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First published on July 5, 2007, doi:10.1177/0091270007302564

The Journal of Clinical Pharmacology 2007;47:970.

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©© 2007 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology , 10.1177/0091270007302564

Article

Lopinavir/Ritonavir Pharmacokinetic Profile: Impact of Sex and Other Covariates Following a Change From Twice-Daily to Once-Daily Therapy

Ighovwerha Ofotokun 1*, Susan K. Chuck 2, Jose N. Binongo 3, Mauricio Palau 1, Jeffrey L. Lennox 1, and Edward P. Acosta 4

1 Emory University School of Medicine
2 Abbott Laboratories
3 Emory University Rollins School of Public Health
4 University of Alabama at Birmingham

* To whom correspondence should be addressed. E-mail: iofotok{at}emory.edu.


  Abstract
The aim of this study was to determine the impact of sex on the pharmacokinetics of lopinavir/ritonavir. Interaction between lopinavir/ritonavir and tenofovir was also evaluated. Steady-state plasma samples were obtained from virologically suppressed HIV-infected patients on lopinavir/ritonavir 800/200-mg soft gel capsule taken once daily. Drug assays were performed by high-performance liquid chromatography. Pharmacokinetic parameters estimated by noncompartmental method were reported as 90% confidence intervals (CIs) about the geometric mean ratio (GMR). There were 9 males and 11 females. No sex differences were observed in lopinavir/ritonavir pharmacokinetics profile. The GMRsex (women compared with men) for lopinavir area under the concentration-time curve (AUC24), maximum concentration (Cmax), and minimum concentration (Cmin) was 0.95 (90% CI, 0.70-1.29), 0.88 (90% CI, 0.67-1.15), and 1.27 (90% CI, 0.60-2.66), respectively. Similarly, the GMRsex for ritonavir AUC24, Cmax, and Cmin was 0.84 (90% CI, 0.57-1.24), 0.79 (90% CI, 0.50-1.22), and 1.02 (90% CI, 0.58-1.80), respectively. Tenofovir coadministration led to a reduction in lopinavir/ritonavir plasma exposure, giving a lopinavir GMRtenofovir for Cmax of 0.72 (90% CI, 0.57-0.93) and AUC24 of 0.74 (90% CI, 0.56-0.98), respectively. No difference in lopinavir/ritonavir plasma concentrations between sexes was demonstrated in this study. However, tenofovir coadministration lowered lopinavir/ritonavir plasma exposure.
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