H-718b Efficacy and safety of darunavir/ritonavir versus lopinavir/ritonavir in ARV treatment-naïve HIV-1-infected patients at Week 48: ARTEMIS DeJesus E,1 Ortiz R,1 Khanlou H,2 Voronin E,3 Van Lunzen J,4 Andrade-Villanueva J,5 Fourie J,6 De Meyer S,7 Haley M,8 Lefebvre E,9 Vanden Abeele C,7 Spinosa-Guzman S7 Orlando Immunology Center, Orlando, FL; 2AIDS Healthcare Foundation, Los Angeles, CA, USA; 3St Petersburg Republic Hospital of Infectious Disease, St Petersburg, Russian Federation; University Medical Center Hamburg Eppendorf, Infectious Diseases Unit, Hamburg, Germany; 5Hospital Civil de Guadalajara, Guadalajara, Mexico; 6Dundee, KZN, Republic of South Africa; 7 Tibotec BVBA, Mechelen, Belgium; 8Tibotec Inc., Yardley, PA, USA; 9Janssen-Cilag, Tilburg, The Netherlands 1 4 Address correspondence to: Edwin DeJesus, MD, Orlando Immunology Center, 1701 North Mills Avenue, Orlando, FL 32803, USA; Fax: +1 407 647 3426; E-mail: [email protected] vs 0 Dosing was based on regulatory approval; switch was made according to local regulatory approval and drug availability No significant changes in calculated creatinine clearance between baseline and Week 48 visits † Chi square analysis • – • – • – – – 36 • – – – • – – *Four deaths (1 in DRV/r group; 3 in LPV/r group) Table includes all data up to the point when the last patient reached week 48 Mean exposure was 56 weeks (range 0–83 weeks) *LPV/r arm included: LPV/r 400/100mg bid or 800/200mg qd, capsule and tablet formulations • • 100 90 80 70 60 50 40 30 20 †At 10 0 2 4 8 12 16 24 36 48 least possibly related to study drug, excluding laboratory-related events • No renal SAEs and no treatment discontinuations due to renal AEs Presented at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, USA, September 17–20 2007. This poster is available on-line at www.tibotec.com. : Waldo Belloso, Liiana Calanni, Lidia Cassetti, Luisa De Wouters, Marcelo Losso : Mark Bloch, David Cooper, Dominic Dwyer, Robert Finlayson, Julian Gold, Mark Kelly, Cassy Workman : Armin Rieger and Norbert Vetter : Nathan Clumeck, Jean-Christophe Goffard, Beatrjs Van der Gucht, Eric Van Wijngaerden : Joss Dewet, Don Kilby, Patrice Junod, Chris Tsoukas, Sharon Walmsley : Juan Ballesteros, Rebeca Northland : Gisela Herrera, Iris Perez : Jan Gerstoft, Lars Mathiesen, Henrik Nielsen : Micelle Bentata, Laurent Cotte, Pierre Dellamonica, Pierre-Marie Girard, Christine Katlama, Thierry Prazuck, Dominique Salmon, Patrick Yeni : Keikawus Arasteh, Gerd Fätkenheuer, FrankDetlef Goebel, Thomas Harrer, Hans Jaeger, Joerg-Andres Rump, Dieter Schuster, Albrecht Stoehr, Jan Van Lunzen : George Chrysos : Eduardo Arathoon, Carlos Mejia-Villatoro : Adriano Lazzarin, Anna Maria Orani : Christopher Lee : Jaime Andrade-Villanueva, Gustavo Reyes-Teran, Juan Sierra-Madero, Angelina Villasis-Keever : Amalio Rodriguez, Nestor Sosa : Javier Morales Ramirez, Carmen ZorrillaMaldonado : Natalia Dushkina, Oleg Kozyrev, Valeriy Kulagin, Alexander Pronin, Vladimir Rafalsky, Oleg Romanenko, Elena Vinogradova, Evgeniy Voronin, Alexey Yakovlev : Poh Lian Lim : Ezio Baraldi, Jan Fourie, Prudence Ive, Lerato Mohapi, Jennifer Pitt : Buenaventura Clotet, Pere Domingo : Milos Opravil : Jen-Hsien Wang, Su Pen Yang : Ploenchan Chetchotisakd, Winai Ratanasuwan, Kiat Ruxrungtham, Khuanchai Supparatpinyo : Martin Fisher, Mark Nelson, Chloe Orkin, Jonathan Weber : Ben Barnett, Alfred Burnside, Thomas Campbell, Philippe Chiliade, Amy Colson, Edwin DeJesus, Richard Elion, Walford Fessel, Lucia Flamm, Dushyantha Jayaweera, Peter Kadlecik, Homayoon Khanlou, Lucia Martinez, David McDonough, Anthony Mills, Karam Mounzer, Robert Myers, Jeffrey Nadler, Brian Onbirbak, Roberto Ortiz, Kristen Patterson, Daniel Pearce, Gerald Pierone, Jayashree Ravishankar, Afsoon Roberts, Barry Rodwick, Stefan Schneider, Michael Sension, Paul Skolnik, Aimee Wilkin, Michael Wohlfeiler, Bienvenido Yangco Supported by Tibotec