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Health Canada Approves Darunavir for Children, Adolescents With HIV NEW YORK -- February 9, 2010 -- Health Canada has approved darunavir (Prezista) twice daily in combination with ritonavir and other antiretroviral agents for children aged 6 to 18 years with HIV. “Growing up with HIV impacts a child’s physical health and their social, emotional, and cognitive development,” said Christos Karatzios, MD, Infectious Disease, Montreal Children’s Hospital, Montreal, Quebec. “It is encouraging that we can now offer [darunavir] as part of a combination therapy to a patient population that traditionally has had fewer treatment options than adults.” The approval for darunavir in children was based on data from the open-label, phase 2 Darunavir Evaluation in Pediatric HIV-1-Infected Treatment-Experienced Patients (DELPHI) trial. The study evaluated the pharmacokinetics, safety, tolerability, and efficacy of darunavir twice daily in combination with other antiretrovirals in treatment-experienced children and adolescents aged 6 to 18 years with HIV. Virologic response was evaluated at week 24 and was defined as a decrease in plasma HIV-1 RNA of at least 1 log10 versus baseline. At week 24, 74% of patients had at least 1 log10 HIV-1 RNA decrease from baseline. The proportion of paediatric patients reaching undetectable viral load (<50 HIV-1 RNA copies/mL) was 50%. The mean CD4+ cell count increase from baseline was 117 cells/mm3. The most common side effects (>= 2%) were vomiting (12.5%), diarrhoea (11.3%), and abdominal pain (10%). Frequency type and severity of adverse drug reactions in the paediatric patient population were comparable to those observed in adults. SOURCE: Johnson&Johnson E-mail this page to a friend or colleague! To print, use this version