Presentation Abstract

Session Number: 073
Monday, Sep 10, 2012, 8:30 AM -11:00 AM
Presentation Title: H-555 - Efficacy and Safety of Elvitegravir/cobicistat/emtricitabine/tenofovir DF from an Integrated Analysis of Phase 2 and 3 Clinical Trials
Location: Room 104
Presentation Number: H-555
Pres. Time: Monday, Sep 10, 2012, 9:45 AM -10:00 AM
Category: H2
Keywords: efficacy; safety
Author(s): D. Ward, MD - Owner1, G. Crofoot, MD - Owner 2, D. Shamblaw, MD - Owner 3, N. Bellos, MD - Owner 4, C. Kinder, MD - Owner 5, M. Rhee, MD - As. Dir. 6;
1Dupont Cir Physicians Gr, Wash, DC, 2Gordon E. Crofoot, MD, Houston, TX, 3La Playa Med and Clin Res, San Diego, CA, 4Southwest Infectious Disease Clin Res., Dallas, TX, 5Kinder Med Gr., Miami, FL, 6Gilead, Foster City, CA.
Financial Disclosures:  D. Ward,
Gilead Sciences Role(s): Investigator.
G. Crofoot,
Gilead Sciences Role(s): Investigator.
D. Shamblaw,
Gilead Sciences Role(s): Investigator.
N. Bellos,
Gilead Role(s): Investigator.
C. Kinder,
Gilead Sciences Role(s): Investigator.
M. Rhee,
Gilead Role(s): Employee.
Abstract: Background: Elvitegravir/cobicistat/emtricitabine/tenofovir DF (“QUAD”) demonstrated noninferior efficacy (margin: -12%) to EFV/FTC/TDF [ATR] (study 102 and 104) and to ritonavir-boosted atazanavir in combination with TDF/FTC [ATV/r+TVD] (study 103) by snapshot analysis at Week (Wk) 48 in randomized, controlled trials of HIV-infected treatment naïve subjects. Methods: Integrated analysis of efficacy and safety. Results: Subjects had similar baseline characteristics (QUAD n=749; ATR n=375; ATV/r+TVD n=355). The rates of virologic suppression (HIV-1 RNA < 50 c/mL) at Wk 48 in QUAD, ATR, and ATV/r+TVD were 88.8, 84.0, and 86.8%; the difference was 5.1% (95% CI: 0.7 to 9.4) between QUAD and ATR; and 1.9% (-2.3 to 6.1) between QUAD and ATV/r + TVD. QUAD efficacy was consistent across subgroups based on demographics, baseline HIV-1 RNA, and CD4 cells. The rates of adverse events (AEs) leading to study drug discontinuation were similar in the 3 groups (QUAD vs ATR vs ATV/r+TVD) (3.5 vs 5.1 vs 5.1%), as were those of serious AEs (9.2 vs 6.7 vs 8.7 %), and deaths (0.1 vs 0.5 vs 0.8%). Fewer QUAD subjects, compared to ATR, reported neuropsychiatric AEs (QUAD vs ATR: 42.9 vs 62.1%; p<0.001) and rash AEs (17.5 vs 27.7%; p<0.001). At Wk 48, a small increase in creatinine (median, mg/dL) was seen in QUAD (+0.13) and ATV/r+TVD (+0.08), but not in ATR (+0.01). These changes were seen as early as Wk 2, and stabilized through Wk 48. QUAD had less increase (median, mg/dL) in total cholesterol (+10 vs +19; p<0.001), LDL (+10 vs +17; p<0.001), and HDL (+5 vs +8; p=0.002), compared to ATR; QUAD also had less increase in triglyceride (+8 vs +23; p=0.006), compared to ATV/r+TVD. Conclusions: QUAD, a new single tablet regimen, demonstrated high rates of virologic suppression comparable to ATR and ATV/r+TVD with potential to overcome toxicities, such as neuropsychiatric symptoms, rash, and hyperlipidemia. Early small increase in creatinine that stabilizes is expected with QUAD due to COBI’s inhibition of renal creatinine tubular secretion.



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