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Once-Daily Darunavir Sufficient to Suppress HIV in Treatment-Naive Patients: Presented at CROI By Ed Susman BOSTON, MA -- February 5, 2008 -- Once-daily dosing of the protease inhibitor darunavir provides sufficient bloodstream concentrations of the antiretroviral to maintain suppression of wild-type HIV, researchers reported here at the 15th Conference on Retroviruses and Opportunistic Infection (CROI). "The median darunavir trough concentration was 37-fold greater than the half maximal effective concentration (EC50) value," said study investigator Vanitha Sekar, PhD, Researcher, Tibotec Inc., Yardley, Pennsylvania. In a poster presentation on February 5, Dr. Sekar said the EC50 required to suppress wild-type HIV was 55 ng/mL. In the Antiretroviral Therapy with TMC114 Examined in Naive Subjects (ARTEMIS) trial, the median trough level of patients on once-daily darunavir was 2041.2 ng/mL. Dr. Sekar, who analyzed the pharmacokinetics and pharmacodynamics of darunavir in the trial, said the trough levels for the new protease inhibitor ranged from 368 to 7,242 ng/mL. Of the 343 patients enrolled in the study, the quantity of sampling data available on 335 patients was sufficient to conduct the analyses. In the ARTEMIS trial, about 84% of patients who were dosed with darunavir 800 mg boosted with ritonavir 100 mg achieved undetectable viral loads using the 50-copies/mL assay. Darunavir was compared with lopinavir/ritonavir 800 mg/100 mg. About 78% of the patients on lopinavir achieved undetectable viral loads. In the study, Dr. Sekar found that once-daily darunavir was effective and had a favorable toxicity profile. She said patients in the 48-week study were able to reduce viral loads by greater than 3log10. Prezista is approved for treatment of HIV infection in treatment-experienced individuals at a dose of 600 mg/100 mg. The study was aimed at expanding the use of the drug as well as increasing its dosage. Funding for the study was provided by Tibotec. [Presentation title: Pharmacokinetic/Pharmacodynamic Analyses of Once-Daily Darunavir in the ARTEMIS Study. Abstract 769] E-mail this page to a friend or colleague! To print, use this version