MONTGOMERY, Ala. and INDIANAPOLIS, July 18, 2011 /PRNewswire/ -- Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company (NYSE: LLY) today released new study results that investigated the potential interaction of cholesterol drug LIVALO (pitavastatin) 4 mg in healthy volunteers taking the protease inhibitor (PI) combination lopinavir/ritonavir, a fixed dose combination drug for the treatment of HIV infection.(1) Protease inhibitors are commonly used antiretroviral HIV medications.(2) The study, presented at the 6th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Rome, Italy, found that when co-administered, the individual drug blood levels for LIVALO or each of the PIs was minimally affected. Based on these data from this FDA-mandated phase IV study, the United States Food and Drug Administration recently approved a labeling change to delete the lopinavir/ritonavir limitation of use from the U.S. LIVALO labeling.
"HIV is a chronic illness today, as opposed to 30 years ago, and patients with HIV are faced with additional challenges concerning dyslipidemia, accentuated by both the disease process as well as antiretroviral therapies. Additionally, these patients are frequently on multiple medications and the management of dyslipidemia can be even more of a challenge. We are pleased with the results of this study and the absence of a significant drug interaction when LIVALO is co-administered with this combination of protease inhibitors," said Craig Sponseller, MD, Vice President of Medical Affairs, Kowa Pharmaceuticals America, Inc.
The study was designed to assess the pharmacokinetic (PK) interaction, or effect on overall exposure in the body, of th