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Effects of Emtricitabine/Tenofovir on Bone Mineral Density in HIV-Negative Persons in a Randomized, Double-Blind, Placebo-Controlled Trial
- Mulligan, Kathleen;
- Glidden, David V;
- Anderson, Peter L;
- Liu, Albert;
- McMahan, Vanessa;
- Gonzales, Pedro;
- Ramirez-Cardich, Maria Esther;
- Namwongprom, Sirianong;
- Chodacki, Piotr;
- de Mendonca, Laura Maria Carvalo;
- Wang, Furong;
- Lama, Javier R;
- Chariyalertsak, Suwat;
- Guanira, Juan Vicente;
- Buchbinder, Susan;
- Bekker, Linda-Gail;
- Schechter, Mauro;
- Veloso, Valdilea G;
- Grant, Robert M;
- Team, for the Preexposure Prophylaxis Initiative Study;
- Vargas, Lorena;
- Sanchez, Jorge;
- Mai, Chiang;
- Saokhieo, Pongpun;
- Murphy, Kerry;
- Gilmore, Hailey;
- Holland, Sally;
- Faber, Elizabeth;
- Duda, John;
- Bewerunge, Linda;
- Batist, Elizabeth;
- Hoskin, Christine;
- Brown, Ben;
- de Janeiro, Rio;
- Beppu-Yoshida, Carina;
- da Costa, Marcellus Dias;
- de Jesus, Sergio Carlos Assis;
- da Silva, Jose Roberto Grangeiro;
- Millan, Roberta;
- de Siqueira Hoagland, Brenda Regina;
- Fernandes, Nilo Martinez;
- da Silva Freitas, Lucilene;
- Grinsztejn, Beatriz;
- Pilotto, Jose;
- Bushman, Lane;
- Zheng, Jia-Hua;
- Guida, Louis Anthony;
- Kline, Brandon;
- Goicochea, Pedro;
- Manzo, Jonathan;
- Hance, Robert;
- McConnell, Jeff;
- Defechereux, Patricia;
- Levy, Vivian;
- Robles, Malu;
- Postle, Brian;
- Burns, David;
- Rooney, James
- et al.
Published Web Location
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4565984/No data is associated with this publication.
Abstract
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.Clinical trials registration
NCT00458393.Many UC-authored scholarly publications are freely available on this site because of the UC's open access policies. Let us know how this access is important for you.