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1302A AASLD ABSTRACTS HEPATOLOGY, October, 2015<br />

CVC and PGZ exposures were slightly lower when both drugs<br />

were co-administered, with a modest decrease in steady-state<br />

C max<br />

and AUC 0–tau<br />

for both drugs, whereas C min<br />

remained<br />

unchanged; GMRs for both drugs were ≥0.80 (Table). Effects<br />

of co-administration on PGZ M-III and M-IV metabolites were<br />

less pronounced, with 90% CI for systemic exposure ratios<br />

within the 0.80–1.25 ‘no effect’ range for all 3 PK parameters<br />

(data not shown). Combination treatment was well tolerated,<br />

with no serious AEs or AEs leading to discontinuation. All AEs<br />

were of mild severity and the 2 most commonly reported were<br />

headache and fatigue. Conclusions: Co-administration of CVC<br />

and PGZ was well tolerated and resulted in a modest interaction<br />

that was not considered clinically significant, which suggests<br />

that dose adjustment is not required when both drugs are<br />

used in combination.<br />

(62.1%) male, with a mean age of 57.7 years. 54 (47%) had<br />

not ultrasonography signals of NAFLD. Between those with<br />

NAFLD (n=61; 53.1%), 34 (29,6%) had NAFLD grade I, 19<br />

(16,5%) grade II and 8 (7%) grade III. 26 (22.4%) patients<br />

had no signals of CAD on their coronary angiography. In 50<br />

(43.1%), serious injury has found. NAFLD showed correlation<br />

with CAD in 57 (64.04%) patients (p 25kg/m 2 ), and 15 patients with<br />

alcoholic (ASH) cirrhosis. Hemostatic status was assessed by<br />

basal and agonist-induced platelet activation using flow cytometry,<br />

thrombin generation testing, thromboelastography (TEG),<br />

a plasma-based clot lysis assay, and an analysis of fibrin pore<br />

structure by permeation analyses. Results: Basal and agonist-induced<br />

platelet activation were comparable between patients<br />

with NAFLD and controls, but agonist-induced platelet activation<br />

was decreased in patients with cirrhosis. Thrombomodulin-modified<br />

thrombin generation was comparable between<br />

patients and controls, although patients with cirrhosis had a<br />

reduced anticoagulant response to thrombomodulin. TEG test<br />

results were comparable between controls and non-cirrhotic<br />

NAFLD patients, but revealed moderate hypocoagulability<br />

in cirrhosis. Plasma fibrinolytic potential was decreased in<br />

NAFLD, but accelerated fibrinolysis was observed in ASH cirrhosis.<br />

Clot permeability was decreased in overweight controls<br />

and patients with NAFLD. Platelet activity, thrombin generation,<br />

and clot lysis test results showed a higher variability in<br />

patients than in controls, suggesting individual patients may<br />

have a more thrombogenic hemostatic profile. Conclusions: The

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