Abstract
BackgroundPre-exposure prophylaxis (PrEP) trials are evaluating regimens containing tenofovir-disoproxil fumarate (TDF) for HIV prevention. We determined the baseline prevalence of low bone mineral density (BMD) and the effect of TDF on BMD in men who have sex with men (MSM) in a PrEP trial in San Francisco.Methods/FindingsWe evaluated 1) the prevalence of low BMD using Dual Energy X-ray Absorptiometry (DEXA) in a baseline cohort of 210 HIV-uninfected MSM who screened for a randomized clinical trial of daily TDF vs. placebo, and 2) the effects of TDF on BMD in a longitudinal cohort of 184 enrolled men. Half began study drug after a 9-month delay to evaluate changes in risk behavior associated with pill-use. At baseline, 20 participants (10%) had low BMD (Z score≤−2.0 at the L2–L4 spine, total hip, or femoral neck). Low BMD was associated with amphetamine (OR = 5.86, 95% CI 1.70–20.20) and inhalant (OR = 4.57, 95% CI 1.32–15.81) use; men taking multivitamins, calcium, or vitamin D were less likely to have low BMD at baseline (OR = 0.26, 95% CI 0.10–0.71). In the longitudinal analysis, there was a 1.1% net decrease in mean BMD in the TDF vs. the pre-treatment/placebo group at the femoral neck (95% CI 0.4–1.9%), 0.8% net decline at the total hip (95% CI 0.3–1.3%), and 0.7% at the L2–L4 spine (95% CI −0.1–1.5%). At 24 months, 13% vs. 6% of participants experienced >5% BMD loss at the femoral neck in the TDF vs. placebo groups (p = 0.13).ConclusionsTen percent of HIV-negative MSM had low BMD at baseline. TDF use resulted in a small but statistically significant decline in BMD at the total hip and femoral neck. Larger studies with longer follow-up are needed to determine the trajectory of BMD changes and any association with clinical fractures.Trial RegistrationClinicalTrials.gov: NCT00131677
Highlights
Low bone mineral density (BMD) is common among HIVinfected individuals [1,2]
Larger studies with longer follow-up are needed to determine the trajectory of BMD changes and any association with clinical fractures
While the Fem-Pre-exposure prophylaxis (PrEP) trial in African women sponsored by Family Health International was stopped early due to futility [12], the Partners PrEP Study [13] and Center for Disease Control and Prevention (CDC) TDF2 Botswana trial [14] demonstrated over 60% efficacy of tenofovir-based PrEP regimens in serodiscordant couples and heterosexual men and women respectively
Summary
Ten percent of HIV-negative MSM had low BMD at baseline. TDF use resulted in a small but statistically significant decline in BMD at the total hip and femoral neck. J. Grinsztejn, Instituto de Pesquisa Clınica Evandro Chagas/Fundacao Oswaldo Cruz, Brazil. Grinsztejn, Instituto de Pesquisa Clınica Evandro Chagas/Fundacao Oswaldo Cruz, Brazil The US Department of Health and Human Services, Centers for Disease Control and Prevention were involved in study design, data collection and analysis, decision to publish, and preparation of the manuscript. The University of California, San Francisco Clinical and Translational Science Institute was involved in data collection only This does not alter the authors’ adherence to all the PLoS ONE policies on sharing data and materials
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