Presentation Outline ICHP Annual Meeting September 13-15

Mean Change (mg/ /dL)
STARTMRK: Lipid Changes From Baseline to
Week 96
40
30
20
10
0
-10
10
38
P < .001 for all lipid
parameters
3
10
21
TC HDL-C LDL-C TG
7
Elvitegravir
(Gilead)
-4
40
RAL
EFV
• Requires boosting
• Ritonavir increases systemic exposure ~ 20
fold and half‐life 3 fold allowing for QD dosing
• Potent HIV Integrase Inhibitor
• Led to development of Cobicistat
Coformulated “QUAD Pill”
Tenofovir/emtricitabine/cobicistat/elvitegravir
300mg / 200mg / 150mg / 150mg
QUAD Regimen Noninferior to ATV/RTV Regimen
at Wk 48
HIV-1 RNA R < 50 c/mL
at Wk 48 (%)
100
80
60
40
20
0
90 87
93 90
Overall HIV-1 RNA
≤ 100,000 c/mL
85
82
HIV-1 RNA
> 100,000 c/mL
QUAD (n=353)
ATV/RTV + Truvada
(n = 355)
• Similar CD4+ cell count increases in both study arms at Wk 48
DeJesus E, et al. CROI 2012. Abstract 627.
Raltegravir Adverse Events
• Well tolerated – N/V/HA most common AE from
clinical trials
‐ creatinine kinase
‐ myopathy
‐ ffew cases of f rhabdomyolysis hbd l i with/without ih/ ih ARF
• Safe with no dosage change during pregnancy
Lennox J, et al. ICAAC 2009. Abstract H-924b.
Virologic Success
(%)
100
80
60
40
20
0
88
Quad vs. Atripla
Efficacy by Baseline VL & CD4
84
90
Sax P, et al. CROI 2012; Seattle. Oral #101LB
QUAD EFV/FTC/TDF
85
84 82
83 84
Overall ≤100,000 >100,000 ≤350 >350
HIV RNA CD4
Quad was non-inferior to EFV/FTC/TDF at Week 48
Elvitegravir vs Raltegravir
• Equally efficacious
• QD vs BID
• Both well tolerated
‐ Few discontinuations due to adverse effects
• Drug Interactions > ELV
• Cross resistance
• Coformulation
• COST ?
• Will any of this matter once Dolutegravir is available?
91
84
8/30/2012
46
8