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Long-Term Results With Vicriviroc Show Decreasing Evidence of Malignancy: Presented at ICAAC/IDSA By Ed Susman WASHINGTON, DC -- October 30, 2008 -- A signal of malignancies seen in early studies of the CCR5 antagonist vicriviroc in treatment of HIV-infected patients appears to be diminishing as longer-term results in greater numbers of patients are examined, researchers stated here at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and Infectious Diseases Society of America (IDSA) 46th Annual Meeting. "What appeared to be a troubling signal now appears to be a fluke," said Lisa Dunkle, MD, Schering-Plough Research Institute, Kenilworth, New Jersey, speaking at her poster presentation here on October 26. Dr. Dunkle and her fellow researchers scrutinised the safety of vicriviroc when, by June of 2006, the rate of malignancy was 6 per 100 person-years. Dr. Dunkle said that as more patients were enrolled in vicriviroc studies and long-term use increased, however, the signal of harm has continued to decrease. As of June 2008, the rate had dipped to less than 3 per 100 person-years of use, Dr. Dunkle noted. Currently, 205 patients have been treated with vicriviroc and have accumulated more than 600 person-years of use. "These data represent the longest treatment duration and clinical experience reported to date for a CCR5 antagonist," Dr. Dunkle noted. The team also reported that the 2 log10 drop in viral load seen with vicriviroc treatment after 48 weeks has been maintained as far as 192 weeks. CD4-positive cell counts, a measure of immune system recovery, continue to increase as well. After 48 weeks, the CD4-postive counts were increased about 110 cells/mm3, but after 192 weeks the increase from baseline was about 160 cells/mm3. "Vicriviroc 30 mg taken once a day as part of an antiretroviral regimen containing a protease inhibitor boosted by ritonavir provides durable suppression of HIV and elevation of CD4-positive cells," Dr. Dunkle concluded. "Vicriviroc therapy has excellent tolerability and is not associated with hepatotoxicity, seizures, or ischaemic cardiovascular events," she added. [Presentation title: Long Term Vicriviroc Safety. Abstract H-1269] E-mail this page to a friend or colleague! To print, use this version