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| |  Darunavir/Ritonavir Achieves Superiority Over Lopinavir/Ritonavir in Suppressing Human Immunodeficiency Virus: Presented at ICAAC/IDSA By Ed Susman WASHINGTON, DC -- October 28, 2008 -- Darunavir/ritonavir in combination with other anti-human immunodeficiency virus (HIV) drugs achieved superiority over a lopinavir/ritonavir-based therapy among treatment-naïve patients, according to trial results presented here at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and Infectious Diseases Society of America (IDSA) 46th Annual Meeting. "Once-daily darunavir/ritonavir offers a new, effective, well tolerated, once-daily, first-line treatment option for treatment-naïve patients," said lead investigator Anthony Mills, MD, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California. The phase 3, randomised, open-label Antiretroviral Therapy With TMC114 Examined in Naïve Subjects (ARTEMIS) trial is a 192-week study comparing the efficacy and safety of the protease inhibitors darunavir/ritonavir and lopinavir/ritonavir. In total, 689 subjects were enrolled: 343 were assigned to receive darunavir/ritonavir and 346 were administered lopinavir/ritonavir. Subjects were treated additionally with a fixed dose of the nucleoside reverse transcriptase inhibitor emtricitabine and the nucleotide reverse transcriptase inhibitor, tenofovir disoproxil fumarate. "Once-daily darunavir/ritonavir 800/100 mg proved noninferior, as well as statistically superior, to lopinavir/ritonavir in treatment-naïve patients," stated Dr. Mills, speaking here at a poster presentation on October 26. At 96 weeks, 79% of adults taking the darunavir combination achieved an undetectable viral load, measured by the 50 copies/mL assay at week 96, compared with 71% of patients taking lopinavir/ritonavir 800/200 mg once daily (P = .012). The 96-week data revealed that the most benefit from treatment with darunavir was achieved by patients with higher viral loads -- above 100,000 copies/mL -- and with lower CD4-postive counts, noted Dr. Mills. Once-daily darunavir/ritonavir also resulted in fewer discontinuations due to adverse events compared with lopinavir/ritonavir, Dr. Mills noted. The darunavir-based combination was associated with lower rates of diarrhoea and smaller mean increases in triglycerides and total cholesterol. Funding for the ARTEMIS study was supported by Tibotec Therapeutics, a division of Ortho Biotech Products, LP. [Presentation title: ARTEMIS: Efficacy and Safety of Darunavir/Ritonavir (DRV/r) 800/100 mg Once-Daily Vs Lopinavir/Ritonavir (LPV/r) in Treatment-Naïve, HIV-1-Infected Patients at 96 Weeks. Abstract H-1250c]
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