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Pharmacokinetics of Lopinavir/Ritonavir in HIV/Hepatitis C Virus-Coinfected Subjects With Hepatic Impairment

From Abbott Laboratories, Abbott Park, Illinois (Dr Peng, Ms Causemaker, Ms Li, Dr DaSilva, Dr Brun); Hospital La Paz, HIV Unit, Madrid, Spain (Dr Lorenzo, Dr Arribas); Hospital 12 de Octubre, HIV Unit, Madrid, Spain (Dr Pulido, Dr Cepeda); and Abbott International, Madrid, Spain (Dr Cabanillas).

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 AUC₁₂ were increased 20% to 30% compared to the controls. Hepatic impairment increased unbound lopinavir AUC₁₂ 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 AUC₁₂ and C_max, respectively) than in the mild impairment group (39% and 61% increase in AUC₁₂ 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.

Key Words: Lopinavir/ritonavir • hepatic impairment • HIV/HCV coinfection • pharmacokinetics

Address for reprints: Joanna Z. Peng, PhD, Abbott Laboratories, Clinical Pharmacology & Pharmacometrics (Department R4PK, Building AP13A-3), 100 Abbott Park Road, Abbott Park, IL 60064-6104.

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