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AIDS Res Hum Retroviruses. 2018 Nov 5. doi: 10.1089/AID.2018.0096. [Epub ahead of print]

Association of Vitamin D Insufficiency and Protective Tenofovir Diphosphate Concentrations with Bone Toxicity in Adolescent Boys and Young Men Using Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Pre-Exposure Prophylaxis.

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1 Department of Pediatrics, Medical College of Wisconsin/Children's Hospital of Wisconsin , Milwaukee, Wisconsin.
2 Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham , Birmingham, Alabama.
3 United States Department of Agriculture, Agricultural Research Service, Western Human Nutrition Research Center , Davis, California.
4 Department of Nutrition, University of California , Davis, California.
5 Department of Pediatrics, University of Cincinnati College of Medicine/Cincinnati Children's Hospital Medical Center , Cincinnati, Ohio.
6 Westat , Rockville, Maryland.
7 Department of Epidemiology, University of Alabama at Birmingham , Birmingham, Alabama.
8 Department of Psychiatry, Stroger Hospital of Cook County , Chicago, Illinois.
9 Department of Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus , Aurora, Colorado.
10 Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development , Bethesda, Maryland.
11 Department of Medicine, University of California at San Francisco , Zuckerberg San Francisco General Hospital, San Francisco, California.


We examined associations of 25-hydroxy vitamin D (25-OHD), tenofovir disoproxil fumarate (TDF), and bone toxicity. We studied TDF/emtricitabine (FTC) HIV pre-exposure prophylaxis (PrEP) in young men who have sex with men (YMSM). Bone toxicity was predefined using bone mineral density/content change from baseline to week 48. Baseline serum 25-OHD was dichotomized as <20 ng/mL (insufficient/deficient) versus ≥20 (sufficient), and week 48 dried blood spot tenofovir diphosphate (TFV-DP) as >700 fmol/punch (protective against HIV acquisition) versus ≤700. Associations were examined by univariate and multivariable logistic regression, reporting crude and adjusted odds ratios (ORs), with 95% confidence intervals (CIs). Of 101 enrolled, 69 had complete bone assessments and 25-OHD; of these, 59 had week 48 TFV-DP data. Median (Q1-Q3) age was 20 (18-21) years; 54% were black/African American. In univariate analysis, participants with baseline 25-OHD <20 ng/mL (OR = 5.4; 95% CI = 1.9-16.5) and blacks (OR = 4.9; 95% CI = 1.7-15.2) had greater odds of bone toxicity than those with 25-OHD ≥20 or other races. TFV-DP was not associated with bone toxicity (OR = 1.6; 95% CI = 0.5-5.5). In multivariable analysis, compared with those with 25-OHD ≥20 and TFV-DP ≤700, those with 25-OHD ≥20 and TFV-DP >700 (OR = 11.5; 95% CI = 1.4-169.6), 25-OHD <20 and TFV-DP ≤700 (OR = 19.4; 95% CI = 3.0-228.7), and 25-OHD <20 and TFV-DP >700 (OR = 32.3; 95% CI = 3.3-653.6) had greater odds of bone toxicity after adjusting for race. In multivariable models, 25-OHD insufficiency, protective TFV-DP concentrations, and black race were significantly associated with bone toxicity after 48 weeks of TDF/FTC PrEP in YMSM. Clinical Trials Registration: NCT01769469.


25-hydroxy vitamin D; HIV pre-exposure prophylaxis; bone mineral density; tenofovir disoproxil fumarate


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