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.

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 -4.5% 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: -3.16 vs -4.19, P = 0.069; spine: -1.96 vs -3.54, P = 0.049). Overall, week 96 results support durable efficacy and safety of EVG/COBI/FTC/TDF in HIV-1-infected patients.

• Authors: 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, GS-236-0103 Study Team
• Journal: Journal of acquired immune deficiency syndromes (1999) (J Acquir Immune Defic Syndr) Vol. 62 Issue 5 Pg. 483-6 (Apr 15 2013) ISSN: 1944-7884 [Electronic] United States
• PMID: 23337366 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-HIV Agents
• Carbamates
• Drug Combinations
• Oligopeptides
• Organophosphonates
• Pyridines
• Quinolones
• RNA, Viral
• Thiazoles
• Triglycerides
• Deoxycytidine
• elvitegravir
• Atazanavir Sulfate
• Tenofovir
• Creatinine
• Aspartate Aminotransferases
• Alanine Transaminase
• Emtricitabine
• Adenine
• Cobicistat
• Ritonavir
• Bilirubin

Topics

• Adenine (analogs & derivatives, therapeutic use)
• Adult
• Alanine Transaminase (blood)
• Anti-HIV Agents (therapeutic use)
• Aspartate Aminotransferases (blood)
• Atazanavir Sulfate
• Bilirubin (blood)
• Bone Density (drug effects)
• Carbamates (therapeutic use)
• Cobicistat
• Confidence Intervals
• Creatinine (blood)
• Deoxycytidine (analogs & derivatives, therapeutic use)
• Double-Blind Method
• Drug Combinations
• Emtricitabine
• Female
• HIV Infections (blood, drug therapy, virology)
• HIV-1 (genetics, isolation & purification)
• Humans
• Male
• Oligopeptides (therapeutic use)
• Organophosphonates (therapeutic use)
• Pyridines (therapeutic use)
• Quinolones (therapeutic use)
• RNA, Viral (blood)
• Ritonavir (therapeutic use)
• Tenofovir
• Thiazoles (therapeutic use)
• Triglycerides (blood)