Eli Lilly Announces New Data Showed Minimal Potential for Drug Interaction Between Cholesterol Drug LIVALO and a Common Antiretroviral Therapy

Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company LLY earlier today released new study results that investigated the potential interaction of cholesterol drug LIVALO (pitavastatin) 4 mg in healthy volunteers taking the protease inhibitor combination lopinavir/ritonavir, a fixed dose combination drug for the treatment of HIV infection. Protease inhibitors are commonly used antiretroviral HIV medications. The study, presented at the 6th International AIDS Society 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.