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 May 1;63(1):96-100. doi: 10.1097/QAI.0b013e318289545c.

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.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Adenine / administration & dosage
  • Adenine / adverse effects
  • Adenine / analogs & derivatives*
  • Adenine / therapeutic use
  • Adult
  • Anti-HIV Agents* / adverse effects
  • Anti-HIV Agents* / therapeutic use
  • Carbamates* / administration & dosage
  • Carbamates* / adverse effects
  • Carbamates* / therapeutic use
  • Creatinine / blood
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Deoxycytidine / therapeutic use
  • Double-Blind Method
  • Drug Combinations
  • Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
  • Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / virology
  • HIV-1 / drug effects
  • HIV-1 / physiology
  • Humans
  • Male
  • Organophosphonates* / administration & dosage
  • Organophosphonates* / adverse effects
  • Organophosphonates* / therapeutic use
  • Oxazines* / adverse effects
  • Oxazines* / therapeutic use
  • Quinolones* / administration & dosage
  • Quinolones* / adverse effects
  • Quinolones* / therapeutic use
  • RNA, Viral / blood
  • Thiazoles* / administration & dosage
  • Thiazoles* / adverse effects
  • Thiazoles* / therapeutic use
  • Treatment Outcome
  • Young Adult

Substances

  • Anti-HIV Agents
  • Carbamates
  • Drug Combinations
  • Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
  • Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
  • Organophosphonates
  • Oxazines
  • Quinolones
  • RNA, Viral
  • Thiazoles
  • Deoxycytidine
  • Creatinine
  • Adenine