Health Canada Approves Darunavir for Pediatric Use

Yael Waknine

February 11, 2010

February 11, 2010 — Health Canada has approved darunavir (Prezista tablets, Janssen-Ortho, Inc) with ritonavir and other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients aged 6 to 18 years.

"Growing up with HIV impacts a child's physical health and their social, emotional and cognitive development," said Christos Karatzios, MD, infectious disease specialist, Montreal Children's Hospital, Canada, in a company news release. "It is encouraging that we can now offer Prezista as part of a combination therapy to a patient population that traditionally has had fewer treatment options than adults."

As with the US Food and Drug Administration (FDA) approval in December 2008, Health Canada's action was based on 24-week data from the open-label, phase 2 Darunavir EvaLuation in Pediatric HIV-1-Infected treatment-experienced patients (DELPHI) study of 80 patients aged 6 to 18 years and weighing at least 44 pounds (20 kg) who received darunavir in addition to background therapy consisting of at least 2 non–protease inhibitor antiretroviral drugs.

Study results showed that 74% of patients achieved virologic response, defined as a 1 log10 or more decrease in plasma HIV-1 RNA levels from baseline and corresponding to a 90% or greater decrease in viral load. Furthermore, 50% of patients demonstrated undetectable viral load (<50 copies/mL); the mean CD4+ cell count increase from baseline was 117 cells/mm3.

Adverse events most commonly reported included vomiting (12.5%), diarrhea (11.3%), and abdominal pain (10%). The safety profile of darunavir in the pediatric study was comparable to that observed in adults.

Safety labeling changes approved by the FDA in October 2008 warn that administration of ritonavir-boosted darunavir can alter the concentration of other drugs and vice versa; coadministration of dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, oral midazolam, triazolam, St. John's Wort, lovastatin, simvastatin, or rifampin is therefore contraindicated.

Because of the potential for drug-induced hepatitis, liver function should be monitored before and during therapy. Mild to severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been reported with darunavir therapy and require discontinuation of therapy. Caution is advised when treating patients with known sulfonamide allergy.

Other potential adverse events include new-onset diabetes mellitus/hyperglycemia, necessitating initiation or dose adjustments of insulin or oral hypoglycemic agents. Redistribution of body fat or immune reconstitution syndrome may also occur, and patients with hemophilia may develop increased bleeding events. Darunavir should not be used in pediatric patients younger than 3 years.

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