title: 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: Department of Medicine I, University of Bonn, Bonn, Germany. juergen.rockstroh@ukb.uni-bonn.de
authors: Jürgen K
authors: JK
authors: Rockstroh
authors: Edwin
authors: E
authors: DeJesus
authors: Keith
authors: K
authors: Henry
authors: Jean-Michel
authors: JM
authors: Molina
authors: Joseph
authors: J
authors: Gathe
authors: Srinivasan
authors: S
authors: Ramanathan
authors: Xuelian
authors: X
authors: Wei
authors: Andrew
authors: A
authors: Plummer
authors: Michael
authors: M
authors: Abram
authors: Andrew K
authors: AK
authors: Cheng
authors: Marshall W
authors: MW
authors: Fordyce
authors: Javier
authors: J
authors: Szwarcberg
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D000069446:Atazanavir Sulfate; D001663:Bilirubin / Q000097:blood; D015519:Bone Density / Q000187:drug effects; D002219:Carbamates / Q000627:therapeutic use; D000069547:Cobicistat; D016001:Confidence Intervals; D003404:Creatinine / Q000097:blood; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D009842:Oligopeptides / Q000627:therapeutic use; D063065:Organophosphonates / Q000627:therapeutic use; D011725:Pyridines / Q000627:therapeutic use; D015363:Quinolones / Q000627:therapeutic use; D012367:RNA, Viral / Q000097:blood; D019438:Ritonavir / Q000627:therapeutic use; D000068698:Tenofovir; D013844:Thiazoles / Q000627:therapeutic use; D014280:Triglycerides / Q000097:blood
chemical_list: D019380:Anti-HIV Agents; D002219:Carbamates; D004338:Drug Combinations; D009842:Oligopeptides; D063065:Organophosphonates; D011725:Pyridines; D015363:Quinolones; D012367:RNA, Viral; D013844:Thiazoles; D014280:Triglycerides; D003841:Deoxycytidine; C509700:elvitegravir; D000069446:Atazanavir Sulfate; D000068698:Tenofovir; D003404:Creatinine; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000068679:Emtricitabine; D000225:Adenine; D000069547:Cobicistat; D019438:Ritonavir; D001663:Bilirubin