Less Bone Loss with Maraviroc- Versus Tenofovir-Containing Antiretroviral Therapy in the AIDS Clinical Trials Group A5303 Study

Babafemi O. Taiwo, Ellen S. Chan, Carl J. Fichtenbaum, Heather Ribaudo, Athe Tsibris, Karin L. Klingman, Joseph J. Eron, Baiba Berzins, Kevin Robertson, Alan Landay, Igho Ofotokun, Todd Brown, I. Martinez, Robert Kalayjian, Cara Wilson, Edward Acosta, David Rusin, Amy Gonzales, Orlando Roman, Kathy MelbourneJames Rooney, Alex Reinhart, Bryan Baugh, Roula Qaqish, Heera R. Jayvant, Laura Napolitano, Charles Walworth, Christos Petropoulos, John Davis, Mark Hite, Edward Seefried, Constance Benson, Nina Lambert, Karen Coleman, Tamara James, Amy Dill, Jenifer Baer, Christine Griesmer, Cathi Basler, Hector Bolivar, Margaret A. Fischl, Roberto C. Arduino, Aristoteles E. Villamil, Beverly Sha, Tondria Green, Brenda Jackson, Fred Nicotera, Geyoul Kim, Mark Rodrieguez, Annie Luetkemeyer, Jay Dwyer, Pamela Poethke, Aadia Rana, Miriam Chicurel-Bayard, Megan Telfer, Cornelius Van Dam, Timothy Lane, Ighovwerha Ofotokun, Melody Palmore, Patricia Walton, Felicia Williams, Jorge L. Santana, Olga I. Mendez, Pablo Tebas, Aleshia Thomas, Teri Flynn, Amy Sbrolla, Raphael Landovitz, Vanessa Cajahuaringa, Shelia Dunaway, Sheryl Storey, Ilene Wiggins, Andrea Weiss, Daniel Reirden, Hannah Bernath, Michael Yin, Jolene Noel-Connor, Rose Kim, Yolanda Smith, Paul Sax, Cheryl Keenan, Princy Kumar, Joseph Timpone, Michael P. DubCrossed Dsign, Bartolo Santos, Mary Adams, Christine Hurley

Research output: Contribution to journalArticle

30 Scopus citations

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. Clinical Trials Registration.NCT01400412.

Original languageEnglish (US)
Pages (from-to)1179-1188
Number of pages10
JournalClinical Infectious Diseases
Volume61
Issue number7
DOIs
StatePublished - Oct 1 2015

Keywords

  • bone
  • darunavir
  • maraviroc
  • tenofovir

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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    Taiwo, B. O., Chan, E. S., Fichtenbaum, C. J., Ribaudo, H., Tsibris, A., Klingman, K. L., Eron, J. J., Berzins, B., Robertson, K., Landay, A., Ofotokun, I., Brown, T., Martinez, I., Kalayjian, R., Wilson, C., Acosta, E., Rusin, D., Gonzales, A., Roman, O., ... Hurley, C. (2015). Less Bone Loss with Maraviroc- Versus Tenofovir-Containing Antiretroviral Therapy in the AIDS Clinical Trials Group A5303 Study. Clinical Infectious Diseases, 61(7), 1179-1188. https://doi.org/10.1093/cid/civ455