TUPE293 - Poster Exhibition
Elvitegravir/cobicistat/emtricitabine/tenofovir DF demonstrates comparable efficacy to efavirenz/emtricitabine/tenofovir DF in subjects with adherence < 95%
P. Shalit1, C. Cohen2, A. Mills3, F. Bredeek4, G. Crofoot5, T. Nguyen6, L. Dau6, M. Rhee6, D. Piontkowsky6, J. Szwarcberg6
1Peter Shalit, Seattle, United States, 2Community Research Initiative of New England, Boston, United States, 3Anthony Mills MD, Inc., Los Angeles, United States, 4Metropolis Medical Group, San Francisco, United States, 5Gordon E. Crofoot, MD, Houston, United States, 6Gilead Sciences Inc., Foster City, United States
Background: Elvitegravir/cobicistat/emtricitabine/tenofovir DF (EVG/COBI/FTC/TDF [STRIBILD]) was well tolerated and demonstrated non-inferior efficacy to efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF [ATRIPLA]) with HIV-1 RNA < 50 copies/mL (c/mL) by snapshot analysis at Week (Wk) 48 (88% vs. 84%, respectively) and Wk 96 (84% vs. 82%, respectively) in a randomized, controlled trial of HIV-infected treatment naïve subjects. EFV/FTC/TDF has previously shown efficacy even in those with adherence < 95%, the standard generally utilized to avoid virologic failure and resistance for antiretroviral therapy.
Methods: Post hoc analysis of efficacy and tolerability in subjects with adherence < 95%, measured by pill count through Wk 96.
Results: In Study 102, 348 subjects in the EVG/COBI/FTC/TDF and 352 subjects in the EFV/FTC/TDF arm were randomized and treated. Median adherence through Wk 96 was 98% for both treatment arms by pill count; 90/346 subjects (26%) had adherence < 95% for EVG/COBI/FTC/TDF (25 [7%] had adherence < 90%) and 86/349 subjects (25%) had adherence < 95% for EFV/FTC/TDF (39 [11%] had adherence < 90%). Rates of virologic suppression (HIV-1 RNA < 50 c/mL) for the subgroup with adherence ≥95% in the EVG/COBI/FTC/TDF group was high and comparable to the EFV/FTC/TDF group, 88.3% vs. 88.6%, respectively. Rates of virologic suppression for the subgroup with adherence < 95% in the EVG/COBI/FTC/TDF group were comparable to the EFV/FTC/TDF group, 74.4% vs. 62.8%, respectively.
Conclusion: Adherence with EVG/COBI/FTC/TDF and EFV/FTC/TDF through Wk 96 was high overall. In subjects with adherence < 95%, the efficacy of EVG/COBI/FTC/TDF was comparable to EFV/FTC/TDF.
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