Invirase Tablet

Kaletra Tablet

The aim of the current study, published in the May 22, 2008 online issue of Pediatric Infectious Disease Journal, was to assess the 48-week efficacy, safety, pharmacokinetics, and resistance of the double-boosted protease inhibitor (PI) regimen of saquinavir (Invirase) and lopinavir/ritonavir (Kaletra) in children who experienced treatment failure on prior nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) and non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens.

In this trial, 50 children at 2 sites in Thailand were treated with standard doses of saquinavir and lopinavir/ritonavir. At baseline, the median age was 9.3 years, median viral load was 4.8 log10, and median CD4 cell percentage was 7%. Centers for Disease Control and Prevention (CDC) disease classification was N: 4%; A: 14%; B: 68%; and C: 14%,

CD4 cells, HIV RNA viral load, plasma drug concentrations, and laboratory safety evaluations were monitored. Virological failure was defined as having 2 consecutive viral load measurements > 400 copies/mL after week 12 of therapy. Intention to treat analysis was performed.

Results

The authors concluded that double-boosted saquinavir/lopinavir/ritonavir "resulted in significant CD4 rise and viral load decline at 48 weeks." They added that hyperlipidemia was common and, further, that the Cmin of both PIs "exceeded therapeutic concentrations."

They added that, poor adherence caused treatment failure in 10% of the participants. Finally, they stated, "No major PI mutations were found."

Khon Kaen University, Khon Kaen, Bangkok, Thailand; HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok, Thailand; Radboud University Nijmegen Medical Center, Netherlands; Chulalongkorn University, Bangkok, Thailand; South East Asia Research Collaboration with Hawaii (SEARCH), Bangkok, Thailand; Roche, Nutley, NJ.

6/10/08

Reference

P Kosalaraksa, T Bunupuradah, C Engchanil, and others (HIV-NAT 017 Study Team). Double boosted protease inhibitors, saquinavir, and lopinavir/ritonavir, in nucleoside pretreated children at 48 weeks. Pediatric Infectious Disease Journal. May 22, 2008 (Epub ahead of print).

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