Journal Article

Higher plasma lopinavir concentrations are associated with a moderate rise in cholestasis markers in HIV-infected patients

Elena Seminari, Gianluca Gentilini, Laura Galli, Hamid Hasson, Anna Danise, Elisabetta Carini, Fernanda Dorigatti, Armando Soldarini, Andriano Lazzarin and Antonella Castagna

in Journal of Antimicrobial Chemotherapy

Published on behalf of British Society for Antimicrobial Chemotherapy

Volume 56, issue 4, pages 790-792
Published in print October 2005 | ISSN: 0305-7453
Published online September 2005 | e-ISSN: 1460-2091 | DOI:
Higher plasma lopinavir concentrations are associated with a moderate rise in cholestasis markers in HIV-infected patients

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  • Medical Oncology
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Objectives: The aim of this study was to evaluate the correlation between liver function markers (necrosis and cholestasis) and plasma lopinavir levels in a cohort of HIV-infected patients treated with lopinavir and ritonavir.

Patients and methods: The blood samples for determining steady-state Ctrough lopinavir levels and analysing liver function were drawn from fasting patients. Steady-state Ctrough lopinavir levels, liver function and immuno-virological markers were assessed on the same day. Plasma lopinavir and ritonavir levels were determined by means of high-performance liquid chromatography.

Results: One hundred and forty-nine patients were included in the analysis [57 were HCV co-infected (34%) and 10 were HBV co-infected (6.7%)]; they had been treated with lopinavir/ritonavir for a median of 232 days (range 132–282). All patients received lopinavir/ritonavir [400/100 mg twice daily or 533/133 mg twice daily if amprenavir or a non-nucleoside reverse transcriptase inhibitor (NNRTI) was part of therapy] and concomitant therapy with NRTI(s). Median (interquartile) lopinavir trough levels were 6391 ng/mL (4121–8726), 5662 (3585–8893) and 6819 ng/mL (5324–8726) in the patients with HIV alone and those with HIV/HCV (or HBV) co-infection, respectively (P = not significant). Univariate analysis showed a significant association between the cholestasis markers and Ctrough lopinavir level. Multivariate analysis selected only gamma glutamyltranspeptidase (GGT) (OR = 1.010, 95% CI: 1.002–1.021) as being independently associated with plasma lopinavir levels of >6425 ng/mL; alkaline phosphatase (OR = 1.004, 95% CI: 1.000–1.010; P = 0.08) and total bilirubin (OR = 3.118, 95% CI: 0.980–11.715; P = 0.07) were not associated.

Conclusions: Elevated lopinavir concentrations are associated with raised GGT.

Keywords: pharmacokinetics; drug monitoring; HIV antiviral pharmacology

Journal Article.  2220 words. 

Subjects: Medical Oncology ; Critical Care

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