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New Data Showed Minimal Potential for Drug Interaction Between Cholesterol Drug LIVALO® and a Common Antiretroviral Therapy
Date:7/18/2011

e combination lopinavir/ritonavir on the PK of LIVALO, and secondarily any potential PK effect of LIVALO on lopinavir and ritonavir.(3)  LIVALO (4 mg) and lopinavir/ritonavir (800 mg/200 mg) were co-administered in 24 healthy, adult volunteers over a 24 day period.  At study end, peak exposure of pitavastatin at steady state, as measured by C(max), was not affected by co-administration of lopinavir/ritonavir. Total exposure of pitavastatin at steady state, as measured by AUC(0-T), was weakly affected by co-administration of lopinavir/ritonavir (decrease of approximately 20%). C(max) and AUC(0-T) of lopinavir and ritonavir at steady state were marginally affected by co-administration of pitavastatin. These effects were not considered to be clinically significant.(4)

A second objective of the study was to investigate any potential effect on the safety of LIVALO by the addition of lopinavir/ritonavir. No significant safety issues were observed. Eighteen of 24 patients reported at least one treatment emergent adverse event (TEAE), with the highest percentage coming from subjects receiving lopinavir/ritonavir only. All TEAEs were mild in severity, except for four subjects who had TEAEs after lopinavir/ritonavir only that were moderate in severity.  One subject was discontinued from the study because of an adverse event (AE) of diarrhea during treatment with lopinavir/ritonavir only. There were no severe AEs, SAEs, or deaths.(5)

"This study is important to caregivers and patients alike, as LIVALO showed minimal drug-drug interactions with a common antiretroviral therapy HIV patients need to fight the disease. For a patient population that is taking multiple medications, this is exciting news," said Dr. Judith Aberg, Director of Virology, Bellevue Hospital Center and Director, Division of Infectious Diseases and Immunology, NYU School of Medicine.  

Elevated cholesterol, particularly the "bad" cholesterol, low density lipoprot
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SOURCE Kowa Pharmaceuticals America, Inc.
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