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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.
| TLOVR | EVG (n=351) | RAL (n=351) | | Virologic response | 47.6% | 45.0% | | Virologic failure | 22.8% | 27.4% | | Death | 0.6% | 2.6% | | Drug discontinuation | 26.5% | 20.8% | | Adverse events | 2.6% | 4.3% | | Lack of efficacy | 3.7% | 2.0% | | Lost to follow-up | 5.4% | 6.8% | | Other reasons | 17.4% | 12.0% | | Emerging major INSTI resistance | 6.6% | 7.4% |
| Virologic response | EVG | RAL | | Missing=Failure | 53.6% (188/351) | 56.4% (198/351) | | Missing=Excluded | 79.0% (188/238) | 83.2% (198/238) |
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