| Author | Mulligan, Kathleen | |
| Author | Glidden, David V. | |
| Author | Anderson, Peter L. | |
| Author | Liu, Albert | |
| Author | McMahan, Vanessa | |
| Author | Gonzales, Pedro | |
| Author | Ramirez-Cardich, Maria Esther | |
| Author | Namwongprom, Sirianong | |
| Author | Chodacki, Piotr | |
| Author | Mendonça, Laura Maria Carvalo | |
| Author | Wang, Furong | |
| Author | Lama, Javier R. | |
| Author | Chariyalertsak, Suwat | |
| Author | Guanira, Juan Vicente | |
| Author | Buchbinder, Susan | |
| Author | Bekker, Linda-Gail | |
| Author | Schechter, Mauro | |
| Author | Veloso, Valdiléa G. | |
| Author | Grant, Robert M. | |
| Access date | 2018-10-15T13:36:45Z | |
| Available date | 2018-10-15T13:36:45Z | |
| Document date | 2015 | |
| Citation | MULLIGAN, Kathleen et al. Effects of Emtricitabine/Tenofovir on Bone Mineral Density in HIV-Negative Persons in a Randomized, Double-Blind, Placebo-Controlled Trial. Clinical Infectious Diseases, v. 61, n. 4, p. 572–580, Aug. 2015. | pt_BR |
| ISSN | 1058-4838 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/29553 | |
| Description | Collaborators: Preexposure Prophylaxis Initiative Study Team: 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, Jr, 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. | pt_BR |
| Sponsorship | This work was supported by the NIH (U01 AI64002, U01 AI84735) and the Bill & Melinda Gates Foundation. Study medication was provided by Gilead Sciences. Some infrastructure support at the University of California, San Francisco was provided by an award from the NIH/National Academy for Advancing Translational Science (UL1 TR000004). | |
| Language | eng | pt_BR |
| Publisher | Oxford | |
| Rights | open access | pt_BR |
| Title | Effects of Emtricitabine/Tenofovir on Bone Mineral Density in HIV-Negative Persons in a Randomized, Double-Blind, Placebo-Controlled Trial | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.1093/cid/civ324 | |
| 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. | pt_BR |
| Affilliation | University of California. San Francisco, USA. | pt_BR |
| Affilliation | University of California. San Francisco, USA. | pt_BR |
| Affilliation | University of Colorado Denver. Aurora, USA. | pt_BR |
| Affilliation | University of California. San Francisco Bridge HIV. San Francisco Department of Public Health. California, USA. | pt_BR |
| Affilliation | Gladstone Institute of Virology and Immunology. San Francisco, California, USA. | pt_BR |
| Affilliation | Investigaciones Medicas en Salud. Peru. | pt_BR |
| Affilliation | Asociacion Civil Impacta Salud y Education. Lima, Peru. | pt_BR |
| Affilliation | Chiang Mai University. Thailand. | pt_BR |
| Affilliation | University of Cape Town. Desmond Tutu HIV Centre and Department of Medicine. South Africa. | pt_BR |
| Affilliation | Universidade Federal do Rio de Janeiro. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | University of California. San Francisco, USA. | pt_BR |
| Affilliation | Asociacion Civil Impacta Salud y Education. Lima, Peru. | pt_BR |
| Affilliation | Chiang Mai University. Thailand Research Institute for Health Sciences. Chiang Mai, Thailand. | pt_BR |
| Affilliation | Investigaciones Medicas en Salud. Peru. | pt_BR |
| Affilliation | University of California. San Francisco Bridge HIV. San Francisco Department of Public Health. California, USA. | pt_BR |
| Affilliation | University of Cape Town. Desmond Tutu HIV Centre and Department of Medicine. South Africa. | pt_BR |
| Affilliation | Universidade Federal do Rio de Janeiro. Hospital Escola São Francisco de Assis. Projeto Praça Onze. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | University of California./ Gladstone Institute of Virology and Immunology. San Francisco, California, USA. | pt_BR |
| Subject | Bone | pt_BR |
| Subject | Tenofovir | pt_BR |
| Subject | Emtricitabine | pt_BR |
| Subject | PrEP | pt_BR |
| Subject | DXA | pt_BR |
| e-ISSN | 1537-6591 | |
