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Title: Effects of Emtricitabine/Tenofovir on Bone Mineral Density in HIV-Negative Persons in a Randomized, Double-Blind, Placebo-Controlled Trial
Authors: Kathleen Mulligan
David V. Glidden
Peter L. Anderson
Albert Liu
Vanessa McMahan
Pedro Gonzales
Maria Esther Ramirez-Cardich
Sirianong Namwongprom
Piotr Chodacki
Laura Maria Carvalo De Mendonca
Furong Wang
Javier R. Lama
Suwat Chariyalertsak
Juan Vicente Guanira
Susan Buchbinder
Linda Gail Bekker
Mauro Schechter
Valdilea G. Veloso
Robert M. Grant
Lorena Vargas
Jorge Sanchez
Chiang Mai
Pongpun Saokhieo
Kerry Murphy
Hailey Gilmore
Sally Holland
Elizabeth Faber
John Duda
Linda Bewerunge
Elizabeth Batist
Christine Hoskin
Ben Brown
Rio De Janeiro
Carina Beppu-Yoshida
Marcellus Dias Da Costa
Sergio Carlos Assis De Jesus
Jose Roberto Grangeiro Da Silva
Roberta Millan
Brenda Regina De Siqueira Hoagland
Nilo Martinez Fernandes
Lucilene Da Silva Freitas
Beatriz Grinsztejn
Jose Pilotto
Lane Bushman
Jia Hua Zheng
Louis Anthony Guida
Brandon Kline
Pedro Goicochea
Jonathan Manzo
Robert Hance
Jeff McConnell
Patricia Defechereux
Vivian Levy
Malu Robles
Brian Postle
David Burns
James Rooney
Keywords: Medicine
Issue Date: 1-Jan-2015
Abstract: © 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.
ISSN: 15376591
Appears in Collections:CMUL: Journal Articles

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