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Pharmacokinetics of Lopinavir/Ritonavir in HIV/Hepatitis C Virus–Coinfected Subjects With Hepatic Impairment
Author(s) -
Peng Joanna Z.,
Pulido Federico,
Causemaker Sonja J. Kemmis,
Li Jianling,
Lorenzo Alicia,
Cepeda Concepción,
Cabanillas Juan A. García,
DaSilva Barbara,
Brun Scott C.,
Arribas José
Publication year - 2006
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270005284853
Subject(s) - lopinavir , ritonavir , lopinavir/ritonavir , pharmacokinetics , cmax , medicine , pharmacology , hepatitis c virus , gastroenterology , human immunodeficiency virus (hiv) , virology , virus , viral load , antiretroviral therapy
The effect of hepatic impairment on lopinavir/ritonavir pharmacokinetics was investigated. Twenty‐four HIV‐1‐infected subjects received lopinavir 400 mg/ritonavir 100 mg twice daily prior to and during the study: 6 each with mild or moderate hepatic impairment (and hepatitis C virus coinfected) and 12 with normal hepatic function. Mild and moderate hepatic impairment showed similar effects on lopinavir pharmacokinetics. When the 2 hepatic impairment groups were combined, lopinavir C max and AUC 12 were increased 20% to 30% compared to the controls. Hepatic impairment increased unbound lopinavir AUC 12 by 68% and C max by 56%. The effect of hepatic impairment on low‐dose ritonavir pharmacokinetics was more pronounced in the moderate impairment group (181% and 221% increase in AUC 12 and C max , respectively) than in the mild impairment group (39% and 61% increase in AUC 12 and C max , respectively). While lopinavir/ritonavir dose reduction is not recommended in subjects with mild or moderate hepatic impairment, caution should be exercised in this population.