96-week resistance analyses of the STaR study: rilpivirine/emtricitabine/tenofovir DF versus efavirenz/emtricitabine/tenofovir DF in antiretroviral-naive, HIV-1-infected subjects

References

• Eviplera 200 mg/25 mg/245 mg Film Coated Tablets. Summary of Product Characteristics. Cambridge: Gilead Sciences Ltd; Revised December 2013.
   Google Scholar
• COMPLERA® (Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate) Tablets. US Prescribing Information. Foster City, CA: Gilead Sciences, Inc.; Revised June 2014.
   Google Scholar
• Cohen CJ, Molina JM, Cahn P, et al. Efficacy and safety of rilpivirine (TMC278) versus efavirenz at 48(weeks in treatment-naive HIV-1-Infected patients: pooled results from the phase 3 double-blind randomized ECHO and THRIVE trials. J Acquir Immune Defic Syndr. 2012;60(1):33–42.
   PubMed Web of Science ®Google Scholar
• Cohen CJ, Andrade-Villanueva J, Clotet B, et al. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet. 2011;378(9787):229–237.
   PubMed Web of Science ®Google Scholar
• Molina JM, Cahn P, Grinsztejn B, et al. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet. 2011;378(9787):238–246.
   PubMed Web of Science ®Google Scholar
• Rimsky L, Vingerhoets J, van Eygen V, et al. Genotypic and phenotypic characterization of HIV-1 isolates obtained from patients on rilpivirine therapy experiencing virologic failure in the phase 3 ECHO and THRIVE studies: 48-week analysis. J Acquir Immune Defic Syndr. 2012;59(1):39–46.
   PubMed Web of Science ®Google Scholar
• Palella FJ, Fisher M, Tebas P, et al. Simplification to rilpivirine/emtricitabine/tenofovir disoproxil fumarate from ritonavir-boosted protease inhibitor antiretroviral therapy in a randomized trial of HIV-1 RNA-suppressed participants. AIDS. 2014;28(3):335–344.
   PubMed Web of Science ®Google Scholar
• Cohen C, Wohl D, Arribas JR, et al. Week 48 results from a randomized clinical trial of rilpivirine/emtricitabine/tenofovir disoproxil fumarate vs. efavirenz/emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV-1-infected adults. AIDS. 2014;28(7):989–997.
   PubMed Web of Science ®Google Scholar
• Cohen C, Wohl D, Arribas J, et al. STaR study: single-tablet regimen rilpivirine/emtricitabine/tenofovir df maintains non-inferiority to efavirenz/emtricitabine/tenofovir DF in ART-naive adults week 96 results [Poster PE7/17]. Paper presented at: 14th European AIDS Conference. Brussels, Belgium 16–19 October, 2013.
   Google Scholar
• Porter DP, Kulkarni R, Fralich T, Miller MD, White KL. Characterization of HIV-1 drug resistance development through week 48 in antiretroviral naive subjects on rilpivirine/emtricitabine/tenofovir DF or efavirenz/emtricitabine/tenofovir DF in the STaR study (GS-US-264-0110). J Acquir Immune Defic Syndr. 2014;65(3):318–326.
   PubMed Web of Science ®Google Scholar
• Rimsky L, van Eygen V, Hoogstoel A, et al. 96-week resistance analyses of rilpivirine in treatment-naive, HIV-1-infected adults from the ECHO and THRIVE phase III trials. Antivir Ther. 2013; 18(8):967–977.
   PubMed Web of Science ®Google Scholar
• Petropoulos CJ, Parkin NT, Limoli KL, et al. A novel phenotypic drug susceptibility assay for human immunodeficiency virus type 1. Antimicrob Agents Chemother. 2000;44:920–928.
   PubMed Web of Science ®Google Scholar
• Mills AM, Cohen C, Dejesus E, et al. Efficacy and safety 48 (weeks after switching from efavirenz to rilpivirine using emtricitabine/tenofovir disoproxil fumarate-based single-tablet regimens. HIV Clin Trials. 2013;14(5):216–233.
   PubMed Web of Science ®Google Scholar
• Azijn H, Tirry I, Vingerhoets J, et al. TMC278, a next-generation nonnucleoside reverse transcriptase inhibitor (NNRTI), active against wild-type and NNRTI-resistant HIV-1. Antimicrob Agents Chemother. 2010;54(2):718–727.
   PubMed Web of Science ®Google Scholar
• Kulkarni R, Babaoglu K, Lansdon EB, et al. The HIV-1 reverse transcriptase M184I mutation enhances the E138K-associated resistance to rilpivirine and decreases viral fitness. J Acquir Immune Defic Syndr. 2012;59:47–54.
   PubMed Web of Science ®Google Scholar
• Xu HT, Asahchop EL, Oliveira M, et al. Compensation by the E138K mutation in HIV-1 reverse transcriptase for deficits in viral replication capacity and enzyme processivity associated with the M184I/V mutations. J Virol. 2011;85(21):11300–11308.
   PubMed Web of Science ®Google Scholar
• Hu Z, Kuritzkes DR. Interaction of reverse transcriptase (RT) mutations conferring resistance to lamivudine and etravirine: effects on fitness and rt activity of human immunodeficiency virus type 1. J Virol. 2011;85(21):11309–11314.
   PubMed Web of Science ®Google Scholar
• Stone C, Ait-Khaled M, Craig C, Griffin P, Tisdale M. Human immunodeficiency virus type 1 reverse transcriptase mutation selection during in vitro exposure to tenofovir alone or combined with abacavir or lamivudine. Antimicrob Agents Chemother. 2004;48(4):1413–1415.
   PubMed Web of Science ®Google Scholar
• McColl DJ, Chappey C, Parkin NT, Miller MD. Prevalence, genotypic associations and phenotypic characterization of K65R, L74V and other HIV-1 RT resistance mutations in a commercial database. Antivir Ther. 2008;13:189–197.
   PubMed Web of Science ®Google Scholar
• Melikian GL, Rhee SY, Taylor J, et al. Standardized comparison of the relative impacts of HIV-1 reverse transcriptase (RT) mutations on nucleoside RT inhibitor susceptibility. Antimicrob Agents Chemother. 2012;56(5):2305–2313.
   PubMed Web of Science ®Google Scholar
• Paquet AC, Solberg OD, Napolitano LA, et al. A decade of HIV-1 drug resistance in the United States: trends and characteristics in a large protease/reverse transcriptase and co-receptor tropism database from 2003 to 2012. Antivir Ther. 2014;19(4):435–441.
   PubMed Web of Science ®Google Scholar
• Zolopa A, Sax PE, DeJesus E, et al. A randomized double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: analysis of week 96 results. J Acquir Immune Defic Syndr. 2013;63(1):96–100.
   PubMed Web of Science ®Google Scholar
• Department of Health and Human Services (DHHS). Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Developed by the HHS Panel on Antiretroviral Guidelines for Adults and Adolescents — A Working Group of the Office of AIDS Research Advisory Council (OARAC). Washington, DC: Revised May 1, 2014 http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf DHHS; 2014;. Accessed June 3, 2014.
   Google Scholar