A randomized, double-blind comparison of coformulated elvitegravir/ cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection: Analysis of week 96 results

Jürgen K. Rockstroh, Edwin Dejesus, Keith Henry, Jean Michel Molina, Joseph Gathe, Srinivasan Ramanathan, Xuelian Wei, Andrew Plummer, Michael Abram, Andrew K. Cheng, Marshall W. Fordyce, Javier Szwarcberg

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Abstract

This ongoing, randomized, double-blind, active-controlled phase 3 international trial demonstrated the noninferior efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir DF (EVG/COBI/ FTC/TDF) compared with atazanavir boosted by ritonavir (ATV/ RTV) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) at 48 weeks. Here, we report the week 96 results. Of 708 treated subjects, virological success (Food and Drug Administration snapshot) was maintained at week 96 with EVG/COBI/FTC/TDF and ATV/ RTV + FTC/TDF (83% vs 82%, difference 1.1%, 95% confidence interval 24.5% to 6.7%). Study drug discontinuations due to adverse events were low (4% vs 6%). Median increases from baseline in serum Cr (mg/dL) in EVG/COBI/FTC/TDF vs ATV/RTV + FTC/TDF at week 96 (0.12 vs 0.08) were similar to those at week 48 (0.12 vs 0.08). EVG/ COBI/FTC/TDF showed similar mean decreases (%) in bone mineral density from baseline vs ATV/RTV + FTC/TDF (hip: 23.16 vs 24.19, P = 0.069; spine: 21.96 vs 23.54, P = 0.049). Overall, week 96 results support durable efficacy and safety of EVG/COBI/FTC/TDF in HIV-1- infected patients.

Original languageEnglish (US)
Pages (from-to)483-486
Number of pages4
JournalJournal of Acquired Immune Deficiency Syndromes
Volume62
Issue number5
DOIs
StatePublished - Apr 15 2013

Keywords

  • Antiretroviral therapy
  • Cobicistat
  • Efavirenz
  • Elvitegravir
  • Emtricitabine
  • HIV
  • Tenofovir
  • Treatment-naive

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