1123. 24-week Safety of Tenofovir When Administered According to Weight Band Dosing in HIV-infected Children ≥ 15 Kg as Part of a Once-daily HAART Regimen
Session: Poster Abstract Session: Pediatric HIV
Friday, October 19, 2012
Room: SDCC Poster Hall F-H
Posters
  • 04_Poster TDF_24wksafety_IDweek_01Oct2012.pdf (371.7 kB)
  • Background: Once-daily dosing is desirable for growing-up children to maintain adherence. Tenofovir (TDF) is a widely used drug for once-daily regimens. However, concerns have been raised about its effects on renal function and bone mineral density (BMD). Our objective was to evaluate the safety of TDF prescribed according to weight band dosing in treatment-experienced HIV-infected children.

    Methods: A prospective open-label study in HIV-infected children aged 3-18 years, weighing ≥ 15 kg and were receiving first-line regimen with virologic suppressed(< 50 copies/mL). After enrollment, their antiretroviral was modified to a once-daily regimen of TDF/lamivudine/efavirenz. TDF was prescribed according to weight band dosing: 150 mg for 15-<22 kg, 225 mg for 22-<33 kg, and 300 mg for >33 kg. A control group consisted of HIV-infected age-, gender-, and CD4- matched children receiving TDF-sparing regimens. Safety assessments including urine analysis, renal function (glomerular, creatinine clearance; tubular, calcium & phosphate excretion), and BMD were performed at entry & week 24. BMD z-score was calculated using age-matched normal Thai children references. Vitamin D level was measured in those with BMD z-score ≤ -1.5.

    Results: Eighty children were enrolled (40 per group). Baseline safety profiles were not different between the two groups. During the 24-week follow-up, all remained clinically stable; 39 of 40 children in the TDF group remained virologic suppressed. From baseline to week 24, there was no significant change in creatinine clearance(179±48 vs. 168±54 mL/min/1.73m2, p=0.06), while there was an increase in fraction excretion of calcium (0.26±0.23 vs. 0.48±0.53, p=0.02) in the TDF group. There was no case of hypocalcemia, hypophosphatemia, hypokalemia, hypouricemia, acidosis, proteinuria, or glucosuria. There was a decrease in mean BMD z-score among children in the TDF group from entry to week 24, but not the control group (0.01 to -0.62, p=0.03 vs. -0.28 to -0.11, p=0.11). Three children in the TDF group with normal baseline developed low BMD (z-score; -2.11, -1.56,-1.57) with normal vitamin D level (>20ng/mL) at week 24.

    Conclusion: We observed a minimal effect of TDF on renal tubular function, no impact on glomerular function, and some decrease in BMD at 24 weeks of treatment. Extended follow-up is warranted to determine long-term safety of TDF in HIV-infected children.

    Linda Aurpibul, MD.1, Thition Narkbunnam, MD.2, Virat Sirisanthana, MD.1, Orasri Wittawatmongkol, MD.2, Wanatpreeya Phongsamart, MD2, Tavitiya Sudjaritruk, MD.3, Tim Cressey, PhD4,5,6 and Kulkanya Chokephaibulkit, MD2, (1)Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand, (2)Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, (3)Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand, (4)Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand, (5)Harvard School of Public Health, Boston, MA, (6)Institut de Recherche pour le Développement (IRD), Marseille, France

    Disclosures:

    L. Aurpibul, None

    T. Narkbunnam, None

    V. Sirisanthana, None

    O. Wittawatmongkol, None

    W. Phongsamart, None

    T. Sudjaritruk, None

    T. Cressey, None

    K. Chokephaibulkit, None

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