Key Research From IDSA 2007: The 45th Annual Meeting of the Infectious Diseases Society of America

1
Key Research From IDSA 2007The 45th Annual
Meeting of the Infectious Diseases Society of
America
Faculty Eric Daar, M.D.
San Diego, California October 4-7, 2007

• This activity is supported by an educational
  grant from

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IDSA 2007 Faculty for This Activity
Eric Daar, M.D. Dr. Daar is the chief of HIV
medicine at Harbor-UCLA Medical Center in Los
Angeles, Calif., and a professor of medicine at
the University of California-Los Angeles' David
Geffen School of Medicine. He has been an active
HIV physician and researcher since the 1980s
during the past three decades, he has led dozens
of studies on a vast range of HIV-related issues,
with a particular focus on coinfections and other
health complications associated with HIV and HIV
treatment, including hepatitis C, metabolic
complications, cardiovascular disease and
psychosocial issues such as depression.
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IDSA 2007 Key Research

• About This Presentation
• This presentation was created to accompany The
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  this program, please visit us on the Web at
  TheBodyPRO.com/IDSA2007
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Disclaimer Knowledge about HIV changes rapidly.
Note the date of this presentation's publication,
and before treating patients or employing any
therapies described in these materials, verify
all information independently. If you are a
patient, please consult a doctor or other medical
professional before acting on any of the
information presented in this presentation.
4
Challenges of Current Antiretroviral Therapy
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Immune Discordance While on HAART Methods

• Retrospective cohort study of patients initiated
  on HAART between January 1996 and July 2006.
• Inclusion criteria
• HIV-1 infection, age 18 years, baseline CD4 T
  cells lt350 cells/mm3 and viral suppression for
  52 weeks.
• Definitions
• Discordant and concordant responders defined by
  CD4 T cell gains of lt150 or 150 cells/mm3 from
  HAART initiation through 52 weeks of viral
  suppression and followed to death, virologic
  failure (lack of re-suppression of viremia) or
  study termination.
• Data collection
• Socio-demographics, clinical, medication and
  laboratory data.
• Sample collection and analysis
• Blood samples from immune discordant and
  concordant responders (total n45) with sustained
  viral suppression, were obtained to determine the
  percentage of CD4 and CD8 T lymphocytes that
  were memory (CD45RO) or activated
  (CD38,HLADR), using three-color flow-cytometric
  analysis on cryopreserved peripheral mononuclear
  cells.
• Statistics
• Data analyzed using SPSS version 14.0. Continuous
  variables compared using the Students t-test or
  Mann-Whitney U test. Chi square or Fishers exact
  tests used for categorical variables.
• All p values were two-tailed and significant at
  lt0.05 and potential predictive factors for immune
  discordance were evaluated using multivariate
  logistic regression analyses.

Nur F. Önen et al. IDSA 2007 abstract 952.
Reprinted with permission.
6
Immune Discordance While on HAART Absolute CD4
T Cell Counts After HAART Initiation
Nur F. Önen et al. IDSA 2007 abstract 952.
Reprinted with permission.
7
Immune Discordance While on HAART Results
Characteristics Discordant (n106) Concordant (n192) OR (95 CI) P value
Male gender Age, (years)a Caucasian African American 89 (84) 41.2 0.9 58 (55) 38 (36) 134 (70) 38.2 0.7 75 (39) 108 (56) 2.27(1.24-4.15) - 1.88(1.80-3.05) - 0.01 0.01 0.01 -
Mode of transmission Men who have sex with men Heterosexual 56 (53) 30 (28) 79 (41) 96 (50) 1.78(1.08-2.93) - 0.02 -
Years since HIV diagnosisa Previous OI Prior ARV experience 9.8 0.5 60 (57) 34 (32) 8.3 0.3 104 (54) 62 (32) - 1.11(0.69-1.78) 1.01(0.61-1.68) 0.01 0.72 1.00
CD4 T cell nadir b Highest HIV RNA viral loada 85 (21-180) 4.90 0.06 54(12-189) 5.11 0.07 - - 0.43 0.05
Chronic Hepatitis C Chronic Hepatitis B 17 (11) 9 (6) 16 (8) 21 (11) 1.97(0.96-4.04) 0.72(0.32-1.62) 0.09 0.55
aMean standard error of mean bMedian
(interquartile range), ARV antiretroviral,
NNRTI non-nucleoside reverse transcriptase
inhibitor, NRTI nucleoside reverse
transcriptase inhibitor, PI protease inhibitor.
Nur F. Önen et al. IDSA 2007 abstract 952.
Reprinted with permission.
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Immune Discordance While on HAART Results
Characteristics Discordant (n106) Concordant (n192) OR (95 CI) P value
At suppressive HAART initiation CD4 T cell count b HIV RNA level a HAART regimen type NNRTI/ 2 NRTI All PI/ 2 NRTI Unboosted indinavir 126 (37-231) 4.68 0.86 45 (42) 58 (55) 27 (26) 88 (19-222) 4.81 0.06 92 (48) 87 (45) 24 (13) - - 0.86(0.52-1.42) - 0.52(0.24-1.13) 0.15 0.19 0.61 - 0.01
No. () with HAART-related side-effects 36 (34) 35 (18) 1.80(1.09-2.96) lt0.001
Weeks to viral suppression b 12 (6-23) 16 (8-28) - 0.04
One year CD4 T cell gain b 99 (50-133) 269 (211-374) - lt0.001
aMean standard error of mean bMedian
(interquartile range), ARV antiretroviral,
NNRTI non-nucleoside reverse transcriptase
inhibitor, NRTI nucleoside reverse
transcriptase inhibitor, PI protease inhibitor.
Nur F. Önen et al. IDSA 2007 abstract 952.
Reprinted with permission.
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Immune Discordance While on HAART Independent
Factors Associated With Immune Discordance on
Multivariable Analyses
Male Gender
Lower pre-HAART HIV-RNA viral load
Any use of unboosted indinavir
Greater number of HAART-related side effects per person
Nur F. Önen et al. IDSA 2007 abstract 952.
Reprinted with permission.
10
Immune Discordance While on HAART Clinical
Outcomes During Long-Term Follow-Up
Clinical Outcomes Discordant (106) Concordant (192) OR (95 CI) P value
Years of viral suppression on HAARTa Highest CD4 T cell count attainedb 4.56 0.2 392 (256-566) 4.51 0.2 682 (479-879) - - 0.88 lt0.001
Death Remains in clinical care Lost to follow up 5 (5) 75 (71) 26 (25) 9 (5) 150 (78) 33 (17) 1.00 (0.33-3.09) - - 1.00
New opportunistic illness Type of opportunistic illness Years after viral suppression OI prophylaxis at 1 yr viral suppression at highest CD4 T cell count 1 NHL 2 and 5 61 (58) 37 (35) 1 Kaposis sarcoma 8 73 (38) 30 (16) - - - 2.21 (1.36-3.58) 2.90 (1.66-5.01) - - - lt0.001 lt0.001
Recurrent genital warts Recurrent shingles Recurrent genital herpes 5 (5) 10 (9) 0 1 (1) 7 (4) 6 (3) 9.46 (1.09-82.0) 2.75 (1.02-7.46) 1.57 (1.44-1.71) 0.02 0.06 0.09
aMean standard error of mean, bMedian and
interquartile range. NHL non-Hodgkins
lymphoma, OI opportunistic infection.
Nur F. Önen et al. IDSA 2007 abstract 952.
Reprinted with permission.
11
Immune Discordance While on HAART Comparison of
Activation and Memory T Cells Between Discordant
vs. Concordant Immune Responders
Data at the time of FACS analysis (mean S.E.M.) Discordant (n20) Concordant (n25) P value
Age Gender Male Female Race Caucasian/Hispanic African American 48.7 2.5 17 (85) 3 (15) 15 (75) 5 (25) 48.7 1.9 19 (76) 6 (24) 10 (40) 15 (60) 0.86 0.71 0.03
CD4 T cell count (cells/mm3) lt200 cells/mm3 201-349 cells/mm3 350 cells/mm3 306 30 20 50 30 683 49 0 0 100 lt0.001
Years of viral suppression 5.6 0.5 7.0 0.4 0.03
CD4 T cellsa CD45RO Naïvememory CD38HLADR 55.0 3.6 1.1 0.3 2.9 0.4 45.1 3.1 1.7 0.3 2.0 0.2 0.04 0.04 0.08
CD8 T cellsa CD45RO Naïvememory CD38HLADR 20.5 2.7 5.2 0.6 1.0 0.2 17.6 1.8 6.4 0.8 1.1 0.1 0.47 0.47 0.38
aPercentage of total events. CD38HLADR marker
of activation, CD45RO marker of memory cell.
Nur F. Önen et al. IDSA 2007 abstract 952.
Reprinted with permission.
12
LPV/r Switch for Patients With Suboptimal Immune
Responses to HAART Despite RNA Suppression Study
Design
David Pitrak et al. IDSA 2007 abstract 955.
Reprinted with permission.
13
Mean Increase in CD4 Count After a Switch to
Lopinavir/Ritonavir vs. Continuation of HAART
Baseline177?68.5
Baseline264?19.1
Lopinavir/Ritonavir (N8) Continuation (N9)
Adapted from David Pitrak et al. IDSA 2007
abstract 955.
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Mean Apoptosis (Percent) of CD4CD45 RA (Naïve) T
Cells After Switch to Lopinavir/Ritonavir vs.
Continuation of Current Regimen
Lopinavir/Ritonavir (N8) Continuation
(N9) HIV-Negative Controls (N10) Complete
Responders (N10)
Adapted from David Pitrak et al. IDSA 2007
abstract 955.
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Mean Apoptosis (Percent) of CD4CD45 RO (Memory)
T Cells After Switch to Lopinavir/Ritonavir vs.
Continuation of Current Regimen
Lopinavir/Ritonavir (N8) Continuation
(N9) HIV-Controls Complete Responders
Adapted from David Pitrak et al. IDSA 2007
abstract 955.
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LPV/r Switch for Patients With Suboptimal Immune
Responses to HAART Despite RNA Suppression Mean
Change in CD4 Count Beyond 24 Months
Lopinavir/Ritonavir (N8) Continuation
(N9) Continuation Obs (N7)
Adapted from David Pitrak et al. IDSA 2007
abstract 955.
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Cross Allergy Between NNRTIs Patient Distribution
Claudia P. Cortes et al. IDSA 2007 abstract 959.
Reprinted with permission.
18
Cross Allergy Between NNRTIs Results

• 1547 patients were treated with efavirenz
  (Sustiva, Stocrin) and 946 with nevirapine
  (Viramune).
• 967 of these treatments required change of
  therapy.
• 554 (57.2) of them, due to drug toxicity and 74
  due to allergy.
• 35 patients with allergy to nevirapine switched
  to efavirenz.
• 2/35 (5.7) developed rash within 30 days. This
  was not significantly different from 4.6 of
  primary allergy to efavirenz in the Chilean AIDS
  Cohort population.
• 31/33 (93) of those without secondary allergy
  obtained viral suppression for at least 15
  months.
• Seven patients with efavirenz-induced rash
  underwent change to nevirapine.
• 2/7 (28.5) developed rash.
• All remaining 5 patients obtained viral
  suppression for at least 15 months.

Claudia P. Cortes et al. IDSA 2007 abstract 959.
Reprinted with permission.
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LPV/r Switch Soft Gel Capsule to Tablet Methods
This was a prospective cohort study that enrolled
clinically stable HIV-infected subjects receiving
LPV/r-based antiretroviral regimen.

• Screening
• HIV-subjects age gt18 years.
• Enrolled prior to, or within eight weeks of
  formulation switch.
• No CD4 cell count restriction.
• No pregnancy/breastfeeding.

• Laboratory Evaluations
• Clinical labs monitored at baseline and at week
  12
• Fasting lipid profile.
• HIV-1 RNA.
• CD4 cell count.

Bowel Movement Evaluation Daily bowel habit (BH)
was assessed prior to switch and at weeks 4 12.
The bowel habit score was assessed using the
scoring system below and dividing the sum by
4. The scale has a minimum of 1 (best BHS
outcome) and a maximum of 5 (worst BHS outcome).
Stool consistency solid 1, loose 3, watery5
Volume small 1, moderate3, large5
Presence of blood in stools no1, yes5
Frequency per day 1 5 (gt4 BM per day scored as 5)
Ighovwerha Ofotokun et al. IDSA 2007 abstract
962. Reprinted with permission.
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LPV/r Switch Soft Gel Capsule to Tablet
Subject Demographic Data at Study Entry
Study population (n 74)
Male sex n () 61 (82)
Race African American n () White n () Hispanic n () 55 (74) 17 (23) 2 (3)
On LPV/r tablet at entry No n () Yes n () 49 (66) 25 (34)
On anti-diarrheal drug No n () Yes n () 67 (92) 6 (8)
On lipid lowering drug No n () Yes n () 54 (74) 19 (26)
Median age years (IQR) 43 (39-47)
Median weight kg (IQR) 80.5 (69.6-88.6)
Median HIV-1 RNA copies/ml (IQR) 135 (50-170)
Median CD4 T-cell counts cell/µl (IQR) 294 (157-455)
LPV/r lopinavir/ritonavir SGC soft gel
capsule IQR inter quartile range Subjects
were already switched from LPV/r SGC to tablets
within eight weeks prior to enrollment 75
percentile, 25th to 75th percentile.
Ighovwerha Ofotokun et al. IDSA 2007 abstract
962. Reprinted with permission.
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LPV/r Switch Soft Gel Capsule to Tablet Change
in Self-Reported Bowel Habit
Bowel habit (BH) score Baseline to Week 4 (n 70) Baseline to Week 4 (n 70) Baseline to Week 12 (n62) Baseline to Week 12 (n62)
Overall change, mean SD -0.281 0.719 0.0017 -0.227 0.707 0.0141
Bowel habit improvements among those reporting a change Baseline to Week 4 Baseline to Week 4 Baseline to Week 12 Baseline to Week 12
Bowel habit improvements among those reporting a change Improvement rate P-value Improvement rate P-value
Decrease in stool frequency among those reporting change 18/28 (64) 0.13 18/32 (56) 0.48
Improved stool consistency among those reporting change 23/30 (77) 0.0035 19/27 (70) 0.0343
Decrease in stool volume among those reporting change 11/16 (69) 0.13 8/13 (62) 0.41
Resolution of blood in stool among those reporting change 5/6 (83) 0.10 4/6 (67) 0.41
SD standard deviation BHS example, a subject
with baseline responses of solid, moderate, no
blood in stool, and frequency of 2 would have a
score of (1 3 1 2)/4 1.75 for their
baseline summary score.
Ighovwerha Ofotokun et al. IDSA 2007 abstract
962. Reprinted with permission.
22
LPV/r Switch Soft Gel Capsule to Tablet
Changes in Fasting Lipid Profile From Baseline to
Week 12
Lipid Lowering Drug Baseline mean (SD) Week 12 mean (SD) Mean change (SD) P-value
TC No (n 38) Yes (n16) Total population (n54) 188 (35.1) 221 (66.2) 198 (48.4) 179 (34.7) 218 (55.8) 190 (45.3) -9.20 (23.20) -2.94 (44.30) -7.33 (30.70) 0.0197 0.795 0.0848
TRIG No (n33) Yes (n14) Total population (n47) 187 (117) 410 (410) 254 (260) 154 (111) 329 (304) 206 (203) -33.10 (86.30) -81.20 (348.30) -47.40 (199.90) 0.035 0.399 0.1108
HDL-C No (n33) Yes (n14) Total population (n47) 47.0 (11.3) 35.1 (15.9) 43.2 (14.0) 42.6 (11.9) 36.8 (15.8) 40.7 (13.4) -4.50 (9.40) 1.70 (9.50) -2.49 (9.78) 0.012 0.490 0.877
LDL-C No (n33) Yes (n14) Total population (n47) 106 (29.4) 123 (54.5) 111 (38.8) 102 (24.4) 127 (32.3) 110 (29.0) -4.20 (21.80) 3.60 (48.60) -1.85 (31.80) 0.283 0.788 0.692
TC total cholesterol TRIG triglyceride
HDL-C high density lipoprotein LDL-C low
density lipoprotein SD standard
deviation Statistically significant (P 0.05).
Ighovwerha Ofotokun et al. IDSA 2007 abstract
962. Reprinted with permission.
23
New Antiretroviral Options Emerging Data From
Recently Approved Agents or Agents Available in
Expanded Access
24
TITAN Study Design
W. David Hardy et al. IDSA 2007 abstract 1209.
Reprinted with permission.
25
TITAN Virologic Response Through Week 48
(ITT-TLOVR) All Patients
W. David Hardy et al. IDSA 2007 abstract 1209.
Reprinted with permission.
26
TITAN Difference in Virologic Response (VL lt50
Copies/mL) at Week 48 Univariate Analysis
W. David Hardy et al. IDSA 2007 abstract 1209.
Reprinted with permission.
27
TITAN Baseline Characteristics
W. David Hardy et al. IDSA 2007 abstract 1209.
Reprinted with permission.
28
TITAN NRTIs and NNRTIs Used in the Optimized
Background Regimen
W. David Hardy et al. IDSA 2007 abstract 1209.
Reprinted with permission.
29
TITAN Impact of IAS-USA Primary PI Mutations at
Baseline on VL lt50 Copies/mL at Week 48
W. David Hardy et al. IDSA 2007 abstract 1209.
Reprinted with permission.
30
TITAN Difference in Virologic Response (VL lt50
Copies/mL, ITT-TLOVR) Multivariate Analyses
W. David Hardy et al. IDSA 2007 abstract 1209.
Reprinted with permission.
31
Summary of Virologic Responses Without (-) and
With () Enfuvirtide (ENF)
Adapted from Jacob P. Lalezari et al. IDSA 2007
abstract 964.
32
DUET 24-Week Efficacy Patients With Viral Load
lt50 Copies/mL at Week 24 (Primary Endpoint
ITT-TLOVR)
Charles Hicks et al. IDSA 2007 abstract 1207.
Reprinted with permission.
33
DUET 24-Week Efficacy Mean Viral Load Reduction
From Baseline (ITT NCF)
Charles Hicks et al. IDSA 2007 abstract 1207.
Reprinted with permission.
34
DUET 24-Week Efficacy CD4 Cell Count Increase to
50 Cells/mm3 or Above
Charles Hicks et al. IDSA 2007 abstract 1207.
Reprinted with permission.
35
DUET 24-Week Efficacy Response (lt50 Copies/mL)
According to Number of Active Background
Antiretrovirals
Charles Hicks et al. IDSA 2007 abstract 1207.
Reprinted with permission.
36
DUET 24-Week Efficacy Response (lt50 Copies/mL)
According to Baseline Viral Load and CD4 Cell
Count
Charles Hicks et al. IDSA 2007 abstract 1207.
Reprinted with permission.
37
DUET 24-Week Efficacy Mutations Associated With
a Decreased Response to TMC125
Charles Hicks et al. IDSA 2007 abstract 1207.
Reprinted with permission.
38
DUET 24-Week Efficacy Response (lt50 Copies/mL)
According to Number of TMC125 RAMS
Charles Hicks et al. IDSA 2007 abstract 1207.
Reprinted with permission.
39
DUET 24-Week Safety Overview of Adverse Events
Parameter, TMC125 group (n599) TMC125 group (n599) Placebo group(n604)
Any AE (any cause) 92 92 93
Grade 3 AE 22 22 25
Grade 4 AE 7 7 9
Serious AE (SAE) 13 13 19
Death (any cause) 1 1 2
Discontinuation due to AE 6 6 4
Most common AEs (gt10 in either group, regardless of severity and causality) Most common AEs (gt10 in either group, regardless of severity and causality) Most common AEs (gt10 in either group, regardless of severity and causality) Most common AEs (gt10 in either group, regardless of severity and causality)
Rash (any type) Rash (any type) 17 9
Diarrhea Diarrhea 15 20
Nausea Nausea 14 11
Headache Headache 9 12

• AEs leading to death were not reported in more
  than one patient except for pneumonia and sepsis
  (n2 each) in the placebo group
• None of the deaths in the TMC125 group were
  considered related to TMC125

excluding injection site reactions p0.0001 vs
placebo AE adverse event
Richard Haubrich et al. IDSA 2007 abstract 1210.
Reprinted with permission.
40
DUET 24-Week Safety Grade 3 and 4 Adverse Events
AE regardless of causality, n () TMC125 group (n599) Placebo group (n604)
Any grade 3/4 AE 25 27
Most common grade 3/4 clinical AEs (gt0.5 in pooled TMC125 group) Most common grade 3/4 clinical AEs (gt0.5 in pooled TMC125 group) Most common grade 3/4 clinical AEs (gt0.5 in pooled TMC125 group)
Rash (any type) 1.3 0
Peripheral neuropathy 1.0 0
Pancreatitis 0.7 0
Pneumocystis jiroveci pneumonia 0.7 0.7
Renal failure 0.7 0.3
excluding injection site reactions and grade 3/4
laboratory abnormalities reported as AEs
Richard Haubrich et al. IDSA 2007 abstract 1210.
Reprinted with permission.
41
DUET 24-Week Safety Rash
Investigator assessment of cause of rash, TMC125 group (n599) Placebo group(n604) Significance
Any cause 17 9.4 plt0.001
Possibly related to study medication 12 4.8

• In the TMC125 group
• Early onset Median 12 days.
• Limited duration Median 11 days.
• Low severity Most mild to moderate 1.3 grade
  3, none grade 4.
• Mostly maculopapular no mucosal involvement.
• Infrequently led to discontinuation 2.2 of
  patients (0 with placebo).
• Most resolved with continued treatment.
• Clinical associations with rash
• No association with baseline CD4 cell count.
• No increased risk with prior NNRTI-related rash.

Richard Haubrich et al. IDSA 2007 abstract 1210.
Reprinted with permission.
42
DUET 24-Week Safety Psychiatric Disorders

• Similar incidence to placebo 13 in TMC125 group
  versus 15 in placebo group (p0.3).
• Low severity mostly grade 1 and 2.
• Infrequently lead to discontinuation 1 patient
  (0.2) in each group.
• No increased risk in patients with a history of
  psychiatric disorders.
• Abnormal dreams/nightmares in 5 patients (0.8)
  in each group and no episodes of hallucinations,
  suicidal ideation or manic symptoms with TMC125.

Patients experiencing psychiatric-related AEs, TMC125 group (n599) Placebo group (n604)
Grade 3 0.2 1.3
Grade 4 0 0.2
Most common (reported in 1.0 of patients in the TMC125 group) Most common (reported in 1.0 of patients in the TMC125 group) Most common (reported in 1.0 of patients in the TMC125 group)
Insomnia 6 7
Depression 3 5
Anxiety 3 3
Sleep disorder 1 1
Richard Haubrich et al. IDSA 2007 abstract 1210.
Reprinted with permission.
43
DUET 24-Week Safety Lipid Changes Over Time
TMC125 group
Placebo group
High Density Lipoprotein
Low Density Lipoprotein Calculated
Change from baseline (mg/dL)
Triglycerides
Total Cholesterol/High Density Lipoprotein
Change from baseline (mg/dL)
Week
Week
Richard Haubrich et al. IDSA 2007 abstract 1210.
Reprinted with permission.
44
DUET 24-Week Safety Hospitalizations
TMC125 group
1700
16
p0.0031
1105
11
Patients hospitalized at least once by 24 weeks
()
Cumulative days hospitalized by 24 weeks
Richard Haubrich et al. IDSA 2007 abstract 1210.
Reprinted with permission.
45
A4001029 Phase 2b Pilot Study Evaluating the
Safety of Maraviroc in Patients With Non-R5 HIV-1
J.M. Goodrich et al. IDSA 2007 abstract LB-2.
Reprinted with permission.
46
A4001029 Baseline Characteristics
J.M. Goodrich et al. IDSA 2007 abstract LB-2.
Reprinted with permission.
47
A4001029 Baseline Characteristics Primary
Study Population
J.M. Goodrich et al. IDSA 2007 abstract LB-2.
Reprinted with permission.
48
A4001029 Percentage of Patients With
Undetectable HIV-1 RNA Over 48 Weeks
J.M. Goodrich et al. IDSA 2007 abstract LB-2.
Reprinted with permission.
49
A4001029 Mean Change From Baseline in CD4 Count
J.M. Goodrich et al. IDSA 2007 abstract LB-2.
Reprinted with permission.
50
A4001029 Summary of Week 48 Safety Results
J.M. Goodrich et al. IDSA 2007 abstract LB-2.
Reprinted with permission.
51
A4001029 Number of Category C Events
J.M. Goodrich et al. IDSA 2007 abstract LB-2.
Reprinted with permission.
52
IDSA 2007 Key Research

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