To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Once-Daily Darunavir Sufficient to Suppress HIV in Treatment-Naive Patients: Presented at CROI URL: http://www.pslgroup.com/dg/21C86E.htm Doctor's Guide February 5, 2008
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] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.