The Food and Drug Administration (FDA) has approved updated labeling for Intelence (etravirine; Janssen) to include treatment-experienced pediatric patients 2 to <6 years of age weighing ≥10kg for the treatment of HIV-1 infection, in combination with other antiretrovirals. Previously, this antiretroviral agent was approved only for patients ≥6 years of age.
The approval of Intelence for this patient population was based on an open-label, single arm trial (N=20) which showed that the safety and efficacy of etravirine + an optimized background regimen (ritonavir-boosted protease inhibitor in combination with 1 or 2 NRTIs [N=14] and/or combination with an integrase inhibitor [N=7]) was comparable to that observed in adults. Study patients had a history of virologic failure while on an antiretroviral regimen, with confirmed HIV-1 RNA plasma viral load >1000 copies/mL and with no evidence of phenotypic resistance to etravirine at screening.
At the Week 24 analysis, 88% of patients (15/17) had <400 HIV-1 RNA copies/mL; for those with available data, 50% of patients (7/14) had <50 HIV-1 RNA copies/mL. The median change from baseline in plasma HIV-1 RNA at Week 24 was -2.14 log10 copies/mL, with a median CD4+ percentage increase of 5%.
Intelence, an NNRTI, is supplied in 25mg, 100mg, and 200mg tablets. The tablets may be dispersed in a glass of water for patients unable to swallow them.
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