title: Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results.
abstract: In 2 double-blind phase 3 trials, 1733 antiretroviral-naive adults were randomized to tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir/cobicistat/emtricitabine (E/C/F). At 144 weeks, TAF was superior to TDF in virologic efficacy, with 84.2% vs 80.0% having HIV-1 RNA <50 copies/mL (difference 4.2%; 95% confidence interval: 0.6% to 7.8%). TAF had less impact than TDF on bone mineral density and renal biomarkers. No participants on TAF had renal-related discontinuations vs 12 on TDF (P < 0.001), with no cases of proximal tubulopathy for TAF vs 4 for TDF. There were greater increases in lipids with TAF vs TDF, with no difference in the total cholesterol to high-density lipoprotein ratio. For initial HIV therapy, E/C/F/TAF is superior to E/C/F/TDF in efficacy and bone and renal safety.
authors.affiliation: *Infectious Diseases Unit, Internal Medicine Service, Hospital Universitario La Paz, Madrid, ES; †AIDS Research Consortium of Atlanta, Atlanta, GA; ‡Division of Infectious Diseases, Brigham and Women's Hospital, Boston, MA; §Internal Medicine, General Hospital Graz-West, Graz, AT; ‖Tarrant County Infectious Disease Associates, Fort Worth, TX; ¶Division of Infectious Diseases, UNC School of Medicine, Chapel Hill, NC; #Orlando Immunology Center, Orlando, FL; **Claude Nicol Centre, Royal Sussex County Hospital, Brighton & Sussex University Hospitals NHS Trust, Brighton, United Kingdom; and ††Departments of Biometrics, Virology, Clinical Operations, and HIV Clinical Research, Gilead Sciences, Inc., Foster City, CA.
authors.forename: José R
authors.initials: JR
authors.lastname: Arribas
authors.forename: Melanie
authors.initials: M
authors.lastname: Thompson
authors.forename: Paul E
authors.initials: PE
authors.lastname: Sax
authors.forename: Bernhard
authors.initials: B
authors.lastname: Haas
authors.forename: Cheryl
authors.initials: C
authors.lastname: McDonald
authors.forename: David A
authors.initials: DA
authors.lastname: Wohl
authors.forename: Edwin
authors.initials: E
authors.lastname: DeJesus
authors.forename: Amanda E
authors.initials: AE
authors.lastname: Clarke
authors.forename: Susan
authors.initials: S
authors.lastname: Guo
authors.forename: Hui
authors.initials: H
authors.lastname: Wang
authors.forename: Christian
authors.initials: C
authors.lastname: Callebaut
authors.forename: Andrew
authors.initials: A
authors.lastname: Plummer
authors.forename: Andrew
authors.initials: A
authors.lastname: Cheng
authors.forename: Moupali
authors.initials: M
authors.lastname: Das
authors.forename: Scott
authors.initials: S
authors.lastname: McCallister
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000409:Alanine; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D015519:Bone Density / Q000187:drug effects; D018791:CD4 Lymphocyte Count; D000069547:Cobicistat / Q000627:therapeutic use*; D004311:Double-Blind Method; D000068679:Emtricitabine / Q000627:therapeutic use*; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D008875:Middle Aged; D015363:Quinolones / Q000627:therapeutic use*; D000068698:Tenofovir / Q000627:therapeutic use* / Q000031:analogs & derivatives; D016896:Treatment Outcome; D014481:United States
chemical_list: D019380:Anti-HIV Agents; D015363:Quinolones; C509700:elvitegravir; D000068698:Tenofovir; C442442:tenofovir alafenamide; D000068679:Emtricitabine; D000225:Adenine; D000069547:Cobicistat; D000409:Alanine