Tibotec Therapeutics announced that the FDA has approved an updated label for Prezista (darunavir tablets) which includes 96-week data from the ARTEMIS and TITAN studies. Both ARTEMIS and TITAN studies evaluated Prezista with ritonavir versus lopinavir/ritonavir in combination with other antiretrovirals (ARVs) for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adult patients, respectively.
At 96 weeks, Prezista was shown to be non-inferior to lopinavir/ritonavir. The ARTEMIS and TITAN 96-week study data showed that 78% and 58%, respectively, of patients in the Prezista/ritonavir arm reached an undetectable viral load compared to 74% and 52%, respectively, of patients in the lopinavir/ritonavir arm.
Prezista is indicated for the treatment of HIV infection in combination with ritonavir and with other antiretroviral agents.
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