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PREZISTA(R) Now Available for Pediatric Patients Six Years of Age and Older as part of HIV Combination Therapy
Date:2/11/2009

ntiretrovirals in 80 antiretroviral treatment-experienced HIV-1-infected pediatric subjects 6 to <18 years of age and weighing at least 44 lbs (20 kg). Virologic response rate was evaluated at week 24.

Virologic response was defined as a decrease in plasma HIV-1 RNA viral load of at least 1 log10 versus baseline. The mean baseline plasma HIV-1 RNA was 4.64 log10 copies/mL, and the median baseline CD4+ cell count was 330 cells/mm3 (range: 6 to 1505 cells/mm3). Most pediatric subjects (79 percent) had previous use of at least one NNRTI and 96 percent of pediatric subjects had previously used at least one protease inhibitor PI.

Pediatric subjects who were at risk of discontinuing therapy due to intolerance of the ritonavir oral solution (e.g., taste aversion) were allowed to switch to the capsule formulation. Of the 44 pediatric subjects taking ritonavir oral solution, 23 subjects switched to the 100 mg capsule formulation and exceeded the weight-based ritonavir dose without changes in observed safety.

At week 24, 74 percent of subjects had at least 1 log10 HIV-1 RNA decrease from baseline. The proportion of pediatric subjects reaching undetectable viral load (<50 HIV-1 RNA copies/mL) was 50 percent, and the proportion of pediatric subjects with <400 HIV-1 RNA copies/mL was 64 percent. The mean change in plasma HIV-1 RNA from baseline was -1.98 log10 copies/mL. The mean CD4+ cell count increase from baseline was 117 cells/mm3.

Important Safety Information

PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

Drug Interactions

  • Coadministration of PREZISTA/r is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (eg, dihydroergotamine, ergonovine, ergotamine,
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SOURCE Tibotec Therapeutics
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