3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

LPV/R (KALETRA®) IN CHILDREN YOUNGER THAN 24 MONTHS — RAPID DECREASE IN VIRAL LOAD AND STABLE CD4 COUNTS DESPITE VERY LOW PLASMA LEVELS

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. MoPe9.2C10

Königs C.¹, Dunsch D.¹, von Hentig N.², Kurowski M.³, Linde R.¹, Kreuz W.^1
1Goethe University, Department fo Pediatrics, Frankfurt, Germany, ²Goethe University, Department fo Pharmacology, Frankfurt, Germany, ³HIV-Lab, Berlin, Germany

Available antiretroviral drugs offer a range of first-line therapies in HIV-1-infected individuals based on sufficient data. Nevertheless treating HIV-positive children is challenging. Many drugs are not available in adequate formulations and limited data is available on children younger than 2 years of age that are treated with a triple drug combination. Five children were followed for up to 18 months who started antiretroviral therapy before 2 years of age according to current guidelines (PAAD). The average age at start of therapy was 8,5 months (range: 1,5 to 22). All children received AZT, 3TC and LPV/r in liquid formulations. LPV/r was given at 230mg/m² twice daily. At baseline and monthly visits, virological and immunological parameters were assessed. At steady state, plasma levels of LPV/r were determined over a dosing interval of twelve hours. Viral load (VL) of 4/5 children was >1,000,000 cps/ml at baseline. After a 2 log decrease of VL within 2 to 4 weeks, VL decreased less rapidly and reached <100cps after 6 to 10 months with 1/5 below detection limit (<20cps/ml). CD4 counts remained stable for children who started therapy before a remarkable loss of peripheral CD4 cells, whereas immuno-compromised children showed an increase in CD4 cells from 23 to 36%. LPV/r plasma levels were lower than described for other age groups: the average minimal concentration was 1355ng/ml (1h after administration), the maximal concentration 2804ng/ml (3h after administration). After initial difficulties in drug administration due to the taste of LPV/r, all children got used to taste and tolerated the liquid formulation well. Using LPV/r in therapy regimens in children <24 months with very high viral loads leads to a rapid drop of viral load and increase in CD4 cell counts. Observed low plasma levels should give rise to further studies evaluating dose adjustment for children below two years of age.

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Clinical | MoPe9.2C10 | Christoph Königs
9.2 10 9.2 Paediatric treatment strategies

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