Darunavir (Prezista) has received European approval for patients starting HIV treatment.
The European licence for the drug had previously restricted its use to patients with previous experience of HIV treatment. Darunavir/ritonavir is already approved for use by treatment-naive patients in the US.
For patients starting combination HIV treatment, the approved dose of darunavir is 800mg boosted by 100 mg of ritonavir (Norvir), once daily with food.
Approval for the use of darunavir/ritonavir by people starting HIV treatment was based upon the results of the ARTEMIS study. This was an open-label trial that compared the safety and efficacy of darunavir/ritonavir-based treatment with HIV therapy based on Kaletra in patients starting HIV treatment. This study showed that darunavir/ritonavir was no less effective than Kaletra (with 84% of darunavir/ritonavir-treated patients having a viral load below 50 copies/ml after 48 weeks, compared to 78% of those who received Kaletra).
For treatment-experienced patients, the dose of darunavir is 600mg with 100mg of ritonavir, twice daily with food. Darunavir is not recommended for patients with liver problems.
Darunavir/ritonavir was not approved for use by treatment-naive patients when the latest edition of UK HIV treatment guidelines went to press. However, the guidelines anticipated that the marketing approval of the drug was likely to change and state that it is an option for patients who initiate antiretroviral therapy with a protease inhibitor-based regimen.