The protease inhibitor darunavir (Prezista) boosted with low-dose ritonavir has been approved in the United States for use in treatment-naïve people with HIV as part of a first-line anti-HIV regimen, in combination with other antiretroviral drugs.
Prezista has been approved by the US Food and Drug Administration for once-daily use on the basis of results from the Artemis study, which showed that patients randomised to receive darunavir/ritonavir had a non-inferior virological response after 48 weeks compared to those randomised to receive lopinavir/ritonavir. However those who started treatment with a viral load above 100,000 copies were significantly more likely to achieve a sustained undetectable viral load if they received darunavir/ritonavir.
Prezista will be dosed as two 400mg tablets once daily, in combination with a 100mg dose of ritonavir. The new 400mg tablets will become available in the United States on November 1st, manufacturer Tibotec said today in a press release. For treatment-experienced adult patients, the dosing for Prezista remains 600mg taken with 100mg ritonavir twice daily.
Ortiz R et al. Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1-infected patients at week 48. AIDS 22(12):1389-97, 2008.