MK-0518, Experimental Integrase Inhibitor from Merck, Shows Significant Potency in HIV Patients with Triple-class Resistant Virus MK-0518 is a novel and potent HIV-1 integrase inhibitor. Integrase inhibitors are a new class of anti-HIV drugs that have shown early promise in the treatment of HIV infection. MK-0518 from Merck is the integrase inhibitor that is in the most advanced stage of development. The current study was a multi-center, double-blind, dose-ranging, randomized study to evaluate safety and efficacy of oral MK-0518 vs. placebo, each plus optimized background therapy (OBT) in HIV-infected patients with HIV RNA > 5000 copies/mL and documented resistance to 3 classes of oral antiretroviral therapies (ARTs). Patients were monitored for safety and antiretroviral effect. Results This pre-planned analysis includes 178 patients. Median duration for prior ARTs was ~9 years. Mean baseline HIV RNA was 4.7 log10 copies/mL. Efficacy data (Non-completers = Failure) are summarized:
According to the authors, for the 50 patients with no active ART in OBT, % achieving HIV RNA < 50 copies/mL at Week 24 was 46 (6/13), 62 (8/13), 54 (7/13) and 0 (0/11) for MK-0518 200, 400, 600 mg, and placebo groups, respectively. MK-0518 was generally well tolerated at all doses. The authors conclude, "In patients with limited treatment options, MK-0518 had superior antiretroviral activity vs control, and was generally well-tolerated." Evandro Chagas Clin Res Inst, Rio de Janeiro, Brazil, Merck & Co., Inc., West Point, PA, Hosp. Pitié Salpêtrière, Paris, France, Univ. of Barcelona, Barcelona, Spain, San Raffaele Sci. Inst., Milan, Italy, Hosp. Paul Brousse, Villejuif, France, NYU School of Medicine, New York, NY. 09-29-06 Reference HIV
and Hepatitis.com Articles on MK-0518 Free Access Opens to MK-0518, Experimental HIV Integrase Inhibitor from Merck Merck
Announces Interim Results from Phase II Study of MK-0518, an Investigational
Oral HIV Integrase Inhibitor
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