; abstract H-1232a. Reprinted with permission.
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
31MERIT: Re-analysis With Enhanced Trofile At Screening Identified ~50% of Patients Who Displayed D/M Virus on Study
MERIT: Re-analysis With Enhanced Trofile At Screening Identified ~50% of Patients Who Displayed D/M Virus on Study
Michael Saag et al. ICAAC/IDSA 2008; abstract H-1232a. Reprinted with permission.
The Body PRO
Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
32MERIT: Percentage of Patients With HIV-1 RNA < 400 and < 50 Copies/mL At Week 48
MERIT: Percentage of Patients With HIV-1 RNA < 400 and < 50 Copies/mL At Week 48
Michael Saag et al. ICAAC/IDSA 2008; abstract H-1232a. Reprinted with permission.
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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ACTG 5211: Coreceptor Tropism by The Original and Enhanced Trofile
ACTG 5211: Coreceptor Tropism by The Original and Enhanced Trofile
Zhaohui Su et al. ICAAC/IDSA 2008; abstract H-895. Reprinted with permission.
25/114
Enhanced Trofile reclassified 25 individuals with R5 virus at screen
15/25 were VCV recipients
12/15 had early detection of X4 virus on study (before week 8) by original Trofile
Original Trofile Enhanced Trofile
Screen Entry On study DM at Screen (n, %)
R5 DM DM/X4 7/12, 58%
R5 R5 DM/X4 9/18, 50%
R5 R5 R5 9/84, 11%
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
34ACTG 5211: Viral Load Reduction in Subjects With R5 Virus at Screen by the Original & Enhanced Trofile Assays
ACTG 5211: Viral Load Reduction in Subjects With R5 Virus at Screen by the Original & Enhanced Trofile Assays
Zhaohui Su et al. ICAAC/IDSA 2008; abstract H-895. Reprinted with permission.
-2
-1.5
-1
-0.5
0
0.5P
lace
bo
5 10 15 Pla
cebo
5 10 15
Day 14 Week 24
Ch
ang
e in
Vir
al L
oad
(Lo
g10
HIV
-1 R
NA
)
Original
Enhanced
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
35
NA-ACCORD: Distribution of 8,374 Study PatientsNA-ACCORD: Distribution of 8,374 Study Patients
First CD4+ Count Between 351 – 500 Measured 1996 – 2006
No Prior AIDS Diagnosis or ARVs (n = 8,374)
Defer HAARTn = 5,901
Initiate HAARTn = 2,473
Transit to CD4+ < 350
Defer HAARTn = 2,229
Initiate HAARTn = 1,220
No Transitn = 2,452
Deaths (Person-Years) in Cohort Analysis
100 (5,815) 137 (5,526) 209 (5,295) 221 (8,358)
Percent Censored in IPW Analysis
57% 0% 10% 0%
Adapted from Mari Kitahata et al. ICAAC/IDSA 2008; abstract H-896b.
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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NA-ACCORD: Baseline Characteristics In Study PatientsNA-ACCORD: Baseline Characteristics In Study Patients
Defer HAART n = 5,901
Initiate HAART n = 2,473
Follow Up Person-Years 16,636 8,358
Hepatitis C Virus Infection (%)* 34 27
History of Injection Drug Use (%)* 21 16
Males (%) 75 83
Median Age Years (IQR) 38 (32, 45) 40 (34, 48)
Median CD4+ Count Cells/mm3 (IQR) 432 (391, 468) 421 (386, 459)
Median log10 HIV RNA Copies/mL (IQR)* 4.1 (3.3, 4.6) 4.3 (3.1, 4.9)
White (%) 38 39
*Among patients with known status
Adapted from Mari Kitahata et al. ICAAC/IDSA 2008; abstract H-896b.
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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NA-ACCORD: Results of Subset AnalysisNA-ACCORD: Results of Subset Analysis
• Both a history of IDU and HCV infection were significantly associated with increased risk of mortality
RH 95% CI P Value
When Restricting the Analysis to Patients With Data Regarding History of Injection Drug Use (IDU) and Adjusting for IDU
1.7 1.2, 2.3 0.003
When Restricting the Analysis to Patients With Data Regarding Hepatitis C Virus (HCV) Infection and Adjusting for HCV
1.7 1.3, 2.1 < 0.0001
RH = relative hazard of death for deferral of HAART; CI = confidence interval
Adapted from Mari Kitahata et al. ICAAC/IDSA 2008; abstract H-896b.
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
38NA-ACCORD: Inverse Probability Weighted Cox Regression Multivariate Analysis
NA-ACCORD: Inverse Probability Weighted Cox Regression Multivariate Analysis
RH* 95% CI P Value
Deferral of HAART at 351 – 500 1.7 1.4, 2.1 < 0.001
Older Age (Per 10 Years) 1.6 1.5, 1.8 < 0.001
Female Sex 1.1 0.9, 1.5 0.290
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. was 1.4, 2.2; and P value was < 0.0001• HIV RNA was not an independent predictor of mortality
RH = relative hazard; CI = confidence interval*Stratified by cohort and year
Adapted from Mari Kitahata et al. ICAAC/IDSA 2008; abstract H-896b.
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Evolving Options for First-Line Therapy: Highlights From ICAAC/IDSA 2008
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• This presentation was created to accompany The Body PRO's summaries of key research presented at ICAAC/IDSA 2008, by David Wohl, M.D.
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