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.
(Logo: http://photos.prnewswire.com/prnh/20100621/NY23523LOGO)
“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
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