7th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2013)

Abstract

TUPE281 - Poster Exhibition


Subgroup analyses of 96-week efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir DF

D. Cooper1, A. Zolopa2, J. Rockstroh3, C. Orkin4, H.J. Stellbrink5, S. Walmsley6, L. Zhong7, M. Fordyce7, M. Rhee7, J. Szwarcberg7

1St Vincent's Hospital, Sydney, Australia, 2Stanford University, Palo Alto, United States, 3University of Bonn, Bonn, Germany, 4Barts and the London NHS Trust, London, United States, 5ICH Study Center, Hamburg, Germany, 6Toronto General Hospital, Toronto, Canada, 7Gilead Sciences, Foster City, United States

Background: Elvitegravir/cobicistat/emtricitabine/tenofovir DF (STB) demonstrated noninferiority at Week 48 to efavirenz/emtricitabine/tenofovir DF (ATR) and to ritonavir-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir DF (TVD) .
Methods: Integrated 96-week analyses of efficacy and safety of two randomized, double blind, double dummy, active-controlled phase 3 clinical studies with subgroup analyses of efficacy
Results: 1408 patients were randomized and treated (STB 701; ATR 352; ATV/r+TVD 355). High rates of virologic suppression (HIV-1 RNA < 50 c/mL) were maintained through Week 96 (84% vs 82% vs 82%). These findings were consistent across demographic subgroups (age, sex, race) and baseline HIV-1 RNA and CD4 cells (Table). Fewer STB patients, compared to ATR, reported neuropsychiatric adverse events (AEs) (44 % vs 66%) and rash AEs (21% vs 31%). Rates of AEs leading to study drug discontinuation were similar in the 3 groups (5% vs 7% vs 6%). Through Week 96, renal discontinuation was infrequent (1.4% vs 0 vs 0.6%). Four proximal tubulopathy cases were reported through Week 48 and none afterwards. Median changes in serum creatinine (mg/dL) at Week 96 in 3 groups (+0.13 vs +0.01 vs +0.08) were unchanged from Week 48 (+0.13 vs +0.01 vs +0.08).
Conclusions: Through Week 96, STB demonstrated high rates of virologic suppression and was well tolerated. The efficacy of STB was consistent across demographic subgroups, baseline HIV-1 RNA, and CD4 cells.


 STB (n=701)Pooled control (n=707)Difference (95% CI)
OVERALL84%82%1.9% (-2.1 to 5.9)
AGE (yrs): <4083%80%2.8% (-2.6 to 8.3)
AGE (yrs): >=4085%84%1.1% (-4.7 to 6.9)
SEX: male85%83%2.6% (-1.5 to 6.7)
SEX: female71%76%-6.6% (-21.4 to 8.2)
RACE: white85%84%1.2% (-3.4 to 5.8)
RACE: nonwhite81%77%4.3% (-3.5 to 12.0)
[Virologic success (HIV-1 RNA < 50 c/mL) at Week 96]




 STB (n=701)Pooled control (n=707)Difference (95% CI)
HIV-1 RNA: <=100K85%82%2.8% (-2.1 to 7.7)
HIV-1 RNA: >100K82%81%0.4% (-6.3 to 7.1)
CD4: <=35081%81%-0.4% (-6.5 to 5.8)
CD4: >35086%82%3.8% (-1.4 to 9.0)
[Virologic success (HIV-1 RNA < 50 c/mL) at Week 96]



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