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

From the Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia (Dr Ofotokun, Mr Palau, Dr Lennox); Abbott Laboratories, Abbott Park, Illinois (Dr Chuck); Department of Biostatistics, Emory University Rollins School of Public Health (Dr Binongo); and Division of Clinical Pharmacology, University of Alabama at Birmingham, Alabama (Dr Acosta).

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 GMR_sex (women compared with men) for lopinavir area under the concentration-time curve (AUC₂₄), maximum concentration (C_max), and minimum concentration (C_min) 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 GMR_sex for ritonavir AUC₂₄, C_max, and C_min 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 GMR_tenofovir for C_max 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.

Key Words: Gender- or sex-related differences • lopinavir pharmacokinetics

Address for correspondence: Ighovwerha Ofotokun, MD, Department of Medicine, Division of Infectious Diseases, Emory University of Medicine, 69 Jesse Hill Jr Drive Atlanta, GA 30303.

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