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Effects of Emtricitabine/Tenofovir on Bone Mineral Density in HIV-Negative Persons in a Randomized, Double-Blind, Placebo-Controlled Trial

  • Author(s): Mulligan, K
  • Glidden, DV
  • Anderson, PL
  • Liu, A
  • McMahan, V
  • Gonzales, P
  • Ramirez-Cardich, ME
  • Namwongprom, S
  • Chodacki, P
  • De Mendonca, LMC
  • Wang, F
  • Lama, JR
  • Chariyalertsak, S
  • Guanira, JV
  • Buchbinder, S
  • Bekker, LG
  • Schechter, M
  • Veloso, VG
  • Grant, RM
  • Vargas, L
  • Sanchez, J
  • Mai, C
  • Saokhieo, P
  • Murphy, K
  • Gilmore, H
  • Holland, S
  • Faber, E
  • Duda, J
  • Bewerunge, L
  • Batist, E
  • Hoskin, C
  • Brown, B
  • De Janeiro, R
  • Beppu-Yoshida, C
  • Da Costa, MD
  • Assis De Jesus, SC
  • Grangeiro Da Silva, JR
  • Millan, R
  • De Siqueira Hoagland, BR
  • Martinez Fernandes, N
  • Da Silva Freitas, L
  • Grinsztejn, B
  • Pilotto, J
  • Bushman, L
  • Zheng, JH
  • Anthony Guida, L
  • Kline, B
  • Goicochea, P
  • Manzo, J
  • Hance, R
  • McConnell, J
  • Defechereux, P
  • Levy, V
  • Robles, M
  • Postle, B
  • Burns, D
  • Rooney, J
  • et al.

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© 2015 The Author 2015. Background. Daily preexposure prophylaxis (PrEP) with oral emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) decreases the risk of human immunodeficiency virus (HIV) acquisition. Initiation of TDF decreases bone mineral density (BMD) in HIV-infected people. We report the effect of FTC/TDF on BMD in HIV-seronegative men who have sex with men and in transgender women. Methods. Dual-energy X-ray absorptiometry was performed at baseline and 24-week intervals in a substudy of iPrEx, a randomized, double-blind, placebo-controlled trial of FTC/TDF PrEP. Plasma and intracellular tenofovir concentrations were measured in participants randomized to FTC/TDF. Results. In 498 participants (247 FTC/TDF, 251 placebo), BMD in those randomized to FTC/TDF decreased modestly but statistically significantly by 24 weeks in the spine (net difference, -0.91% [95% confidence interval {CI}, -1.44% to -.38%]; P =. 001) and hip (-0.61% [95% CI, -.96% to -.27%], P =. 001). Changes within each subsequent 24-week interval were not statistically significant. Changes in BMD by week 24 correlated inversely with intracellular tenofovir diphosphate (TFV-DP), which was detected in 53% of those randomized to FTC/TDF. Net BMD loss by week 24 in participants with TFV-DP levels indicative of consistent dosing averaged -1.42% ± 29% and -0.85% ± 19% in the spine and hip, respectively (P <. 001 vs placebo). Spine BMD tended to rebound following discontinuation of FTC/TDF. There were no differences in fractures (P =. 62) or incidence of low BMD. Conclusions. In HIV-uninfected persons, FTC/TDF PrEP was associated with small but statistically significant decreases in BMD by week 24 that inversely correlated with TFV-DP, with more stable BMD thereafter.

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