title: Brief Report: Long-Term (96-Week) Efficacy and Safety After Switching From Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in HIV-Infected, Virologically Suppressed Adults.
abstract: In a double-blind, phase 3 trial, 663 HIV-infected, virologically suppressed adults were randomized to switch to tenofovir alafenamide (TAF; n = 333) vs. remain on tenofovir disoproxil fumarate (TDF; n = 330), each coformulated with emtricitabine (FTC), while continuing their third agent (boosted protease inhibitor or unboosted third agent). At week 96, 88.6% on FTC/TAF and 89.1% on FTC/TDF had HIV-1 RNA <50 copies per milliliter [adjusted difference -0.5% (95% confidence interval: -5.3 to 4.4%)]. Proteinuria, albuminuria, proximal renal tubular function, and bone mineral density improved after switching to TAF- from TDF-containing regimens. These longer-term data support FTC/TAF as a safe, well-tolerated, and durable nucleotide reverse transcriptase inhibitor backbone.
authors.affiliation: *CHU de Nantes, Nantes, France; †Grahame Hayton Unit, Royal London Hospital, London, United Kingdom; ‡Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom; §Hotel Dieu University Hospital, Paris, France; ‖Southwest CARE Center, Santa Fe, NM; ¶Los Angeles Biomedical Research Institute at Harbor-UCLA, Torrance, CA; #Hennepin County Medical Center, Minneapolis, MN; **University of Puerto Rico School of Medicine, Rio Piedras, PR; ††Jacobi Medical Center, Bronx, NY; ‡‡Southwest Infectious Disease Clinical Research, Dallas, TX; §§Pacific Oaks Medical Group, Beverly Hills, CA; and ‖‖Gilead Sciences, Foster City, CA.
authors.forename: François
authors.initials: F
authors.lastname: Raffi
authors.forename: Chloe
authors.initials: C
authors.lastname: Orkin
authors.forename: Amanda
authors.initials: A
authors.lastname: Clarke
authors.forename: Laurence
authors.initials: L
authors.lastname: Slama
authors.forename: Joel
authors.initials: J
authors.lastname: Gallant
authors.forename: Eric
authors.initials: E
authors.lastname: Daar
authors.forename: Keith
authors.initials: K
authors.lastname: Henry
authors.forename: Jorge
authors.initials: J
authors.lastname: Santana-Bagur
authors.forename: David K
authors.initials: DK
authors.lastname: Stein
authors.forename: Nicholaos
authors.initials: N
authors.lastname: Bellos
authors.forename: Anthony
authors.initials: A
authors.lastname: Scarsella
authors.forename: Mingjin
authors.initials: M
authors.lastname: Yan
authors.forename: Michael E
authors.initials: ME
authors.lastname: Abram
authors.forename: Andrew
authors.initials: A
authors.lastname: Cheng
authors.forename: Martin S
authors.initials: MS
authors.lastname: Rhee
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000409:Alanine; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D004311:Double-Blind Method; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology*; D015497:HIV-1 / Q000187:drug effects* / Q000276:immunology; D006801:Humans; D008875:Middle Aged; D000068698:Tenofovir / Q000008:administration & dosage* / Q000627:therapeutic use* / Q000031:analogs & derivatives; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects
chemical_list: D019380:Anti-HIV Agents; D000068698:Tenofovir; C442442:tenofovir alafenamide; D000225:Adenine; D000409:Alanine