key research from idsa 2007: the 45th annual meeting of the infectious diseases society of america
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Faculty Eric Daar, M.D. Key Research From IDSA 2007: The 45th Annual Meeting of the Infectious Diseases Society of America. San Diego, California | October 4-7, 2007. This activity is supported by an educational grant from. IDSA 2007: Faculty for This Activity. Eric Daar, M.D. - PowerPoint PPT PresentationTRANSCRIPT
Key Research From IDSA 2007:The 45th Annual Meeting of the Infectious Diseases Society of America
This activity is supported by an educational grant from
San Diego, California | October 4-7, 2007
FacultyEric Daar, M.D.
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IDSA 2007: Faculty for This ActivityIDSA 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 ResearchIDSA 2007: Key Research
About This Presentation
• This presentation was created to accompany The Body PRO's podcast summary of key research presented at IDSA 2007, featuring an interview with Eric Daar, M.D. For more information about this program, please visit us on the Web at: TheBodyPRO.com/IDSA2007
• Please feel free to use this slide presentation for personal reference or for your own presentations; however, we ask that you not modify any aspects of the slides contained within this presentation so proper attribution can be retained. If you would like to publish all or part of this presentation, or repost any of these slides online, you must first obtain permission from Body Health Resources Corporation.
• Our gratitude goes out to all who granted permission for their slides to be adapted for this presentation.
DisclaimerKnowledge 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.
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New Antiretroviral Options: Emerging Data From Recently Approved Agents or
Agents Available in Expanded Access
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TITAN: Study DesignTITAN: Study Design
W. David Hardy et al. IDSA 2007; abstract 1209. Reprinted with permission.
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TITAN: Virologic Response Through Week 48 (ITT-TLOVR) – All PatientsTITAN: Virologic Response Through Week 48 (ITT-TLOVR) – All Patients
W. David Hardy et al. IDSA 2007; abstract 1209. Reprinted with permission.
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TITAN: Difference in Virologic Response (VL <50 Copies/mL) at Week 48: Univariate Analysis
TITAN: Difference in Virologic Response (VL <50 Copies/mL) at Week 48: Univariate Analysis
W. David Hardy et al. IDSA 2007; abstract 1209. Reprinted with permission.
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TITAN: Baseline CharacteristicsTITAN: Baseline Characteristics
W. David Hardy et al. IDSA 2007; abstract 1209. Reprinted with permission.
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TITAN: NRTIs and NNRTIs Used in the Optimized Background RegimenTITAN: NRTIs and NNRTIs Used in the Optimized Background Regimen
W. David Hardy et al. IDSA 2007; abstract 1209. Reprinted with permission.
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TITAN: Impact of IAS-USA Primary PI Mutations* at Baseline on VL <50 Copies/mL at Week 48
TITAN: Impact of IAS-USA Primary PI Mutations* at Baseline on VL <50 Copies/mL at Week 48
W. David Hardy et al. IDSA 2007; abstract 1209. Reprinted with permission.
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TITAN: Difference in Virologic Response (VL <50 Copies/mL, ITT-TLOVR): Multivariate Analyses
TITAN: Difference in Virologic Response (VL <50 Copies/mL, ITT-TLOVR): Multivariate Analyses
W. David Hardy et al. IDSA 2007; abstract 1209. Reprinted with permission.
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Summary of Virologic Responses Without (-) and With (+) Enfuvirtide (ENF)Summary of Virologic Responses Without (-) and With (+) Enfuvirtide (ENF)
Adapted from Jacob P. Lalezari et al. IDSA 2007; abstract 964.
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DUET 24-Week Efficacy: Patients With Viral Load <50 Copies/mL at Week 24 (Primary Endpoint; ITT-TLOVR)
DUET 24-Week Efficacy: Patients With Viral Load <50 Copies/mL at Week 24 (Primary Endpoint; ITT-TLOVR)
Charles Hicks et al. IDSA 2007; abstract 1207. Reprinted with permission.
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DUET 24-Week Efficacy: Mean Viral Load Reduction From Baseline (ITT NC=F)DUET 24-Week Efficacy: Mean Viral Load Reduction From Baseline (ITT NC=F)
Charles Hicks et al. IDSA 2007; abstract 1207. Reprinted with permission.
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DUET 24-Week Efficacy: CD4 Cell Count Increase to 50 Cells/mm3 or AboveDUET 24-Week Efficacy: CD4 Cell Count Increase to 50 Cells/mm3 or Above
Charles Hicks et al. IDSA 2007; abstract 1207. Reprinted with permission.
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DUET 24-Week Efficacy: Response (<50 Copies/mL) According to Number of Active Background Antiretrovirals
DUET 24-Week Efficacy: Response (<50 Copies/mL) According to Number of Active Background Antiretrovirals
Charles Hicks et al. IDSA 2007; abstract 1207. Reprinted with permission.
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DUET 24-Week Efficacy: Response (<50 Copies/mL) According to Baseline Viral Load and CD4 Cell Count
DUET 24-Week Efficacy: Response (<50 Copies/mL) According to Baseline Viral Load and CD4 Cell Count
Charles Hicks et al. IDSA 2007; abstract 1207. Reprinted with permission.
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DUET 24-Week Efficacy: Mutations Associated With a Decreased Response to TMC125
DUET 24-Week Efficacy: Mutations Associated With a Decreased Response to TMC125
Charles Hicks et al. IDSA 2007; abstract 1207. Reprinted with permission.
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DUET 24-Week Efficacy: Response (<50 Copies/mL) According to Number of TMC125 RAMS
DUET 24-Week Efficacy: Response (<50 Copies/mL) According to Number of TMC125 RAMS
Charles Hicks et al. IDSA 2007; abstract 1207. Reprinted with permission.
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DUET 24-Week Safety: Overview of Adverse EventsDUET 24-Week Safety: Overview of Adverse Events
Parameter, %TMC125 group
(n=599)Placebo group
(n=604)
Any AE (any cause) 92 93
Grade 3 AE 22 25
Grade 4 AE 7 9
Serious AE (SAE) 13 19
Death (any cause) 1 2
Discontinuation due to AE 6 4
Most common AEs (>10% in either group, regardless of severity and causality)*
Rash (any type) 17§ 9
Diarrhea 15 20
Nausea 14 11
Headache 9 12
• AEs leading to death were not reported in more than one patient except for pneumonia and sepsis (n=2 each) in the placebo group
• None of the deaths in the TMC125 group were considered related to TMC125
*excluding injection site reactions; §p=0.0001 vs placebo; AE = adverse event
Richard Haubrich et al. IDSA 2007; abstract 1210. Reprinted with permission.
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AE regardless of causality, n (%)TMC125 group
(n=599)Placebo group
(n=604)
Any grade 3/4 AE 25 27
Most common grade 3/4 clinical AEs (>0.5% 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
DUET 24-Week Safety: Grade 3 and 4 Adverse EventsDUET 24-Week Safety: Grade 3 and 4 Adverse Events
Richard Haubrich et al. IDSA 2007; abstract 1210. Reprinted with permission.
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DUET 24-Week Safety: RashDUET 24-Week Safety: Rash
• 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.
Investigator assessment of cause of rash, %
TMC125 group (n=599)
Placebo group(n=604) Significance
Any cause 17 9.4 p<0.001
Possibly related to study medication 12 4.8
Richard Haubrich et al. IDSA 2007; abstract 1210. Reprinted with permission.
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DUET 24-Week Safety: Psychiatric DisordersDUET 24-Week Safety: Psychiatric Disorders
Patients experiencing psychiatric-related AEs, %TMC125 group
(n=599)Placebo group
(n=604)
Grade 3 0.2 1.3
Grade 4 0 0.2
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
• Similar incidence to placebo: 13% in TMC125 group versus 15% in placebo group (p=0.3).
• 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.
Richard Haubrich et al. IDSA 2007; abstract 1210. Reprinted with permission.
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-100-80-60-40-20
02040
0 8 16 24 32 40 48
-200
-150
-100
-50
0
50
0 8 16 24 32 40 48
High Density LipoproteinLow Density Lipoprotein Calculated
DUET 24-Week Safety: Lipid Changes Over TimeDUET 24-Week Safety: Lipid Changes Over Time
Total Cholesterol/High Density Lipoprotein Triglycerides
Cha
nge
from
ba
selin
e (m
g/dL
)
Cha
nge
from
ba
selin
e (m
g/dL
)
Week Week
0
20
40
60
80
100
0 8 16 24 32 40 48
-5
0
5
10
15
20
0 8 16 24 32 40 48
TMC125 group Placebo group
Richard Haubrich et al. IDSA 2007; abstract 1210. Reprinted with permission.
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DUET 24-Week Safety: HospitalizationsDUET 24-Week Safety: Hospitalizations
0
5
10
15
20
Pat
ient
s ho
spita
lized
at l
east
onc
e by
24
wee
ks (
%)
16%
11%
Placebo groupTMC125 group
p=0.0031
0
500
1000
1500
2000
1700
1105
Cum
ulat
ive
days
hos
pita
lized
by
24
wee
ks
Richard Haubrich et al. IDSA 2007; abstract 1210. Reprinted with permission.
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A4001029: Phase 2b Pilot Study Evaluating the Safety of Maraviroc in Patients With Non-R5 HIV-1
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.
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A4001029: Baseline CharacteristicsA4001029: Baseline Characteristics
J.M. Goodrich et al. IDSA 2007; abstract LB-2. Reprinted with permission.
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A4001029: Baseline Characteristics – Primary Study PopulationA4001029: Baseline Characteristics – Primary Study Population
J.M. Goodrich et al. IDSA 2007; abstract LB-2. Reprinted with permission.
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A4001029: Percentage of Patients With Undetectable HIV-1 RNA Over 48 Weeks
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.
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A4001029: Mean Change From Baseline in CD4+ CountA4001029: Mean Change From Baseline in CD4+ Count
J.M. Goodrich et al. IDSA 2007; abstract LB-2. Reprinted with permission.
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A4001029: Summary of Week 48 Safety ResultsA4001029: Summary of Week 48 Safety Results
J.M. Goodrich et al. IDSA 2007; abstract LB-2. Reprinted with permission.
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A4001029: Number of Category C EventsA4001029: Number of Category C Events
J.M. Goodrich et al. IDSA 2007; abstract LB-2. Reprinted with permission.
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• Visit The Body PRO for comprehensive coverage of IDSA 2007.This presentation was created to accompany The Body PRO's summary of key research presented at IDSA 2007, by Eric Daar, M.D. Learn more at: TheBodyPRO.com/IDSA2007
• In addition, be sure to browse through The Body PRO’s extensive coverage of IDSA 2007, which includes:– A full written summary with expert discussion and analyses of key
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MP3 player.– Slides and in-depth data analyses.
• Visit TheBodyPRO.com/IDSA2007 today for a full listing of our conference materials!
IDSA 2007: Key ResearchIDSA 2007: Key Research