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A phase I single-arm, multicenter pilot study aimed at validating γ-OHPdG as a biomarker and testing the effects of Polyphenon E® on its levels in patients with cirrhosis

Results/Findings:

Liver γ-OHPdG levels were measured using IHC and LC/MS-MS. All prescreened and enrolled participants had IHC scores ranging from 5 to 6 at baseline, which remained in this range following Polyphenon E treatment. LC/MS-MS measures were available for eight participants, seven of whom had paired baseline and end-of-treatment data. Baseline γ-OHPdG ranged from 3 to 30 γ-OHPdG adducts per 109 deoxynucleotides. Six participants showed a decline in the liver γ-OHPdG adduct number after 6 months of Polyphenon E treatment (P value ¼ 0.2). The average liver γ-OHPdG decreased from 13 (n ¼ 3) to 6.3 (n ¼ 2) γ-OHPdG per 109 deoxynucleotides in DC 1 and from 13 to 5 γ-OHPdG per 109 deoxynucleotides in DC 3 (n ¼ 2); liver γ-OHPdG decreased from 7 to 5.5 γ-OHPdG per 109 deoxynucleotides in DC 4 (n ¼ 1). In DC 2 (n ¼ 2), γ-OHPdG increased from 17 to 36 per 109 deoxynucleotides for one participant and decreased from 10.5 to 8 per 109 deoxynucleotides for another participant. Plasma and urine PK data for EGC were available for the five participants enrolled at GUH. Baseline plasma EGC levels differed between participants. The pattern of change in serum plasma levels of EGC was similar across DCs 1, 2, and 3. After oral administration, plasma EGC levels increased toward a peak over 1.25 to 3.5 hours, declining rapidly with levels decreasing to close to baseline 8 hours after dosing. However, one participant in DC 4 showed increasing plasma EGC levels during the 8- hour PK analysis, with the highest levels detected 8 hours after dosing. Baseline urine EGC levels were 0 in four of five participants. After oral administration, urine EGC levels increased toward a peak from 1.25 to 3.5 hours and then declined rapidly. The levels were still higher than baseline at 8 hours after dosing.

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