title: Efficacy and safety of emtricitabine/tenofovir alafenamide (FTC/TAF) vs. emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as a backbone for treatment of HIV-1 infection in virologically suppressed adults: subgroup analysis by third agent of a randomized, double-blind, active-controlled phase 3 trial<sup/>.
abstract: FTC/TAF was shown to be noninferior to FTC/TDF with advantages in markers of renal and bone safety.
  
  
  
  To evaluate the efficacy and safety of switching to FTC/TAF from FTC/TDF by third agent (boosted protease inhibitor [PI] vs. unboosted third agent).
  
  
  
  We conducted a 48-week subgroup analysis based on third agent from a randomized, double blind study in virologically suppressed adults on a FTC/TDF-containing regimen who switched to FTC/TAF vs. continued FTC/TDF while remaining on the same third agent.
  
  
  
  We randomized (1:1) 663 participants to either switch to FTC/TAF (N = 333) or continue FTC/TDF (N = 330), each with baseline third agent stratifying by class of third agent in the prior treatment regimen (boosted PI 46%, unboosted third agent 54%). At week 48, significant differences in renal biomarkers and bone mineral density were observed favoring FTC/TAF over FTC/TDF (p < 0.05 for all), with similar improvements in the FTC/TAF arm in those who received boosted PI vs. unboosted third agents. At week 48, virologic success rates were similar between treatment groups for those who received a boosted PI (FTC/TAF 92%, FTC/TDF 93%) and for those who received an unboosted third agent (97% vs. 93%).
  
  
  
  In virologically suppressed patients switching to FTC/TAF from FTC/TDF, high rates of virologic suppression were maintained, while renal and bone safety parameters improved, regardless of whether participants were receiving a boosted PI or an unboosted third agent. FTC/TAF offers safety advantages over FTC/TDF and can be an important option as an NRTI backbone given with a variety of third agents.
authors.affiliation: a Kings College Hospital NHS Foundation Trust , Weston Education Centre (2.53) , London , UK.
authors.forename: Frank A
authors.initials: FA
authors.lastname: Post
authors.affiliation: b Service des Maladies Infectieuses et Tropicales , Hospital Bichat-Claude Bernard , Paris , France.
authors.forename: Yazdan
authors.initials: Y
authors.lastname: Yazdanpanah
authors.affiliation: c Manchester Centre for Sexual Health , Manchester , UK.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Schembri
authors.affiliation: d Divisione di Malattie Infettive , IRCCS Ospedale San Raffaele , Milano , Italy.
authors.forename: Adriano
authors.initials: A
authors.lastname: Lazzarin
authors.affiliation: e Departement Des Maladies Infectieuses et Tropicales , CHU Gui De Chuliac , Montpellier , France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Reynes
authors.affiliation: f US di Terapia Antivirale, USC di Malattie Infettive , Azienda Ospedaliera Papa Giovanni XXIII , Bergamo , Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Maggiolo
authors.affiliation: g Departments of Biometrics, Virology, Clinical Operations, and Clinical Research , Gilead Sciences Inc. , Foster City , CA , USA.
authors.forename: Mingjin
authors.initials: M
authors.lastname: Yan
authors.affiliation: g Departments of Biometrics, Virology, Clinical Operations, and Clinical Research , Gilead Sciences Inc. , Foster City , CA , USA.
authors.forename: Michael E
authors.identifier: 0000-0002-2341-5319
authors.initials: ME
authors.lastname: Abram
authors.affiliation: g Departments of Biometrics, Virology, Clinical Operations, and Clinical Research , Gilead Sciences Inc. , Foster City , CA , USA.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Tran-Muchowski
authors.affiliation: g Departments of Biometrics, Virology, Clinical Operations, and Clinical Research , Gilead Sciences Inc. , Foster City , CA , USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Cheng
authors.affiliation: g Departments of Biometrics, Virology, Clinical Operations, and Clinical Research , Gilead Sciences Inc. , Foster City , CA , USA.
authors.forename: Martin S
authors.initials: MS
authors.lastname: Rhee
mesh_terms: D016263:AIDS-Associated Nephropathy / Q000453:epidemiology / Q000473:pathology; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods*; D001851:Bone Diseases, Metabolic / Q000453:epidemiology / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000072230:Sustained Virologic Response; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents
keywords: Bone mineral density; HIV; Randomized controlled trial; Renal safety; Tenofovir alafenamide; Tenofovir disoproxil fumarate; Third ARV agents