肝损伤患者的ETV用量无须调整(11.4 AASLD)

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Entecavir May Be Administered to Patients with Hepatic Impairment without Dose Adjustment Summary statistics for pharmacokinetic (PK) parameters are listed below. Pharmacokinetic ParameterChild-Pugh

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Statistical analysis showed that both Cmax and AUC(INF) were unaffected by hepatic impairment. The point estimates (90% Confidence Intervals) for the hepatic impairment to healthy Cmax ratio and AUC(INF) ratio were 1.036 (0.942, 1.139) and 0.928 (0.813, 1.059), respectively, and were both well within the pre-specified no effect interval (0.67-1.50). Other entecavir (ETV) PK parameters in subjects with hepatic impairment were comparable to those of healthy subjects. ETV administered as a single 1.0 mg oral dose was safe and well tolerated in healthy subjects and in subjects with moderate to severe hepatic impairment. Conclusions The authors conclude, ?ETV exposure was not significantly altered in subjects with moderate to severe hepatic impairment when compared to healthy subjects. ETV may be administered to patients with hepatic impairment without dose adjustment.?/span> 11/05/04 Reference M Bifano and others. HEPATIC IMPAIRMENT DOES NOT ALTER SINGLE-DOSE PHARMACOKINETICS AND SAFETY OF ENTECAVIR. Abstract 1149 (poster). 55th AASLD.

[此贴子已经被作者于2004-11-5 17:49:30编辑过]