title: Glycyrrhizin in patients who failed previous interferon alpha-based therapies: biochemical and histological effects after 52 weeks.
abstract: Chronic hepatitis C patients often fail to respond to interferon-based therapies. This phase III study aimed at confirming the efficacy and safety of glycyrrhizin in interferon + ribavirin-based therapy non-responders. A randomised, double-blind, placebo-controlled, comparison of glycyrrhizin, administered intravenously 5×/or 3×/week, and 5×/week placebo for 12 weeks to 379 patients, was followed by a randomised, open comparison of glycyrrhizin i.v. 5×/versus 3×/week for 40 weeks. Primary endpoints were: (1) the proportion of patients with ≥50% ALT (alanine aminotransferase) reduction after 12 weeks double-blind phase, and (2) the proportion of patients with improvement of necro-inflammation after 52 weeks as compared with baseline. The proportion of patients with ALT reduction ≥50% after 12 weeks was significantly higher with 5×/week glycyrrhizin (28.7%, P < 0.0001) and 3×/week glycyrrhizin (29.0%, P < 0.0001) compared with placebo (7.0%). The proportion of patients with improvement in necro-inflammation after 52 weeks was 44.9% with 5×/week and 46.0% with 3×/week, respectively. Glycyrrhizin exhibited a significantly higher ALT reduction compared to placebo after 12 weeks of therapy and an improvement of necro-inflammation and fibrosis after 52-weeks treatment. Generally, glycyrrhizin treatment was well tolerated.
authors: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany. manns.michael@mh-hannover.de
authors: M P
authors: MP
authors: Manns
authors: H
authors: H
authors: Wedemeyer
authors: A
authors: A
authors: Singer
authors: N
authors: N
authors: Khomutjanskaja
authors: H P
authors: HP
authors: Dienes
authors: T
authors: T
authors: Roskams
authors: R
authors: R
authors: Goldin
authors: U
authors: U
authors: Hehnke
authors: H
authors: H
authors: Inoue
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D019695:Glycyrrhizic Acid / Q000008:administration & dosage* / Q000009:adverse effects*; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D016898:Interferon-alpha; D010919:Placebos; D019695:Glycyrrhizic Acid; D000410:Alanine Transaminase