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Pitavastatin safe, effective when coadministered with lopinavir/ritonavir
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No significant interactions were observed when pitavastatin was coadministered with lopinavir/ritonavir in healthy adult volunteers, according to data presented at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Rome.
Compared with pivastatin alone, the geometric mean ratio was 80 for pitavastatin area under the concentration time curve (90% CI, 73.4-87.3) and 96.1 for pitavastatin maximum concentration with lopinavir/ritonavir (90% CI, 83.6-110.4).
In the phase 4, single-center, open-label, fixed-sequence, two-way drug-drug interaction study, the researchers investigated the pharmacokinetic interaction of lopinavir/ritonavir on pitavastatin among 23 otherwise healthy adult participants with HIV.
Researchers administered a once-daily 4 mg oral dose of pitavastatin on days 1 through 5, and days 20 through 24; 400 mg/100 mg of lopinavir/ritonavir was administered twice-daily on days 9 through 24.
Pharmacokinetic sampling performed on days 5, 19 and 24 indicated a geometric mean ratio of 91.1 (90% CI, 85.7-96.8) for lopinavir area under the concentration time curve, 92.8 (90% CI, 87.8-98.1) for lopinavir maximum concentration, 88.9 (90% CI, 80.5-98.1) for ritonavir area under the concentration time curve, 89 (90% CI, 79.5-99.7) for ritonavir maximum concentration, with pitavastatin vs. lopinavir or ritonavir alone, according to the report. No significant adverse events were reported.
For more information:
- Morgan R. #MOPE170. Presented at: The 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention; July 17-20, 2011; Rome.
HMG Co-A reductase inhibitors (ie, statins) are first-line therapy for reducing LDL cholesterol, however drug interactions are a major concern with statins and antiretroviral medications in persons with HIV. Pitavastatin is minimally metabolized by cytochrome P450 enzymes, so it has less potential for cytochrome P450-mediated drug interactions with HIV drugs. When administered with the HIV protease inhibitor, lopinavir/ritonavir, exposures of the primary pitavastatin metabolite (an inactive lactone) were reduced 58%, however, exposures of pitavastatin itself were reduced only 20%. This indicates that pitavastatin can be safely administered with lopinavir/ritonavir.
– Jennifer Kiser, PharmD
University of Colorado Denver
Disclosure: Dr. Kiser reports no relevant financial disclosures.
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