title: Limited sampling estimates of epigallocatechin gallate exposures in cirrhotic and noncirrhotic patients with hepatitis C after single oral doses of green tea extract.
abstract: BACKGROUND
  Epigallocatechin-3-gallate (EGCG) has antiangiogenic, antioxidant, and antifibrotic properties that may have therapeutic potential for the treatment of cirrhosis induced by hepatitis C virus (HCV). However, cirrhosis might affect EGCG disposition and augment its reported dose-dependent hepatotoxic potential.
  
  
  OBJECTIVE
  The safety, tolerability, and disposition of a single oral dose of EGCG in cirrhotic patients with HCV were examined in an exploratory fashion.
  
  
  METHODS
  Eleven patients with hepatitis C and detectable viremia were enrolled. Four had Child-Pugh (CP) class A cirrhosis, 4 had Child-Pugh class B cirrhosis, and 3 were noncirrhotic. After a single oral dose of green tea extract 400 mg containing 94% pure EGCG, blood for EGCG levels and safety parameters was ascertained at 2, 4, and 10 hours.
  
  
  RESULTS
  C(max) and AUC to EGCG overlapped among the 3 groups, which suggests that the disposition of EGCG was not significantly altered in these patients with cirrhosis.
  
  
  CONCLUSIONS
  A single 400-mg oral dose of EGCG was safe and well tolerated by all of the patients in the study. These results provide guidance for the continued investigation of the long-term safety and antitumor potential of EGCG in cirrhotic patients with HCV.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania 19107, USA. dina.halegoua-demarzio@jeffersonhospital.org
authors.forename: Dina
authors.initials: D
authors.lastname: Halegoua-De Marzio
authors.forename: Walter K
authors.initials: WK
authors.lastname: Kraft
authors.forename: Constantine
authors.initials: C
authors.lastname: Daskalakis
authors.forename: Xie
authors.initials: X
authors.lastname: Ying
authors.forename: Roy L
authors.initials: RL
authors.lastname: Hawke
authors.forename: Victor J
authors.initials: VJ
authors.lastname: Navarro
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000975:Antioxidants / Q000009:adverse effects* / Q000493:pharmacokinetics; D019540:Area Under Curve; D002392:Catechin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D005260:Female; D005500:Follow-Up Studies; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000188:drug therapy; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy / Q000473:pathology* / Q000821:virology; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000009:adverse effects / Q000493:pharmacokinetics; D013662:Tea / Q000737:chemistry; D013997:Time Factors
chemical_list: D000975:Antioxidants; D010936:Plant Extracts; D013662:Tea; D002392:Catechin; C045651:epigallocatechin gallate