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Pharmacokinetics of the New Hepatitis C Virus NS3 Protease Inhibitor Narlaprevir following Single-Dose Use with or without Ritonavir in Patients with Liver Cirrhosis

V. Isakov, D. Koloda, N. Tikhonova, T. Kikalishvili, E. Krasavina, K. Lekishvili, I. Malaya, M. Ryska, M. Samsonov, V. Tolkacheva,

. 2016 ; 60 (12) : 7098-7104. [pub] 20161121

Jazyk angličtina Země Spojené státy americké

Typ dokumentu klinické zkoušky, fáze I, klinické zkoušky kontrolované, časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc17031425
E-zdroje Online Plný text

NLK Free Medical Journals od 1972 do Před 6 měsíci
Freely Accessible Science Journals od 1995 do Před 6 měsíci
PubMed Central od 1972 do Před 6 měsíci
Europe PubMed Central od 1972 do Před 6 měsíci
Open Access Digital Library od 1972-01-01
Open Access Digital Library od 1972-01-01

Odkazy

PubMed 27645244
DOI 10.1128/aac.01044-16
Knihovny.cz E-zdroje

In this study we sought to evaluate narlaprevir (NVR) pharmacokinetics (PK) after a single dose with or without ritonavir (RTV) in cirrhotic versus healthy subjects. NVR at 200 mg was administered to 8 healthy and 8 cirrhotic subjects, and NVR at 100 mg with RTV at 100 mg was administered to 8 healthy and 8 cirrhotic subjects. PK analysis was performed. The geometric mean maximum concentration of a drug in serum (Cmax) and the area under the concentration-time curve from 0 to infinity (AUC0-∞) were 563.1 ng/ml and 4,701.8 ng · h/ml in cirrhotic patients versus 364.8 ng/ml and 1,917.1 ng · h/ml in healthy volunteers, respectively. The geometric mean ratios of the PK parameters of cirrhotic subjects to healthy volunteers were 1.54-fold (90% confidence interval [CI] = 1.05 to 2.27) for Cmax and 2.45-fold (90% CI = 1.56 to 3.85) for AUC0-∞ The geometric mean Cmax and AUC0-∞ in cirrhotic and healthy subjects were similar: 1,225.7 ng/ml for Cmax and 15,213.1 ng · h/ml for AUC0-∞ in cirrhotic subjects and 1,178.9 ng/ml for Cmax and 14,257.2 ng · h/ml for AUC0-∞ in healthy volunteers. The corresponding geometric mean ratios were 1.04 (90% CI = 0.67 to 1.62) for Cmax and 1.07 (90% CI = 0.72 to 1.58) for AUC0-∞ Higher exposures in cirrhotic subjects were safe and well tolerated. We found that NVR exposures after a 200-mg single dose were higher in cirrhotic subjects than in healthy subjects and that a 100-mg single dose of NVR boosted with RTV at 100 mg resulted in no significant PK differences between cirrhotic and healthy subjects.

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