Week 96 analyses of emergent drug resistance from the STaR Study: rilpivirine/emtricitabine/ tenofovir DF vs. efavirenz/emtricitabine/tenofovir DF single-tablet regimens

• Published in: Antiviral therapy Vol. 19; p. A123
• Main Authors: Porter, D P, Kulkarni, R, Fralich, T, Miller, M D, White, K L
• Format: Journal Article
• Language: English
• Published: 01.01.2014
• Subjects: Human immunodeficiency virus 1
• ISSN: 1359-6535

STaR (GS-US-264-0110) is a 96-week Phase 3b study evaluating the safety and efficacy of two single-tablet regimens, rilpivirine/emtricitabine/tenofovir DF (RPV/FTC/TDF) and efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF) in treatment-naive HIV-1-infected subjects with no restriction on viral load at study entry. At Week 48 and Week 96, RPV/FTC/TDF was non-inferior to EFV/FTC/TDF for HIV-1 RNA< 50 copies/mL by FDA snapshot analysis. Here, we present resistance analyses through Week 96. Resistance development to[>or=]1 component of RPV/FTC/TDF was lower for subjects with baseline viral load [ 100,000 copies/mL. The most common emergent resistance substitutions to RPV/FTC/ TDF were E138K/Q, Y181C/I, K101E, and M184V/I in RT. Resistance development post-Week 48 was infrequent for both arms.