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 JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES Zolopa, A., Sax, P. E., deJesus, E., Mills, A., Cohen, C., Wohl, D., Gallant, J. E., Liu, H. C., Plummer, A., White, K. L., Cheng, A. K., Rhee, M. S., Szwarcberg, J. 2013; 63 (1): 96-100

Abstract

We report week 96 results from a phase 3 trial of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF, n = 348) vs efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF, n = 352). At week 48, EVG/COBI/FTC/TDF was noninferior to EFV/FTC/TDF (88% vs 84%, difference +3.6%, 95% confidence interval: -1.6% to 8.8%). Virologic success (HIV-1 RNA <50 copies/mL) was maintained at week 96 (84% vs 82%, difference +2.7%, 95% CI: -2.9% to 8.3%). Discontinuation due to adverse events was low (5% vs 7%). Median changes in serum creatinine (mg/dL) at week 96 were similar to week 48. These results support the durable efficacy and long-term safety of EVG/COBI/FTC/TDF.

View details for DOI 10.1097/QAI.0b013e318289545c

View details for Web of Science ID 000319112200022

View details for PubMedID 23392460