XIX International AIDS Conference


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TUAB0105 - Oral Abstract Session

Efficacy and safety results from a randomized, double blind, active controlled trial of elvitegravir (once-daily) versus raltegravir (twice-daily) in treatment-experienced HIV-positive patients: long term 96-week data

Presented by Richard Elion (United States).

R. Elion1, J.-M. Molina2, J.-R. Arribas-Lopez3, D. Cooper4, F. Maggiolo5, E. Wilkins6, B. Conway7, Y.-P. Liu8, L. Zhong8, N. Margot8, J. Szwarcberg8, M. Rhee9, A. Cheng8

1Whitman-Walker Health, Washington, United States, 2Hopital Saint Louis, Service des Maladies infectieuses, Paris, France, 3Hospital Universitario La Paz, Servicio de Medicina Interna, Unidad VIH, Madrid, Spain, 4Kirby Institute, University of New South Wales, Sydney, Australia, 5Ospedali Riuniti di Bergamo, Bergamo, Italy, 6North Manchester General Hospital, Manchester, United Kingdom, 7Vancouver ID Research & Care Centre, Vancouver, Canada, 8Gilead Sciences, Foster City, United States, 9Gilead Sciences, HIV Clinical Research, Foster City, United States

Background: Once-daily elvitegravir (EVG) was noninferior in efficacy and well-tolerated relative to twice-daily raltegravir (RAL) in combination with a fully active ritonavir-boosted protease inhibitor (PI/r) and another second agent in a phase 3 study of treatment-experienced patients (GS-US-183-0145) at Week 48. We present the blinded 96-week results.
Methods: Randomized, double-blinded, active-controlled, 96-week noninferiority trial. Key eligibility criteria were HIV-1 RNA ≥ 1,000 copies/mL, any CD4 cell count, and resistance to and/or 6 months' experience with at least two classes of antiretroviral drugs. Primary endpoint was achievement and maintenance of HIV-1 RNA < 50 copies/mL through Week 48 (time to loss of virologic response [TLOVR] analysis).
Results: All 712 randomized and treated subjects (EVG: 354, RAL: 358) were included for safety evaluation; 702 of 712 (EVG: 351, RAL: 351) for efficacy evaluation (10 subjects were excluded due to protocol violation). At Week 96, 47.6% in EVG and 45.0% in RAL group were suppressed (difference 2.6% [95% CI: -4.6 to 9.9]) (Table). Mean increases in CD4 cell count (cells/mm3) were similar in EVG and RAL group (205 vs. 198). Nine subjects died while receiving study drug (2 in EVG and 7 in RAL group). Similar percentages in EVG and RAL group reported serious adverse events (AEs) (20.1 vs. 23.5%), grade 3 or 4 AEs (24.3 vs. 23.7%), or discontinued study drug due to AEs (3.1 vs. 4.2%). Grade 3 or 4 AST and ALT elevations (> 5 x ULN) were less common on EVG vs. RAL (2.3 vs. 5.9%; 1.7 vs. 5.3%). No other differences in graded laboratory abnormalities were seen.
Conclusions: At Week 96, once-daily EVG in combination with a fully active PI/r and another second agent in treatment-experienced patients continue to be noninferior to twice-daily RAL in efficacy with excellent tolerability. These data support the long-term use of EVG in treatment-experienced patients.

TLOVREVG (n=351)RAL (n=351)
Virologic response47.6%45.0%
Virologic failure22.8%27.4%
Drug discontinuation26.5%20.8%
Adverse events2.6%4.3%
Lack of efficacy3.7%2.0%
Lost to follow-up5.4%6.8%
Other reasons17.4%12.0%
Emerging major INSTI resistance6.6%7.4%
[Efficacy at Week 96 (HIV-1 RNA < 50 copies/mL)]

Virologic responseEVGRAL
Missing=Failure53.6% (188/351)56.4% (198/351)
Missing=Excluded79.0% (188/238)83.2% (198/238)
[Efficacy at Week 96 (HIV-1 RNA < 50 copies/mL)]

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