Influence of Ritonavir, and Lopinavir/ritonavir on fenofibrate pharmacokinetics

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All thirteen subjects have completed this pharmacokinetic study. Pharmacokinetic samples from this study are currently being analyzed; however, to date there are no results available. With regard to safety, one subject experienced Grade 3 transaminitis secondary to treatment with lopinavir/ritonavir (LPV/r) that resolved when the drug was withdrawn secondary to study completion. This resulted in 2 Serious Adverse Event reports to the IRB (including the follow-up report, explaining that the transaminitis resolved). Of note, we have had no repeat problems of marked transaminitis in our study subjects. One subject experienced Grade 1 indigestion and bloating; another experienced Grade 1 flushing and Grade 2 constipation; and a third subject experienced Grade 1 headache and anorexia. These adverse events were possibly related to the study medications. Lastly, one subject experienced a Grade 2 increase in total cholesterol (from 198 mg/dL at baseline to 275 mg/dL) that was noted at end-of-study safety labs and likely due to lopinavir-ritonavir administration. No other increases in cholesterol have been noted thus far in this study.