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Impact on bone mineral density of tenofovir-containing HAART in HIV-1 infected children and adolescents: a report from 5 years of clinical experience
Journal of the International AIDS Society volume 11, Article number: P215 (2008)
Purpose of the study
Tenofovir disoproxil fumarate (TDF) is not approved for use in HIV-infected children (<18 years). In clinical practice a TAMs-sparing regimen may be needed. Use of TDF in children seems to be associated with decrease in bone mineral density that sometimes can stabilize after 24 weeks. The primary purpose was to characterized the change in bone mineral density (BMD), as measured by osteosonography (QUS), during and after treatment with tenofovir-containing HAART.
We enrolled all HIV-infected children (6–18 years), who required a change in therapy. They received TDF (children aged 2–8 years, 8 mg/kg once daily; children aged >8 years, median dose of 210 mg/m2 once daily, maximum dose of 300 mg once daily) as part of HAART, and were longitudinally observed during a follow-up of 62 months. QUS were measured at five follow-up steps: 12, 25, 35, 46, 62 months. At every step at least two patients had BMD measurements.
Summary of results
We evaluated eight perinatally HIV-infected patients (mean age 11.3 years ± 4.1. 6 males). All subjects, except one, had extensive antiretroviral treatment exposure (mean time 116.1 ± 51.5 months). Not all the patients were evaluated about the BMD annually, but everybody had at least two measurements. At baseline (median time before TDF treatment 9 months), the median ADSoS Z-score was -0.39 (SD 0.75) and the BTT Z-score was -0.12 (SD 0.61). In our patients, ADSoS and BTT Z-score values, observed during all the follow-up period, did not show significant statistical differences from the baseline values (t-student, 2-tails). At week 62, mean AD-SoS z-score and BTT Z-score were -0.12 and 1.37, respectively. Response to therapy was good: five patients maintained their same therapy with a median increase in absolute CD4 T-cell of +98 cells/mm3 and an undetectable viral load; the other three patients, except one, changed their HAART, maintaining TDF, and obtain an undetectable viral load. No patients presented renal toxicity or any other clinically significant adverse events correlated to TDF. See Figures 1 and 2.
Our young patients do not seem to be at greater risk for bone toxicity. And a non-invasive technique, such as QUS technology, opens up new interesting perspectives, allowing following of bone mass changes in vertically infected patients and better multiple evaluation of the role of disease-related conditions or treatments able to interfere with bone mass acquisition during growth.
Purdy JB, et al: Decreased bone mineral density with off-label use of tenofovir in children and adolescents infected with human immunodeficiency virus. J Pediatr. 2008, 152 (4): 582-4. 10.1016/j.jpeds.2007.12.020.
Gafni RI, 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, 118 (3): e711-8. 10.1542/peds.2005-2525.
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Rosso, R., Di Biagio, A., Parodi, A. et al. Impact on bone mineral density of tenofovir-containing HAART in HIV-1 infected children and adolescents: a report from 5 years of clinical experience. JIAS 11, P215 (2008). https://doi.org/10.1186/1758-2652-11-S1-P215
- Bone Mineral Density
- Bone Mass
- Bone Mineral Density Measurement
- Significant Adverse Event