Presentation Abstract

Session Number: 102
Monday, Sep 10, 2012, 11:15 AM - 1:15 PM
Presentation Title: H-879 - Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF (Quad) Demonstrates Comparable Efficacy and Favorable Tolerability to Efavirenz/Emtricitabine/ Tenofovir DF in Patients ≥50 Years
Location: Halls A-C
Presentation Number: H-879
Pres. Time: Monday, Sep 10, 2012, 11:15 AM - 1:15 PM
Category: H2
Keywords: Quad; Age; Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF
Author(s): G. J. Richmond, MD - . 1, P. Ruane, MD - . 2, W. Robbins, MD, FACP - . 3, U. Bredeek, MD, PhD, FACP - .4, P. Shalit, MD - . 5, D. Hardy, MD - . 6, K. Workowski, MD - . 7, M. Rhee, MD - . 8, D. Piontkowsky, MD, JD - . 8;
1Gary Richmond MD PA, Fort Lauderdale, FL, 2Peter Ruane MD Inc, Los Angeles, CA, 3Value Hlth. MD, Orlando, FL, 4Metropolis Med, San Francisco, CA, 5Tribal Med, Seattle, WA, 6Cedars-Sinai Med. Ctr., Los Angeles, CA, 7Emory Clinic, Atlanta, GA, 8Gilead Sci., Foster City, CA.
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Abstract:
G RichmondFort Lauderdale, FL
P RuaneLos Angeles, CA
W RobbinsValue Health MD, LLC, Orlando, FL
F BredeekMetropolis Med Group, San Francisco, CA
P ShalitTribal Med, Seattle, WA
D HardyCedars-Sinai Med Ctr, Los Angeles, CA
K WorkowskiEmory University, Atlanta, GA
M BlochHoldsworth House Med Practice, Sydney, NSW, Australia
W TownerKaiser Permanente, Los Angeles
T LutzInfektio Research GmbH /Infektiologikum Frankfurt, Frankfurt, Germany
C OrkinBarts and the London NHS Trust, London, UK
J SzwarcbergGSI, Foster City, CA
E Quirk
H Liu
X Wei
M Rhee
D Piontkowsky



Background: Elvitegravir/cobicistat/emtricitabine/tenofovir DF (“Quad”) demonstrated non-inferior efficacy to EFV/FTC/TDF [ATR] (88% vs. 84%) and ritonavir-boosted atazanavir (ATV+RTV) plus emtricitabine/tenofovir DF (FTC/TDF), (90% vs. 87%) at Week 48, with favorable tolerability. Efficacy and safety of ARVs in patients ≥ 50 yrs is important given the aging HIV population.
Methods: An analysis of safety and efficacy (% with HIV-RNA <50 copies/mL at Week 48 per FDA snapshot analysis) in two Phase 3 Quad studies in patients ≥ and < 50 yrs was performed.

Results: Subjects in the 236-0102 study by age were ≥ 50 yrs (n=49) and < 50 yrs (n=299) for Quad vs 56 and 296 for ATR. Rates of virologic suppression (HIV-1 RNA < 50 c/mL) were comparable between age subgroups, Quad (86 vs 88%) and ATR (82 vs 84%). CD4 changes, adverse events and changes in eGFR are given in Table 1 below.
In Study 236-0103, 48 subjects were ≥ 50 yrs and 305 were < 50 yrs for QUAD, vs 48 and 307 for ATV+RTV +FTC/TDF. Rates of virologic suppression were comparable between age subgroups, Quad (94 vs 89%) and ATV+RTV+FTC/TDF (88 vs 87%). CD4 cells changes, adverse events and changes in eGFR are given in Table 1 below.
Table 1: Age Analysis
GS 236-0102: Quad vs Atripla
Quad ≥50 yrs
(n=49)		Quad <50 yrs
(n=299)		ATR ≥50 yrs
(n=56)		ATR <50 yrs
(n=296)
Efficacy86%88%82%84%
Mean CD4 increases cells/mm3199246194208
AEs
-AEs Leading to DC
-Serious AEs
-Neuropsych
-Rash		6.1%
18.4%
32.7%
10.2%		3.3%
10.7%
44.5%
18.1%		10.7%
8.9%
60.7%
28.6%		4.1%
6.4%
62.8%
27.7%
Median changes in eGFR mL/min-12.0-14.8-7.5-1.6
GS 236-0103: Quad vs. ATV + RTV + FTC/TDF
Quad ≥50 yrs
(n=48)		Quad <50 yrs
(n=305)		ATV+RTV
+FTC/TDF
≥50 yrs
(n=48)		ATV+RTV
+FTC/TDF <50 yrs
(n=307)
Efficacy94%89%88%87%
Mean CD4 increases cells/mm3176212200213
AEs
-AEs leading to DC
-Serious AEs		2.1%
8.3%		3.9%
7.2%		6.3%
8.3%		4.9%
8.8%
Median Changes in eGFR mL/min-10.2-13.4-7.3-10.0

Conclusions: QUAD efficacy was comparable to ATR and ATV+RTV+FTC/TDF, in younger and older subjects, with fewer neuropsychiatric or rash AEs than ATR and with a similar tolerability profile to ATV+RTV+FTC/TDF in patient ≥ 50 yrs.



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