Limited Sampling Estimates of Epigallocatechin Gallate Exposures in Cirrhotic and Noncirrhotic Patients With Hepatitis C After Single Oral Doses of Green Tea Extract
Year: 2021
Type: article
Study design: Clinical Trial
Abstract: Background: Epigallocatechin-3-gallate (EGCG) has anti-angiogenic, anti-oxidant, and anti-fibrotic properties that may have therapeutic potential in Hepatitis C Virus (HCV) induced cirrhosis. However, cirrhosis may impact 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 cirrhosis Child-Pugh (CP) class A, four CP class B, and three were non-cirrhotic. Following a single oral dose of green tea extract 400mg containing 94% pure EGCG, blood for EGCG was ascertained at 2, 4, and 10 hours. Results: Maximum plasma concentrations (Cmax) and exposures (AUC) to EGCG overlapped among the three groups suggesting that the disposition of EGCG is not significantly altered in patients with cirrhosis. Conclusions: A single 400 mg oral dose of EGCG was safe and well tolerated by all of the subjects 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.
DOI: 10.17615/9f1e-4388
Authors: Ying, Xie, Halegoua-De Marzio, Dina, Hawke, Roy, Daskalakis, Constantine, Navarro, Victor, Kraft, Walter
Institution: University of North Carolina at Chapel Hill
Language: English
Topic: Tea Polyphenols and Effects
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4299298664