[MoPe9.2C21] Pharmacokinetics and 24 week safety and efficacy of Lopinavir/ritonavir (LPV/r) BID or QD as part of ART regimen in naïve children

3rd International AIDS Society Conference on HIV Pathogenesis and Treatment

Rio de Janeiro - July 24 - 27, 2005

PHARMACOKINETICS AND 24 WEEK SAFETY AND EFFICACY OF LOPINAVIR/RITONAVIR (LPV/R) BID OR QD AS PART OF ART REGIMEN IN NAïVE CHILDREN

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. MoPe9.2C21

Rosso R.¹, Di Biagio A.², Dentone C.¹, Bassetti M.², Ferrazin A.², Castelli Gattinara G.³, Viganò A.⁴, Giaquinto C.⁵, De Maria A.⁶, Bassetti D.¹
¹University of Genoa, Infectious Diseases, Genoa, Italy, ²San Martino Hospital, Infectious Diseases, Genoa, Italy, ³Bambin Gesù Children Hospital, Rome, Italy, ⁴L. Sacco Hospital, Milan, Italy, ⁵University of Padua, Padua, Italy, ⁶University of Genoa, Genoa, Italy

INTRODUCTION: The approved paediatric dose of LPV/r is 230/57.5 mg/m² twice daily (BID). A once-daily (QD) antiretroviral regimen including LPV/r may offer an advantage with regard to compliance while maintaining antiviral potency in ARV-naïve patients.

METHODS: We planned interim analysis at 24 weeks of ongoing, prospective, open label study at 3 Italian hospital with 29 pts protease inhibitor-naïve. They were treated with 2 NRTIs + LPV/r given BID or QD at 230/57.5 mg/m2 or 460/115 mg/m². Children were assessed to week 24. Median length of therapy with LPV/r at the time of blood sampling was 18.5 months (range 4 to 44). Blood samples were drawn at following times after a steady state dose of LPV/r: time 0, 1, 3, 4, and 6 hours. LPV/r plasma concentrations were determined with a validated HPLC methods.

RESULTS: Baseline median data were: age 9.25 years (3.5 to 14), weight 27,78 kg (range 14 to 48), body mass index 16.51 (7.68 to 21.64), 11 males, 4 Hispanic, 5 Black, and 20 Caucasian. Median viral load (VL) at baseline was 121,500 copies/mL (3900 to 1,900,000), CD4+ 450 cells/mm³ (4 to 1452), CD4+ 20% (1 to 35), triglycerides 91 mg/dL, total cholesterol (TotCHOL) 138 mg/dL. At week 24 median VL was 50 (50-1460), CD4+ 785 cells/mm³ (250-2042), CD4+ 29% (14-36). Significant rises of triglycerides and TotCHOL were seen with median change of 58 and 54 mg/dL respectively (p=0.01). Of the 29 children, 7 received the QD dose. C_min results were lower with QD regimen than BID (p<0.05).

CONCLUSIONS: The variability of pharmacokinetics parameters was extremely high. QD of LPV/r dosing regimen can achieve similar C_min and C_max concentrations observed in the BID pharmacokinetics studies. Significant improvement in CD4+ and VL were observed. LPV/r regimen was well tolerated and produced encouraging virologic and immunologic responses also in QD regimen.

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050724
Clinical | MoPe9.2C21 | Raffaella Rosso
9.2 21 9.2 Paediatric treatment strategies

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