The protease inhibitor darunavir (Prezista) is to be made available to any treatment-experienced patient, the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use has recommended.
Prezista was previously indicated only for the treatment of HIV in combination with other antiretroviral medicines in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor. The drug should always be boosted with a 100mg dose of ritonavir.
It was originally licensed on the basis of results from the POWER study, a randomised comparison of darunavir/ritonavir with other ritonavir-boosted protease inhibitors in patients with experience of all three classes of antiretroviral drug available at the time the study began. Participants in this study had relatively high levels of protease inhibitor resistance.
A subsequent study, TITAN, compared darunavir/ritonavir to lopinavir/ritonavir (Kaletra) in treatment-experienced patients with less exposure to protease inhibitors, 82% of whom still had virus sensitive to at least four licensed protease inhibitors. This study showed that darunavir was superior to lopinavir/ritonavir in this population, with a lower rate of virological failure and a lower rate of new protease inhibitor resistance mutations after viral rebound among those who received darunavir.
These findings have now led the EMEA to extend the drug’s licensing terms so that it can be used by any treatment-experienced patient in the European Union.
Prezista was recently approved for use by people starting HIV treatment for the first time by the US Food and Drug Administration; a European license for first-line treatment is still under consideration.