Clinical and laboratory observation
Decreased Bone Mineral Density with Off-Label Use of Tenofovir in Children and Adolescents Infected with Human Immunodeficiency Virus

An abstract of this study was presented at the 14th Conference on Retroviruses and Opportunistic Infections, February 25-28, 2007, in Los Angeles, California.
https://doi.org/10.1016/j.jpeds.2007.12.020Get rights and content

5 of 6 children infected with human immunodeficiency virus (HIV) receiving Tenofovir disoproxil fumarate (TDF) experienced absolute decreases in bone mineral density (BMD). 2 pre-pubertal subjects experienced >6% BMD decreases. 1 subject was the smallest child and experienced a 27% decrease, necessitating withdrawal of TDF. Subsequently, her BMD recovered. Monitoring of children infected with HIV who require treatment with TDF is warranted.

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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,

References (7)

  • R.I. Gafni et al.

    Tenofovir disoproxil fumarate and an optimized background regimen of antiretroviral agents as salvage therapy: impact on bone mineral density in HIV-infected children

    Pediatrics

    (2006)
  • R. Hazra et al.

    Single-dose and steady-state pharmacokinetics of tenofovir disoproxil fumarate in human immunodeficiency virus-infected children

    Antimicrob Agents Chemother

    (2004)
  • R. Hazra et al.

    Tenofovir disoproxil fumarate and an optimized background regimen of antiretroviral agents as salvage therapy for pediatric HIV infection

    Pediatrics

    (2005)
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Supported by the Intramural Research Program of the National Institutes of Health, National Cancer Institute, Center for Cancer Research.

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