IAS 2011 Abstract - 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

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 96 (Table).

Table 1

[Table 1]

VF_res up to Week 48 was 10.6% for RPV (4.2% were rebounders) and 5.3% for EFV (2.6% rebounders). VF_res, 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 VF_res 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.
Conclusion: RPV gave sustained antiviral efficacy that was similar to EFV over 96 weeks. While the VF_res rate was higher with RPV than EFV, similar small increases in VF_resfor 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).