title: Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results.
abstract: In 2 double-blinded Phase 3 trials, 1733 antiretroviral-naive participants were randomized to tenofovir alafenamide (TAF), a tenofovir prodrug versus tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir/cobicistat/emtricitabine (E/C/F). At 96 weeks, 86.6% in the TAF arm and 85.2% in the TDF arm had HIV-1 RNA <50 c/mL [difference 1.5%; (95% CI: -1.8% to 4.8%)]. With TAF, there are smaller declines in bone mineral density and more favorable changes in proteinuria, albuminuria, and tubular proteinuria, and no cases of proximal tubulopathy compared with 2 for TDF. These longer-term data support E/C/F/TAF as a safe, well-tolerated, and durable regimen for initial HIV-1 treatment.
authors.affiliation: *Department of Medicine, University of North Carolina, Chapel Hill, NC; †AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan; ‡Department of Infectious Diseases, CHU Saint-Pierre University Hospital Brussels, Brussels, Belgium; §Elton John centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom; ‖Central Texas Clinical Research, Austin, TX; ¶Department of Internal Medicine, Mercer University School of Medicine, Macon, GA; #The Miriam Hospital, Alpert Medical School of Brown University, Providence, RI; **Infectious Diseases Unit, Internal Medicine Service, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain; ††Capital Center for Travel and Tropical Medicine, Washington, DC; ‡‡Internal Medicine Unit, Le Kremlin-Bicêtre Hospital, AP-HP Infectious Diseases Unit, Centre Hospitalier de Tourcoing Descartes University, Necker Hospital, AP-HP, Paris, France; §§Medicine, Maple Leaf Research, Department of Family and Community Medicine, University of Toronto, Toronto, CA; ‖‖Clinica delle Malattie Infettive e Tropicali, University of Modena and Reggio Emilia, Modena, Italy; ¶¶Department of Medicine and Center for AIDS Research, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; ##Division of Infectious Diseases and Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA; and ***Gilead Sciences, Foster City, CA.
authors.forename: David
authors.initials: D
authors.lastname: Wohl
authors.forename: Shinichi
authors.initials: S
authors.lastname: Oka
authors.forename: Nathan
authors.initials: N
authors.lastname: Clumeck
authors.forename: Amanda
authors.initials: A
authors.lastname: Clarke
authors.forename: Cynthia
authors.initials: C
authors.lastname: Brinson
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Stephens
authors.forename: Karen
authors.initials: K
authors.lastname: Tashima
authors.forename: Jose R
authors.initials: JR
authors.lastname: Arribas
authors.forename: Bruce
authors.initials: B
authors.lastname: Rashbaum
authors.forename: Antoine
authors.initials: A
authors.lastname: Cheret
authors.forename: Jason
authors.initials: J
authors.lastname: Brunetta
authors.forename: Cristina
authors.initials: C
authors.lastname: Mussini
authors.forename: Pablo
authors.initials: P
authors.lastname: Tebas
authors.forename: Paul E
authors.initials: PE
authors.lastname: Sax
authors.forename: Andrew
authors.initials: A
authors.lastname: Cheng
authors.forename: Lijie
authors.initials: L
authors.lastname: Zhong
authors.forename: Christian
authors.initials: C
authors.lastname: Callebaut
authors.forename: Moupali
authors.initials: M
authors.lastname: Das
authors.forename: Marshall
authors.initials: M
authors.lastname: Fordyce
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000409:Alanine; D000419:Albuminuria / Q000473:pathology; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015519:Bone Density / Q000187:drug effects; D018791:CD4 Lymphocyte Count; D000069547:Cobicistat / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D000068679:Emtricitabine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D008297:Male; D011507:Proteinuria / Q000473:pathology; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D000068698:Tenofovir / Q000009:adverse effects / Q000627:therapeutic use* / Q000031:analogs & derivatives
chemical_list: D019380:Anti-HIV Agents; D004338:Drug Combinations; D015363:Quinolones; D012367:RNA, Viral; C509700:elvitegravir; D000068698:Tenofovir; C442442:tenofovir alafenamide; D000068679:Emtricitabine; D000225:Adenine; D000069547:Cobicistat; D000409:Alanine