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Clin Infect Dis. 2015 Aug 15;61(4):572-80. doi: 10.1093/cid/civ324. Epub 2015 Apr 23.

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

Author information

1
University of California, San Francisco.
2
University of Colorado Denver, Aurora.
3
University of California, San Francisco Bridge HIV, San Francisco Department of Public Health, California.
4
Gladstone Institute of Virology and Immunology, San Francisco, California.
5
Investigaciones Medicas en Salud.
6
Asociacion Civil Impacta Salud y Education, Lima, Peru.
7
Chiang Mai University, Thailand.
8
Desmond Tutu HIV Centre and Department of Medicine, University of Cape Town, South Africa.
9
Federal University of Rio de Janeiro, Brazil.
10
Chiang Mai University, Thailand Research Institute for Health Sciences, Chiang Mai, Thailand.
11
Federal University of Rio de Janeiro, Brazil Projeto Praca Onze, Hospital Escola Sao Francisco de Assis.
12
Instituto de Pesquisa Clinica Evandro Chagas-Fundaçao Oswaldo Cruz, Rio de Janeiro, Brazil.
13
University of California, San Francisco Gladstone Institute of Virology and Immunology, San Francisco, California.

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.

KEYWORDS:

DXA; PrEP; bone; emtricitabine; tenofovir

PMID:
25908682
PMCID:
PMC4565984
DOI:
10.1093/cid/civ324
[Indexed for MEDLINE]
Free PMC Article

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