To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Boosted Lopinavir Safe and Tolerable in Once-Daily Dosing and in Tablet Formulation: Presented at CROI URL: http://www.pslgroup.com/dg/21C86A.htm Doctor's Guide February 5, 2008
By Maria Bishop BOSTON, MA -- February 5, 2008 -- Patients with HIV infection taking lopinavir coformulated with ritonavir (LPV/r) can switch safely from 3 capsules twice daily to a 4 tablets once daily without increasing the risk of adverse effects, according to researchers reporting here at the 15th Conference on Retroviruses and Opportunistic Infections (CROI). During the first 48 weeks of treatment in an ongoing 96-week, phase 3 study, no clinically important differences were identified in the safety and tolerability of once-daily versus twice-daily dosing of the protease inhibitor, according to the researchers. The study, which was presented on February 4, was led by Joseph Gathe Jr., MD, Clinical Instructor, Department of Internal Medicine, Baylor College of Medicine, and president of Therapeutic Concepts, P.A., Houston, Texas. According to researchers, LPV/r was initially approved as a twice-daily soft-gel capsule formulation that required refrigeration. The standard daily dose of LPV/r of 6 capsules (800/200 mg) needed to be taken with food. The tablet formulation, by contrast, requires only 4 tablets daily, with no need for refrigeration, and can be consumed with or without food. Overall, 664 antiretroviral-naive subjects were enrolled in this multicenter, international study. All had HIV-1 RNA levels of 1000 copies/mL or greater. The 4-arm study randomized subjects on a 1:1:1:1 basis to the following cohorts for 8 weeks: once-daily soft-gel capsules; twice-daily soft-gel capsules; once-daily tablets; or twice-daily tablets. At week 8, all subjects receiving soft-gel capsules were switched to the tablet formulation while maintaining their same randomized dosing schedule. All subjects also received emtricitabine 200 mg once daily and tenofovir disoproxil fumarate 300 mg once daily. Subjects were evaluated every 2 weeks through week 16, then every 8 weeks through week 48. From week 48 through week 96, subjects were evaluated every 12 weeks. The primary efficacy analysis (intention to treat, noncompliance equals failure) demonstrated that 77% of subjects on once-daily treatment and 76% of those on twice-daily treatment achieved a viral load of less than 50 copies/mL. Sensitivity analysis showed an estimated difference in response rates of 1% (95% confidence interval). In previous studies, the subjects on once-daily dosing experienced higher rates of diarrhea, but at the interim analysis of this current study, significant differences in rates of diarrhea were not observed between treatments during direct comparison (15% rate of diarrhea for the twice-daily group and 17% for the once-daily group). The rates of other adverse events were also similar between the 2 groups. Patients have previously noted a preference for the tablet formulation, and this study proved similar. Questionnaire data after the switch overwhelmingly demonstrated that patients preferred the tablets to the soft-gel capsules at a rate of 75% in the once-daily group and 80% in the twice-daily group. Only 3% in the once-daily group preferred the capsules and only 5% in the twice-daily group preferred them. [Presentation title: Study M05-730 Primary Efficacy Results at Week 48: Phase 3, Randomized, Open-label Study of Lopinavir/ritonavir Tablets Once Daily Vs Twice Daily), Co-Administered With Tenofovir DF + Emtricitabine in ARVl-Naive HIV-1-infected Subjects. Abstract 775] --------------------------------------------------------------------------------------------- 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.