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Efavirenz Is Associated With Higher Bone Mass in South African Children With HIV....after switching to EFV from LPV/r
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Reported by Jules Levin
CROI 2016 Feb 22-24 boston
WEBCAST:http://www.croiwebcasts.org/console/player/29481?mediaType=audio&
Stephen M. Arpadi1; Stephanie Shiau1; Renate Strehlau2; Faeezah Patel2; Louise Kuhn3; Ashraf Coovadia2; Don McMahon1; Jonathan J. Kaufman4; Michael T. Yin1; for the CHANGES Bone Study Team
1Columbia Univ Med Cntr, New York, NY, USA;2Univ of the Witwatersrand, Johannesburg, South Africa;3Columbia Univ, New York, NY, USA;4Mount Sinai Sch of Med, New York, NY, USA
Program Abstract
Ritonavir-boosted lopinavir (LPV/r) is recommended as the first line regimen for HIV-infected children but has limitations for long term use. A randomized clinical trial was undertaken in Johannesburg, South Africa to evaluate the safety and efficacy of pre-emptive switching to efavirenz (EFV) vs. remaining on LPV/r in children initially suppressed on LPV/r. The primary results of the trial have been previously reported but here we investigate whether the switch to EFV is associated with beneficial outcomes in terms of bone development. HIV infection affects bone accrual but there are limited data on how to optimize antiretrovirals to improve bone outcomes in children.
220 HIV-infected children aged 5-10 years (mean 6.4) were enrolled 1-4 years (mean 2.1) after randomization in the trial. 180 similarly-aged HIV-uninfected children were recruited at the same site in Johannesburg for comparison. Physical activity (PA) and dietary intake were assessed by questionnaire. Bone mineral content (BMC), fat mass, and lean body mass of the whole body (WB) were was assessed by DXA (Hologic Discovery W). Sex-specific BMC-for-height Z-scores for the infected children were generated using the BMC-for-height distribution of the uninfected controls. Children with HIV currently receiving EFV were compared to those on LPV/r. Results were adjusted for age, fat mass, lean mass, vigorous PA, and dietary vitamin D and calcium, CD4, and viral load. Analyses were also stratified by sex. Intent-to-treat analyses based on the original assigned regimen were also done.
Among HIV-infected children 110 were on EFV and 110 LPV/r at the time of assessment. All children were also on 2 NRTIs, including 3TC and ABC, AZT, or d4T. None were on TDF. The BMC Z score was -0.49 in the EFV group and -1.07 in the LPV/r group. This association remained significant (p<0.001) and of a similar magnitude (Z-score difference 0.58) after adjustment for age, fat mass, lean mass, vigorous PA, dietary vitamin D and calcium, CD4, and viral load. Sex-stratified analysis showed similar size effects in both boys and girls. In intent-to-treat analyses based on the originally assigned regimen, results were similar. Higher fat and lean body mass were also independently associated with better bone mass outcomes.
Accrued bone mass is positively associated with switching to EFV-based ART (compared to remaining on LPV/r). Use of bone friendly drugs may be beneficial for bone health in children with HIV.
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