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

摘要: Author(s): 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 Carvalo; Wang, Furong; Lama, Javier R; Chariyalertsak, Suwat; Guanira, Juan Vicente; Buchbinder, Susan; Bekker, Linda-Gail; Schechter, Mauro; Veloso, Valdilea G; Grant, Robert M; Preexposure Prophylaxis Initiative Study Team | Abstract: BackgroundDaily preexposure prophylaxis (PrEP) with oral emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) decreases the risk of human immunodeficiency virus (HIV) acquisition. Initiation TDF bone mineral density (BMD) in HIV-infected people. We report effect FTC/TDF on BMD HIV-seronegative men who have sex transgender women.MethodsDual-energy X-ray absorptiometry was performed at baseline 24-week intervals a substudy iPrEx, randomized, double-blind, placebo-controlled trial PrEP. Plasma intracellular concentrations were measured participants randomized to FTC/TDF.ResultsIn 498 (247 FTC/TDF, 251 placebo), those decreased modestly but statistically significantly by 24 weeks spine (net difference, -0.91% [95% confidence interval {CI}, -1.44% -.38%]; P = .001) hip (-0.61% CI, -.96% -.27%], .001). Changes within each subsequent not significant. week correlated inversely diphosphate (TFV-DP), which detected 53% FTC/TDF. Net loss TFV-DP levels indicative consistent dosing averaged -1.42% ± 29% -0.85% 19% hip, respectively (P l .001 vs placebo). Spine tended rebound following discontinuation There no differences fractures .62) or incidence low BMD.ConclusionsIn HIV-uninfected persons, PrEP associated small significant that TFV-DP, more stable thereafter.Clinical trials registrationNCT00458393.