TULBPE032 - Poster Exhibition
Pooled week 96 efficacy, resistance and safety results from the double-blind, randomised, phase III trials comparing rilpivirine (RPV) versus efavirenz (EFV) in treatment-naïve, HIV-1-infected adults
C. Cohen1, J.-M. Molina2, I. Cassetti3, P. Chetchotisakd4, A. Lazzarin5, F. Rhame6, H.-J. Stellbrink7, L. Taisheng8, H. Crauwels9, L. Rimsky9, S. Vanveggel9, P. Williams9, K. Boven10
1Community Research Initiative of New England, Boston, United States, 2Department of Infectious Diseases, Paris, France, 3Helios Salud, Buenos Aires, Argentina, 4Faculty of Medicine, Khon Kaen, Thailand, 5Vita-Salute,San Raffaele University, Milan, Italy, 6Abbott Northwestern Hospital, Minneapolis, United States, 7ICH Study Center, Hamburg, Germany, 8Department of Infectious Diseases, PUMCH, Beijing, China, 9Tibotec BVBA, Beerse, Belgium, 10Tibotec, Titusville, United States
Background: RPV (TMC278) showed non-inferior efficacy to EFV (84% vs 82%
ITT-TLOVR response, respectively) at Week 48 (primary endpoint) with a more
favourable tolerability/safety profile in treatment-naïve HIV-1-infected adults
in the primary analysis of the Phase III ECHO and THRIVE trials. Pooled 96-week
(final analysis) results are presented.
Methods: Patients received RPV 25mg qd or EFV 600mg qd (1:1), plus tenofovir-disoproxil-fumarate/emtricitabine
(ECHO) or tenofovir-disoproxil-fumarate/emtricitabine, zidovudine/lamivudine or
abacavir/lamivudine (THRIVE). Secondary objectives were efficacy and safety/tolerability
over 96 weeks.
Results: Similar response rates for RPV and EFV were observed at Week
VFres up to Week 48 was
10.6% for RPV (4.2% were rebounders) and 5.3%
for EFV (2.6% rebounders). VFres, beyond Week 48 and up to Week 96
was 3.2% for RPV (2.9% rebounders) and 2.3% for EFV (2.1% rebounders). The proportions of
VFres patients developing NNRTI or N(t)RTI RAMs from Week 48 to
96 was similar between groups. During this time, there were no new safety
concerns with either NNRTI, and the incidence of at least possibly treatment-related
Grade 2-4 AEs increased only 1% with RPV and 2% with EFV.
RPV gave sustained antiviral efficacy that was similar to EFV over 96
weeks. While the VFres rate was higher with RPV than EFV, similar small
increases in VFres for both groups beyond Week 48 were
observed. RPV showed lower incidences than EFV of grade 2-4 overall AEs, rash,
dizziness, abnormal dreams/nightmares, grade 3-4 lipid abnormalities and AEs leading
to discontinuation (mainly rash and dizziness).
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