The approval for Prezista was based on data from the Delphi trial. In the open-label, Phase 2 trial, the pharmacokinetics, safety, tolerability and efficacy of Prezista dosed twice daily in combination with other antiretrovirals in treatment-experienced HIV-1 infected pediatric patients, six to 18 years of age, weighing at least 44 pounds were analysed.
In the trial Virologic response was evaluated at week 24 and was defined as a decrease in plasma HIV-1 RNA (viral load) of at least 1 log10 (at least a 90% reduction in viral loads) versus baseline.
At week 24, 74% 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%. The mean CD4+ cell count increase from baseline was 117 cells/mm3.
Tibotec said that in the trial survival rates in children have improved as a result of effective treatment with combination antiretroviral therapy. While Prezista does not cure HIV infection or AIDS, or prevent a child from passing HIV to others, it may decrease the blood levels of HIV and thereby improve a child’s immune system and decrease the risk of secondary infections.
Christos Karatzios, infectious disease specialist at Montreal Children’s Hospital, said: “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.”
Prezista has been available for use in adults with HIV in Canada since 2006, and has proven to be effective in significantly reducing viral load and increasing CD4+ cell counts in adults living with HIV. Prezista dosing for children is different from adults; it is based on body weight.