Clinical and laboratory observationDecreased Bone Mineral Density with Off-Label Use of Tenofovir in Children and Adolescents Infected with Human Immunodeficiency Virus
Section snippets
Methods
The primary objective of this study was to characterize the change in BMD, as measured with lumbar spine dual-energy x-ray absorptiometry (DXA; QDR 4500; Hologic, Bedford, Mass), during and after treatment with TDF-containing HAART. Originally, 40 subjects were to be studied, but the trial was terminated early because of administrative reasons unrelated to the trial. We now report on the 6 subjects who underwent DXA scanning before receiving 300 mg of TDF as part of a new HAART regimen. The
Results
Six treatment-experienced, perinatally HIV-infected children and adolescents underwent DXA scanning before receiving 300 mg of TDF (median, 268 mg/m2) as part of a new HAART regimen that included a ritonavir-boosted protease inhibitor and at least 2 other antiretroviral medications (Table). All subjects except 1 had extensive antiretroviral treatment experience that included earlier therapy with 3 classes of antiretroviral agents.
Five of the 6 children (all but subject 3) experienced absolute
Discussion
In our first trial of TDF in children infected with HIV, with a 75-mg formulation of the drug, we saw BMD decreases >6% in 6 of the 15 subjects evaluated longitudinally.1, 2, 3 Because of widespread TDF use and a report showing no effect of TDF on BMD in children,7 we designed this study in a separate cohort of HIV-infected pediatric patients to provide more data on the use of TDF in children and adolescents infected with HIV. The study was terminated early because of administrative reasons,
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Supported by the Intramural Research Program of the National Institutes of Health, National Cancer Institute, Center for Cancer Research.