title: Less Bone Loss With Maraviroc- Versus Tenofovir-Containing Antiretroviral Therapy in the AIDS Clinical Trials Group A5303 Study.
abstract: BACKGROUND
  There is a need to prevent or minimize bone loss associated with antiretroviral treatment (ART) initiation. We compared maraviroc (MVC)- to tenofovir disoproxil fumarate (TDF)-containing ART.
  
  
  METHODS
  This was a double-blind, placebo-controlled trial. ART-naive subjects with human immunodeficiency virus type 1 RNA load (viral load [VL]) >1000 copies/mL and R5 tropism were randomized to MVC 150 mg or TDF 300 mg once daily (1:1), stratified by VL <100 000 or ≥100 000 copies/mL and age <30 or ≥30 years. All subjects received darunavir 800 mg, ritonavir 100 mg, and emtricitabine 200 mg daily. Dual-energy X-ray absorptiometry scanning was done at baseline and week 48. The primary endpoint was percentage change in total hip bone mineral density (BMD) from baseline to week 48 in the as-treated population.
  
  
  RESULTS
  We enrolled 262 subjects. A total of 259 subjects (130 MVC, 129 TDF) contributed to the analyses (91% male; median age, 33 years; 45% white, 30% black, 22% Hispanic). Baseline median VL was 4.5 log10 copies/mL and CD4 count was 390 cells/µL. The decline in hip BMD (n = 115 for MVC, n = 109 for TDF) at week 48 was less with MVC (median [Q1, Q3] of -1.51% [-2.93%, -0.11%] vs -2.40% [-4.30%, -1.32%] for TDF (P < .001). Lumbar spine BMD decline was also less with MVC (median -0.88% vs -2.35%; P < .001). Similar proportions of subjects in both arms achieved VL ≤50 copies/mL in as-treated and ITT analyses.
  
  
  CONCLUSIONS
  MVC was associated with less bone loss at the hip and lumbar spine compared with TDF. MVC may be an option to attenuate ART-associated bone loss.
  
  
  BACKGROUND
  NCT01400412.
authors.affiliation: Division of Infectious Diseases, Northwestern University, Chicago, Illinois.
authors.forename: Babafemi O
authors.initials: BO
authors.lastname: Taiwo
authors.affiliation: Statistical and Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts.
authors.forename: Ellen S
authors.initials: ES
authors.lastname: Chan
authors.affiliation: Division of Infectious Diseases, University of Cincinnati, Ohio.
authors.forename: Carl J
authors.initials: CJ
authors.lastname: Fichtenbaum
authors.affiliation: Statistical and Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts.
authors.forename: Heather
authors.initials: H
authors.lastname: Ribaudo
authors.affiliation: Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Athe
authors.initials: A
authors.lastname: Tsibris
authors.affiliation: HIV Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.
authors.forename: Karin L
authors.initials: KL
authors.lastname: Klingman
authors.affiliation: Departments of Infectious Diseases.
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Eron
authors.affiliation: Division of Infectious Diseases, Northwestern University, Chicago, Illinois.
authors.forename: Baiba
authors.initials: B
authors.lastname: Berzins
authors.affiliation: Neurology, University of North Carolina at Chapel Hill.
authors.forename: Kevin
authors.initials: K
authors.lastname: Robertson
authors.affiliation: Department of Immunology/Microbiology, Rush University Medical Center, Chicago, Illinois.
authors.forename: Alan
authors.initials: A
authors.lastname: Landay
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Emory University, Atlanta, Georgia.
authors.forename: Igho
authors.initials: I
authors.lastname: Ofotokun
authors.affiliation: Division of Endocrinology, Diabetes, and Metabolism, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Todd
authors.initials: T
authors.lastname: Brown
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D015519:Bone Density / Q000187:drug effects*; D003510:Cyclohexanes / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D000077592:Maraviroc; D008875:Middle Aged; D010384:Pelvic Bones; D000068698:Tenofovir / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D014230:Triazoles / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D003510:Cyclohexanes; D014230:Triazoles; D000068698:Tenofovir; D000077592:Maraviroc
keywords: bone; darunavir; maraviroc; tenofovir