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PHARMACOKINETICS

Lopinavir/Ritonavir Pharmacokinetics in a Substitution of High-Dose Soft-Gelatin Capsule to Tablet Formulation

Mark W. Hull, MD, MHSc, Marianne Harris, MD, Viviane Lima, PhD, Silvia Guillemi, MD, P. Richard Harrigan, PhD and Julio S. G. Montaner, MD

From the Canadian HIV Trials Network, Vancouver, Canada (Drs Hull, Harris, and Montaner); BC Centre for Excellence in HIV/AIDS, Vancouver, Canada (Drs Hull, Lima, Guillemi, Harrigan, and Montaner); and University of British Columbia, Vancouver, Canada (Drs Lima, Guillemi, Harrigan, and Montaner).

Guidelines recommend that when soft-gelatin capsules of lopinavir/ritonavir are co-administered with CYP3A4-inducing agents, doses should be increased to 4 capsules (533 mg/133 mg) twice daily. No evidence is available to guide dosing of lopinavir/ritonavir in tablet formulation in this setting. A single-center study is conducted to compare the pharmacokinetics of high-dose lopinavir/ritonavir in 34 patients on stable HAART regimens including 4 soft-gelatin capsules twice daily who then switch to 3 tablets (600 mg/150 mg) twice daily. Median Cmin on soft-gelatin capsule and tablets is 4700 ng/mL (interquartile range [IQR] 2310, 6000 ng/mL) and 5640 ng/mL (IQR 4290, 8080 ng/mL), respectively, for those on inducing agents (n = 17). For patients not on inducing agents (n = 17), median Cmin on soft-gelatin capsule and tablets is 5170 ng/mL (IQR 3640, 6210 ng/mL) and 5640 ng/mL (IQR 4290, 8080 ng/mL), respectively. Among treatment-experienced patients on lopinavir/ritonavir capsules 533/133 mg twice daily, a switch to tablets 600/150 mg twice daily produces comparable pharmacokinetics, regardless of whether they receive concomitant CYP3A4-inducing antiretroviral agents.

Key Words: Lopinavir-ritonavir • pharmacokinetics • cytochrome P450 inducers

Address for reprints: Julio S. G. Montaner, MD, BC Centre for Excellence in HIV/AIDS, 667-1081 Burrard Street, Vancouver BC V6Z 1Y6 Canada; e-mail: jmontaner{at}cfenet.ubc.ca.


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