Abstract
BackgroundTenofovir-emtricitabine (TDF-FTC) pre-exposure prophylaxis (PrEP) has been found to be effective for prevention of HIV infection in several clinical trials. Two studies of TDF PrEP among men who have sex with men showed slight bone mineral density (BMD) loss. We investigated the effect of TDF and the interaction of TDF and hormonal contraception on BMD among HIV-uninfected African men and women.MethodWe evaluated the effects on BMD of using daily oral TDF-FTC compared to placebo among heterosexual men and women aged 18–29 years enrolled in the Botswana TDF2 PrEP study. Participants had BMD measurements at baseline and thereafter at 6-month intervals with dual-energy X-ray absorptiometry (DXA) scans at the hip, spine, and forearm.ResultsA total of 220 participants (108 TDF-FTC, 112 placebo) had baseline DXA BMD measurements at three anatomic sites. Fifteen (6.8%) participants had low baseline BMD (z-score of <−2.0 at any anatomic site), including 3/114 women (2.6%) and 12/106 men (11.3%) (p = 0.02). Low baseline BMD was associated with being underweight (p = 0.02), having high blood urea nitrogen (p = 0.02) or high alkaline phosphatase (p = 0.03), and low creatinine clearance (p = 0.04). BMD losses of >3.0% at any anatomic site at any time after baseline were significantly greater for the TDF-FTC treatment group [34/68 (50.0%) TDF-FTC vs. 26/79 (32.9%) placebo; p = 0.04]. There was a small but significant difference in the mean percent change in BMD from baseline for TDF-FTC versus placebo at all three sites at month 30 [forearm −0.84% (p = 0.01), spine −1.62% (p = 0.0002), hip −1.51% (p = 0.003)].ConclusionUse of TDF-FTC was associated with a small but statistically significant decrease in BMD at the forearm, hip and lumbar spine. A high percentage (6.8%) of healthy Batswana young adults had abnormal baseline BMD Further evaluation is needed of the longer-term use of TDF in HIV-uninfected persons.Trial RegistrationClinicalTrials.gov NCT00448669
Highlights
Several clinical trials have demonstrated that pre-exposure prophylaxis (PrEP), a strategy in which human immunodeficiency virus (HIV) uninfected persons take antiretroviral medication to reduce their infection risk, is a promising approach for the prevention of HIV transmission [1,2,3,4]
A total of 220 participants (108 TDF-FTC, 112 placebo) had baseline dual-energy X-ray absorptiometry (DXA) bone mineral density (BMD) measurements at three anatomic sites
A high percentage (6.8%) of healthy Batswana young adults had abnormal baseline BMD Further evaluation is needed of the longer-term use of TDF in HIV-uninfected persons
Summary
Several clinical trials have demonstrated that pre-exposure prophylaxis (PrEP), a strategy in which human immunodeficiency virus (HIV) uninfected persons take antiretroviral medication to reduce their infection risk, is a promising approach for the prevention of HIV transmission [1,2,3,4]. Use of tenofovir resulted in decreased bone mineral density (BMD) in HIV-infected patients in clinical trials [8 and 9] and cases of fractures and/or osteomalacia due to tenofovir use have been reported [10]. In a randomised clinical trial of PrEP among men who have sex with men in San Francisco, 10% of HIV-negative men had low BMD (z-score ,22.0) at baseline; tenofovir use resulted in a small but statistically significant decline in BMD at the hip and femoral neck [11]. Tenofovir-emtricitabine (TDF-FTC) pre-exposure prophylaxis (PrEP) has been found to be effective for prevention of HIV infection in several clinical trials. We investigated the effect of TDF and the interaction of TDF and hormonal contraception on BMD among HIV-uninfected African men and women
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